Information
Sterility test isolator

A sterility test isolator is a fully enclosed isolator system specifically designed for carrying out sterility tests in accordance with Ph. Eur. 2.6.1 and USP 71>. The integrated NHP (Nebulised Hydrogen Peroxide) decontamination system – developed in-house by FASTER – completely and reproducibly inactivates all micro-organisms within the chamber prior to each test run. FASTER manufactures the sterility test isolator GloveFAST Aseptic in accordance with EU GMP Annex 1 and ISO 14644 – TÜV SÜD certified for equipment safety and GMP documentation.

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What is a sterility test isolator and what is it used for?

Sterility test isolators are isolator systems in which the interior is decontaminated prior to each test run using atomised hydrogen peroxide – automatically, fully documented and in accordance with validated cycle parameters. The process achieves log₆ inactivation (bioindicators in accordance with EN ISO 11135) and leaves no active residues after the ventilation phase.

Sterility test isolators are used wherever it is mandatory to carry out sterility tests in accordance with Ph. Eur. 2.6.1 in a regulatory-compliant, aseptic Class A (ISO 5) cleanroom environment is absolutely essential – without the need to set up a dedicated ISO Class B cleanroom.

What is NHP technology?

NHP stands for ‘Nebulised Hydrogen Peroxide’. Unlike VHP (vaporised hydrogen peroxide) systems, which vaporise H₂O₂ and therefore require higher concentrations, FASTER NHP technology uses fine aerosol droplets at a lower concentration. The result: uniform wetting of all surfaces, no risk of condensation on sensitive surfaces and reproducible log-6 inactivation. The NHP system is GS-certified by TÜV SÜD – both for equipment safety and for GMP compliance of the qualification documentation. No other manufacturer in this segment offers this dual certification for an integrated H₂O₂ system.

The fully automatic NHP cycle consists of five defined phases:

All cycle parameters (temperature, humidity, H₂O₂ concentration, exposure time) are stored in the integrated PLC control system and can be printed out at any time as a GMP-compliant log or exported to the quality management system. The audit trail complies with FDA 21 CFR Part 11.

How does NHP differ from VHP (vaporised hydrogen peroxide)?

VHP systems vaporise liquid H₂O₂ at elevated temperatures and typically operate at concentrations of 200–1000 ppm. They are effective, but require materials with specific resistance properties and precise temperature control. The FASTER NHP system atomises H₂O₂ at ambient temperature into fine aerosol droplets. The lower operating concentration reduces material stress on seals, gloves and electronic components – whilst maintaining the same microbiocidal efficacy (log 6). The aeration time is shorter, and the overall cycle is more efficient.

How does the sterility test isolator differ from the H₂O₂ and cytostatic isolator?

All three types of isolator use FASTER’s H₂O₂-NHP system – but differ significantly in terms of their primary purpose, pressure operation, regulatory framework and equipment. The following table provides clarity:

When is a sterility test isolator the right choice – and when should an H₂O₂ or cytostatic isolator be used?

The sterility test isolator is specifically tailored to the regulatory procedure for sterility testing in accordance with Ph. Eur. 2.6.1 – featuring an integrated sterility test pump for membrane filtration procedures and a validated H₂O₂ cycle prior to each test run. It completely eliminates the need for a conventional ISO Class B cleanroom for sterility testing.

The general-purpose H₂O₂ isolator, without specific sterility testing equipment, is suitable for aseptic manufacturing processes, fill-and-finish applications and research laboratories. The cytostatic isolator (GloveFAST Cyto Pharma) is a negative-pressure system designed primarily to ensure personal protection – H₂O₂ is optional, not mandatory.

What standards apply to sterility test isolators in the pharmaceutical industry?

