hi Sharon
for packaging validation most praxticle way is to go through environmental validation, using IEC standards for transport, and verification that the peoduct is still operative.
for labeling the best practice is to perform incoming inspection per batch.

Merav Shefer Hi Sharon
in addition to Yuval's comment above -
look at ASTM D4169...you can also consult with the Technion - they perform transportation tests.

Sharon Shachar Yuval Shapiro Environmental is for design validation . I'm looking for process validation , when the process create the packaging/labeling

Sharon Shachar Environmental is for design validation. I'm looking for process validation at packaging (speaking on labeling it is relevant when your process produce the label and you need to validate it)

Hi Sharon Shachar. it is difficult to answer you without further informations. you can validate many things in the packaging process such as the packaging manufacturing, the packaging operation, the shelf life, the transport, etc... WE can discuss privately about that if you need to. Best regards

Arauz Sergio ASTM D4169 TESTING SHIPPING / ASTM D642 Compressive resistance of shipping / ASTM D999 Vibration testing for labeling depends on what kind of sterilization will be used

Arauz Sergio are asking packaging testing ?

Jonathan Wacks Define representative lots size (e.g., one-shift production). Based upon User Needs/Design Requirements and Risk Analysis, develop In-Process QC documents. Perform IQ equipment

Chuck H. Mograbi No, team here are focusing on the products, you need to focus on your packaging process starting with you process risk assessments of all potential issues that can happen like open seal, burned seal, seal too strong, label in not readable, font is not correct.....and start testing for these issue (only high Risk):
How you determine if the seal is not strong ? through Pull force test..
How do you determine if your label use the wrong font: through visual inspections..... 30 samples per test will give you 90% confidence & 99% reliability.
No need to do any environmental testing or vibrations....these are already done through during the product validation...
Focus on validating your process...not your products...

G M Butcher If one starts with a risk analysis exercise one will know what to do.

Chuck H. Mograbi In manufacturing, you need to have the conclusive evidence that your process can provide a conclusive evidence for repeatable & safe products....
To start you have to create your risk assessment for your process which include the potential defect, detect-ability & for example:
Seal is not welded Product not retained Risk is high
Seal partially welded Product not retained Risk is high
Seal too strong Difficult to open Risk is Med
Burning in weld Aesthetic problem Risk is low
Of course, the above are just an example.

Assuming there is a potential risk that the seal may not be welded with a high risk..... Then you need to test for pul test with 99% reliability. (30 samples). There is possibility the weld is burning the edges, you you test for Visual inspection.. I would use 30 samples for each test.... you do not need to test for low risk...
I hope this will help..

Doug Simmans Hi Sharon, Are you looking to check the packaging is correct to the approved artwork prior to packing the product?

Doug Simmans If you are looking to validate that the printed label or other packaging conforms to the approved artwork then you will need a comparator system that has been validated for the task.

Cezar Lucki Also don't forget to qualify against ISTA standards: https://www.ista.org/pages/procedures/ista-standards.php

In addition to Chuck H. Mograbi, you need to perform some engineering study as DOE, in order to identify the windows parameters according to your requeriments, machine specifications established by the manufacturer, and according to the materials to be used, for example films, tyveks, etc. in addition to that the pouch size is important to identify the parameters because if you have differents sizes, you should need extra windows parameters.

Sharon Shachar Chuck H. Mograbi Thanks for the detailed answer , focusing on the packaging process (rather than Design validation). This was what I was looking for.
Can you tell me what will you do for a process that produce many types of packaging ?

Chuck H. Mograbi I also forgot to mention that you need to have three batches, tested by three different operators and perform & attach the " Analysis of Variances" (Anova through Minitab) to make sure all the results are statistically alike.
If you have any other questions, you may email me.

Sharon Shachar Thanks a lot , exactly what I was looking for around packaging process, specifically for labeling.
What do you recommend for a process that produce many labeling ?

Chuck H. Mograbi Sharon, if you are using the same process on all your packaging,, then you only need to validate this particular process regardless how many types of packages you use on this machine.
Assuming you have the same process for all you packages; then try to use the same methodology for the labeling machine or use the packages that represent the worst case risk scenario, or the most difficult to make. you can evaluate this during your risk assessment.
Again, you are not validating your products, so your focus must be on your process.
Any questions, let me know!

Chuck H. Mograbi Sharon Shachar - you are not validating the products, you are validating the process. For labeling machine, of course you use it for dozens of products and you use the same software on all the labels.
you may ask, which label I may used during the process validation?
Use the most difficult label to make.
but as an option Let's use something innovative: as example:
33 labels X 3 batches
during each batch of the 30 labels you use :
11 labels (the smallest)
11 labels (Medium )
11 Labels ( Largest side)
Repeat this process for the three batches. ( 3 Operators)
If all the labels sizes passes, , now, you have a conclusive evidence that YOUR PROCESS is stable to produce any product that fall between the smallest to the largest...
support your data with 3 separate ANOVA for three batches sizes, one ANOVA for the small size, One ANOVA for medium & one ANOVA for the large sizes.
For the label process, I think your data is attribute (Pass or Fail) any Questions?

Mark Proulx, CQA, cSSBB Sharon Shachar best thing to do is an Operational Qualification that takes into account the "extremes" of what you are producing. Find out the worst case scenarios of each product you package and perform testing on these. That should give you evidence your process is sound for a variety of different types of packaging. If you don't know that yet, you'll need a DOE to determine all that before performing OQ.

David P Norby, PhD, CQE (ASQ) Sharon, I would describe most of what Chuck H. Mograbi described as good designs for process characterization. But this is not the same as process validation. If you have a process that produces a lot of units, you will go through a lot of labels during the course of producing a batch. The process needs to be shown to work just as well at the end of the batch as at the beginning. Consider the possibility that the labels coming off of the source roll initially retain a bit of curvature from being on the roll. At the outset, when the roll has its largest diameter, the curvature will be the least, but as you get toward the end of the roll, there will be much more initial curvature. The reliability of the mechanism that picks up the label and transfers it to your individual unit may be affected by this curvature variation. You will only observe this by running the process at full batch size.

David P Norby, PhD, CQE (ASQ) Similarly, if lot- or unit-specific information is printed within the labeling machine somewhere in the process of applying the label, the quality of the printing performance needs to be shown to be as good at the end of the process as at the start.
If your packaging process involves automatic conversion of flat box stock to formed boxes and box inserts and automatic insertion of product and any related documentation, you need to take into account for the potential need to show that each of these steps is robust enough to handle ordinary variation of raw material (e.g., dimensions).
If the product being packaged has sensitivity to light, heat, physical shock or other environmental effects, you will need to include some demonstration that the product is assured sufficiently from such influences that the customer can be highly assured of receiving product that performs to its specifications.

Hany M. EL Debeky I propose to read carefully the FDA guidance document "Process Validation: General Principles and Practices" . it is helpful and illustrative
https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf

Jonathan Wacks Here's a reasonable roadmap:
Assume 10/min heat seal/on the fly printing operation (approx 5,000/shift)
1. Create User Needs and Design Requirements
2. Perform Risk Analysis (DFMEA/PFMEA)
3. Design outer packaging/packing configuration, based on risk/requirements
4. Test final packaging (e.g. ASTM-1A) and verify/validate design
5. Develop heat seal, print and QC processes
6. Run three shifts (8 hour production), and sample min 120 units, run SPC charts for heat seal strength and print quality (or whatever the key control parameters are).
7. Determine control limits and Cp/Cpk values.
Adjust above based on risk, and quantity!