GMP requires a cleanroom or clean area for pharmaceutical manufacturing. Within the GMP there are further standards for the materials used in the construction of a cleanroom or are compliant with GMP. All materials must be able to withstand frequent cleaning and disinfection. Additionally, materials must be free of cracks, smooth and level, and able to interlock seamlessly. Particulate materials may not be used due to the risk of contamination. Aside from GMP compliance, other factors such as durability, ease of installation, and cost come into consideration when designing a cleanroom. We will guide you through the design process step by step to ensure that both GMP standards, your needs, and your budget are all satisfied.

1) It is crucial to maintain a contaminant-free clean environment when manufacturing medical devices such as biological
implants. This starts with the clean room design and management systems. The clean room design prevents outside contamination, while regular maintenance and sanitation upkeep minimize the risk of contamination originating within the clean room itself.