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

B

Banken

#1
Dear Guys,

I am pulling my hair out right now (the little that I have) trying to figure out how to do packaging validation for our product. We deliver our products non-sterilized, so I dont really thing that ISO 11607 is the most appropriate and it seems quite burdensome. I have checked the GHTF 's final document Quality Management Systems-Process validation Guidance, but am still at a lost.:bonk:

I guess my biggest problem is IQ OQ and PQ, and how they integrate into validating a process vs. a single machine. We have conducted ISO 2247 and 8318, but I dont know if that is sufficient.

Please Help!!!!
 
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D

Denis

#2
Re: Help!!! Packaging Validation is Sufficating me!!

Need some more information to help you here.

Are you installing a new piece of packaging equipment? or using an existing piece of equipment to validate tha packaging performance.

If it's a new piece of equipment - do you have a URS?
Base the validation around the URS, there will be critical characteristics that you can measure as part of the packaging validation.

I would concentrate on these aspects, cycle time, burst / seal strenght etc.
Print quality and repeatability.

Need more information about the validation to be of help.
 
B

Banken

#3
Re: Help!!! Packaging Validation is Sufficating me!!

The purpose is to validate the entire process, including the packaging procedures. But, the equipment is not new. Would simply validating the equipment used be enough to validate the entire process. We've been shipping things for years and have never gotten a complaint or mention of damaged goods upon delivery. But things shipped are made of titanium, so i guess the can be expected. We have done vibration testing of the final shipping container on a worst case basis, but im not convinced that would be sufficient.

Thanks for your reply....:thanx:
 
D

Denis

#4
Ok, so this is a retro spective validation.

Forget the IQ, as the equipment is established and in place.

There must be some form of the following documents in place, so use these in compiling the OQ.
Preventative maintenance schedule
Operation of the equipment
Training records
In process control checks

You will need to compile a table of the products that are processed on this equipment. Compile a table of all the different products and their critical requirements. If there are alot of products I would make a rationalisation to say that (say two or three) are the worst case, and I'll base my testing around these products (as they present the greatest challenge to the equipment).

Run the chosen products against the established settings / procedures and measure the critical to quality characteristics.

You should try and push the boundaries of the equipment settings to demonstrate that the product characteristics can be achieved with settings that are slightly outside of the settings in the procedure. By doing this you are demonstrating that the eventual settings chosen are robust.


This is the core of your OQ validation protocol - you should repeat this three time on different batches to confirm the settings used give reliable (repeatable) results.

If the results meet the OQ criteria then the OQ passes and move to the PQ.

I would run one confirmation batch in the PQ.

Hope this helps.
 

yodon

Staff member
Super Moderator
#5
Maybe I'm off the mark here, but are you wanting to validate your packaging equipment / process or the packaging itself? Typically, our clients need to validate the packaging itself to determine suitability (i.e., no breakage due to the rigors of expected transportation, packaging integrity through expected shipping and storage conditions, etc.). Since your product is made of titanium and you've never had any complaints, clearly your risk is low. If this is what's making you uneasy, though, you can do a risk analysis to address the various conditions (you've already established through testing that the packaging sufficiently protects the material from damage through vibration).
 
B

Banken

#6
Thanks guys for the replies.

I am being asked to deliver packaging validation to a Regulatory body for device registration. I am not sure if they want me to validate the process or the individual packaging. But validating the process requires me to validate the individual packaging... I suppose my biggest problem is writing the protocol and doing the actual validating in house. I am trying to avoid out sourcing the process. I suppose I will have to think a little harder on what aspects to include in the protocol. (which is my biggest problem) have never done this before. Thanks again for all the help.

Banken:thanx:
 
B

blueapple

#7
These are the issues that you should consider putting into your validation protocol:
1.[FONT=&quot] [/FONT]Definitions (where you can put copies of the standard where the definitions are found)
2.[FONT=&quot] [/FONT]References
3.[FONT=&quot] [/FONT]Purpose
4.[FONT=&quot] [/FONT]Method
6.[FONT=&quot] [/FONT]Responsibilities (where you state the manufecturer, and the responsible presons for operation, for QC, for maintenance)
7.[FONT=&quot] [/FONT]General description of production building and facilities
8.[FONT=&quot] [/FONT]General description of production process
10.[FONT=&quot] [/FONT]Product Specification
11.[FONT=&quot] [/FONT]Q.C. inspection
12.[FONT=&quot] [/FONT]Operator training
13.[FONT=&quot] [/FONT]Maintenance plan
14.[FONT=&quot] [/FONT]Electrical drawings, Building’s drawings and Operating-Cleaning-Maintenance instructions manual
15.[FONT=&quot] [/FONT]Revalidation
16.[FONT=&quot] [/FONT]Certification of Validation
17.[FONT=&quot] [/FONT]Approval of the Validation Protocol
 
B

blueapple

#8
I have few questions regarding validation. We have performed validation on packaging machine (we took 3 different batches, made dimensional functional tests, burst, peel tests before and after sterilization), but when the manufacturer of the machine was here, he reccomended to decrease one of the parameters (forming time-which does not affect the sealing).
1. So according to the standard, can it just be Verification, or sholud we name this as a Revalidation?
2. And can we just take empty packages and perform the tests before sterilization only?
 

bio_subbu

Super Moderator
#9
I have few questions regarding validation. We have performed validation on packaging machine (we took 3 different batches, made dimensional functional tests, burst, peel tests before and after sterilization), but when the manufacturer of the machine was here, he reccomended to decrease one of the parameters (forming time-which does not affect the sealing).
1. So according to the standard, can it just be Verification, or sholud we name this as a Revalidation?
2. And can we just take empty packages and perform the tests before sterilization only?
Hi

The concept is simple, if you see the process validation definition in FDA 21 CFR 820.75(c)

“When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation" where appropriate. & ISO 11607 point No 6.5.2 “Processes shall be revalidated if changes are made to the equipment, product, packaging materials or packaging process which compromise the original validation and affect the sterility, safety or efficacy of sterile medical devices”

So if you change the process “forming time” you should consider as a revalidation. These activities shall be documented for monitor process to detect changes, assess impact of changes on the process and revalidate changes or provide justification why revalidation is not required.

Before sterilization, you can do the visual testing to evaluate the uniformity and consistency of forming, but no assurance that effectiveness of the packaging until and unless to perform the sterility test (after sterilization).

Thanks and Regards
S. Subramaniam
 
R

Rolande Hall

#10
I have few questions regarding validation. We have performed validation on packaging machine (we took 3 different batches, made dimensional functional tests, burst, peel tests before and after sterilization), but when the manufacturer of the machine was here, he reccomended to decrease one of the parameters (forming time-which does not affect the sealing).
1. So according to the standard, can it just be Verification, or sholud we name this as a Revalidation?
2. And can we just take empty packages and perform the tests before sterilization only?
:cool:
You have conducted your validation, if the results are satisfactory then I would thank the machine manufacturer for his advice, but take no action.

It is your validation, your responsibility. :notme:

Contrary to often quoted normal thermoforming practice, I have often found it necessary to thermoform with the MAXIMUM energy input that the process will accept.

If you reduce the forming time you may find that your sealing flanges will have an increased tendancy to curl during the sealing process and that formings tend to crack when stressed at low temperatures due to the increased amount of locked in stress. Forming definition may also not be as precise as you wish.

Changing the process would need money spent on re-validation before production can continue.

I would recommend that you stay with the settings you have validated unless there is direct evidence that change is needed.
 
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