Packaging Validation is Suffocating me - We deliver our products non-sterilized

B

blueapple

#11
Hello!
Thank you very much guys. This forum is very helpfull for us, I really appreciate your help!
I'm still in dilemma. First I wanted to tell you that the instructions from our boss are to change the parameters (We are decresing the forming time in order to have more products packed per minute) and report this as verifications and to perform tests on EMPTY packages, without any product inside!
I really can not find any logic in this. Isn't the point of making all the tests when changing the parametes proving the sterility of the product after sterilization, not the sterility of the package or the sealing of the package because of itself??!
 
Elsmar Forum Sponsor
J

Juan Dude

#12
I am not sure if they want me to validate the process or the individual packaging.
It is essential that you clarify the scope of the validation before starting, as a matter of fact you have to document the validation scope on validation protocol(s).
 
D

Denis

#13
Some of my work is based around the same issues of packaging machines and product sterility 10-6.

This is how I would approach the validation.

The machine will have variable settings such as temperature, speed, pressure etc.

The packaging should produce an air tight seal which is robust enough. Therefore you wil need to determine the settings for the packaging material(s), and test for the airtight seal using a burst testing machine of some description. I use a test that looks at the rate of pressure drop or decay over time.

This determines the equipment settings to use.

Confirming product sterility - I use the VD Max method. A finished product is subject to bioburden measurement and then determining if 25kGy (gamma) irradiation is sufficient to call the product sterile 10-6.

The machine settings, BOM, manufacturing environment, people etc are all inputs in determining product sterility.

I cannot see how you can perform this work on empty packages though.

Hope this helps.
 
R

Rolande Hall

#14
Hello!
Thank you very much guys. This forum is very helpfull for us, I really appreciate your help!
I'm still in dilemma. First I wanted to tell you that the instructions from our boss are to change the parameters (We are decresing the forming time in order to have more products packed per minute) and report this as verifications and to perform tests on EMPTY packages, without any product inside!
I really can not find any logic in this. Isn't the point of making all the tests when changing the parametes proving the sterility of the product after sterilization, not the sterility of the package or the sealing of the package because of itself??!
You now have a reason for the proposed parameter changes. Clearly you must avoid the change of forming conditions having an adverse effect on the product/package quality. Remember to maintain the audit trail by issuing an Engineering Change document (referencing your new validation) that specifies the new parameters and gives this reason for change.

The new validation protocol should also give the improved efficiency as the reason for validation; this is to avoid the presumption that your first validation was somehow defective and needed to be redone.

The approach that Denis outlines is OK for non-porous packages but more difficult to apply to formings with porous lidding. Remember also that, when conducting unrestrained Burst Testing, the values obtained vary not only when the seal strength changes but also when the lid or forming stiffness changes and is dependant on the package geometry.
If you wish to verify that the seal strength is not effected by forming or sealing parameter changes then you must include peel strength tests.

It depends upon your sealing process as to whether sealing and testing the seal of empty packages is relevent; could the weight or volume of your product impact on the sealing process?
Clearly you cannot change parameters and then conduct handling tests on empty packages. You can put spores into an otherwise empty package and check that they are killed by the sterilisation process, however this approach does not check that the most difficult part of your product to sterilise would be treated (such as fliud pathways). Unfortunately if your seals are defective the pack interior may not remain sterile long term. My view is that the ommission of product from your sterility testing is not an effective test of package suitability; I would expect an external auditor to issue a critical report if you procede with your bosses plan.
 
J

Juan Dude

#15
Hello!
Thank you very much guys. This forum is very helpfull for us, I really appreciate your help!
I'm still in dilemma. First I wanted to tell you that the instructions from our boss are to change the parameters (We are decresing the forming time in order to have more products packed per minute) and report this as verifications and to perform tests on EMPTY packages, without any product inside!
I really can not find any logic in this. Isn't the point of making all the tests when changing the parametes proving the sterility of the product after sterilization, not the sterility of the package or the sealing of the package because of itself??!
I didn't want to reply to you because you hijacked this thread instead of making your own but here it goes:

Sealing force is a major indicator of seal integrity so you can perform (part/all, depending on your requirements) packaging validation with empty packages to perform pull testing of seal strips to determine seal force.
 