Sterility test isolators in GMP-regulated environments are subject to a multi-layered regulatory framework covering not only the isolator system itself but also the decontamination procedure and the test methodology:

• Ph. Eur. 2.6.1: European Pharmacopoeia – Sterility testing. Mandatory methodology for membrane filtration and direct inoculation; isolators are specified as the preferred aseptic environment for sterility testing
• USP 71>: Harmonised procedure (ICH Q4B Annex 8): equivalent to Ph. Eur. 2.6.1 in ICH regions – relevant for manufacturers with US marketing authorisation
• EU GMP Annex 1 (2022): Mandatory requirements for aseptic manufacturing processes and sterility testing. Section 10.6: Sterility testing must be carried out under aseptic conditions – isolators are the preferred solution
• EN ISO 11135: Validation of sterilisation processes for medical devices – applicable to H₂O₂ decontamination cycles for the validation of microbiocidal efficacy (log 6 reduction)
• ISO 14644-1: ISOClass 5cleanroom in the isolator’s working area – complies with EU GMP Class A
• FDA 21 CFR Part 11: Electronic records and signatures – all FASTER isolators store cycle logs in compliance with this US requirement
• TÜV SÜD GS certification: Equipment safety of the NHP-H₂O₂ system and GMP compliance of the qualification documentation – unique in the sterility test isolator segment
• DIN 12980:2017 / EN ISO 14644-7: Design and performance requirements for safety cabinets and isolators

FASTER provides complete qualification documentation for all GloveFAST models: DQ, IQ, OQ, PQ, FAT (Factory Acceptance Test) and SAT (Site Acceptance Test) – in German and English, ready for direct integration into existing QM systems.

What sterility test isolators does FASTER offer?

FASTER offers sterility test isolators in two main designs – as a fully integrated sterility test system with an integrated test pump, and as a universal aseptic isolator with an optional sterility test pump. All models can be fitted with the optional rapid decontamination airlock for accelerated material transfer.

GloveFAST Aseptic Sterility Test – the specialised sterility test isolator
The GloveFAST Aseptic Sterility Test is the version of the GloveFAST Aseptic optimised for sterility testing in accordance with Ph. Eur. 2.6.1. Before each test run, the integrated NHP system automatically performs a validated decontamination cycle. The integrated sterility test pump enables membrane filtration tests to be carried out directly within the closed isolator – without disrupting the aseptic environment. This variant completely eliminates the need for a conventional ISO 5 cleanroom for sterility testing.

Optional features: Rapid decontamination airlock for accelerated material transfer with decontamination verification, SIEMENS HMI touch panel, audit trail (FDA 21 CFR Part 11 compliant), remote access function.

GloveFAST Aseptic with optional sterility test pump – the universal isolator
The GloveFAST Aseptic is the flagship of the FASTER aseptic range. The fully integrated NHP system performs automatic decontamination cycles before aseptic processes are initiated. Overpressure operation (+80 to +120 Pa) protects the product from external contamination. A sterility test pump can be integrated as an option. The system is TÜV SÜD GS-certified – both for equipment safety and for GMP compliance of the qualification documentation (DQ, IQ, OQ, PQ).

In which areas are sterility test isolators used?

FASTER sterility test isolators are used wherever sterility testing in accordance with Ph. Eur. 2.6.1 must be carried out under regulatory-compliant, reproducible conditions:

• Pharmaceutical quality control: Routine sterility testing of sterile medicinal products prior to batch release – membrane filtration and direct inoculation carried out directly within the sealed isolator
• Hospital pharmacies: Testing of patient-specific sterile preparations (e.g. parenteral preparations, eye drops) under aseptic conditions without the need for a dedicated Class B cleanroom
• Contract Research Organisations (CROs): Sterility testing as a service for pharmaceutical manufacturers – validated environment, GMP-compliant documentation, reproducible results
• Medical device manufacturing: Sterility testing of medical devices in accordance with ISO 11737 in a validated aseptic environment
• Research & Development: Sterility testing for investigational medicinal products and biologicals in pre-clinical and clinical development
• Veterinary medicine & diagnostics: Sterile handling of biological samples where cross-contamination and sample contamination must be ruled out