We obtain the sterile components from our suppliers in pouches and kit them with other components into boxes to be sold as final products. We don't alter or remove any of the supplier's sterile barrier packaging but we do remove their secondary/shipper packaging. The suppliers have performed their own ISO 11607 studies. Would it be best for us to conduct an additional distribution study with our kit configuration and shipper, e.g., ISTA 3A or ASTM D4169?
ISO 11607 Distribution Study
- Thread starter suzytan10
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Yes
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