1565 Bustard Road
Lansdale, PA 19446
Phone: 610-287-3433 Fax: 610-287-0233
Web: www.integratedservicesolutions.com
Document Type: Standard Operating Procedure Effective Date: 06 Jun 2021
Title: Gravimetric Calibration of Volumetric Apparatus and PM Practices
ID: ISO-SOP-3023 Revision: 26.00 Page: 51 Of 56
19.0 Addendum: Example of Accredited Certificates:
Below is an example of a certificate issued for a pipette calibration accredited to ISO
17025:2005. It differs from a non-accredited certificate in that it includes uncertainty values,
the A2LA logo, and the decision rule.
© COPYRIGHT 2021-2024, CONFIDENTIAL & PROPRIETARY
Integrated Service Solutions, Inc., A Trescal Company
1565 Bustard Road
Lansdale, PA 19446
Phone: 610-287-3433 Fax: 610-287-0233
Web: www.integratedservicesolutions.com
Document Type: Standard Operating Procedure Effective Date: 06 Jun 2021
Title: Gravimetric Calibration of Volumetric Apparatus and PM Practices
ID: ISO-SOP-3023 Revision: 26.00 Page: 52 Of 56
20.0 Addendum: Examples of Calibration Labels:
Below are examples of the types of labels issued for pipette calibrations.
© COPYRIGHT 2021-2024, CONFIDENTIAL & PROPRIETARY
Integrated Service Solutions, Inc., A Trescal Company
1565 Bustard Road
Lansdale, PA 19446
Phone: 610-287-3433 Fax: 610-287-0233
Web: www.integratedservicesolutions.com
Document Type: Standard Operating Procedure Effective Date: 06 Jun 2021
Title: Gravimetric Calibration of Volumetric Apparatus and PM Practices
ID: ISO-SOP-3023 Revision: 26.00 Page: 53 Of 56
21.0 Revision History
Rev. Date Description of Change Approvals
No. ERES-Signature
0.00 01 Aug 2000 Initial Process Development Review/Editor: See Master File
C. Digerolamo
Approval: See Master File
J. Uricchio
1.00 01 Oct 2000 Initial release, with Validation of program Review/Editor: See Master File
W. Salerno
Approval: See Master File
J. Uricchio
2.00 10 May 2001 Clarification of Sample Vessel (balance) Review/Editor: See Master File
W. Salerno
Approval: See Master File
J. Uricchio
3.00 22 Aug 2001 Revised section 5.3.2, removed ‘Air Temperature’ Review/Editor: See Master File
table 1 changed Densities with footnote C. Cabanas
reference Approval: M. See Master File
Morwald
4.00 09 Apr 2004 Revised format to current SOP format, and Review/Editor: See Master File
included section M. Cabanas
Approval: See Master File
M. Morwald
5.00 16 Jul 2004 Set Photometric / Volumetric Range limit at 49 Review/Editor: See Master File
µLiter / 50 µLiter respectively M. Cabanas
Updated Title to include reference to Approval: See Master File
‘Volumetric/Photometric Practices’ J. Morwald
6.00 02 Aug 2004 Created Alternate Gravimetric ≤ 4:1 TAR Review/Editor: See Master File
Procedure; from 1 µLiter to 19 µLiter, adjusted M. Cabanas
the cut-off point for Photometric Calibrations to Approval: See Master File
start at 19 µLiter or less. J. Morwald
6.10 19 Jan 2004 Update Density Formula reference Review/Editor: See Master File
M. Cabanas
Approval: See Master File
J. Uricchio
7.00 31 Jan 2004 Included Client Specified Test Accuracy and Review/Editor: See Master File
optional Set-Point Requirements examples. M. Cabanas
Revision to Water Density Table, per validation Approval: See Master File
requirements. J. Uricchio
7.10 31 Mar 2006 Changed “largest” to smallest in section 16.0. Review/Editor: See Master File
(Typo). Added note, “as needed in 15.16. added S. DeSmedt
note 7.2 Approval: M. See Master File
Cabanas
8.00 14 Aug 2007 Revised to include Sartorius MPC ‘Speed•Cal™’; Review/Editor: See Master File
added updated definitions and references to ISO M. Cabanas
8655-1/2/3/4/5/6. Approval: S. See Master File
DeSmedt
© COPYRIGHT 2021-2024, CONFIDENTIAL & PROPRIETARY
