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Ms. Jan Gates

PackWise Consulting

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PackWise Consulting
Work: (650) 743-5780

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1 to 15 of 15 total

RE: Sea freight in your supply chain

Posted By Jan Gates 02-16-2026 08:00 PM
Found In Egroup: MDPTC \ view thread
Did you get an answer? There were multiple talks and papers on ocean cargo shipment by or from ISTA. ISO 4180 Packaging - Complete, filled transport packages - General rules for the compilation of performance test schedules includes references to ocean cargo shipping. ------------------------------ ...

RE: ASTM D7611/D7611M-20 Standard Practice for Coding Plastic Manufactured Articles for Resin Identification

Posted By Jan Gates 01-13-2026 08:02 PM
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I wish, but there is a potential $10,000 fine and blacklisting that could occur. ------------------------------ Jan Gates PackWise Consulting WA ------------------------------

ISO Working Groups

Posted By Jan Gates 09-16-2021 02:22 PM
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The USA Technical Advisory Group Lead for the Packaging Technical Committee and Package Testing (ISO 122 and ISO 122/SC03) no longer has a representative to combine the US vote on ISO standards and working groups for the committees. If interested in doing this Lead work, please let the ASTM D10 Chairman, ...

Textured Label

Posted By Jan Gates 09-16-2021 02:15 PM
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Is there a company that can print small labels with texture? I need some with alcohol resistance in a few colors. ------------------------------ Jan Gates PackWise Consulting WA ------------------------------

RE: Medical Device Assurance Levels in Distribution Transportation Simulations?

Posted By Jan Gates 05-14-2019 10:23 AM
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John Chomistek says it well. Depending on the distribution system I have changed assurance levels for the various schedule tests and added tests not included in the D4169 or ISTA test standards but necessary for the packaged product. Justification for the test protocol used is required for medical ...

RE: BOPP Packaging Film Issues

Posted By Jan Gates 03-21-2019 01:36 PM
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Very good point Charlie. That has been an issue I forgot about. ------------------------------ Jan Gates PackWise Consulting CA ------------------------------

RE: BOPP Packaging Film Issues

Posted By Jan Gates 03-14-2019 12:59 PM
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If it is a new supplier of the material, the material thickness or sealant layer may be giving issues. If it is the same supplier the lots should be similar. My experience with similar wrapping products, the same supplier, was static electricity and/or humidity in the area. Nylon can be sticky ...

RE: Peel open distance for pouches in Med Device Packaging

Posted By Jan Gates 10-10-2018 03:14 PM
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Agree with Jennifer, page 3 in ASTM F2599: 6.4.1 Peeled pouch seal characteristics and requirements should be indicated ........ therefore, the performance peel assessment may include: 6.4.1.1 Full pouch length if less than 15 cm [6 in.] long. 6.4.1.2 One half (1⁄2 ) the pouch length if 15 to 45 cm ...

RE: AQL sampling

Posted By Jan Gates 09-14-2018 08:23 AM
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Thank you, Colleen! Your explanation is the best I have seen and makes sense. Now to find out, with my current client, what work was done in the original pharmaceutical development phase and clinical trials -- when existing or new packaging was developed for a product. The testing for the devices ...

AQL sampling

Posted By Jan Gates 08-17-2018 10:07 AM
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I have been a medical device package engineering for many years and am now working several large pharmaceutical companies. My background for sampling is to develop risk assessments around the packaging system User Requirements Specifications for product delivery to a user. This leads to defects of different ...

RE: Package for sharpened steel

Posted By Jan Gates 07-28-2018 10:19 AM
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Depending on the type of metal, the tray and or lid used could allow too much moisture into the package and affect the metal -- oxidation making the sharp edge dull. I have occasionally seen a sharp scratching the coating off a Tyvek lid too, depending on the snap fit of the item into a tray. Usually, ...

RE: Working in Virtual teams

Posted By Jan Gates 07-24-2018 02:51 PM
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I have worked in that situation for several years. A short bio with high points and one "I like to" sentence with a picture helps when starting. Then virtual meetings, whenever possible, to discuss projects or situations seem to help work together - this might be early mornings or late evenings for some ...

RE: Pouch Hang Hole Testing Help

Posted By Jan Gates 06-26-2018 03:30 PM
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I would develop a pull test on an Instron or similar for the hang hole. Then test new and accelerated aged material to see if there is a difference in the hang hole pull force for deformation and break (or stretch to some distance that is reasonable). The amount of pull force tested should show more ...

Medical Devcices

Posted By Jan Gates 06-06-2018 03:02 PM
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Does someone understand why pharmaceutical packaging development processes are so different from medical devices? Examples -- only one PQ needed, PQ needs to be real-time - lab testing is not acceptable, and statistical sampling by ANSI Z4.1 without patient risk understanding. There are many more examples. ...

RE: What do you think about using clarified polypropylene vs. PETG material for medical device thermoformed trays?

Posted By Jan Gates 06-06-2018 10:01 AM
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Yes, you hit some of the high and low points. Two more points to think about...1. recyclability is lower for PP than PETG (though many recyclers complain about PETG). 2. PP is brittle at low temperatures. However, I have heard of good success with shallow trays being used and PP being a better moisture ...