Isolators
Sterility test isolators
GloveFAST Aseptic with integrated H₂O₂-NHP system - TÜV SÜD-certified, GMP-compliant, ready for use
The FASTER GloveFAST Aseptic is a highly specialised sterility test isolator designed specifically for use in aseptic testing, filling processes and microbiologically controlled workflows. Thanks to the fully integrated NHP (Nebulised Hydrogen Peroxide) decontamination system, it offers maximum product safety, complete separation of operator and product as well as validated decontamination cycles - reproducible and documentable at all times.
The H₂O₂ system is GS-certified by TÜV SÜD and therefore fulfils the highest requirements for product safety and process stability. In addition, all qualification documents (DQ, IQ, OQ, PQ) are GMP-certified by TÜV SÜD - an indispensable basis for official recognition in both licensed and unlicensed pharmaceutical facilities, laboratories and research centres.
We offer a range of standard isolators as well as customised isolators, all with fully integrated hydrogen peroxide bio-decontamination systems.
H₂O₂ decontamination - fast, safe, validated
The innovative NHP system from FASTER enables the implementation of customised bio-decontamination cycles with nebulised hydrogen peroxide, ideal for use in GMP-regulated environments. The entire cycle - consisting of gassing, contact time and aeration - can be centrally controlled, precisely documented and reproduced at any time.
For even greater efficiency and flexibility, the isolator can be equipped with an optional rapid gassing lock. This allows materials and samples to be introduced quickly - with guaranteed proof of decontamination before the process begins.
An optional feature that can be integrated is the sterility test pump directly in the working chamber. It allows microbiological sterility tests to be carried out inside the sealed isolator - contamination-free and documented.
Typical areas of application
- Sterility tests according to pharmacopoeia (e.g. Ph. Eur., USP)
- Aseptic filling processes for small production batches
- Terminally sterilised enclosures for packaging and transport
- Production of sterile dosage forms and investigational medicinal products
- Research and development in microbiologically sensitive areas
System benefits at a glance
- GS-certified H₂O₂ system from TÜV SÜD - tested safety and efficiency
- GMP-compliant qualification documents (DQ, IQ, OQ, PQ) - certified by TÜV SÜD
- Closed system with ergonomic glove ports for safe handling
- HEPA or ULPA filter for cleanliness class ISO 5 or better
- Flexible pressure control: positive pressure (product protection) or negative pressure (personal protection)
- Complete cycle control and data logging
- Quick gassing lock optionally available
- Sterility test pump can be integrated
- Cleanroom-compatible materials (e.g. AISI 316L stainless steel)
- Modular design - adaptable to customer-specific requirements
Validation & authorisation - professionally supported
For each GloveFAST Aseptic, we offer a comprehensive, GMP-compliant validation package that is internationally recognised:
- Design Qualification (DQ) - documentation of the system design
- Factory Acceptance Test (FAT) - testing and approval prior to delivery
- Installation Qualification (IQ) - documented commissioning at the place of use
- Operational Qualification (OQ) - Functional test under operating conditions
- Performance Qualification (PQ) - Optional support from our experts
All documents are available in German or English and can be integrated directly into your quality management systems.
