Tyvek Pouch Seal - Visual Inspection

N

Nimrod81

#1
I want to write an internal inspection procedure for the visual inspection of flexable (Tyvek) seals. I'm using the ASTM F1866/F1866M-9 as a reference standard and would like some advice or possibly a sample procedure - I'm looking to spec. conditions such as channels, wrinkles/foldovers, overseald areas, seal width, etc. - do i need to include pictures of acceptable and unacceptable conditions or can I get away with verbal descriptions? I think what I'm looking for primarily are ideas and opinions on what visible conditions to spec. and how to classify....

Thanks
 
Last edited by a moderator:
Elsmar Forum Sponsor
D

DrM2u

#2
I would suggest that you use as many pictures as and as few words as possible. Why? Because:

:evidence: - You can arrange pictures on multiple pages and create a flow of the tasks involved, acceptable criteria, how to inspect, etc.

:evidence: - Pictures help overcome any language or educational barriers. This is more true in multi-cultural organizations or in areas where education is a commodity or not a priority

:evidence: - People are more prone to 'read' pictures than words. Think about when you pick up a magazine and don't have much reading time available. What do you do first? Do you look at the pictures and see what grabs your attention or do you start reading the articles?

I like to ask the operators to demonstrate and pose while creating visual work instructions. They seem to take a lot more pride in and pay more attention to their work when they see themselves in the pictures. I also like to create separate visual aids with examples of acceptable parts and defects encountered over time.:read:

I am sure there are many more reasons to push for visual over written instructions and other fellow posters will expand on this. That's my :2cents: on this for now.
 

Michael Malis

Quite Involved in Discussions
#3
I want to write an internal inspection procedure for the visual inspection of flexable (Tyvek) seals. I'm using the ASTM F1866/F1866M-9 as a reference standard and would like some advice or possibly a sample procedure - I'm looking to spec. conditions such as channels, wrinkles/foldovers, overseald areas, seal width, etc. - do i need to include pictures of acceptable and unacceptable conditions or can I get away with verbal descriptions? I think what I'm looking for primarily are ideas and opinions on what visible conditions to spec. and how to classify....

Thanks
Visual aids are great! However, you can't get a good sense of package integrity just with visuals...

So the major Q that you need to answer - how you verify that package integrity is acceptable? Foldovers, seal width, wrinkles, channels, etc. does provide the overview, but can't find pin size holes...
 
A

arios

#4
I like to ask the operators to demonstrate and pose while creating visual work instructions. They seem to take a lot more pride in and pay more attention to their work when they see themselves in the pictures. I also like to create separate visual aids with examples of acceptable parts and defects encountered over time.:read:
I liked this idea very much, thanks for sharing!
 
B

Bill Goss

#6
I think a picture is worth 1,000 words, so my position is visual inspection accept/reject criteria can be much better done with photos. Is there any reason why you want to use words rather than photos showing acceptable versus rejectable conditions?
 

somashekar

Staff member
Super Moderator
#7
I want to write an internal inspection procedure for the visual inspection of flexable (Tyvek) seals. I'm using the ASTM F1866/F1866M-9 as a reference standard and would like some advice or possibly a sample procedure - I'm looking to spec. conditions such as channels, wrinkles/foldovers, overseald areas, seal width, etc. - do i need to include pictures of acceptable and unacceptable conditions or can I get away with verbal descriptions? I think what I'm looking for primarily are ideas and opinions on what visible conditions to spec. and how to classify....

Thanks
Pouch sealing process is perhaps one requiring validation. If you have validated same, then what criteria were used to optimize the process ? Did it include any visual criteria ?
Perhaps this directly will give you the visual inspection criteria, and you may include Ideal / acceptable / not acceptable pictures for helping proper decision making in bulk sealing process. This also would have been derived during your OQ / PQ stage of the validations...
 
N

Nimrod81

#8
Does anyone have a sample "pouch seal visual inspection" procedure? I think what I'm after most, are pictures of pouches/seals that have been "deemed" good or bad... or somehow graded.... Visual inspection of seals (acceptance criteria) is somewhat subjective e.g. "oversealed", "nonhomogeneous or undersealed areas, etc. I'd like to see what others have used as guidelines....
 
