Express Pharma December 2017

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International
standarts:

 FDA compliant
 ISO2000-9001
 ISO14001
 OHSAS18001
 ISO15378
 HACCP

Aluminum Tubes

Since 1967, LAGEENTUBES has been offering tailor-made,
cutting edge aluminum packaging tube solutions for the leading
pharmaceutical companies in over 30 countries across the globe.

As a western best quality aluminum tubes manufacturer,
LAGEENTUBES caters to the Indian pharmaceutical up-market
industry who seeks to grow their business in the western world.

Our aluminum tubes are produced through an impact extrusion
process, and include application of internal and external lacquers,
decorations & capping.

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Salient Features

Please Contact: Mr. Sandip Lagad 9665388555 Mr. Rajkumar Hange 9890002120

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TECHNIC PHARMA EQUIPMENTS

Mfg. of: Pharmaceuticals, Food, Cosmetic & Chemicals Machinery

Liquid - Syrup Zero Hold Up
Manufacturing Plant Filter Press

Rapid Mixer Fluid Bed Dryers
Granulator

Double Cone Blender

Mass Mixer Automatic Ointment
Manufacturing Plant

Coating Pan Starch Paste Kettle Tray Dryer

Octagonal Blender

CONTACT : Fact.: Gala No. 16, Building, No. B-11, Sagar Industrial Estate, Dhumal Nagar, Waliv, Vasai (E), Dist. Palghar-401208.
Raj Yadav : 07798007538, 08888911581 Mohan Sahani : 09730252310, 08080802767

Email: [email protected], [email protected] Visit us: www.technicpharmaequipments.com

PMBE2SOC8tMatIhnnBd-Ad3VYNi0aiosEtiex:hthDxuNih6sbo6iaivbt,teiiHomtnaioblClneNern2o2t0:0r6e1177 Pride in Every action Agency Division
Bectochem Consultants
To widen our offerings and horizons through innovation & technology, we have extended our hands for and Engineers Pvt. Ltd.
Technical Collaboration for mutual benefits to enable us spearhead in Turnkey, Single window Solution
to Customers. We are associated with companies like - Loedige GmbH, Fitzpatrick USA, MPE USA, CSP
ireland, RML Engineerinf, New Zealand.

CONTAINED CHILSONATOR SYSTEM CCS Series Roll Compactor
Also, Suitable for product which need process Isolation/ Containment

Contained Chilsonator System CCS 1025 Model Modern Process Equipment FitzPatricks, USA,
• Sealed technical area (MPE), USA - Chainvey Contained Chilsonator System (CSS)
• "Free-Standing" or "In-Wall" Installation
A Traditional of innovation in Particle Forming • Integrated roll process housing and milling GL Filtration Limited - World Leader Industrial & Chemical
Technology for Pharmaceuticals, API, Food & system minimizes headroom requirement in Solid- Liquid Seperation Compactor
Cosmetics • Utilities enter technical area from the back of
machine Efficient Agitator System Metal Detector Contained Tablet Press
Contained Chilsonator System CCS 220 Lab • Ease of disassembly is considered in the design of from Viscojet, Germany and Separator
Model ALL components
Ideal for R&D, Pilot plant and Small • Wash-In-Place (WIP) option Bectochem Consultants and Engineers Pvt. Ltd.
• Ultimate GMP and Process flexibility • Automated controls allow ALL adjustments to be Building 5C/204, Mittal Estate, Andheri-Kurla Road.
• Wide range of capacities from 50 grams to 20 made from the control panel Andheri(E), Mumbai-400059, India
• Fully instrumented with convenient display and Tel: (91) 22-39277900/ 28500008/ 657018999
kgs/hr logging of variables Fax: (91) 22-28506785
• Fully instrumented with automated controls • 21 CFR part 11 complaint capable Email: [email protected] Website:www.bectochem.com
• Scales up to larger roll compaction • Multiple layers of password
• Low profiles/minimal headroom required security Advantages of the
• Process flexibility with Various- Product Containment System
Roll Surfaces, Size reduction Rotor • Minimal product exposure to
• Automated Controls for Consistent Product operator and environment
• Prevents product
contamination
• Minimal product loss

"Why PASS Number of times it's possible in One PASS"
Exploit the Fitz Experience

168 December 1-15, 2017 EXPRESS PHARMA

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CIN: U51503MH2001PTC132921

V1, June 2017

EXPRESS PHARMA December 1-15, 2017 169

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ISO 9001 - 2015 Certified

Photon Cleantech Inc.

Manufacturer and Supplier of Cleanroom Turnkey Projects & Cleanroom Equipments

Ceiling Suspended LAF Lupin Modular Operation Dispensing Booth Air Shower Bio Safty Cabinet

Cleanroom Panel Doors PB Lupin Garment Cabinet
CERTIFIED
Fore more info contact:
ISO 9001:2015
Photon Cleantech Inc.
EXPRESS PHARMA
Survey No. 106 A/3, Office No. A-6, Surya Lok Nagari, Pune - 411028, India.
Mobile: +91 880506011l1 / Email: [email protected] / Website: www.photoncleantech.com

170 December 1-15, 2017

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OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India
Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: [email protected] Web: www.rosalina.in

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Wiper Type Sight Glass DIN 100 Light Glass LED

Swastik Associates

Shed No. 1, 2 & 3, Sr. No. 30/7,
Behind Dran Company,
Dhayari-Pune 411041
Phone : 020 24690268 / 24690041,

9923124949 / 9028716622,
9028716222
Email : [email protected]
[email protected]

Our other product details Sight Glass Flange with LED LED Bush
u SS Fittings
u SS Valves Manual & Pneumatic 4W / 15W / 20W / 24W
u SS Filters Manhole Elliptical
u SS Pumps: Centrifugal, Self

Priming & Shear Pump
u SS Powder Blender
u SS Steam & Water Mixing Station
u Drain Trap

Manhole Round Dia 450 Manhole Pressure Type

YOUR PARTNERS FOR
STERILE FLUID TRANSFER

174 December 1-15, 2017 Contact Details:
Wadala Shree Ram Indl. Estate, Unit No. C-32, 3rd Floor, G. D. Ambekar Marg,

Wadala, Mumbai - 400 031, Maharashtra India.
Phone: +91 22 4356 0400 Fax: +91 22 4356 0425 Email: [email protected]

www.shahbros.com

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Pharmaceutical Applications

NASAL ORAL TOPICAL

The One Point Source for Tamper Evident Sprayers

IVTEC, PUNE. FEATURES u
u Tamper Evident
Complete Solution To Pharma Business u Sterilizable u Tablet Applicators
u Accurate dosage delivery u Cream Applicators
Services Offered: u Available in different dosages u Tablet Containers

• Gap Analysis as per Different GMP guidelines SANTAPET POLYMERS LIMITED
• GMP Audit Services for API Facilities,
Office: 8 Sheriff Devji Street, 1st Floor, Mumbai - 400 003. India
Vendors and Plants Tel.: +91-22-23420381 l 66151691 Fax: +91-22-23441578
• GMP Trainings for Pharma companies
Email: [email protected] l Website: www.santapetpolymers.com
and Pharma students
• GMP and GLP Quality Documentations
• Qualifications and Validations services
• ISO 9001:2015 Certification with Documentation
• Due diligence for Acquisitions
• Productivity Improvement
• Cost Reduction
• Microbiological / Biological Tests & Validations

Email id: [email protected]

176 December 1-15, 2017 EXPRESS PHARMA

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KILITCH
HEALTHCARE INDIA LTD.

Avoid the India’s first ever
Preservative Free
Harmful
Ophthalmic
Side Effects of Manufacturing Facility
Preservatives

Widely accepted
by Ophthalmologist

Patented
Pure Flow
Technology

EXPRESS PHARMA For contract manufacturing contact:
Kilitch Healthcare India Ltd.
902/B Godrej Colesium,
Behind Everad Nagar,
Near Priyadarshani Cirlce,
Sion (East), Mumbai – 400022.
Tel. : 022 6137 2222
Mr. Divya Mehta : +91 9819724957
www.kilitchhealthcare.com
[email protected]

December 1-15, 2017 177

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® Laboratory Glass Syringes

Chromatography Consumables GLASS SYRINGES

CERTIFIED VIALS, CAPS, SEPTAS • 0.25ml,0.5ml,1ml, 2ml, 3ml, 5ml,
10ml,20ml, 30ml, 50ml & 100ml
New
Metal Luer Lock Tip Metal Luer Slip Tip

Glass Luer Slip Tip

CONTROL GLASS SYRINGE
• 2ml, 5ml & 10ml
• 3 Ring offers better grip

while use in Laboratory
especially for Filteration

High Recovery FILLING MACHINE SYRINGES
Storage Vial
• 2ml, 5ml,10ml, 20ml, 30ml,50ml
Range:
• HPLC Vials (1.5ml / 1.8ml / 2ml) - 9mm, & 100ml
3/8 UNF Thread
8-425, 11mm (crimp & snap)
• 4ml - 13mm Wide Mouth Glass Tip Tip
• GC Vial, 20mm - 10ml / 20ml
• Vial Inserts, Shell Vials 1/4 UNF Thread Tip Open Barrel
• EPA Vials - 20ml - 60ml
• Storage Vials 2ml -60ml PRESSURE LABORATORY
GLASS SYRINGE (PLS Syringe)
GAS TIGHT SYRINGES
• 2ml, 5ml,10ml, 20ml, 30ml, 50ml & 100ml
• 5ML,10ML, & 25ML • Tested upto 43.50 PSI
• Gas chromatography • Very Smooth (Loss of Resistance)
• Zero Dead Volume for • Graduation starting from 0.02ml

Syringe pumps SELF REFILLING SYRINGE
• 60 mm Stroke
• 0.5ml, 1ml, 2ml & 5ml
Glass Tip Teflon luer lock • Repititive Dispensing

Fixed Needle 3/8 UNF Of Preset Volumes
Thread Nut • Feed Tube Set, Vial

Holder Set
• Fully Autoclavable

• SS Piston, Glass Barrel, No O-ring

REUSABLE MICRO
NEEDLES CAPILLARIES
• TLC,ETE,etc.