Thread starter Similar threads Forum Replies Date
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 39
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
V Tyvek packaging for Medical device process validation Qualification and Validation (including 21 CFR Part 11) 2
shimonv Packaging Validation for Non-Sterile Package EU Medical Device Regulations 6
R Medical Device Packaging Label Validation Other US Medical Device Regulations 8
P Sterile Medical Packaging and Shelf Life Validation Sample size ISO 13485:2016 - Medical Device Quality Management Systems 10
R Can a Distributor perform Packaging Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Packaging Validation - IOQ Protocol template for a Sartorius Checkweigher Design and Development of Products and Processes 2
I Work Instruction for Validation of Packaging to EN ISO 11607-2 Requirements Document Control Systems, Procedures, Forms and Templates 3
P Sterile Packaging Validation Requirements - Accredited Laboratory or not? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Sterile Packaging Validation - FDA Requirements for Statistically Valid Tests 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
G Packaging Re-Validation - Sealer machine broke down or was changed to a new one Other ISO and International Standards and European Regulations 11
ScottK Validation of SAP - Secondary Packaging Manufacturer Qualification and Validation (including 21 CFR Part 11) 8
J Shelf Life Validation for new Heat Impulse Medical Packaging Sealer Qualification and Validation (including 21 CFR Part 11) 2
W Packaging / Heat Sealer Validation - IOQ (Installation/Operational Qualification) Qualification and Validation (including 21 CFR Part 11) 15
S Does Package Validation required for Service Parts Packaging Carton Box? ISO 13485:2016 - Medical Device Quality Management Systems 1
T Packaging Validation - New Machinery - Terminally Sterilized Medical Devices Qualification and Validation (including 21 CFR Part 11) 7
M Do I need to do Packaging Validation? Other Medical Device and Orthopedic Related Topics 3
B Packaging Validation - Storage Distribution Testing Qualification and Validation (including 21 CFR Part 11) 4
A Packaging Validation / Qualification Report for Medical Devices - Example ISO 13485:2016 - Medical Device Quality Management Systems 5
M Packaging standards - ASTM vs ISTA Other Medical Device Related Standards 0
M Packaging studies - ISTA vs ASTM CE Marking (Conformité Européene) / CB Scheme 0
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
C Packaging Long Parts Manufacturing and Related Processes 3
G Special 510K possible? Only the packaging has changed Other US Medical Device Regulations 0
B Setting flexible packaging specification limits ISO 14971 - Medical Device Risk Management 4
V Packaging in Distributor Practices EU Medical Device Regulations 0
R Green dot required on packaging? Medical Device and FDA Regulations and Standards News 2
shimonv Single lot release for sterile packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 4
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
C 21 CFR 803 malfunction detected during packaging - report? Other US Medical Device Regulations 1
E Latex in packaging Other Medical Device Related Standards 4
H Expired packaging material - Expired unused Tyvek pouches Other Medical Device and Orthopedic Related Topics 2
A GUDID - Packaging Levels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
A Packaging device with accessories already on the market Other Medical Device Regulations World-Wide 0
T Root Cause Failure Analysis - Not following Customer packaging Specification Problem Solving, Root Cause Fault and Failure Analysis 9
Q EU Rep for Packaging waste, WEEE and Battery disposal CE Marking (Conformité Européene) / CB Scheme 0
L AS5553 Clause 3.1.7 e "Control packaging material ..................reused" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L Packaging unsterile medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
M MDR - Packaging - Secondary Medical Device Boxes EU Medical Device Regulations 2
M UDI size on packaging EU Medical Device Regulations 3
M UDI placement - Packaging levels EU Medical Device Regulations 2
E Unit Dose Packaging Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
K Packaging and Damaged Parts returned from a Service Provider (Anodize) - Who is Responsible? Manufacturing and Related Processes 20
B 510(k) clearance claim on medical device product packaging Other US Medical Device Regulations 6
E Packaging Specifications Mercedes-Benz U.S. International IATF 16949 - Automotive Quality Systems Standard 4
T Colour of symbols on Medical Device labelling and packaging Other Medical Device Related Standards 1
R Labels on sterile packaging EU Medical Device Regulations 5

Similar threads

Top Bottom