SBS - The Best Value in QMS software

OQ (Operational Qualification) of a Freeze Dryer

B

ben83

#1
Hi all,

I have a question regarding an OQ of a freeze dryer. Im Validation Manager in a medium size medical devices company and have the task to create a qualification plan for a freeze dryer (IQ/OQ/PQ) and encountered a problem while writing the OQ-plan. I have to say, I was never involved in any freeze drying process/qualification/ etc.

Maybe you guys can give me some advice..

The condenser capacity shall be tested. My idea of testing the condenser capacity was the following:

Stated capacity by manufacturer is 3kg

-make 2000mL of a 5% mannitol solution
-split the solution in 5 different glas beakers
-freeze dry the mannitol solution
-do a karl fisher titration to determine the residual moisture

-repeat the same process with the same volume of 5% mannitol solution but use 10 glas beakers a 200mL instead of 5 a 400mL

-Calculate the mean residual moisture for all dried product mentioned above.

Now to test capacity

for safety reasons (to not do any damage to the vacuum pump) I wouldnt test the absolute upper limit which is 3kg but 2.7kg instead (10% safety gap)

therefore:

-make 2400mL 5% mannitol solution (i choose 2400mL because this volume will lead to 2.7 kg ice)
-split the 2400mL in 6 glas baeakers a 400mL
- freeze dry mannitol solution
-do a karl fisher titration to determine the residual moisture

-Compare the results of this tests to the results before. Residual moisture should be the same as with the 2000mL tests if condensor capacity is really 3kg resp. 2.7kg.

What do you think about the test procedure so far ?

Next question is:

How can I test the condenser capacity if there is NO possibility to determine residual moisture ? Any ideas ?

I really hope you guys can help me on that topic, as I think that there a many very qualified people in this forum.

Thanks a lot

Best Regards,

Ben
 
Elsmar Forum Sponsor

ifserav

Involved In Discussions
#2
Hi Ben

usually when i tested Freeze dryers, to test this i use to put a quatity of destilated water in shelf or recipients and run a cycle, after that i weigth the restant water and i could show how many water can be condensated by the equipment, i hope it help you.

Sergio ?vila
 
Q

Quengineer

#3
Ben, were you able to conclude this OQ plan. i am in same need. could please help me out in developing the approach of checking the capacity of freeze dryer?
 
Thread starter Similar threads Forum Replies Date
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 5
Z Operational Qualification for Injection Molding Supplier Quality Assurance and other Supplier Issues 6
J Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L Heated Sealed Packages - Sample Size for OQ (Operational Qualification) and PQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
E Operational Qualification of a Drug Box Coding Device in Production Other Medical Device and Orthopedic Related Topics 1
J OQ (Operational Qualification) for Liquid-Water Isotope Analyser Other Medical Device and Orthopedic Related Topics 2
B Usage of Parts from OQ (Operational Qualification) Mold Validation ISO 13485:2016 - Medical Device Quality Management Systems 4
S Barcode Scanner IOPQ (Installation/Operational/Performance Qualification) Requirement Qualification and Validation (including 21 CFR Part 11) 9
M Determining Sample Size needed for Operational Qualification (OQ) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 24
L OQ (Operational Qualification) for Electropolish - Orthopedic Cutting Tools Other Medical Device Related Standards 3
W Packaging / Heat Sealer Validation - IOQ (Installation/Operational Qualification) Qualification and Validation (including 21 CFR Part 11) 15
Q Operational Qualification of a CNC machine ISO 13485:2016 - Medical Device Quality Management Systems 4
D Laser Weld Operational Qualification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Operational Qualification for injection molding process Qualification and Validation (including 21 CFR Part 11) 2
C CNC Machine Operational Qualification Recoverability Testing Other Medical Device and Orthopedic Related Topics 1
W IQ, OQ, PQ (installation, operational & performance qualification) compared to PPAP ISO 13485:2016 - Medical Device Quality Management Systems 5
H Basic questions about Installation, Operational & Performance Qualification - PCBA Qualification and Validation (including 21 CFR Part 11) 11
C ISO 13485 and IQ (Installation Qualification), OQ (Operational Qualification) ISO 13485:2016 - Medical Device Quality Management Systems 30
C Generate IQ, OQ & PQ (installation/operational/performance qualification) Report Document Control Systems, Procedures, Forms and Templates 11
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
Richard Regalado Top 10 operational risks of 2019 for business continuity planning Business Continuity & Resiliency Planning (BCRP) 6
I ISO 22000:2018 - Operational Prerequisite Program Examples Food Safety - ISO 22000, HACCP (21 CFR 120) 2
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
L OpEx (Operational Excellence) Documents in QMS? Document Control Systems, Procedures, Forms and Templates 0
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
M Informational UK – Brexit operational readiness guidance for the health and care system in England Medical Device and FDA Regulations and Standards News 3
T Operational setup of how FIFO / Process Map on Lithium Batteries is done Manufacturing and Related Processes 1
C AS9100D, Clause 8.1 - Operational Planning and Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
Q Management control Procedures & Operational Control Procedures ISO 14001:2015 Specific Discussions 1
R AS9100D Cl. 8.4.2 - Identify Raw Material as a Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Quality Department - Operational Framework Service Industry Specific Topics 2
A Operational Procedure for an IT Service Industry Quality Department Service Industry Specific Topics 1
M Integrated Phased Processes - AS9100D cl. 8.1 Operational Planning - Clarification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A IT Managed Services Company Quality Department - Operational Document ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G How have you addressed Cl 4.4.6 Operational Control ISO 14001:2015 Specific Discussions 4
I Quality and Operational Excellence Training Institutes in Europe Training - Internal, External, Online and Distance Learning 1
W ISO 14644 Cleanroom Validation - "Operational" Other Medical Device Related Standards 3
M Quality Manual - ISO 17025 required Mandatory and Operational Procedures ISO 17025 related Discussions 7
J OHSAS 18001 Clause 4.4.6 Operational Control Example Procedure Occupational Health & Safety Management Standards 9
G Evaluation of Training for Operational Staff Training - Internal, External, Online and Distance Learning 8
K Operational Prerequisite Programmes (oPRP) Food Safety - ISO 22000, HACCP (21 CFR 120) 2
S What does "Operational Review" mean as tool - Effectiveness of Internal Control Risk Management Review Meetings and related Processes 3
A ISO 14001:2004 Clause 4.4.6 - Operational control (in English) ISO 14001:2015 Specific Discussions 2
D Good operational definition for Schedule Variance Software Quality Assurance 2
A Sample Documented Procedures that satisfy 4.4.6 Operational Control wanted ISO 14001:2015 Specific Discussions 2
D Procedures in Communication, Operational Control, etc. - ISO 14001 Document Control Systems, Procedures, Forms and Templates 12
V Identification of Operational Prerequisite Programs (oPRP) for ready to eat products Food Safety - ISO 22000, HACCP (21 CFR 120) 4
P Operational QMS (Dubai) vs. compliant QMS (UK) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4

Similar threads

Top Bottom