(Manufactorer & Exporters Since 1964)

Top Syringe Compound, W.E. Highway, Pandurang Wadi, Mira Road (East), Thane 401 104. INDIA
Tel: +91 9769175036 Email id: [email protected] Website: www.top-syringe.com

www.kesarcontrol.com

www.kesarcontrol.com

www.kesarcontrol.com

Humidity Chamber Cold Chamber

178 December 1-15, 2017 Service Network all over INDIA

Mfg. Unit : B/8, Karma Industrial Estate, Nr. Trikampura Patiya, Vatva,
Ahmedabad - 382445. Gujarat, INDIA. Tele : 079 - 25890727
Mobile : 09427613646 Email : [email protected]

EXPRESS PHARMA

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No. 1, Ravi Prakash, Nagwekar Marg, December 1-15, 2017 179
Prabhadevi, Mumbai 400 025. INDIA
Tel: +91 22 2422 8562 / 1849,
Fax: +91 22 2422 1849
Email: [email protected] / [email protected]
Website: www.diecraftmachines.com

EXPRESS PHARMA

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Experiment With The Truth

Certified ISO 9001: 2008

A BENCHMARK FOR

QUALITY SOLUTIONS

STABILITY CHAMBER

WALK-IN STABILITY CHAMBER AUTOCLAVE-WINGNUT

PRODUCT RANGE

l Autoclave l Muffle Furnace B.O.D INCUBATOR
l BOD Incubator l Photo Stability Chamber
l Bacteriological Incubator l Pharma Refrigerator oswwowrclowdmi.ndia.
l Cooling Incubator l Stability Chamber
l Deep Freezer l Vacuum Oven
l Hot Air Oven l Walk-in Stability Chamber

Osworld Scientific Equipments Pvt. Ltd.

B-44, New Empire Industrial Premises, Kondivita, J. B. Nagar,
Andheri (East), Mumbai - 400 059. India
Tel.: +91-22-28320880 / 28390487 E-mail: [email protected]

Goggles & Writing Accessories For Cleanroom

u Cleanroom Paper & Pad (Autoclavable) To Advertise in
u Sterile Pen & Marker
u S S Writing Pad & S S Pen With Chain Business Avenues
u Cleanroom Vinyl Sterile Tape 1/2”, 1” & 2”
Please Contact:
NBoAiownctlAie-vfaoangilLaVabeulrensc-iohn u Clear view Autoclavable Panoramic ■ Mumbai: Rajesh Bhatkal

u Thermoplastic rubber Body Goggles With BCAP 09821313017
40 Autoclave Cycles ■ Ahmedabad: Nirav Mistry

Can Be Worn Over Eyeglass With Grid For 09586424033
Marking Autoclaving Goggles ■ Delhi: Ambuj Kumar

u Cleaview 09999070900
■ Chennai ■ Bangalore:
Autoclavable Goggles u Grid For Marking
BCAG With 40 Autoclave With Autoclaving Kailash Purohit
+91 9552537922
Grid For Marking ■ Hyderabad: Mujahid
09849039936
Autoclaving Goggles Grid ■ Kolkata: Ajanta

11X14EPAd02June Enterprises Pvt. Ltd. l www.june4gmp.com 09831182580
[email protected] l 9930359528
EXPRESS PHARMA
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28-30 Nov 2017, BEC, Mumbai
Visit us : Booth No.: N52, Hall No.: 5

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Federation of Pharma Entrepreneurs The Council of EU Chambers
HELIOS CONCREW of Commerce in India

PVT. LTD. EXPRESS PHARMA

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Philosophy

Engineered--to--Order

"Together Thinking Enginering Out Of The Box"

SINGLE POINT PROCESS ENGINEERING SOLUTION

DESCRIPTION:

ACE MILL (INTEGRATED SYSTEM)

We have experienced that your entire process problem
comes from use of a Multimill in Pharmaceutical API &
Bulk drug industries. Old Multimill were not complying
cGMP and any other pharma standards.

A Pharmaceutical Powder Pulverizer (innovative
conceptual design) is really another kind of
technology, extremely sophisticated. which will meet ,
FDA, USFDA, FDA 21 CFR Part 11 standards.

This Ace Mill will give proven ideas to involves AIR PERMEABLE DUST RETAINER
re-defining the internal Geometry to achieve a perfect
milling without dusting in production area with Using a dust retainer to connect the mill discharge to the
maximum through put. product container will contain the material being processed
and vent the process air created by the rotor.
FEED VESSEL WITH SCREW
SCOPE OF SUPPLY :
The feed rate to the mill is an important factor to
determine PSD (Particle Size Distribution) & output, ► Powder Pulverizing (Milling) unit.
the result is depends upon residence time in the ► Feedvesselwith Screw feeder.(Volumetric)
milling chamber, the feeder is an important tool in ► Powder collection portable vessel.
controlling residence time. ► Specially designed Cyclone Separator with air flushing

However, as with any process, the product flow & it's arrangement.
characteristics will often determine the best feed ► Exhaust Blower.
method. ► Control Panel for system.
► Can be supplied Scrubber.
FEED RATE ► Gravity material feed unit with load cell weighing

As with all feeders, this rate range is dependent upon arrangement can be provided.
the type of screw configuration chosen as well as the
drive type and available turn down ratio. INNOVATIVE PROCESS EQUIPMENT:

VARIABLE FEED SCREW (VFS) SYSTEM ► Ace Airo-Jet Micronizer- Size 1 to 36 inch
► Ace Fluid Bed Dryer- Cap 2 kg to 800 kg.
Overfeeding can cause unpredictable results starving ► Ace Fluid Bed Coater/Processor- Cap 1 kg to 200 kg
can produce a wider-than-desired range of particle ► Ace Comills for Dry and Wet Milling Application
sizes. The ACE-Mill can be built with a (VFS) option to ► Trial Equipment is available.
assure precisely controlled feed rate. A variable feed
screw (VFS) helps minimize waste, eliminates operator
variables, and achieves particle uniformity.

Plot No.36, “Shramsafalya” Bungalow,Veer Savarkar Nagar, ASSOCIATES:
Thane (W)-400606,Maharashtra, INDIA.
E mail:[email protected]/ [email protected] Mr.S. D. Botre/ Mr.Sameer Kotwal
Mr.S. D. Botre(Technical Director ), Ms Jhanvi. Botre(CEO) Mobile:+91-9820103114/09320413888
Mobile: +91 -98201 03114 / 9167122060 / 9167122709 [email protected]/ [email protected]

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OF COMMITMENT &25 YEARSSUPPORT

Anniversary

www.chromline.in

Eurospher I – HPLC columns
Analytical, Semi Prep & Prep

K-7400S Semi-Micro Osmometer AZURA Analytical HPLC Azura Compact Bio-LC AZURA FPLC

Spare Parts and Accessories Win GPC Unichrom Software GPC/SEC Columns

Reference Materials

PSS Reference Materials with
Spare Parts and Accessories

HPTLC - Applicator AS30 Auto Sampler BS35 Automated AS30 & BS35

HPTLC Densitometr CD 60

Simultaneous Thermal Analyzer (STA) Biostep PC based Automated Reagent Sprayer Biostep HPTLC Photo documentation
Model Chromajet DS 20 System model DD 70

For further details contact Exclusive Distributor:

CHROMLINE EQUIPMENT COMPANY

Unit No. 17, Udyog Bhavan, Sonawala Road, Goregaon (East), Mumbai 400 063, India.

Tel.: 022 2686 0816 / 61887317 Website: www.chromline.in E-mail: [email protected]

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CPhI & P-MEC INDIA 2017 SPECIAL

Biopharmax: Enable operational excellence

and competitive advantage

Atul Pabalkar, Sr GM Engineering and Projects, extends the views expressed by the CEO
Biopuremax Shlomo Sackstein about holistic measures which should be taken to ensure that all
system function as one entity

MORE AND more businesses tomisation to client needs ◗ In many cases, the client re- before sanitisation. costs of: maintenance, new
these days are beginning to un- quests to repair or replace a parts and much more reliable
derstand the importance of ho- Biopharmax Water System specific component that cre- Why is this not good than all the other solutions in
listic approach, or in other ates a bottle-neck only result- enough? the market.
words, total system analysis. ◗ The development of ing in a new bottle-neck in a dif-
Especially in complex systems Biopuremax process is a per- ferent part of the system. ◗ Inefficient commonly used I identified the
such as pharmaceutical manu- fect example of holistic ap- ◗ Therefore, it is crucial to find water purification systems cre- bottle-neck, now I can
facturing facilities, looking at proach the root of the problem and ate microbial build up and mi- solve the problem
the big picture and knowing ◗ Rather than accepting the look at the system as a whole, croorganism proliferation in
that all the systems have to current drawbacks of water often improving the entire softeners. These microbes Not necessarily. Solving one
function as one entity, is crucial purification systems, the for- process and saving costs of fu- were fed directly to the reverse bottleneck can create a new
for success. Biopharmax has mer CEO of Biopharmax in- ture maintenance and repairs. osmosis membranes and bottleneck.
had this approach from the vented a first-of-its-kind solu- caused surface contamination
start, insisting on a turnkey tion which includes an ESR Constant maintenance, is and fouling of those mem- Existing state and client
method, focussing on the way (Electrolytic Scale Reducer) it really inevitable? branes with impact on product reported problem
all the system components in- and a HOD (Hydro Optic De- water and operational parame-
terrelate and how they work Chlorination), which in combi- It can be avoided! ters. ◗ Distillation process for hot
within the context of the larger nation, maximise all water per- A client owning an existing ◗ As a result, constant mainte- WFI production, storing the
system. formance criteria: high nance was required, having to water at 90OC and cooling it
reliability, low maintenance, vaccination production facility stop the system for rigorous before use. Water cooling
Holistic approach low bacteria, low operational has contacted Biopharmax re- cleaning and possibly having to process is too slow, creating a
costs, no regenerations, no porting unreliable final prod- replace the system compo- holdup in the production
◗ Viewing and treating a com- chemicals, no organic media. uct. nents at some point. schedule.
plex systems as one entity. ◗ Resulting in substantial low
◗ Looking at the big picture, life cycle costs and low environ- Identified problem Solution offered What is the real
considering the entire process mental foot print. problem?
rather than specific compo- Even though the final product ◗ Holistic view of the problem,
nents Thinking 'outside of the Open-minded clients seems to be clean according looking at the big picture and 1. After analysing the system as
box,' not being afraid to make to standards, the reality was identifying the true problem: a whole, it was identified that:
substantial changes ◗ It is not enough for the con- that the entire process was contamination throughout the ◗ Heat exchanger are too small
◗ Develop entirely new mind- tractor to have an holistic ap- contaminated. Only thanks to entire process. ◗ 93 per cent of WFI is used
sets and solutions to problems proach, as few clients are able the RO, the final product was ◗ Biopuremax system, includ- cold
◗ Dramatic improvements to to approach a problem 'open clean enough. There was a ing ESR and HOD ◗ In addition to insufficient
take optimise functionality minded' bacterial breakthrough and ◗ The solution is proven to save cooling capacity, the WFI stor-
◗ Making sure the system the system was taken off line age tank was always at critical
reaches its full potential as a low level.
whole, rather than having
strong areas and weak areas Options for solution?

