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Status:Closed    Asked:May 14, 2014 - 12:02 PM
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JY

Can you list some key points in selecting a test lab?

Is there a guidelines for selecting a test lab? This is to test insulated packaging system for both thermal and physical. System is use to ship pharmaceutical product.

 
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Hi There, to select a suitable test lab I would have the following point you need to look at


1. What standard/protocals of your test requirment

2. What test items/element have been included in the required protocal/standard

3. Check with your familiar labs to see whether they can take all the tests items you need to do with equipment/instrument.

4. find whether the lab(s) you have picked up have the certifications to what your test needs


No much ideans for FDA test doc. but for the medical devices, other words, the sterilised materials/products, the ref. packaging test doc. will be ISO-11607 part 1 and the guidnace doc. for ISO 11607 would be ISO16775 whcih has more detailed guidance for how you can operate with the ISO-11607 correctly. in the ISO-11607, it recgonized ASTM D4169, ISTA 1, 2 and 3 series as well ISO 4180-1.Wish this is helpful.

 

May 20, 2014 - 12:22 AM

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