南宫NG28

Clean room facilities and system verification

CTI provides you with pharmaceutical clean plant facilities and system validation, water system validation and cleaning validation services. We can perform GMP validation of water system (purified water, water for injection, etc.), clean plant facilities (air-conditioning system, clean room, etc.), and cleaning process of production equipment in accordance with the requirements of the GMP regulations and guidelines, and we have independent microbiological and chemical laboratories in compliance with the requirements of the GMP, as well as a professional We have an independent microbiology and chemistry laboratory complying with GMP requirements and a professional GMP verification team.

Clean Plant Facilities and System Validation

CTI provides different levels of air conditioning system (HVAC) and clean room environmental performance validation services according to the requirements of ISO14644, GB/T16292, GB/T16293, GB/T16294, GB 50457, GMP regulations/guidelines, etc., in order to prove that the clean room (area) can consistently comply with the standards under the normal operating methods and process conditions.

Production Facility/Equipment Cleaning Verification

CTI provides validation services of the cleaning process and its effects in accordance with GMP regulations and guideline requirements, in conjunction with the cleaning methods of production equipment and production lines to ensure the effectiveness of the cleaning methods and to avoid cross-contamination.