Turnkey projects Increasing the size of the cool-
ing system – will solve the
◗ One of the biggest advantages cooling bottleneck, but will
of turnkey projects is being come up against a new bottle
able to integrate subsystems neck in production capacity
into the total system because of low levels of WFI in
◗ Old fashioned way: Execute the tank.
each part of the project sepa-
rately, which limits the options Recommended solution:
needed to optimise the system Split the WFI system into hot
as a whole and cold systems. The existing
◗ Turnkey: Streamlines the en- system will continue to supply
tire process of fitting all the the hot consumers, and a new
components together for ideal cold generation with cold stor-
integration age will supply the cold users.
◗ Responsibility for project suc- In this way, energy savings are
cess by meeting present crite- maximised, no new cooling or
rion heating utilities are needed,
◗ Allows flexibility and cus- and the system pays itself back
with a year due to infrastruc-
ture and ongoing energy
savings.

190 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

CCIT(Container Closure IntegrityTesting)
& HGA(Headspace GasAnalysis) methods

METHODS FOR detecting holes in the tray or lid materi- manually deblistered and in- integrity packaging before the (>30 µm). The system is uses
leaks in blister packaging and als, faulty seals and channel spected for dye ingress. This start of clinical trials. This en- qualified thresholds which al-
analysing headspace gas in leaks between pockets. technique has two main prob- sures that laboratories and lows the detection of faulty
ampoules and vials have tradi- lems; it is subjective as it relies R&D departments can rule out packs without operator sub-
tionally involved a destructive Destructive vs non- on operator judgment and it is the variable of package in- jectivity. The system does not
and non-deterministic process. destructive testing destructive to the blister pack- tegrity during a study. require dedicated tooling for
However, non-destructive and aging and product as all blis- each pack type and allows
deterministic methods, which The current industry standard ters need to be destroyed after Sepha VisionScan multiple packs to be tested in a
do not result in wasted prod- for testing blister pack in- testing in blue dye water. single test cycle.
ucts, have emerged as viable tegrity is non-deterministic The Sepha VisionScan is a
alternatives. Bonfiglioli Engi- blue dye testing, which con- Sepha have developed a tool-less, non-destructive leak Headspace gas analysis
neering and Sepha, both part sists of placing a selection of number of technologies which detection device developed for systems for parenteral
of TasiTest, are leading spe- packs into blue dye water, sub- are deterministic and non-de- testing pharmaceutical blister manufacturing processes
cialists in these packaging leak
test and inspection solutions. jecting the packs to a vacuum structive in the evaluation of packs. It measures pack de- Headspace content verification
Between them, Sepha and of typically 400-600mBar for package integrity, enabling all flection using camera and pro- is a solution to ensure par-
Bonfiglioli have developed a several minutes and then re- defect free packs to be re- jection technology in response enteral product stability and
number of innovative deter- moving the vacuum, which al- turned to the production to an applied vacuum. Images sterility maintenance. In-
ministic and non-destructive lows any defective pockets to process. Sepha’s technology of the pack surface before and tegrity defects as well as fail-
solutions for pharmaceutical take up the dye. The packs are also enables companies to test after the application of two ures in the aseptic manufac-
container closure integrity re- vacuum levels are compared. turing process, including
quirements. The lidding material of a good unexpected variability in the
pack will deform when a vac- nitrogen flushing or vacuum
Blister pack leak testing uum is applied due to differ- application, pose a risk to
ences in pressure between the product quality and patient
Demonstrating the integrity of pocket interior and the applied safety.
pharmaceutical blister packs vacuum. Any defect will allow
is critically important, any de- this pressure differential to Monitoring the mainte-
fects can affect the shelf life equalize and change the way in nance of container headspace
and efficacy of the contents. In which the pack deflects when conditions is needed for sterile
addition, it is also an FDA re- the vacuum is applied. drugs such as oxygen sensitive
quirement as specified in cur- liquid products and lyophilised
rent Good Manufacturing The Sepha VisionScan or powdered products; any
Practice (cGMP) 21 CFR generates accurate, reliable modification in the headspace
211.166 for finished pharmaceu- and repeatable results with pressure, moisture or oxygen
ticals. clear pass or fail information. level may result in the degra-
It can detect defects in indi- dation of the active drug, like-
Ensuring a robust, objec- vidual blister pockets, channel wise in the reduction of drug
tive and repeatable process leaks and weak seals equiva- potency and product shelf life.
(deterministic) for leak testing lent to a 7µm laser drilled pin
is key to proving product sta- hole. It has a rapid test time Specific requirements for
bility and reducing the risk of down to 10 seconds for micron sterile drugs packaged under
product recalls or contamina- holes (<30µm) and as low as full or partial vacuum are cov-
tion, in addition to preventing six seconds for gross holes ered by EU GMP Annex 1
a reduction in drug efficacy. 'Manufacture of Sterile Medi-
cinal Products,' section 123:
Blister packs typically are “Containers sealed under vac-
composed of a thermoformed uum should be tested for main-
polymer or cold formed alu- tenance of that vacuum after
minum tray, with a number of an appropriate, pre-deter-
individual pockets to hold the mined period.”
product. After the tablets or
capsules are placed in the In addition to that, new reg-
pockets, the packs are heat ulations are expected to enter
sealed with a paper or foil lam- into force and are to include
inate sheet. During these pro- measures to demonstrate the
duction stages, there is a risk maintenance of sterility over
of microbial containment or time for drug products into
degradation of the products if controlled headspace gas pack-
any defects are present in the aging. In particular the pro-
packaging. Such defects can posed revision of USP <1207>
take the form of rips or pin- 'Sterile Product – Package In-
tegrity Evaluation“ is expected

To subscribe: [email protected] EXPRESS PHARMA 191

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

to provide clearer guidance for the headspace critical gas con- cant advantages over other ex- finished containers and of the sure integrity in pharmaceuti-
headspace critical content ver- tent. Most of the headspace isting system including the cal finished containers.
ification through the entire gas measurement methods Bonfig LaserCube. maintenance of the proper
product life cycle, from stabil- available on the market are de- The Bonfig LaserCube is a
ity studies to commercial pro- structive, therefore they are Bonfig LaserCube headspace conditions for prod- compact and lightweight sys-
duction stage. generally performed on sam- tem that is easy to use and set
ples, at regular intervals, dur- The Bonfig LaserCube is a ucts packaged under modified up via an integrated PC or any
Destructive vs non- ing the production cycle. The benchtop system that uses a wireless touchscreen tablet. It
destructive Headspace main disadvantage of these de- non-destructive and non-inva- atmosphere or under vacuum. is suitable for inspection of a
Gas Analysis structive approaches arises sive laser-based inspection wide range of different sized
when out of specification con- technology for measuring the The HGA inspection glass containers including
Even with a well-defined manu- ditions are detected and the level of gases including oxygen, vials, ampoules, bottles and
facturing process in places, it entire batch is to be rejected. moisture content and absolute process is based on the Tun- pre-filled syringes.
is still almost impossible to pressure in the headspace of
keep up with regulatory and Bonfiglioli Engineering has sterile pharmaceutical con- able Diode Laser Absorption ACE technologies is an offi-
quality requirements without developed different innovative, tainers. It is mainly focussed cial representative of Tasitest
a system ensuring a reliable non-destructive solutions in on the inspection of the closure Spectroscopy (TDLAS) in India.
and repeatable monitoring of the field of HGA with signifi- integrity of pharmaceutical Contact details
method which uses a laser [email protected]

beam to detect the target mole-

cules within container head

space, ideal for the accurate in-

spection of translucent con-

tainers, head space conditions

for products packaged under

modified atmosphere and clo-

Clean room high speed doors a necessity ing of door is quick enough to
separate outside environment
DOES YOUR business plan and internal facility.
include the development of an
area in your plant for clean High speed clean room
manufacturing? doors designed by Gandhi
automation are engineered
Better quality or better carefully with feature
yield is the primary reason for below:-
investing in a cleanroom ◗ Concept of low air perme-
space. It goes straight to your ability in pressurised rooms
bottom line. Numerous manu- with positive and negative air
facturing facilities now require pressure
a controlled environment in ◗ Designed to fit inside the
which you limit the amount of columns
dust and dirt in the area of the ◗ Self-supporting construc-
manufacturing. Medical in- tion
strument manufacturing and ◗ Minimises air leakage
packaging, electronics and ◗ Can be equipped with trans-
computer manufacturing, food parent PVC horizontal sec-
preparation and some military tions or vision windows
applications are but a few of ◗ Special side guides to tightly
the instances that have strict integrate the curtain
requirements for maintaining ◗ High leak tightness due to
a clean environment. Clean the close filling curtain in the
rooms have become integral guide rails
part of pharma manufacturing ◗ High door efficiency with
facilities. and low permeability values,
EN 12426 EN 12427: < 12
One of the most important m3/m2 h Δ 50 PA.
aspects of cleanrooms are the ◗ Control device enclosure in
doors chosen for cleanroom fa- Stainless Steel SS 316
cility. Time for which door is
open will play a critical factor in Contact details
avoiding dust, outside tempera- Gandhi Automations
ture, humidity etc. Opening and Chawda Commercial Centre
closure of door has to quick Link Road, Malad (W) Mum-
enough to isolate the outside en- bai – 400064
vironment and internal facility. Off: +91 22 66720200 /
66720300(200 Lines)Fax: +91
Gandhi Automations pro- 22 66720201Email:
vide clean room high speed [email protected]:
doors specifically designed for www.geapl.co.in
above purpose. The clean
room high speed doors are
best suited for facilities where
controlled environment is re-
quired. The opening and clos-

192 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Atlantium innovation takes UVto next generations

