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What Environment Is Required For Sampling Primary Packaging Materials For Non-sterile Products? Can They Be Sampled In The Warehouse? |
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Answer» CLAUSE 3.9 also describes the physical requirements for the area being used to sample primary packaging material for non-sterile products. As product contact components, primary packaging materials should be sampled within an ENVIRONMENT that adequately protects the packaging from contamination. The standard of AIR quality is optional and HVAC is not expected. However, SAMPLING of primary packaging materials in an open warehouse WOULD not be allowed. Clause 3.9 also describes the physical requirements for the area being used to sample primary packaging material for non-sterile products. As product contact components, primary packaging materials should be sampled within an environment that adequately protects the packaging from contamination. The standard of air quality is optional and HVAC is not expected. However, sampling of primary packaging materials in an open warehouse would not be allowed. |
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