L

Laura Halper

#9
Way back in the day when I was a production manager for an operation that included sterile packaging, some vigorous discussions arose when there was a "questionable" seal. Pictures can be a great help, especially pictures showing a range of seal characteristics. As Somashekar said, "ideal/ acceptable / not acceptable." The more examples you can show in the gray middle area the better.

Also, in addition to enlisting the help of the operators in collecting samples to be photographed, I suggest asking QC personnel to discuss each sample with operations to get consensus whether each sample is acceptable or not. There is usually no issue with obviously good or obviously defective seals. I found photographs to be most helpful in that in-between area, and this is where you want consensus between production and QC.

Laura
 
D

DesiQE

#10
Nimrod,

Were you able to come up with a visual inspection procedure? Would you mind sharing? I am in the same boat now, as you were a few months back, and would appreciate any criteria used.

Thanks,
DesiQE
 
Thread starter Similar threads Forum Replies Date
N Tyvek Pouch Seal - Pressure needed to conduct Vacuum Seal Leak test? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Validation and Verification - Catheter into a tyvek pouch ISO 13485:2016 - Medical Device Quality Management Systems 2
F Sterile Barrier Package (Tyvek Pouch) Validation Question ISO 13485:2016 - Medical Device Quality Management Systems 7
H Expired packaging material - Expired unused Tyvek pouches Other Medical Device and Orthopedic Related Topics 2
V Tyvek packaging for Medical device process validation Qualification and Validation (including 21 CFR Part 11) 2
M Tyvek Blister Pack Testing Requirements - ISO 11607 Other ISO and International Standards and European Regulations 7
B DuPont plans Engineering Changes for Tyvek 1073B & 1059B - 2011 Other Medical Device and Orthopedic Related Topics 3
D What is your Sterile Medical Device Pouch Peel Strength Spec? Other Medical Device Related Standards 3
B EO Sterilization Indicators on Pouch and/or Carton EU Medical Device Regulations 4
B IVD Internal Label (Pouch) Requirements CE Marking (Conformité Européene) / CB Scheme 1
D Water in sterile pouch from Sterilization? Other ISO and International Standards and European Regulations 2
B Pouch Sealing and Peel Testing Process Improvement ISO 13485:2016 - Medical Device Quality Management Systems 10
Sam Lazzara Bar Sealer vs. Impulse Sealer for Medical Pouch Heat Sealing Qualification and Validation (including 21 CFR Part 11) 4
P ASTM F2054 specification for burst testing on sealed foil & laminate pouch Manufacturing and Related Processes 3
chris1price Sterile Pouch Peel Force of 1 pound/inch width Other Medical Device Related Standards 10
J Validation Sample Size for Tray Seal Qualification and Validation (including 21 CFR Part 11) 3
A Statistic Tools to Know Capability of Sealing Machine for Seal Width Capability, Accuracy and Stability - Processes, Machines, etc. 3
A Packaging seal inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A Capability Analysis for Packaging Seal Strength with spec. >0.1 Kgf using Minitab Using Minitab Software 6
U Measurement of Water in a Seal Groove Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
N Symbol for Medical Device Sterile Packaging - "Inspect Seal Before Opening" Other Medical Device Related Standards 5
M "Streamlining Package Seal Validation" - I'm looking for this article reference Book, Video, Blog and Web Site Reviews and Recommendations 2
AnaMariaVR2 Sartorius launches device to cut and seal single-use tubes US Food and Drug Administration (FDA) 0
R Seal Packaging - Burst and Leak Specifications for a Foil Seal applied to a PTFE well Manufacturing and Related Processes 4
R Pressure Test Seal Surface - To machine or not to machine? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
M ASTM F88 Standard Test Method for Seal Strength - Designation F88-09/M88-09 ver 15.1 Reliability Analysis - Predictions, Testing and Standards 6
K Seal or Logo of gluten-free foods that gluten intolerant people look for Food Safety - ISO 22000, HACCP (21 CFR 120) 7
D Critical quality characteristics on a heat seal machine - Design of Experiments help Quality Tools, Improvement and Analysis 20
ScottK ASME B&PVC Section VIII Div 1 question regarding "Seal" Various Other Specifications, Standards, and related Requirements 0
S Control Plans - Same seal now required by another customer FMEA and Control Plans 1
S Wheel seal testing facility needed Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6

Similar threads

Top Bottom