Atlantium Technologies, air block. This unique configu- ters is not within the required
founded in 2003, provides wa- range. The data logging system
ter-dependent industries such ration uses fibre-optic princi- enables traceability over time to
as dairy, food and beverage, monitor data for analysis and
pharmaceutical and aquacul- ples to trap the UV light pho- proof of compliance. Reports
ture, as well as municipalities, can be printed out at the touch
with UV (ultraviolet) based tons and repeatedly bounce of a button.
treatment to meet the growing
need for safe water. them along the length of the Medium pressure UV
lamps
The company’s cost-effec- quartz walls and back into the
tive and environmentally- Atlantium's medium pressure
friendly hydro-optic solutions water chamber at different an- high intensity UV lamps pack
deliver unprecedented micro- a much stronger dose in a sig-
bial inactivation, taking water become a source of food for var- Medium pressure ultra-vi- gles, effectively lengthening nificantly smaller footprint
safety to levels never before ious types of bacteria. olet (UV) treatment of the than low pressure or other UV
achieved with other UV sys- ◗ The active carbon requires process water prior to the RO their paths, recycling the en- lamps. When a microorganism
tems. frequently-scheduled mainte- membrane easily reduces free has been inactivated by low
nance procedures such as hot available chlorine in produc- ergy, and creating a uniform pressure UV it can still repair
Atlantium’s Hydro-Optic sanitation and backwash. tion lines to undetectable lev- upstream. Atlantium medium
system is field proven and vali- ◗ SMBS is a source for sulphate els and therefore protects the UV dose distribution. At the pressure high intensity tech-
dated to the highest regulatory bacteria and makes an ideal en- RO membranes from being nology disables the proteins
standards including EPA, FDA vironment for anaerobic mi- damaged. At the same time, same time, the water is opti- and enzymes needed to enable
and PMO. The company has an croorganisms, creating slime UV irradiation inactivates mi- repair.
international customer base croorganisms and represses mally engineered to move in a
with installations all over the Sustainable alternative their repair mechanism, which Atlantium UV lamps, placed
world. field proven in global inhibits regrowth downstream controlled hydraulic perpendicular to the water flow
companies without requiring additional in thick glass tubes, can be re-
Non-Chemical chemicals or causing harmful pattern. placed quickly without draining
Dechlorination – Safe Hydro-Optic UV is a clean, chemical by-products that the unit in only four minutes.
and Sustainable green alternative to activated may damage membrane per- The result is that the UV Being much easier to handle
carbon and SMBS that offers formance. than long lamps, they are far
Atlantium Technologies' Hy- the bio-pharma Industry re- dose is uniformly distributed less likely to break.
dro-Optic UV is a clean, green duced risk, better protection Fully compliant with PW
solution that has been engi- and lower operating expenses. and WFI standards, Atlantium across the entire volume of wa- Compliant and user
neered for maximum efficiency It reduces Free Available-Chlo- systems provide a powerful friendly
and economy, using medium rine (FAC) in production lines enough dose to use as the pri- ter, with no 'dead' areas that re-
pressure polychromatic UV to undetectable levels, and pro- mary disinfectant in a purified Atlantium cGMP compliant
light and Hydro-Optic princi- vides the following added value: water loop. main untreated. The user ben- systems are a small-footprint
ples that optimise UV energy to ◗ Protects products from chlo- solution that easily integrates
its full potential, reducing car- rine contamination Innovative technology efits from 'recycled' UV light with existing plant processes.
bon footprint. It provides the ◗ Protect RO (reverse osmosis) drives efficiency and Equally effective with cold or
bio-pharma industry with two membranes sustainability for maximised efficacy using hot water, they can be installed
sustainable solutions in one sys- ◗ Protects EDI (Electro De-Ion- anywhere along the process
tem: efficient dechlorination ization) modules ◗ Total internal reflection less energy. line, either horizontally or ver-
and powerful disinfection bar- ◗ Protects chlorine-sensitive Atlantium UV technology tically. Customisable options in-
rier, on-demand and with no equipment Two sensors per lamp for clude remote control, data log-
chemicals. Atlantium systems ◗ Provides high level disinfec- leverages fibre optic and hy- total accuracy ging and monitoring.
comply with cGMP standards. tion to PW water draulic principles to harness
the full power of UV light using Effective UV water disinfection ACE technologies is an offi-
The disadvantages of com- Field studies have proven Total Internal Reflection (TIR) – depends on three parameters: cial representative of Atlantium
monly used methods that feed water treated with an optical phenomenon where UV intensity, water UV trans- in India.
medium pressure UV actually quartz is used to extend the mittance and water flow rate. Contact details
Commonly used dechlorination lengthens the membrane lifes- paths light photons take over Since these parameters are dy- [email protected]
process methods include reduc- pan, reduces bio-fouling, re- very long distances. namic and fluctuate, they need
tion of chlorine compounds by duces pressure drop, enhances to be measured continuously.
activated carbon or by dosing of flux and extends time between The core of the Hydro-Optic The Atlantium system meas-
SMBS (sodium metabisul- chemical CIPs, saving in both system is a water treatment ures these critical data in real
phite), which both serve as nu- CAPEX and OPEX. chamber made of high quality time and uses sophisticated val-
trients for microbial popula- quartz (instead of the tradi- idated algorithms to adjust op-
tions, in effect creating an ideal tional metal) surrounded by an erations. Integrated sensor cal-
environment for aerobic and ibration makes sure the sensors
anaerobic bacterial growth, re- are reading accurately.
quiring increased maintenance
and a more complex operation. Automatic control and
monitoring
The active carbon grains’
relatively large surface areas A user-friendly touch screen
and filter pores make it easy for provides a real-time status dis-
microorganisms to attach and play of critical parameters in-
cluding actual delivered dose,
water flow rate, lamp intensity
and water UVT. An alarm is
triggered if any of the parame-

To subscribe: [email protected] EXPRESS PHARMA 193

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

TE-ring remains firmly attached
to dropper bottle in line with
FDA requirements

THE TE-RING fixed to the type easy to make, owing to experi- molding (EBM) process. Radia-
A eye-dropper bottle in accor- ence with the type B dropper tion or ETO sterilisation is pos-
dance with the new FDA regula- bottle, which already has a fixed sible on request. All caps protect
tions is one good example. TE-ring. Only minor adjust- the original contents and can
ments were made to the design, also be supplied with a child-
“It’s often the technical de- while the dimensions, proper- proof screw cap.
tails that add the finishing ties, and the materials are the Contact details
touches to packaging,” says Niels same. The bottle and the drop- Gerresheimer
Düring, Global Executive Vice per are made from LDPE and Klaus-Bungert-Strasse 4
President, Gerresheimer Plastic the cap from HDPE. The exist- 40468 Düsseldorf
Packaging. Production of US ing type A dropper bottles can Germany
dropper bottles with a fixed TE- therefore be used for stability Jens Kürten
ring will be operational in Q3, tests. Group Senior Director Com-
2017 and production will besides munication & Marketing
Poland also be produced out of Gerresheimer produces type Phone +49 211 6181-250
both India and US. A dropper bottles holding 2-360 Fax +49 211 6181-241
ml under clean-room conditions. E-mail j.kuerten@ger-
The US Food and Drug Ad- Depending on the size of the con- resheimer.com
ministration (FDA) now stipu- tainer, they are produced using Internet
late that the TE-ring must be the injection blow molding www.gerresheimer.com
firmly attached to the bottle. (IBM) or the extrusion blow
This product change was very

CryoCube F740 series
by Eppendorf makes
ULT sample storage
future-proof

BASED ON the reliable and Options such as air-cooling Contact details
durable Innova U725/ -G mod- or water-cooling, right- M Anthoni Jai Kumar
els, the new CryoCube F740 handed or left-handed doors, Senior Manager - Marketing
series by Eppendorf makes and three or five interior com- Eppendorf India
ULT sample storage future- partments set new bench- Plot No. 18, 19, 20 (Part),
proof. marks for user demands. Ambit Park Road
Sidco Industrial Estate
An increased capacity of The CryoCube F740 is net- (South Phase)
740 L/ 576x boxes, improved work-compatible and can be Ambattur
energy efficiency without sac- monitored through smart Ep- Chennai – 600 058
rificing temperature accuracy, pendorf VisioNize systems – Direct: +91 44 66 312 207
and a considerable noise re- directly at the device’s touch- Board: +91 44 66 312 222
duction create a safe storage screen or flexibly at a com- Mobile: +91 938 017 6423
environment. puter or tablet in the office.

194 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

When inspection needs perfection

Sterile injectable products are spection machines for injectable products contained in syringes, tion solution of Brevetti CEA. 4. 21 CFR part 11 compliance
extensively used in healthcare. pharma products. The company ampoules, vials, cartridges and With its state-of-the-art technol- for electronic records (recipes,
Despite all efforts for producing first concentrated on the pro- bottles. These innovative ma- ogy and a total re-designed look, batches/sub-batches, audit trail)
sterile parenteral drugs that are duction of semi-automatic ma- chines are designed according the 'BH-S600' will definitely be
'essentially free' of particles, chines until when, thanks to the to the newest and most compre- the undisputed protagonist of the 5. Ethernet connection
achieving such result has proven intuition of the owner, the pro- hensive concepts that cover the upcoming P-Mec show which will 6. User-friendly interface
to be very challenging for the duction shifted its focus on fully- entire Brevetti CEA product be held in Mumbai. 7. Manual loading
pharmaceutical industry. In automated inspection systems, line allowing customers to fur- 8. In-line connection to up-
many cases the observation of which now represent the core ther enhance the recognised Main features stream and downstream equip-
particles or container defects business of Brevetti CEA. advantages of Brevetti CEA ment
have led to product recall, some- technology. 1. Particles, fill level and cos- ACE technologies is an offi-
times causing drug shortage to The first automatic inspec- metic inspection cial representative of Brevetti
patients. tion machine was manufactured To complete its product port- CEA in India.
in 1980 when the availability of folio, Brevetti CEA has recently 2. RPV Remote parameteri-
Process improvement is an first photodiode sensors made it launched the new 'BH-S600' sation and validation Contact details
expectation of clinicians and pa- possible to automatically detect machine. Conceived to satisfy [email protected]
tient population while quality particles that contaminate the most demanding production 3. 'Fail safe' reject verification
standards are becoming more pharma products. Today, lines, the 'BH-S600' can inspect system (Optional)
stringent. Each individual con- Brevetti CEA boasts of more ampoules, vials and cartridges
tainer shall, therefore, be in- than 2.000 inspection machines filled with liquid products at the
spected to the extent possible for installed worldwide, half of maximum speed of 36.000 units
the presence of observable for- which fully automatic. per hour.
eign and particulate matter or
other type of defects, such as A continuous commitment to Within the range of clear solu-
container integrity. research, development and to tions and vaccine products, the
parenteral product safety, has combination of cutting-edge
With billions of injectable brought the company to become cameras with a new dedicated
doses administrated annually an undiscussed leader in inspec- 'Tracking Algorithm' software
worldwide, the need of reliable, tion. for defects detection, grants high
efficient and technologically ad- inspection performances.
vanced automatic inspection Fully responding to the ex-
machines has increased consis- pectations coming from the Ground-breaking technolo-
tently. most advanced pharma sectors, gies, optimised mechanics and re-
Brevetti CEA offers a complete markable value for money are
Since the late 1950’s, Brevetti range of automatic inspection just some of the strong points
CEA has been manufacturing in- machines for injectable pharma which distinguish the new inspec-

BH-S600 TECHNICAL DATA-SHEET

TECHNICAL SPECIFICATION

Inspected containers: Vials,Ampoules, Cartridges

Products to be inspected Waterlike, Suspensions, Oily

Container size Diameter: from 8mm to 32mm
Height: up to 135

Machine nominal speed up to 600 pcs/min (36.000 pcs/h)

