CAPD C-01 Ver C 30 Sep 2021

ILLUSTRATIVE COMPILATION

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DDDDIIIISASACLCLYYOOSSNNIISSNNESSECYYCTSSTTTPPEEEEMMRRI(T(ICCTOAOANPNPEDDAE) )LAL

MADE IN MALAYSIA TENDER T/P&P 138/2021

QT210000000031964

TARIKH TUTUP: 08-10-2021

CONTENTS

Content Page

TECHNICAL DATA SHEET 1-4

APPLICATION 5

CATALOGUE CONTENT TECHNICAL FEATURES 6

DIALYSIS SOLUTION BAG 7

TRANSFER SET 8 - 10
CAP FOR TRANSFER SET 11
DISPOSABLE DRESSING SET 12
HYGIENIC AND SURGICAL 13
HAND DISINFECTION SOLUTION
14
PERITONEAL CATHETER CLAMP 15
FACE MASK

MONTHLY HOME DELIVERY PRESCRIPTION 16
STARTER PACK 17
PERITONEAL CATHETER CLAMP 18
PD CATHETER 19
PACKAGING 20 - 21

CONTINUOUS AMBULATORY PERITONEAL
DIALYSIS (CAPD) SYSTEM

Disconnect Double Bag System with a Luer Lock Connector

Application
1.1 Continuous Ambulatory Peritoneal Dialysis (CAPD) is indicated for chronic kidney

disease patients (CKD) with end stage renal disease when dialysis is prescribed as a renal
replacement therapy by the healthcare professionals for adults and children as prescribed
by the nephrologists.

Features TECHNICAL DATA SHEET
2.1 The CAPD System is a disconnect double-bag system with a luer lock connector. The

disposable system is completely integrated and closed and consists of one pre-filled (solution
bag) and one empty bag. The integrated system can safely connect to a transfer set with a
‘Y’ connector technology for continuous ambulatory PD therapy.

Key features as follows:

• 2.2 Flush before fill technology.
• 2.3 Closed System.
• 2.4 Integrated inflow and outflow colour coded clamps.
• 2.5 Ex-vivo solution flow rate of minimum 7ml/sec.

Components of System

Dialysate Formulation • Compendial as per BP Standards.
• APIs qualified to BP Standards.
• APIs used in accordance with Islamic values.
• 3.2.5 Dextrose concentrations of 1.5%, 2.5% and 4.25%.
• 3.2.7 Calcium concentrations of 1.25mmol/L and 1.75mmol/L.

Dialysate Solution Bag • 3.2 Made of clear Polypropylene material.
(Environmentally Green & Non-PVC)
• 3.2.2 Variable volume content of 2.0 Litres and 2.5 Litres.
• 3.2.3 Separate sampling / injection port.

• 3.2.4 Provision for hanging bags during therapy.
• 3.2.6 Dialysate concentration identifiable by colour codes.
• 3.2.8 All bags have common connectology and can be
used interchangeably.

• Printed information on bag:
> 3.2.9 Name of product.
> 3.2.9 Formulation specifications.
> 3.2.9 Fill volume.
> 3.2.9 Manufacturing date.
> 3.2.9 Expiry date.
> 3.2.9 Lot Number.
> 3.2.9 Product registration number with local authority.
> 3.2.9 Manufacturer name and address.

1

Disconnect Double Bag System with a Luer Lock Connector

Components of System

Drainage bag • Made of clear material to enable assessment of effuent.

