All Member Forum

All, I am in medical device industry and when I am doing ISTA tests for transportation study of newly developed product, I usually have debate with quality team on why we do not need huge sample size, traditionally compared to our other product posing high risk to patient (while in use), if anything was damaged during shipping, those products may not be used to begin with so I am looking for appropriate source to understand the ISTA sample sizes for this situation? Any leads

Thank you all! 

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Juned Khakhi CPP
Senior Packaging Material
Leica Biosystems
Richmond IL
(316) 516-8048
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The best sample size for ISTA test depends on fragility and hazard of product/s being package. I have always use 10 samples for 6 Series ISTA test methods. The heavier the product the less the samples. 

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Alfred Kipngeno Kirui
Packaging Engineer
Victaulic
Easton PA
(215) 910-5421
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Original Message:
Sent: 05-22-2024 09:30 AM
From: Juned Khakhi
Subject: Sample size for ISTA tests

All, I am in medical device industry and when I am doing ISTA tests for transportation study of newly developed product, I usually have debate with quality team on why we do not need huge sample size, traditionally compared to our other product posing high risk to patient (while in use), if anything was damaged during shipping, those products may not be used to begin with so I am looking for appropriate source to understand the ISTA sample sizes for this situation? Any leads

Thank you all! 

------------------------------
Juned Khakhi CPP
Senior Packaging Material
Leica Biosystems
Richmond IL
(316) 516-8048
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