Spindle Rotation 54 brushless servo-motors

Rotation speed Continuous regulation. Up to 4000 rpm

Loading By trays or in line

Unloading Accepted By trays or in line

Unloading Rejected By trays

SERVICES REQUIRED

Electric supply 400V ±10%-50/60 Hz-3Ph+N+PE

Power 10kW

Compressed air 6bar, 600 Nl/min

Dimensions (WxDxH) 2500x2300x1990mm

Weight 2100 kg

Loading height 970 mm ± 25 mm

Unloading height 970 mm ± 25 mm

Noise < 75 dB(A)

To subscribe: [email protected] EXPRESS PHARMA 195

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Dividella:The future remains modular

Overview which itself performs a defined or technologies, with minimum to work to best effect, it is vital Modularity in top loading
task or purpose, but which can material waste that each module actually con-
Modularity is built into every as- be linked with other modules to ◗ It makes it easier to adopt a nects properly with neighbour- Modular design and construc-
pect of Dividella’s packaging form a larger system. The modu- systemic overview across facili- ing modules, that each module tion allows Dividella’s NeoTOP
and cartoning products and lar approach has three key ad- ties and process, allowing faster forms its own discrete ‘centre family of TOPLoader machines
services, from the design of vantages: identification of bottlenecks and of excellence’ without need- to form a continuous upgrade
NeoTOP machinery to its wide ◗ It makes it easier to configure a priority areas for further invest- lessly duplicating the functions path from manual packaging of
range of packaging solutions. system to an exactly defined ment. of others and that each module small lots up to 100,000 unites
purpose with minimal redun- can match the capabilities of per year to fully automated high
For Dividella and its clients, dancy of components or capa- However, to maximise these the system. Otherwise, there is speed production of more than
the future is modular: providing bility key advantages means over- the damage that the whole sys- 24 million packs annually
easy upgrade and expansion ◗ It makes it easier to expand or coming the principal chal- tem will only perform at the
paths and a wider range of inno- upgrade the system to incorpo- lenges of modularity: intercon- speed of ‘the slowest ship in the The five machine family
vative solutions on materials rate new functions, capabilities nection, interoperability and convoy’. ranges from NeoTOPx, de-
and packaging. compatibility. For modularity signed for semi automated
packaging of small batches of
Modular design has always blisters, ampoules, vials, sy-
been a core characteristic of Di- ringes, injectors and similar
vidella’s NeoTOP cartoners and products, through to the flag-
top loading machinery, enhanc- ship NeoTOP 804 designed for
ing service life, upgradeability fully automated high speed pro-
and flexibility to minimise Total duction of very large lots.
Cost of Ownership (TCO).
Across the range, there is
Similarly, an integrated consistent sharing of specialised
range of complementary pack- modules that add specific capa-
aging modules allows clients to bilities, such as tailored infeed-
adopt more space and cost-ef- ing.
fective solutions and a wider
range of materials to reduce To- The modular concept allows
tal Cost of Package (TCP). NeoTOP machines to expand at
any time to integrate, for exam-
Dividella is itself part of a ple, different product inserters
modular ecosystem of related or a manual insertion stage I the
skills and competences within process.
the Medipak Systems group,
along with Fargo Automation, The NeoTOP concept is
Mediseal, Seidenader, Rondo adaptable to accommodate ex-
and Werum IT Solutions. treme product changes and
complex pack arrangements.
These sister companies are
each highly expert in their re- Modularity in packaging
spective core areas, able to col-
laborate with each other to pro- Dividella’s TOPLoading packag-
vide complementary modules of ing solutions for pharmaceutical
innovation and specialised capa- products follow a similarly mod-
bility.

Each of these modules is be-
coming increasingly relevant to
questions of how the pharma in-
dustry can generate sustainable
competitive advantages within
the Industry 4.0 concept that
leverages the very latest infor-
mation and communications
thinking to generate innovation
and progress.

A modular approach to In-
dustry 4.0 allows Dividella to of-
fer leading edge solutions in
smart packaging, smart devices,
Condition Monitoring and Pre-
dictive Analytics, Plug & Pro-
duce Internet of Things (IoT)
functionalities and Enterprise
Manufacturing Intelligence
(EMI).

The modular philosophy

The core meaning of ‘module’ is
a self-contained unit or item,

196 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

ular philosophy emphasising a ◗ Cold-chain storage and distri- These solutions include: chine operator gains significant simply and straightforwardly:
component-based approach to bution savings: Reduction in freedom of movement can per- Plug & Produce.
design, assembly and regulatory package volume easing logistics Smart packaging form tasks more efficiently, re-
compliance. burden of refrigerated truck sulting in higher quality and Enterprise Manufacturing
and internal cold-chain storage Smart packaging takes product hugely simplified changeover, Intelligence (EMI)
These features include pro- space personalisation and product se- setup or maintenance.
vision of flat blanks for cartons ◗ Damage reduction: Specifi- curity to a new level, envisaging EMI can improve product quality
and partitions allowing printing cally tailored partitioned design packs that communicate with Condition monitoring and (process stability) and produc-
on all sides, safe automated prevent breakage and reduce the patient and with the ma- predictive analytics tivity (process efficiency) by
erecting of packs and a safer risks to container closure in- chines in the production translating production data into
loading process, enabling 100 tegrity process. Using digitally encoded Condition monitoring and pre- usable information for decision
per cent verification after load- ◗ Packing/Processing efficien- data within the package can rev- dictive analytics can reduce making. The customer can make
ing. cies: Easier tamper evident seal- olutionise information and serv- downtimes and optimise deploy- well-founded decisions that im-
ing for improved overall equip- ice options for providers and ment of personnel and re- prove process stability and
This approach offers a vari- ment effectiveness (OEE). end-users of pharma products, sources by collecting data in process efficiency, thereby in-
ety of advantages for pharma ◗ Material cost savings: Elimina- such as: digital patient informa- real time but interpreting it creasing product quality and
companies and their customers, tion of plastic-based blister tion leaflets, audio patient infor- more meaningfully to detect productivity. Production can be
influencing the complete pro- trays and lids can result in over mation leaflets, digital tamper- critical incidents before they oc- supervised in virtually real time
duction and logistical process 400 per cent reduction in mate- proof protection, health cur and schedule preventative and can be continuously verified.
and allowing a wider choice of rial unit costs. management, intake reminder maintenance. Reactive or pre-
materials. All these have posi- and automatic repeat order. In ventive maintenance is replaced Target sectors
tive effects on TCO and TCP. Pharma 4.0 modularity production, smart packaging by using data mining, modelling,
can instruct the machine to vary statistics and machine learning ◗ Pre-clinical research
It also allows Dividella to in- Dividella is working in tandem settings to the requirements of ◗ Drug discovery
corporate innovative concepts with its fellow Medipak Systems the individual package and even Plug and produce ◗ Drug delivery
like folding ’wing’ format, ex- companies in their respective an individual end user. ◗ Clinical trials and studies
tended fifth panel flap, inte- core areas to find answers to the Plug and produce lays the basis ◗ CRO, CMO, CRAMS & CDMO
grated partitioning, external question of how the pharma in- Smart devices for IoT functionalities by using ◗ Formulation and ingredients
tamper evident wafer seals, use dustry can generate sustainable standardised interfaces to allow ◗ RA & compliance
of 100 per cent recyclable mate- competitive advantages with Smart control devices provide vertical integration between ◗ Manufacturing and produc-
rial and space-saving designs the aid of Industry 4.0 concepts. the right information at the MES, automation and control tion
that minimise footprint and lo- right time and place, enabling systems. Like connecting an
gistics costs. They are developing a mod- machine operators or produc- electronic device via a USB in- ACE technologies is an offi-
ular family of advanced solu- tion managers to operate and terface, it should be possible in cial representative of Dividella
In turn these deliver further tions that can work in isolation monitor the machine or system, the future to link a line, a system (KORBER SOLUTIONS) in In-
cost-saving benefits that include or in combination as part of a even remotely. By means of the or a machine such as a packag- dia.
◗ Distribution improvements: Pharma 4.0 approach. mobile, 'extended' HMI, the ma- ing machine to the network, Contact details
economies in warehouse stor- [email protected]
age

ZhengLi Pharmaceutical Packing: Focus on process innovation

ZHENGLI Pharmaceutical cosmetics etc., which can match cartridges packed in special 10 years---- Long-term coop- dustry. ZhengLi people always
Packing was found in 1991 that with products like freeze-dryer, nest formats. eration with six china national treat its products not just as a
specialises in vials,cartridges, powder injection and hydro bio-tech research centre. container, but as a part of drugs.
syringes and other glass con- acupuncture. And ZhengLi can 500—More than 500 domes- ZhengLi will always focus on
tainers development, manufac- also provide customers reliable tic and international outstand- 80 per cent----------80 per process innovation and provid-
turing and supplying . ZhengLi pre-fillable syringes, vials and ing pharmaceutical enterprises cent market share in domestic ing advanced products.
passed ISO9001:2000 in 2000, choose ZhengLi as supplier. biological pharmaceuticals.
FDA DMF in 2017, Contact details
ISO9001:2008 in 2009 and 50 per cent -------- 50 per cent Robin
ISO15378:2011 in 2016. market share in domestic high- Sales Director -- India
end pharmaceuticals. Mob :0091-9108088888
To adapt to constantly devel- Mail: [email protected]
oping market, ZhengLi invested 15 per cent -------- 15 per cent Zhengli Pharmaceutical Pack-
more than $ 40 million to design products are exported to Eu- aging
and built top level plant with ad- rope, the US, the Middle East
vanced equipment and clean and other country and areas. http://www.zlpharmapkg.com
room from Grade D / C / A base
on GMP standard. The annual ZhengLi ‘s perspective is to
capacity achieves to two billion be responsible for a health in-
pieces of glass containers.

With strong R&D team,
ZhengLi has certified as high-
tech enterprise of China, and
owns 26 authorised patents and
seven invention patents.