Consumables • Transfer set *

> 3.3.1 Length between 19 - 45 cm

• Cap for Transfer Set/Catheter Extension *

> 3.4.1 Pre-filled with povidone iodine

(Sterile and individually packed)

• Disposable dressing set *

TECHNICAL DATA SHEET > 3.5.1 3 compartments tray

> 3.5.2 3 forceps

> 3.5.3 Sterile and individually packed
> 3.5.4 1 dressing towel
> 3.5.5 1 waste disposal bag
> 3.5.6. 5 pcs of gauze
> 3.5.6 6 pcs of cotton


• Hand disinfection solution

> 3.6.1 Bottle of 500ml
> 3.6.2 Does not contain fragrances and dye
(Hypoallergenic)
> 3.6.3 Broad spectrum of activity: effective against
bacteria, fungi, and viruses

• 3.7 Catheter clamp
> Made of plastic
> Sterile and individually packed

• Face mask
> 3.8 3 ply non-woven material

• Starter kit

> 4.1 Peritoneal Catheter Clamp
> 4.2 Locking Titanium Adapter
> 4.4 PD Catheter, curl, 2 cuff
> Transfer set
> Safety caps
> Dressing kits/Face mask/Tapes
> Hand sanitiser
> Disinfection solution
> PD solutions and others as per prescription

*Sterile & individually pack

2

Disconnect Double Bag System with a Luer Lock Connector

Components of System

Packaging • 5.1 Non PVC Bags. Made of polypropylene materials
• 5.2.1.2 4 bags per carton in accordance with daily usage
to ensure clean storage of unused bags and
avoid mix-up.
• 5.2.1.4 Dialysate concentration is identifiable by

colour code.
• 5.2.1.5 Calcium Concerntrated of PD Solution.
• 5.2.1.6 Volume of PD Bags on labels.



• User Leaflet in every carton.

Distribution • 5.4.3 In accordance with the GDP guidelines. TECHNICAL DATA SHEET
• 5.4.3 To hospitals or patient homes as per request.

Training and Support • 6.1.1 Professional technical training and support for patient.
• 6.1.2 Healthcare personnel training;
> Provided under the CPD program as per request
or at a minimum 6 monthly interval.
• 6.1.3 Caregiver training.
• 6.1.3 CAPD Home visits and training;

> Available on request by healthcare providers.


Standards and Safety • 7.1 The PD solution is registered with the Malaysian
National Pharmaceutical Regulatory Authority NPRA)
and other local Regulatory bodies.
• 7.2 PD solution is produced in GMP certified facility.


3

SOFT FLOW SC - Peritoneal Dialysis Solution

No. Products Fill Volume (L) Remarks

1 SOFT FLOW SC Low Calcium (2.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 1.5% w/v 2.5L CAPD / APD
MAL18116041AZ 5L
APD

NPRA REGISTRATION 2 SOFT FLOW SC Low Calcium (2.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 2.5% w/v 2.5L CAPD/APD
MAL18116042AZ 5L
APD

3 SOFT FLOW SC Low Calcium (2.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 4.25% w/v 2.5L CAPD/APD
MAL18116040AZ 5L
APD

4 SOFT FLOW SC Normal Calcium (3.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 1.5% w/v 2.5L CAPD/APD
MAL21026039AZ 5L
APD

5 SOFT FLOW SC Normal Calcium (3.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 2.5% w/v 2.5L CAPD/APD
MAL21026040AZ 5L
APD

6 SOFT FLOW SC Normal Calcium (3.5mEq/L) 2L CAPD
Peritoneal Dialysis Solution with Dextrose 4.25% w/v 2.5L CAPD/APD
MAL21026041AZ 5L
APD

4

1.0 APPLICATION APPLICATION

1.1 The Disposable Integrated Disconnect CAPD System

• Used in end-stage renal disease patients (ESRD)
• Adults and children as prescibed by nephrologists
• Prescription Rx only
• Poison Group C (Pharmaceutical)

5

2.1 INTEGRATED DISPOSABLE SYSTEM (TWIN BAG)

2.1 One (1) Empty
Drain Bag

2.1 One Pre-filled
(solution bag)

TECHNICAL FEATURES 2.4 Integrated
Outflow Clamps

2.4 Integrated
Inflow Clamps
“Y” Connection
2.1 Technology

2.2 Flush Before Fill Technology
2.3 Closed System
2.5 Flow Rate of Minimum 7ml/sec

TECHNICAL INFORMATION/PACKAGING

PRODUCT BAG Polypropylene (Non-PVC) STERILITY Sterile
SHELF LIFE
COLOUR Transparent Low Calcium : 3 Years
BRAND Normal Calcium : 2 Years
CAPACITY 2.0 litres and 2.5 litres PACKAGING Soft Flow
DEXTROSE 1.5%, 2.5% and 4.25% COLOUR CODED
CALCIUM 1.25mmol/L and 1.75mmol/L FOR DEXTROSE Individual Pack (4 bag/carton)
CONCENTRATION 2.5mEq/L and 3.5mEq/L CONCENTRATION
Black (1.5%), Blue (2.5%) and Red (4.25%)