Integrated Service Solutions, Inc., A Trescal Company
1565 Bustard Road
Lansdale, PA 19446
Phone: 610-287-3433 Fax: 610-287-0233
Web: www.integratedservicesolutions.com
Document Type: Standard Operating Procedure Effective Date: 06 Jun 2021
Title: Gravimetric Calibration of Volumetric Apparatus and PM Practices
ID: ISO-SOP-3023 Revision: 26.00 Page: 54 Of 56
Rev. Date Description of Change Approvals
No. ERES-Signature
9.00 19 Sep 2008 Revised to current process. Merged precision Review / Editor: See Master File
syringes SOP. ISO-SOP-3154 is now rescinded. L. Gage / S. Lucas
Final Approval: See Master File
S. DeSmedt
10.0 19 Feb 2010 Performed complete review of document, and Edit/Review: See Master File
re-formatted. M. Cabanas
Approval: See Master File
K. Hawblitz
11.0 11 Aug 2010 Amended section 15 & 22 to clarify Burette Review / Edit: See Master File
method (8655-6:2002) utilized with Metrohm A. Padmaraju
application note 281/1e for titration’s. Approval: See Master File
Added section 23.0 Z table extracted from M. Cabanas
ISO:8655-6
12.0 20 Mar 2012 Added Automatic Leak testing. Review / Edit: See Master File
Edited Sections 14 through 16 to reflect current A. Padmaraju
Speed•Cal™ Procedure. Approval: See Master File
M. Cabanas
13.0 01 Aug 2012 Reformatted & reordered paragraphs to improve Review / Edit: See Master File
flow. Updated Safety Practices to include A. Padmaraju
minimal PPE requirement. Added sections to Approval: See Master File
conform to template master format. M. Cabanas
13.10 02 Jan 2013 Minor Update: Correction of Header errata: Review / Edit: See Master File
Starting on page 14, the Header Block was A. Padmaraju
showing the incorrect Document ID, ISO-SOP- Approval: See Master File
3007, was corrected to ISO-SOP-3023. M.Cabanas
14.00 22 Apr 2013 Up dated Section 12.6.1 Daily set up to include, Review/Edit: See Master File
logbook recording. Added an instruction note on F. Aponte
how to proceed when an OOT is in the As Found Approval: See Master File
data due to a lose tip. M. Cabanas
15.00 28 May 2014 Updated Section 1.0 Solution to Solutions, Review/Edit: See Master File
Updated Section 6.31 USP35-NF30 to current F.Aponte
USP 37-NF32, Updated Section 13.3 SOP
reference from ISO-SOP-3012 to current ISO-
QSP-2010, Updated Section 11.11 adding a
clarification note: The leak test is an optional, See Master File
add on service that is quoted separately. It is not Approval:
L. Myles
part of the standard calibration procedure and
therefore is subject to contract negotiations.
Updated Section: 10.0 Lubricant specifications:
OEM Silicone Lubricant. All references to grease
changed to OEM silicone Lubricant.
© COPYRIGHT 2021-2024, CONFIDENTIAL & PROPRIETARY
Integrated Service Solutions, Inc., A Trescal Company
1565 Bustard Road
Lansdale, PA 19446
Phone: 610-287-3433 Fax: 610-287-0233
Web: www.integratedservicesolutions.com
Document Type: Standard Operating Procedure Effective Date: 06 Jun 2021
Title: Gravimetric Calibration of Volumetric Apparatus and PM Practices
ID: ISO-SOP-3023 Revision: 26.00 Page: 55 Of 56
Rev. Date Description of Change Approvals
No. ERES-Signature
15.01 30 May 2014 Corrected Typo on Effective date month, from Review/Edit: See Master File
Mar to May. F.Aponte
Approval: See Master File
L. Myles
16.00 06 Aug 2014 The title and scope were changed to specify Review/Edit: See Master File
gravimetric, more description of frequency, limits L. Myles
and test points were added, formatting, materials, Approval: See Master File
and references were updated, the balance F.Aponte
verification instructions were updated; they are
now recorded in the Pipette Calibration software.