ZhengLi Products are used
in anti-tumour, biotech, vaccine
blood products, contact lenses,

To subscribe: [email protected] EXPRESS PHARMA 197

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

When seal quality matters – I2VS

When you open a bottle of of time and effort. It’s not a the bottle,” says Schapiro. every now and then. “And from sampling to 100 per cent
pills you bought at the phar- proper engineering process.” “Until now, there was no way some cases are difficult to dis- to packagers in additional in-
macy, you assume that the to know if that was done prop- cover, like if the company has dustries.”
manufacturer has sophisti- DIR is an Israeli company erly since the bottle is closed, received damaged raw mate-
cated processes in place to as- with a strong background in but our imaging can see rial and the seal doesn’t sit We are not alone
sure the medicine or vitamins thermal imaging. DIR’s through the cap and if there is right, or the liners are defec-
will do the job they’re sup- founders and key managers a problem with a seal you can tive. It is a big leap from sam- “One of the best indicators of
posed to. The integrity of the came from the advanced Is- discover that single one and pling to true process control the market need for the real
seal and how it could affect raeli defence industry, where get rid of it. The system can where you check every single time inspection of seals, is the
the contents of the bottle is they were scientists and de- be adapted to any existing bottle and find out not only if number of competitors that
something that most users velopers. line, and can work at produc- something is good or bad, but started to copy the I2VS” says
never think of. tion speeds above 400 bottles also get an indication why it Schapiro. “In a very short pe-
“Thermal imaging reads per minute.” went wrong.” riod of time, we started to see
Surprisingly, after the bot- the inherent heat signature similar systems being
tles get sealed there wasn’t from the sealing process that He explains that sealing For example, trends might launched in India and the US.
any way to test the quality of heats through the cap of the problems are bound to occur reveal that more seals are The main difference between
the seal aside from random bottle and glues the lining to found to be defective on a spe- the original I2VS and the
sampling -- until the Israeli cific work shift, and the man- copies, is the know-how be-
company DIR Technologies agement can take steps to cor- hind it. The I2VS was devel-
(http://www.dir- rect the situation. oped by scientists that truly
technologies.com/) invented a understand thermal imaging
system that checks every Not only for pharma and have been working in this
sealed package via thermal discipline for year. Anyone
imaging. Operators can find To provide a suitable re- can buy a thermal camera and
and fix the factor causing the sponse to non-pharma users, put some image processing al-
faulty seals whenever they oc- DIR came with I²VS Lite, a gorithms in place, but there’s
cur, without destroying a sam- simplified version intended something else needed to
ple or holding up the produc- for packagers of food, cosmet- achieve a robust and consis-
tion line. ics, cleaning supplies, auto- tent system, and that’s under-
motive and other non-pharma standing correctly what the
DIR’s Induction Integrity applications. camera is detecting and pro-
Verification System (I2VS) cessing the data accordingly.
was launched in 2013 and was Anything with a heat-ap- That’s why the I2VS remains
quickly adopted by some of plied seal under its lid, from the leader of this market. It’s
the largest pharmaceutical coffee to make-up, “is where the only system done by the
and nutraceutical manufac- we could fit in,” says Schapiro. experts.”
turers worldwide, like Pfizer, The Lite version uses the
Merck, Abbvie, Hetero same core technology but it’s ACE technologies is an of-
Pharma and many more. more modular and less costly ficial representative of DIR
because it doesn’t have to technologies in India.
The importance and rele- comply with the pharma in-
vance of product was recog- dustry’s heavy set of regula- Contact details
nised by the international tions. “We’re pleased to now [email protected]
community when in 2015 won be able to offer the same leap
the Innovation Award at the
ACHEMA World Forum,
(http://www.achema.de/en/ho
me.html) an international
event for chemical engineer-
ing and the process industry.

“The packaging of medi-
cine is considered part of the
medicine, because it directly
affects the medicine’s quality,”
says Fabian Schapiro, Mar-
keting VP, DIR. “There is
some type of technology to
test every part of the packag-
ing process except after the
package is sealed. Every so of-
ten in a batch, someone takes a
package off the line and
checks it manually. But you
don’t really know the quality
of the rest, and if you find one
with a problem, you don’t
know how many are affected,
leading to a significant waste

198 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Virosil Pharma:ASwiss eco-friendly disinfectant

Virosil Pharma effectively protects critical surfaces that come in contact with pharma products

SANOSIL BIOTECH, a less, odourless, tasteless dis- How effective is it? How safe is it ?
Mumbai-based company is infectant which is non-car-
the first company to pioneer cinogenic, non-mutagenic, Even at low dosages,Virosil Pharma has the It cannot pollute waste water, because it breaks
the novel concept of eco- revolutionary and can be power of penetrating bio-film and killing the down into water and oxygen, i.e. it produces no
friendly fumigation in sterile used where other chlorine actual bacteria, thereby providing a long residual noxious by-products.
areas completely replacing based disinfectants have been level of disinfection
the use of carcinogenic feared.
proven formalin. The product VIROSIL PHARMA
Virosil Pharma is based on Virosil Pharma is For bacteria- free surface &
Hydrogen Peroxide (H2O2) presently being used in or-
with Silver ions. The combi- ganisations and institutions Pipelines
nation of these two ingredi- such as Pfizer, Cipla, Dabur,
ents gives a synergistic broad Ranbaxy, J&J, Abbott, Serum How does it compare to chlorine? How does it work ?
spectrum of activity on all Institute, Dr Reddy’s, Lupin
kinds of viruses, bacteria, Labs, Cadila Healthcare, Virosil Pharma is superior to chlorine since it H2O2 is a strong oxidising agent (more powerful
fungi, yeasts, molds, protozoa Wockhardt, Biocon, As- imparts no taste or odour to the water and is than chlorine or chlorine dioxide).The oxygen
and algae. It is a clear, colour- trazeneca, Reliance Life Sci- highly effective at both hot and cold temperatures separated from H2O2 destroys the biofilm,enabling
ences, etc., as a very effective the silver to help destroy any bacteria or virus.

RESULTS TABLE 1- Count of standard culture B subtilis used fumigant and disinfectant Virosil Pharma not only
providing an environment successfully penetrates bio-
Standard Culture CFU/ml Log Value with microbial containment films and eliminates bacteria
and a completely safe and but also maintains a long
B subtilis 270000000 8.4313 sterile environment residual level of disinfection
in water tanks and pipelines.
Virosil Pharma effectively
protects critical surfaces that Using Virosil Pharma
come in contact with pharma overcomes the disruption
products. Manufacturing, fill- problem because it is ab-
ing, packing and storage ar- solutely safe to leave it in the
eas; Instruments, equipment, water. Better still, the longer
water tanks and pipelines – it’s in the water, the better the
can now be pathogen free. results since it will attack the
biofilms which harbour most
What’s more, there’s no of the bacteria populations.
need to re-wash disinfected
surfaces or instruments since The company also offers a
H2O2-based Virosil Pharma customised disinfection audit
safely decomposes into water on its website; www.sanosil-
and oxygen. biotech.com

The formulation has been Contact details
tested in various reputed in- Dev Gupta, CEO,
stitutions in Switzerland, Sanosil Biotech
France, Germany, Australia Warden House,
and India. 1st floor,
Sir PM Road, Fort,
MIC determination - Bombay 400 001
Method based on modified Tel No. 022 22872295 /
BSEN13704 (sporicidal) 43112700 / +919820016292
email:
Test Organisms: 1) Bacil- [email protected]
lus subtilis ATCC 6633

Disinfecting biofilms
using Virosil Pharma

RESULTS TABLE2- Microbial Counts Post Disinfectant Exposure in CFU/ml

Microbial Counts in CFU/ml Microbial Counts in Log Values Log Reductions Log Reductions

Virosil l0% Virosil l0% Virosil l0% Virosil l0%

5 mins 30 mins 60 mins 5 mins 30 mins 60 mins 5 mins 30 mins 60 mins 5 mins 30 mins 60 mins

B subtilis 4900 2300 310 4.7411 5.0696 5.9400 3.6901 3.36178 2.4913 99.9981 99.9991 99.9998

To subscribe: [email protected] EXPRESS PHARMA 199

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Understanding serialisation challenges: Flexibility
matches with performances

ACE TECHNOLOGIES of- since the documentation up- the provisioning or auto gen-
fers SEA Vision’s complete date affects only the new func- eration of unique random se-
Track & Trace solution, tionality. rial numbers (and for their
whose major benefit relies on posting to Level 4), in order to
the architecture of the solu- One server, help Brand owners and CMOs
tion itself. Thanks to its mod- cross-efficiency to face serialization and ag-
ular and configurable struc- gregation compliance in a safe
ture, built and designed on The site server allows the and flexible way.
best practice, this is the most communication towards all
flexible and reliable solution Level 4 players (Serial Num- Line manager
on the market to face up ac- bers Providers and/or govern-
tual Track and Trace chal- mental Agencies) and Level 2 All the systems installed on
lenges. The complete soft- vision systems on the packag- the line can be managed by a
ware suite covers from level 1 ing lines. It is the unique single centralised client pro-
to level 3 and is composed repository, monitoring and co- vided with a user-friendly
namely: Site Server, HMI Su- ordinating all serialisation touch screen-interface, that
pervisor, Vision systems for and aggregation events across could be located next to the
serialisation and aggregation. the mentioned levels. Being a packaging line: SEA Vision
The complete software suite centralised platform, it facili- Line Manager provides an
covers from level 1 to level 3 tates data redundancy and overall view on the whole line
and is composed namely: Site backup activities for safer status and on the current
Server, HMI Supervisor, Vi- processes. batch parameters. SEA Vision
sion systems for serialisation Line Manager is a SCADA
and aggregation. This solu- Moreover data exchange Client providing several func-
tions - at a software level – between the site server and tions to execute easily the
can be fully configured in or- vision systems occurs only main operations on the pack-
der to match initial client during the batch start/end, aging line.
needs and can be upgraded in granting an independent man-
the future at any time in or- agement of all serialisation Serialisation vision
der to comply with any future data during the production systems
regulation or customer ex- processes.
pansion. Developed by SEA Vision, the
Serial numbers provi- serialisation vision systems to
Site server sioning/Autogeneration, be equipped on print and
managing complexity check machines is able to
It’s a system based on Win- manage Level 1 devices, thus
dows Server and integrated Site server is responsible for performing the physical in-
with SQL database. This ar- spection of codes printed on
chitecture consists of multiple serialised cartons/bottles.
modules that allow the Server
to communicate with: Aggregation vision
◗ IT systems along the Enter- systems
prise Level (Level 4) including
ERP, regulatory agencies, L4 Thanks to a long-time experi-
corporate repository ence integration on automatic
◗ Line Level vision systems in- and semi-automatic ma-
stalled on the packaging line chines, SEA Vision has devel-
(Level 2) oped a system able to inspect
the codes cartons in the case
Functionalities and build the parent-child ag-
extension, low validation gregation covering all the ag-
impact gregation levels.

