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Container Closure Integrity A Risk-Based Approach To Ensure Drug Product Quality

Container Closure Integrity A Risk-Based Approach To Ensure Drug Product Quality
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Container Closure Integrity A Risk-Based Approach To Ensure Drug Product Quality

Container Closure Integrity A Risk-Based Approach To Ensure Drug Product Quality
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CCIT Solutions For The Pharmaceutical Industry

CCIT Solutions For The Pharmaceutical Industry The quality, safety and effectiveness of drugs significantly depends on their proper packaging.   The quality, safety and effectiveness of drugs significantly depends on their proper packaging: Sterile products and moisture/oxygen sensitive drugs require excellent barrier during the shelf life of the product (up to a couple of years). The key risks for contamination are by humidity, oxygen or microbiological ingress, which can impact the drug stability throughout the product life cycle. To prevent the risks of stability failure integrity tests with a high sensitivity are required. In a study that was published in 2000, the risk in regards to microbiological ingress related to different orifice sizes has been evaluated. As shown in figure 1 the critical leak size is at 0.2 µm, respectively 6·10-6 mbar l/s. This value is widely used as the so-called MALL (maximum allowable leak level).

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