Freeze drying sterile testing isolator MIS1800C

Freeze drying sterile testing isolator MIS1800CApplication:

A sterile isolation system used for aseptic filling, sampling, inspection, freeze-drying, liquid preparation and other operations.

Freeze drying sterile testing isolator MIS1800CFeatures:

•Positive pressure vertical unidirectional flow design; According to the requirements of the Chinese Pharmacopoeia, the isolator needs to be a unidirectional laminar flow. Greatly reduce the probability of cross contamination occurring. And the uniformity of airflow distribution is better, greatly ensuring the sterilization effect of hydrogen peroxide.

•Built in vaporized hydrogen peroxide sterilization system; Adopting dry sterilization technology, using“flash evaporation'The method can effectively penetrate high-efficiency air filters and achieve biological indicatorslog6Microbial decay occurs without any form of condensation.

•Excellent sealing performance;GPPIStrictly following international standards for leak rate testing can achieve≤0.5%Vol/hrEven lower, excellent sealing greatly ensures the sterile retention inside the equipment, while ensuring the safety of personnel and the environment.•Excellent integration ensures the smooth and stable operation of all integrated components. It can integrate environmental monitoring devices such as particle counters and microbial samplers, operate through touch screens, and provide functions such as storage, electronic output, or printing of sterilization data and environmental monitoring data reports according to different customer needs. The design of the control system can meet the requirements of Good Automation Production Practice Guidelines (GAMP 5) and 21 CFR Part 11 for electronic records and electronic signatures.

•Provide professional hydrogen peroxide sterilization cycle development and validation services; According to the actual process, while ensuring the sterilization effect, sterilization parameters can be optimized and the sterilization cycle can be shortened to save users validation costs and time costs.

•Provide high-quality after-sales service; Having a team of professional and experienced engineers, with an average of5There are multiple experienced isolator engineers with over years of experience in safety, commissioning, maintenance, and repair of similar projects, who can quickly solve after-sales problems for customers. Consumables accessories, supplied by localized manufacturers, can be quickly replaced for customers. Training can be provided to operators to ensure independent operation of equipment, and equipment maintenance personnel can be trained to repair common equipment faults and maintain them according to the required maintenance methods.