Aiming at granting the maxi- Since 2012 SEA Vision has
mum system scalability, addi- successfully deployed over
tional new licenses can be 350 pharma serialisation
added in time, in order to: lines worldwide, over 70 per
support new T&T markets, be cent of them including full ag-
compliant with serialisation gregation, with less than
regulations; add new features three months average deliv-
not foreseen in the initial proj- ery time.
ect. Each added licence has no
impact on the Server core in If you would like to discover,
terms of validation processes, how we can help you on your se-
rialisation journey, contact us at
200 EXPRESS PHARMA [email protected] for
more information.
December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

BEC — small letters,BigValue

HIGHLY FLEXIBLE and effi-
cient: these are the strengths
common to the global success
story of the BEC family. The bi-
ography commenced in 1999
with the first Blister Express
Center (BEC) and culminates
for the time being in 2015 with
the introduction of the three-
lane BEC 700. Reason enough
to look behind the scenes and
identify the most significant de-
velopments.

Flashback to the 1990s:
signs of a shift in pharmaceuti-
cal production are visible
around the Globe. Mergers and
acquisitions, globalisation, as
well as the growing competi-
tion from generics manufactur-
ers is leaving a noticeable im-
pact. The market for
nonproprietary products is
growing and that for original
products is on the decline. At
the same time, orders ranging
from 500 to 15,000 blisters are
increasing at a fast pace, but
frequently packaged on high-
performance lines. The nega-
tive effect is twofold: bulk or-
ders are hindered and the
smaller ones are not cost effec-
tive because of time-consum-
ing format changeovers. In
many cases, the OEE fails to
reach even 50 percent.

Evolution of new concept Well-engineered for maximum flexibility: the Blister line BEC 500
An integrated, end-to-end system perfectly combining a blister and a cartoner module in a line approx. ten metres in length
Good reasons for Uhlmann to
think about developing a com- for the productive interaction direct blister transfer: these stretch-banding machine, over- and forming materials at an
pletely new machine concept of the three elements are the merits, in addition to fast for- wrapper, case packer, or pal- output of 300 blisters and 150
that also takes the logistical en- 26-synchronised servo-regu- mat changeovers, are the suc- letiser, the BEC 500 can be sup- cartons per minute. One per-
vironment into account. Result: lated drives, which automati- cess factors of all the blister plemented with end-of-line son can complete a format
the ‘Blister Express Center’, in cally control all the drive func- lines of the BEC family. The packaging systems suited to changeover in 20 minutes. The
short BEC. Managing Director tions, and a central operation BEC family includes the high- the particular application. BEC 300 also made a mark
Siegfried Drost summarised its and visualisation system con- performance BEC 500, which with its attractive price. Cus-
merits at the time as follows: trolled via a touchscreen. An- Uhlmann presented at BEC 300: Built to impress. tomers receive a single-lane,
“Everything about the BEC is other highlight at the trade ACHEMA in 2006. Unlike the Priced to move continuous motion packaging
minimised: the footprint, num- show was the live format first BEC, the BEC 500 ap- line ready for immediate pro-
ber of tools, setup times, and changeover from PVC/Al to peared with the configuration Low procurement and running duction.
operating effort. Our cus- Al/Al in just 15 minutes – a mi- common to all blister lines costs, proven Uhlmann quality,
tomers find precisely this idea nor sensation! since then: blister machine plus and convincing performance Simplicity in perfection:
convincing.” cartoner. What was the reason data are factors with which the The new BEC 500
Basic principle: Flexibility for omitting the stretch-band- Blister line BEC 300 attracted
Just how convincing it be- ing machine? Additional flexi- attention at FachPack 2009 in On account of the radical
came was pretty evident at In- Unmanned production, self- bility when it comes to end-of- Nuremberg. The single-lane changes in production struc-
terpack in 1999. Combining a monitoring and self-regulating, line packaging! Whether line processes all common tures, the pharmaceutical
blister machine, cartoner, and and a reliable process owing to types of solid dose products manufacturers not only have
a stretch-banding machine,
Uhlmann presented a linked
system for the cost-effective
handling of short order runs
completed in minutes. Crucial

To subscribe: [email protected] EXPRESS PHARMA 201

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

to cope with sinking batch Efficient packaging with the BEC Blister Lines. cept of combining a blister and
sizes, but also find themselves Left: BEC 700. The top performer with high output on account of three-lane operation a cartoner module, which dates
confronted with other chal- Maximum output: 700 blisters/min. and 300/500 cartons/min back to 1999. The footprint,
lenges such as a shortage of Middle: BEC 500. Proven technology for maximum flexibility combined with low operating costs. Maximum number of tools, setup times
qualified personnel, stricter output: 500 blisters/min and 300/500 cartons/min and operating effort remain at
quality specifications, and less Right: BEC 300. Attractive price and excellent production performance in customary top Uhlmann quality. a minimum, while there is no
scope for investments. The re- Maximum output: 300 blisters/min. and150/300 cartons/min limit to productivity with the
placement of an older packag- three output Range – BEC 300,
ing line is only viable when the BEC 500 & BEC 700.
new line is more flexible and
productive. The Blister line The BEC journey
BEC 500 is tailored to meet
these needs. Revised in all re- ◗ 1999 The Blister Express
spects, the two-lane line pre- Center combines a blister ma-
sented in 2012 is geared to han- chine, cartoner, and stretch-
dle batches of 30,000 to banding machine in a single
150,000 packs. The line is unit and revolutionises the con-
available with Flat or Rotary ventional production struc-
sealing. Consequently, a tures in the pharmaceutical in-
broader range of requirements dustry.
can be met, e.g., complex prod- ◗ 2006 The BEC 500 combines
uct shapes, rigid aluminum maximum flexibility with high
pockets, or calendar packs. output.
◗ 2009 Built to Impress. Priced
The modular design allows to Move. Two strong argu-
individual configuration, and ments in favor of the Blister
guidance through a format line BEC 300, the flexible sys-
changeover is provided by the tem comprising a blister and a
Smart Control operating sys- cartoner module.
tem. As is the case with all the ◗ 2012 The new BEC 500. The
models of the BEC family, line for alternating batches of
Track & Trace by Uhlmann up to 150,000 packs scores with
can also be integrated to meet innovative features such as
the statutory requirements of servo-regulated drives, radi-
the relevant countries. cally simplified format
changeovers, the new Smart-
BEC 700: Three lanes for Control operating system, and
higher output two-lane operation.
◗ 2014 BEC 300 containment
The latest member of the BEC solution: a special, highly flexi-
range, introduced in 2015, is the ble alternative based on the
blister line BEC 700. Compact standard blister line.
and powerful, it is the right line ◗ 2015 The new BEC 300 gener-
needed for rapidly expanding ation – developed in close coop-
markets with high potential. eration with Uhlmann cus-
The BEC 700 celebrated its de- tomers. Suitable for all types of
but in China for this reason. forming materials, product
The pharmaceutical market shapes, cartons, and leaflets.
there is developing at a fast ◗ 2016 The efficient packaging
pace and the demand for medi- of bulk volumes on three lanes
cines is on the increase. This without forgoing flexibility: the
means that there is also the BEC 700 rounds off the BEC
need for lines capable of han- family to a higher output level.
dling various forms of packag-
ing and large batches. The top Uhlmann India presents the
performer BEC 700 is based on BEC 500 in action during the
the proven concept of the BEC PMEC at Bombay Exhibition
range, but its three-lane opera- Centre at Booth No J2, Hall
tion offers significantly higher No 5 from November 28 to 30,
output – up to 40 per cent com- 2017.
pared to the BEC 500.
Contact details
BEC — A convincing idea The SmartControl operating system is designed for simple and efficient operation Uhlmann India
Niranjan Mirje, Head of Sales
The addition of the new BEC Phone +91 20 6628 6219
700 to the BEC family means Mobile +91 9146003482
that the ideal solution is avail- [email protected]
able for every production sce- www.uhlmann.de
nario. The BEC lines are in op- Please follow us:
eration all over the world. They Facebook and LinkedIn
prove and validate round the
clock that the innovative con-

202 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Lighthouse USAlaunches lightest,smallest
100 LPM portable particle counter

LIGHTHOUSE USA has ing programme to the next ApexZ50 starts with the most closure that is sealed, easy to cleaning solutions, and much
launched industry’s light- level, the ApexZ50 is your so- complete system of self-diag- wipe-down, and chemically more.
est(3.8Kg) and smallest (not lution. The power of the nostics in the industry, an en- compatible with all major Real-time monitoring
only footprint, but also vol- ApexZ50 can be used as a
ume) 100 LPM portable air- wireless real time sensor.
borne particle counter. Rooms and custom sample
Built in web browser. With in- recipes can help to automate
tegrated web browser one can and simplify your monitoring
access real time data locally or routine. The ApexZ50 gives
anywhere in the building on you various user and security
iPhone, iPad, Android, Win- levels, audit trails, and data
dows Tablet Data View tags that allow you to record
Built-in cleanroom certifica- things like batch and lot infor-
tion reports FS 209E, ISO mation, room status, or any
14644-1:1999, ISO 14644-1:2015, other information you want as-
& EU GMP regulatory sociated with your particle
pass/fail reports on screen or counts.
printer
Handle with integrated sta- CONTACT DETAILS
tus lights, an app for remote Jyoti Gangwani
control and configuration, in- Measuretest Corporation
tegrated Wi Fi and Bluetooth 94 Atlanta,Nariman Point
Self-diagnostics Mumbai - 400021
When you are looking to take ph:- 022-22027982
your environmental monitor- www.measuretest.com

Labchrom Scientific launches Automatic Amino Acid Analyzer

THE INNOVATIVE auto- The S433 system includes temperature profiles, auto-
matic Amino Acid Analyzer S an autosampler with cooled matic uses control of buffer
433 combines the advantages sample storage and partial loop and reagent solutions, SOS
of the classical ion exchange fill technique without sample feature in case of pressure er-
separation method with the loss, as well as a 2-plunger rors, manual control of each
modern technique of high per- buffer pump, a dual beam pho- single unit.
formance liquid chromatogra- tometer, a column oven with
phy. The complete package of active cooling capabilities, a Optional fluorescence
sophisticated instrumenta- Ninhydrine pump, a 4-channel detector (for OPA
tion, a wide variety of pre- vacuum de-gaser and a refrig- applications)
packed and tested separation erated reagent organiser with
columns combined with opti- integrated inert gas application Consumables including ready
mised ready-to-use buffer so- system. made buffer solutions, separa-
lutions and chemicals, creates tion columns, ready made Nin-
the right answer for any rou- Multi-step separation, hydrine solutions and variety of
tine or research problem in cooled reagent storage, inte- standard solutions.
amino acid determination. grated autosampler ( 120
More than 30 years experi- Vials), integrated vacuum de- Application area includes
ence in developing and operat- gasser, separation column physiological fluids, protein hy-
ing sophisticated amino acid oven, high temperature reac- drolysates.
analysers results in un- tor, integrated reagent dosing
matched performance. pump, complete inert design, Contact details
safety devices intuitive soft- LABCHROM SCIENTIFIC
In exchange chromatogra- ware control for complete 253, Udyog bhavan,
phy with post column Ninhy- control of gradient pro- Sonawala Road, Goregaon
drin detection is one of the gramme, column and reactor East, Mumbai – 400063,
most common methods em- temperature. programmable Maharashtra, India
ployed for quantitative amino sample sequence with individ- Tel : +91 22 26851182 / 83
acid analysis. ual run times gradient and Fax : +91 22 26851183
Email : [email protected]
To subscribe: [email protected]
EXPRESS PHARMA 203

