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AT A GLANCE A leading pharmaceutical manufacturer launched a new site in Durham, North Carolina, dedicated to producing injectable drug products. As part of this greenfield project, the client needed to validate their parts washers used to clean reusable components essential to sterile production. Performance Validation (PV) provided hands-on execution support for the cleaning validation […]
Read MoreCategory: Cleanroom
Ensuring EU Annex 1 Compliance with Expert Room Recovery Testing for a Pharmaceutical Manufacturer
AT A GLANCE A large pharmaceutical manufacturer in Indianapolis, IN, partnered with Performance Validation (PV) to validate that its air handling systems in classified cleanroom airlocks effectively removed airborne particles, ensuring compliance with the updated EU Annex 1 requirements. Performing Room Recovery Testing for Air Handling Systems Performance Validation (PV) was tasked with verifying that […]
Read MoreTailored Room Recovery Testing Solutions for CDMO Cleanroom Compliance
At A Glance An Indianapolis-based contract development and manufacturing organization (CDMO) for injectable pharmaceutical manufacturing partnered with Performance Validation (PV) for cleanroom recovery testing. During a client’s compliance audit relating to ISO 14644 and EU Annex 1 requirements, the CDMO realized they lacked proper testing documentation demonstrating room recovery requirements. This discovery led to the […]
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