High Efficient Sterility Test Isolator Clean Environment Examination

high efficient clean environment examination sterility test isolator sterility test isolator

PVC sterility test isolator.pdf

The aseptic isolation system is specially designed and manufactured for medical and health care products according to the requirements of Good Manufacturing Practice (GMP).

And a barrier system that requires a higher level of environmental control protection. This system can prevent product contamination and protect the operator's safety and avoid toxic substances. Provides perfect environmental control technology solutions for sterility testing, aseptic processing and protection against highly sensitizing and toxic drug production. The PDA recommends that the following definitions of isolation systems be adopted by the healthcare industry worldwide:

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;