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Romaco Group to demonstrate single-sided rotary
press for bi-layer and effervescent tablets

The KTP 590X single-sided rotary press, the newest model in Romaco Kilian’s established KTP
series, will be the main highlight at the exhibition stand

THE ROMACO Group will based on compression force or cGMP compliant balcony archi-
demonstrate its extensive know- displacement controlled. The tecture affords a better view of
how regarding pharmaceutical ROCO Pack software addition- the process and reduces the risk
applications with selected tech- ally simulates the operation of of cross-contamination. All line
nologies for tableting and sec- granulating mills on request. clearance measures can be com-
ondary packaging. The KTP This extreme versatility is a hall- pleted in a very short time. The
590X single-sided rotary press, mark of the STYL’ONE Evolu- optimal access to all components
the newest model in Romaco Kil- tion tableting robot. The remark- and the retractable carton maga-
ian’s established KTP series, will able precision of the test batches zine simplify cleaning and enable
be the main highlight at the exhi- means powder properties can be faster product and format
bition stand. analysed very realistically, for in- changes. The operator simulta-
stance. By the same token, scale- neously profits from the car-
Romaco Kilian KTP 590X ups or test series to optimise ex- toner’s lower noise level and er-
single-sided rotary press
Intermittent motion cartoner series Romaco Promatic P 91
The KTP 590X is an extremely
versatile single-sided rotary Romaco Kilian KTP 590X single-sided rotary press
press from Romaco Kilian which
can be used to manufacture both Romaco Kilian STYL’ONE to the design principles of Ro- isting processes or troubleshoot gonomic working height. The use
mono-layer and bi-layer tablet Evolution tableting robot maco Kilian’s successful KTP se- errors can be performed on the of servo technology and Venturi
formats. It can be switched be- ries: 'Cool, Fast & Clean.' laboratory press. The new models vacuum systems not only re-
tween mono-layer and bi-layer also have an interchangeable duces noise emissions; it also en-
mode without any modifications Romaco Kilian STYL’ONE process worktable, which is an sures reproducible processes
to the compression units. Bi- Evolution tableting robot advantage if the products in and gentle handling of the prod-
layer tablets can be compressed question are highly abrasive. The ucts and packaging. What’s
at any time on the version with In the newest generation of Ro- STYL’ONE Evolution is capable more, the intuitive HMI terminal
three compression rollers. The maco Kilian’s STYL’ONE Evolu- of compressing up to 1,750 tablets of the P 91S intermittent motion
tablet press is equipped for this tion single-stroke press, the com- per hour in configurations for cartoner from Romaco Promatic
purpose with two standard fill pression cycles have been mono-layer, multilayer or core provides maximum ease of use.
shoe modules, which distribute speeded up by more than 60 per tablets. On show at P-MEC in Mumbai
the powder absolutely uniformly cent and the maximum compres- (India) from November 28 to 30,
in the die. Thanks to the opti- sion force increased to 50 kN. Romaco Promatic P 91S 2017 (Bombay Exhibition Centre,
mised paddle design, even poorly The technology is thus ideal for intermittent motion Stand D40).
flowing or sticky powders can be simulating high speed presses cartoner Contact details
processed efficiently and com- like the Romaco Kilian KTP Susanne Silva
pressed homogeneously. With its 420X at up to 104 revolutions per In the high-speed version, the Market Communications
three separate compression sta- minute. The compression force Promatic P 91S intermittent mo- The Romaco Group
tions, the Kilian KTP 590X is profiles of all standard rotary tion cartoner achieves a maxi- Am Heegwald 11
equally suited for manufacturing presses are stored in ANALIS, mum output of 140 cartons a 76227 Karlsruhe
effervescent tablets. The powder the intelligent PAT software, and minute. This compact machine Germany
is simply tamped initially to pre- can be accessed easily when has a small footprint which T +49 (0)721 4804 0
vent air pockets and capping, needed. Furthermore, depend- makes it perfect for many phar- F +49 (0)721 4804 225
then pre-compressed and finally ing on the test set-up, the com- maceutical applications and line E [email protected]
converted into finished tablets in pression processes can be either configurations. The cartoner’s
the main compression unit. The
dwell time is significantly longer
owing to the use of Kilian 28/41
tooling, meaning harder tablets
can be made. All in all, the Ro-
maco Kilian KTP 590X single-
sided rotary press boasts a max-
imum output of up to 510,000
tablets per hour, even in bi-layer
mode. Low process tempera-
tures, efficient cleaning and re-
tooling and a mature hygiene
concept – the KTP 590X single-
sided rotary press, too, conforms

204 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

How sweet is your HPLC?

SUGAR IS a simple carbohy- chemical detector. The choice injection valve and column ther- index detector make the sys- available for fulfilling the mod-
drate belonging to a class of of detector depends on the mostat (AZURA CT 2.1) and is tem appropriate for analytical ern challenges facing the food
chemically-related sweet-fla- method type (gradient or iso- compatible with a range of sepa- and semi-preparative pur- and beverage industries.
vored substances. Since sugars cratic) and sensitivity required. ration columns. This simple and poses. The extended dynamic
are omnipresent in our life, we Refractive index detection is a low maintenance system offers range option enables the linear Applications
need the tools and applications so-called universal detection a price optimised configuration, dynamic range of the AZURA
to reliably analyse or purify method that can detect almost able to cover a wide range of RID 2.1L to be broadened in ◗ Routine analysis of ingredi-
them. any sample components that standard applications. +100 per cent (-1000 μRIU off- ents in wine
have a different refractive in- set) or -100 per cent (+1000 ◗ Simplified scale up for sugars
Sugars typically found in dex from the mobile phase. Preparative HPLC can be μRIU offset). This prevents ◗ Xylitol HPLC extraction from
foods and beverages are mono- This detection method is the readily used to purify monosac- the need to dilute samples, fermented biomass
saccharides (galactose, glucose, most common for sugars, ar- charides and their simple de- which saves time and money ◗ Semi-preparative xylitol pu-
and fructose) and disaccha- guably due to its low cost and rivatives from synthetic or nat- and diminish additional errors rification
rides (sucrose, lactose, and robustness. ural matrices. A similar system during sample preparation (e.g.
maltose). Sorbitol, xylitol, man- to the AZURA Analytical pipetting errors). Contact details
nitol and erythritol are a type The KNAUER dedicated Sugar System is the dedicated KNAUER Wissenschaftliche
of sugar alcohol that because of AZURA Analytical Sugar Sys- AZURA Semi-Preparative The analysis and purifica- Geräte GmbH
their relative sweetness, are tem is equipped with a differen- Sugar System. This system can tion of sugars is an essential Hegauer Weg 38,
also used as sweeteners. tial refractive index detector be operated up to 10 ml/min, task for increasing awareness 14163 Berlin, Germany
(AZURA RID 2.1L), an isocratic and the extended dynamic and improving health. Simple +49 30 809727-0,
We were all told as children pump (AZURA P 6.1L), manual range of the included refractive KNAUER system solutions are +49 30 8015010 (Fax)
that too much sugar rots our
teeth. However, the adverse ef-
fects of sugar according to
health organisations can be
even more drastic than dental
issues. The WHO (World Orga-
nization of Health) and Ameri-
can Heart Association urge
people to restrict their added
sugar intake due to their asso-
ciation with obesity, heart dis-
ease and type II diabetes.

To keep control of sugar lev-
els, it is helpful to know how
much sugar there is in the food
and beverages we consume.
Nutritional labelling is a great
controlling aid, as food prod-
ucts are required to list sugar
and total carbohydrate con-
tent. The measurement of sug-
ars in food stuffs are typically
carried out via HPLC.

Another issue facing the
food and beverage industry is
adulteration. Good examples
are wine and honey. The price
of natural bee honey is much
higher than other sweeteners
making it susceptible to adul-
teration with cheaper sweeten-
ers, primarily sucrose. As well
as sucrose, high fructose corn
syrup and lactose (high in calo-
ries) are added to some foods
to increase sweetness at a low
cost. Adulteration can often be
monitored via HPLC.

Sugars and sugar alcohols
display almost no ultraviolet
absorption, and are therefore
typically detected using a dif-
ferential refractive index detec-
tor (RID), evaporative light
scattering detector or electro-

To subscribe: [email protected] EXPRESS PHARMA 205

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Rommelag to display products at P-MEC Mumbai 2017

ROMMELAG WILL display
its products at the P-MEC in
Mumbai to be held from No-
vember 28-30, 2017. The serv-
ice areas Rommelag Engi-
neering and Rommelag Flex
will be presenting innovations
for the pharma industry, such
as the aseptic, fully isolated
filling process or the fully-au-
tomated inspection of BFS
containers.

As the slogan 'Filling your
needs' says, the Rommelag
Group is presenting special
solutions that make these ap-
plications easier, safer and
faster to use. If you are look-
ing for information about our
service options and the world-

Rommelag Blow fill process with one mould and sealed parison value products and simple for-
Engineering There are practically no limits with regards to container design for bottlepack BFS containers mat changes.
will
demonstrate Until recently, several
the aseptic steps with manual interven-
Blow-Fill-Seal tions were necessary to detect
filling process. particles and cosmetic defects
The bottelpack in containers. The particle in-
bp 434 has a spection machine (PIM) now
completely enables a 100 per cent inline
sealed parison check. BFS containers can
with just one now be checked fully automat-
rotating mould ically for particles and cos-
metic defects.
wide availability of specialists,
come to the fair stand J-32 in Rommelag Flex will
Hall 5. Rommelag Service, demonstrate new application
which offers comprehensive options for transport, storage,
maintenance and customer transferring and weighing in
service, has an information the field of flexible contain-
point set up specifically for ment solutions for powders
this purpose. and bulk goods. Including Fle-
cofilm, a film approved for the
Rommelag Engineering pharma industry. The antista-
will demonstrate the aseptic tic property of this film in-
Blow-Fill-Seal filling process. creases product yields.
The bottelpack bp 434 has a
completely sealed parison Contact details
with just one rotating mould. Andreas HäußnerDirector
The advantages here are max- Marketing
imum safety when filling high- Rommelag
Fabrikweg 16
206 EXPRESS PHARMA 5033 Buchs,
Switzerland
December 1-15, 2017 Andreas.
[email protected]
www.rommelag.com

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