6

3.2 DIALYSIS SOLUTION BAG (NON-PVC)

3.2.4 Hole for Hanging • Leak Proof
Variable Dextrose 3.2.1 • Made of

3.2.5 Concentration Clear Material
1.5%, 2.5%, 4.25%
Calcium
Manufacturer’s Concentration
3.2.9.4 Name and 3.2.7 1.25 mmol/L

Address 1.75mmol/L DIALYSIS SOLUTION BAGS

Variable Volume
3.2.2 2L (2000ml)

2.5L (2500ml)

3.2.3 Injection Port

3.2.9.3 Lot Number 3.2.9.1 Manufacturing 3.2.9.2 Expiry Date
Date

3.2.6 Color Coded

Dextrose 1.5% Dextrose 2.5% Dextrose 4.25%
(Black) (Blue) (Red)

7

CAPD SYSTEM CONSUMABLES 3.3 TRANSFER SET (STERILE)

Connection Device : Transfer Set

3.3.1 Length available between 19 - 45 cm
3.3.2 Sterile and Individually Packed

8

3.3 TRANSFER SET COMPATIBILITY TO CYCLERS TRANSFER SET COMPATIBILITY

Used in conjunction with CAPD Twin BAG System and
MiniCap with Povidone-Iodine

33

3.3.3 Transfer Set Connection Tubing is compatible with
the currently available PD cyclers in MOH hospitals

FEATURES:

1. Twist Lock Connection Design.

2. Completely sealed connection, decreases risk of contamination.

3. PD transfer set consists of female locking connector, twist
clamp, tubing, and male locking connector. This set is to be
used with locking titanium alloy adaptor for Peritoneal Dialysis.

9

3.3 TRANSFER SET COMPATIBILITY TO EXISTING SYSTEM

CAPD SYSTEM COMPATIBILITY Peritone System

CAPD SYSTEM IS Existing System
COMPATIBLE TO THE

EXISTING SYSTEM

10

3.4 CAP FOR TRANSFER SET (STERILE)

Sterile and Open CAPD SYSTEM CONSUMABLES
3.4.2 Individually

Packed

Close

3.4.1 Pre-Fillled with
Antiseptic Agent

*Enlarged image

MiniCap with Providone-Iodine 10% is a plastic cap with
safety cover designed to isolate and disinfect the transfer

set for Peritoneal Dialysis.

11

3.5 DISPOSABLE DRESSING SET (STERILE)

Dressing Set is sterile, used to clean and promote wound
healing and prevent infection or further harm.

CAPD SYSTEM CONSUMABLES 3.5.1 Tray with Three 3.5.2 Three (3) 3.5.4 Two (2)
(3) Compartment Disposable Forceps Dressing Towel

3.5.5 One (1) Waste 3.5.6 Five (5) Pieces 3.5.6 Six (6) Pieces
Disposal Bag of Gauze of Cotton

3.5.3 Individually Packed One (1) One (1)
Patient Drape Sterile Field

12

3.6 HYGIENIC AND SURGICAL HAND
DISINFECTION SOLUTION

An alcohol-based hand sanitizer that is Virucidal, CAPD SYSTEM CONSUMABLES
Bactericidal and Germicidal. It is suitable for use in any
environment that practices hand hygiene and cleanliness to

prevent cross contamination.

• Broad Antiseptic
Spectrum

3.6.3 • Effective Against
Bacteria, Fungi
and Viruses

WHO
Recommended

Formulation
Fragrance
Free

3.6.2 Hypo-
Allergenic

3.6.1 500 ml NOT Number

MADE IN MALAYSIA

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3.7 PERITONEAL CATHETER CLAMP (STERILE)

Designed to clamp the Peritoneal Catheter when required.

