Sterility test Isolator
At present, Isolation technology has become very common in the pharmaceutical industry, and the numbers of the sterility test isolator and production isolator continues to grow at a fairly rapid rate. The technology is considered a major improvement over traditional clean rooms.
One of the main benefits derived from using Isolator in the QC laboratory is the avoidance of if false positive and the resultant product waste. The reduction of false positives has increased staff confidence and has also decreased operational cost, especially for those involved with pharmaceutical manufacturing of costly aseptically filling products. Achieve isolation of the operation mainly adapts RTP, transfer chamber and split butterfly valve.
What are Laboratory Sterility test Isolator like?
Considering the maintenance and service life, people will choose Isolator composed of stainless steel and toughened glass which is a hard wall structure. The internal environment is dynamic class A and unidirectional airflow. Use gloves for operation. They are relatively closed systems in which the incoming and exhaust air is filtered by HEPA, positively pressurized, and adapts hydrogen peroxide sterilization which it is up to a 6-log spore killing level to reach a sterile internal environment. Siemens PLC system for full automatic monitor of pressure, air speed, sealing pressure and other parameters, integrated display of hydrogen peroxide concentration, and with a loss of pressure alarm function.
Here attached the contrast list between traditional sterile room and Geevo sterility test Isolator.
Regulations and Guidelines
1. USP <1208> Sterility testing - Validation of isolator systems
2. European Pharmacopoeia 2.6.1. Sterility
3. 2015 Chp 9206Validation guidelines for isolation systems for sterility tests
4. PDA TR 34 on Design and Validation of Isolator Systems for the manufacturing and testing of Health care Products
5. UK Isolators for the aseptic preparation of Pharmaceuticals