Pvc Compounding Isolator Sterility Test Isolator In Pharm Industry Bacteria Detection

merck Millipore pvc compounding isolator Single side in pharmaceutical industry

PVC sterility test isolator.pdf

• The system adopts Siemens PLC for control, integrating signals for acquisition, real-time data display, high and low voltage alarm, data record storage and printing functions;
• The hourly leakage rate is ≤0.5%, which guarantees the reliability of product quality and the safety of operators. The test is based on ISO14644-7.2004 and GB/T25915.7-2010 standards;
• Special design systems and configurations can be provided according to different process characteristics and requirements of customers, which are suitable for different batches and process flows;
• The air lock chamber can continuously perform biological decontamination on the surface of the article, avoiding pollution caused by material transfer, and meeting the needs of rapid multi-batch experiments;
• Positive and negative pressure adjustable, can be used for aseptic testing, positive bacteria detection, aseptic sampling (weighing, dispensing), etc.

The isolation system is sealed or has a microbial filtration system (HEPA) that provides air and is self-cleaning. When confined, use only the purified interior surface or use the fast transfer channel for material transfer. When opened, material is only allowed to pass in and out through a specific, designed and verified opening to remove the transfer of contamination. It can be used to isolate active mixtures during aseptic processing or for both sterilization and isolation

2,Parameter

• Hard hatch structure consisting of fully enclosed stainless steel and tempered glass;
• The cabin is welded integrally with 316L stainless steel, and all internal angles of the inner cavity are arc angles, which are convenient for
• Hard hatch structure consisting of fully enclosed stainless steel and tempered glass;
• The cabin is welded integrally with 316L stainless steel, and all internal angles of the inner cavity are arc angles, which are convenient for cleaning and sterilization operations;
• Completely unidirectional airflow mode provides an exceptional aseptic operating area;
• The airflow mode is a vertical unidirectional airflow that quickly eliminates biofouling during ventilation;
• The material door is inflated and sealed, with pneumatic locking and working state interlocking function;
• Integrated or independent hydrogen peroxide sterilization can effectively reduce bioactive substance pollution up to 106;
• Integrated YT-601B/YT-608B aseptic detection system to reduce the occupation of operating space;
• The system adopts Siemens PLC for control, integrating signals for acquisition, real-time data display, high and low voltage alarm, data record storage and printing functions;
• The hourly leakage rate is ≤0.5%, which guarantees the reliability of product quality and the safety of operators. The test is based on ISO14644-7.2004 and GB/T25915.7-2010 standards;

The aseptic isolation system is mainly used for sterility testing of products, which can effectively reduce or eliminate the false positive risk of sterility testing, and ensure the accuracy and authenticity of the sterility testing operating environment and test results. Compared to traditional sterile clean rooms, the isolation system is able to avoid personnel activities, so there is no potential for microbial contamination. The isolator solution simplifies the design of the QC laboratory and is installed in clean areas where no cleanliness is required, saving space and operating costs.