17.00 16 Feb 2015 The calibration of dispensers was added. Default Review/Edit: See Master File
Service levels were added to Section 8.0. A L. Myles
preventive maintenance section was added. Approval: See Master File
F. Aponte
18.00 22 Sep 2015 The balance verification test points were updated Review/Edit: See Master File
from 5g, 20g, 50g, 100g, and 120g to 1mg, 10mg, L. Myles
100mg, 1g, 10g, 20g, 50g, 100g, and 110g. More Approval: See Master File
specific information was added to the sections F. Aponte
10.0 Materials and Equipment, 11.2 Pipette
Preventive Maintenance, and training information
in 11.1. Formatting was also updated.
19.00 29 Jan 2016 Section 9.0 was updated to include the Review/Edit: See Master File
requirement to verify pipettes have been G.Henriksen
decontaminated. Reference to a pop-up box that Approval: See Master File
reminds the technician about PPE requirements L. Myles
was also added.
Section 11.6.9 includes the requirement to
document a reason if data is changed.
20.00 11 Aug 2016 Pipette service level descriptions were updated to Review/Edit: See Master File
reflect current practices. G.Henriksen
Approval: See Master File
L. Myles
21.00 04 Oct 2016 Specific instructions for the AND balance were Review/Edit: See Master File
added to Section 11.4. G.Henriksen
Approval: See Master File
L. Myles
22.00 14 Oct 2016 Section 11.2 was revised reflect software updates Review/Edit: See Master File
that display PM intervals and performed dates. G.Henriksen
Examples of pipette labels were added to Section Approval: See Master File
20.0. L. Myles
23.00 03 Oct 2017 Sections were added to describe use of the Mobile Review/Edit: See Master File
Speedcal with the wedge software. The balance G.Henriksen
verification section was also updated to include Approval: See Master File
the Mobile Speedcal. More screenshots were L. Myles
added throughout.
24.00 25 Jul 2018 Use of the evaporation trap under all Review/Edit: See Master File
© COPYRIGHT 2021-2024, CONFIDENTIAL & PROPRIETARY
Integrated Service Solutions, Inc., A Trescal Company
1565 Bustard Road
Lansdale, PA 19446
Phone: 610-287-3433 Fax: 610-287-0233
Web: www.integratedservicesolutions.com
Document Type: Standard Operating Procedure Effective Date: 06 Jun 2021
Title: Gravimetric Calibration of Volumetric Apparatus and PM Practices
ID: ISO-SOP-3023 Revision: 26.00 Page: 56 Of 56
environmental conditions was added. Updated to G.Henriksen
include use of a pump to empty the collection Approval: See Master File
vessel. A requirement to always use a 5 place L. Myles
decimal setting when optional was added. A
check to make sure the balance was clean was
added.
25.00 09 Dec 2020 References to Trescal were added throughout the Review/Edit: See Master File
document. Section 8.0 was updated to make 10%, G.Henriksen
50%, and 100% the default setpoints and the ISO Approval: See Master File
8655 limits the default limits for clients obtained L. Myles
after 01 Jan 2021.
26.00 30 Mar 2021 Section 8.0 was updated include the ISO 8655 Review/Edit: Digitally signed by
limits in the procedure instead of referencing the A. Gaydos Andrew Gaydos
standard. Section 11 was updated to add the PPE Reason: I reviewed this
document
and decontamination form confirmation to the Date: 2021.06.07
13:49:41 -04'00'
procedure, in addition to the requirement in the
safety section. The requirement to use the pump Approval: Digitally signed
was removed. L. Myles by Lisa Myles
Date:
2021.06.07
14:06:04 -04'00'
This document when printed from the electronically secured and controlled TMS program is an uncontrolled
document. Current revision level should be verified via TMS prior to use.
© COPYRIGHT 2021-2024, CONFIDENTIAL & PROPRIETARY
Integrated Service Solutions, Inc., A Trescal Company