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Status:Closed    Asked:Nov 30, 2012 - 12:30 PM

what's the requirment if we want to certify the 7E LAB.

hi,we are a chinese company focus on pharma shipping,we would like to certify the 7E lab.

can you please provide some information about:

1)what's the equipment needed? any recommended Brand,Model,Specification

2)any requirment on area,people

3)what's the standard and procedure?

4)how long it will took usually.


Apperciated for your early reply.

thanks!

 
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Answers

Hello,


The following webpage lays out the certification process step-by-step (including pricing). Click here.


The use of ISTA Standard 14 is required to become an ISTA Certified Thermal Transport Laboratory. Standard 14 provides the minimum requirements for thermal transit packaging laboratories to receive ISTA certification to perform ISTA thermal transit testing procedures and for those laboratories to be approved to designate specific packaging solutions as “certified” per applicable ISTA published standards, ISTA 7E.


This standard establishes the minimum criteria to be met for thermal transit packaging laboratories to become ISTA certified in the areas of laboratory processes and procedures, as well as equipment qualification.

Specific areas covered include: quality manuals, material handling; calibration, preventative maintenance, equipment qualification and re-qualification, training, document control, operating procedures, quality management system, data integrity and storage and data management files.


Equipment required includes an atmospheric chamber and instruments used for measuring, monitoring and recording temperature calibrated against NIST traceable standards with stated measurement uncertainties. The thermal laboratory shall have at least one employee who has attained Certified Thermal Professional Level II status.

Source: ISTA Staff

 

Nov 30, 2012 - 12:30 PM

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