CAPD SYSTEM CONSUMABLES 3.7 BETA CLAMP

Individually Packed

*Enlarged image

14

3.8 FACE MASK

3-Ply Medical Face Mask

MIDDLE LAYER INNER LAYER CAPD SYSTEM CONSUMABLES

Meltblown filter Soft absorbent non-woven layer

OUTER LAYER ELASTIC EARLOOP TIE

Hydrophobic non-woven layer Fits your ear gently

15

3.9 MONTHLY HOME DELIVERY PRESCRIPTION

MONTHLY DELIVERY SOFT FLOW SC CAPD 3.9.2 MINICAP 3.9.3 DRESSING SET
3.9.1 (2L & 2.5L)

1.5% / 2.5% / 4.25%

3.9.4 HAND SANTIZER 3.9.5 3-PLY DISPOSABLE
FACE MASK

3.9.6 4 bags per day
4 pieces per day
Soft Flow SC CAPD (2L & 2.5L), DEXTROSE 1.5%/ 2.5%/ 4.25% 1 bottle per month
MiniCap with Povidone Iodine
Hand Sanitizer, 500ml 1 set daily
Dressing Set 4 pieces daily
3 Ply Disposable Face Mask (50 pcs/box) As required
CAPD Record Book

16

4.0 STARTER PACK

4.1 PD CATHETER 4.2 LOCKING TITANIUM
CLAMP ADAPTER

STARTER PACK

4.4 PERITONEAL
DIALYSIS CATHETER

4.4.1

STARTER PACK CONTENT
PD Catheter Clamp 1 Piece
Locking Titanium Adapter 1 Piece
Peritoneal Dialysis Catheter (Length 47-62cm) 1 Piece

17

4.1 PERITONEAL CATHETER CLAMP

Sterile and
Individually Packed

CAPD SYSTEM CONSUMABLES Peritoneal Catheter Clamp

4.2 LOCKING TITANIUM ADAPTOR

4.2.1 Locking Titanium Adaptor

3

Individually Packed FEATURES:

• Used to connect the PD Catheter to
Transfer Set

• Material Titanium Alloy
Lightweight, durable, resistant to

rust, non-magnetic.

• Smooth, Glossy, No Spaces
Decreases the possibility of damage

to the pipeline and decreases the
chances of peritoneum infection.

• Locking Design
Fine sealed connection, decreases

possibility of contamination.

18

4.4 PD CATHETER

4.4 PD Catheter

4.4.2 Made of Silicone CAPD SYSTEM CONSUMABLES

4.4.1 • Length 62cm
• Others 47-62cm

4.4.4 Double Cuffed

4.4.3 Coiled

19

5.2 PACKAGING FOR PD SOLUTION

5.2.1.3 Names of the PD solution Strength
Product 5.2.1.4 with color coded

labels for Dextrose %

PACKAGING 5.2.1.6 Volume Per Bag 5.2.1.8 Expiry Date
2000ml / 2500ml 5.2.1.7 Manufacturing Date
5.2.1.9 Batch/Lot Number
5.2.1.5 Calcium Concentration 5.2.1.2 4 PD Bags/Carton
of PD Solution

20

5.2 PACKAGING FOR PD SOLUTION

5.2.1.11 Kementerian Kesihatan
Malaysia (KKM)

5.2.1.12 Sealing Tape
Easy Peel

5.2.1.10 Manufacturer’s PACKAGING
Name and Address

5.2.1.4 PD Solution Strength
with Color Coding

VARIABLE INFORMATION ON LABEL YES
PD Solution strength with colour coding Yes
Volume per bag Yes
Manufacturing date Yes
Expiry date Yes
Batch / Lot Number Yes
Manufacturer’s name & address Yes
Kementerian Kesihatan Malaysia (KKM) label Yes
Sealing tape easy peel Yes

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MADE IN MALAYSIA