Standard Sterility Test Isolator
Overview
Photos
Sterility test isolator
The sterility test consists of checking that sterile pharmaceutical products are free from microbial contamination. The isolator consists of :
- The main chamber,
- The SAS,
- The VPHP H2O2 generator,
- The peristaltic pump,
Customised Technical Solution
Static and Dynamic Protection
Quick Installation and Implementation
Easy-to-clean Surface
A modular range
Some modular elements :
- Technical cabinet, Bio-decontamination SAS
- Work chamber 2 gloves, 4 gloves, 6 gloves,
- Exit via SAS entrance or front panel, SAS exit or continuous RTP liner
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Technical specifications
- Camfil H14 filter;
- Tightness class 2 ;
- Manufactured exclusively in 316L stainless steel;
- Optimised cleaning from filter to filter;
- Short bio-decontamination times;
- Unidirectional flow (laminar and non-turbulent) to guarantee Grade A;
- Bio-decontamination by nebulisation SOLIDFOG ;
- Peristaltic pump integration.
Options
- Option 1: Double H14 filtration at intake;
- Option 2: Double H14 filtration on discharge;
- Option 3: Integrated MAS-100 aerobiocollector;
- Option 4: Integrated PMS IsoAir Pro-E particle counter;
- Option 5: Wi-Fi MK glove tester.
A sterility test isolator is essential equipment in the pharmaceutical industry for testing the sterility of products, particularly injectable products. Key features include
- Controlled environment: creates a hermetically sealed environment to prevent contamination.
- HEPA filtration: uses HEPA filters to ensure ultra-clean air.
- Physical barrier: provides separation between operator and product.
- Aseptic handling: equipped with gloves and transfer locks for safe handling.
- Automated control: incorporates automated systems to regulate temperature and humidity.
- Applications: used for sterility testing in the pharmaceutical industry.
- Regulatory compliance: designed to meet pharmaceutical quality standards.
In short, sterility test isolators play an essential role in the quality control of pharmaceutical products, ensuring that products are free from microbial contamination.
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