中文

Based on in-depth analysis and understanding of pharmaceutical products of the client and related contamination risk, AUSTAR pharmaceutical process contamination control application is committed to providing clients with compliant and customized solutions for contamination control strategy and professional validation service for decontamination effect. AUSTAR also designs and builds the continuously verified and improved sterility quality assurance system that meets the latest ISPE C&Q requirement to realize effective control of microbial contamination, process residues, particulate contamination and cross-contamination of pharmaceutical process and reduce contamination risk. 

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Clean Room Contamination Control Application

Based on the requirement and risk of pharmaceutical clean environment, the application provides clients with life cycle application solutions for cleaning and disinfection of the clean room from design of cleaning and disinfection program for non-product contact surface, disinfectant selection, cleaning tools selection, disinfectant efficacy testing, disinfectant rotation strategy guidance and clean room cleaning maintenance etc. At the same time, the system solution, based on personnel protection and the risk of cross contamination under pharmaceutical aseptic manufacturing environment,  provides the clients with the cleanroom microbial control strategy and the validation service of sterile garment, so as to help the clients achieve continuous and stable clean environment required by pharmaceutical production and effectively avoid the cross contamination in the process of pharmaceutical production under the conditions of clean production.

Process System Contamination Control Application

Based on in-depth understanding of drug life cycle and comprehensive assessment of the risk of contamination for pharmaceutical process, the application, aiming at process residues and other system contaminations during the pharmaceutical process, provides pharmaceutical clients with development of CIP and COP process technical parameters based on QbD design concept and customized applications such as cleaning verification, system de-rouging and de-biofim. At the same time, one-stop integrated solutions including moist heat sterilization process design, parameters development, sterilization efficiency and performance qualification and effect verification of steam sterilization indicator conforming to the requirements of the latest Chinese pharmacopoeia are provided to the client , helping clients achieving cleaning and sterile assurance for pharmaceutical production process and establishing the compliant and effective control & management system for microbial, particulate and cross contamination to reduce contamination risk based on the risk and control strategy and the continuous improvement perspective.