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Validation of GMP Utility System

GMP (Good Manufacture Practice) utility systems include water supply and drainage system, process water, electricity, automation, air purification, compressed air, steam, chilled water, vacuum and inert gas systems. These systems play a very important role in production, or create a comfortable and clean environment for production, or provide the necessary heat (cold) for each production operation process, brake support, or directly generate material supply into production. GMP is a set of effective advanced scientific management system, especially plays an important role in eliminating the pollution, confusion and errors in the production process of drugs, and ensuring product quality.

Our Advantages

A team led by professional scientists and data reports that meet the registration requirements of various countries

Our core members have more than 20 years of work experience, proficient in domestic and international clean environment applicable standards

Laboratory personnel and pathogen handling personnel are scientists with specific training and advanced training

Equipped with GMP public system verification instruments such as ultra-clean workbench, biological safety cabinet, microbial detector, dust particle counter, plankton sampler, compressed air sampling system, etc.

Comparison of Global Clean-Room Testing Projects

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Current Regulations and Guidelines for Validation of GMP Utility System

《药品生产质量管理规范(2010年修订)》

AEME, BPE-2009, Bioprocesing Equipment

ASME, B31.3-2006 Process Piping

ASTM, A380-99(2005), 不锈钢零件、设备和系统的清洗、除垢和钝化

ASTM, A967-01, 不锈钢零件的化学钝化处理

ISO 8573-1 ~9, Compressed air

ISO 14644-1~9, Cleanrooms and associated controlled enviroments

GB50073-2013;GB 50591-2010;GB/T 16292-2010;GB/T 16293-2010;GB/T 16294-2010...

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