Information
H₂O₂ isolator

An H₂O₂ isolator is a fully enclosed isolator system equipped with an integrated hydrogen peroxide decontamination system (H₂O₂, also abbreviated to ‘h2o isolator’). The nebulised hydrogen peroxide – implemented by FASTER as the NHP system (Nebulised Hydrogen Peroxide) – completely and reproducibly inactivates all microorganisms within the interior before aseptic processes commence. FASTER manufactures H₂O₂ isolators 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 an H₂O₂ isolator and what is it used for?

H₂O₂ isolators are isolator systems in which the interior is decontaminated prior to the start of each process using atomised or vaporised hydrogen peroxide – automatically, fully documented and in accordance with validated cycle parameters. This method is far superior to manual wiping with disinfectants: it reaches all surfaces evenly, achieves log-6 inactivation (bioindicators in accordance with EN ISO 11135) and leaves no active residues after the ventilation phase.

H₂O₂ isolators are used wherever validatable, residue-free decontamination is absolutely essential – in particular in the aseptic manufacture of sterile medicinal products, in sterility testing in accordance with Ph. Eur. 2.6.1 and in GMP-regulated fill-and-finish processes.

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 the strain on materials such as 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 H₂O₂ isolator differ from the sterility test isolator and the cytostatic isolator?

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

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

An H₂O₂ isolator without specific sterility testing or cytostatic equipment is suitable for aseptic manufacturing processes, fill-and-finish applications and research laboratories that require validated decontamination but do not carry out mandatory sterility testing in accordance with the European Pharmacopoeia and do not work with CMR substances. It is the most versatile system in the GloveFAST range.
The Sterility Test Isolator, on the other hand, is specifically tailored to the regulatory procedure for sterility testing – featuring an integrated sterility test pump and a validated H₂O₂ cycle prior to each test run. The cytostatic isolator (GloveFAST Cyto Pharma) is a negative-pressure system designed primarily to ensure personal protection – H₂O₂ is optional here, not mandatory.

What standards apply to H₂O₂ isolators in the pharmaceutical industry?

H₂O₂ isolators in GMP-regulated environments are subject to a multi-layered regulatory framework covering both the isolator system itself and the decontamination process:

• EU GMP Annex 1 (2022): Mandatory requirements for aseptic manufacturing processes. Isolators with validated H₂O₂ decontamination are the preferred system for aseptic fill-and-finish processes in accordance with the revised Annex 1
• 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: Cleanroom class ISO 5 in the isolator’s working area – equivalent to 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 this market 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, and directly integrable into existing QM systems.

What H₂O₂ isolators does FASTER offer?

FASTER offers H₂O₂ isolators in two main configurations – as a fully integrated standard aseptic system and as a specialised sterility test isolator. All models can be fitted with the optional rapid decontamination airlock for accelerated material transfer.

GloveFAST Aseptic with integrated H₂O₂ NHP system – the universal H₂O₂ isolator
The GloveFAST Aseptic is the flagship of the FASTER H₂O₂ 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. The system is TÜV SÜD GS-certified – both for equipment safety and for GMP compliance of the qualification documentation (DQ, IQ, OQ, PQ).

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

GloveFAST Aseptic Sterility Test – H₂O₂ isolator for Ph. Eur. 2.6.1
The GloveFAST Aseptic variant optimised for sterility testing. Before each test run, the NHP system automatically performs a validated decontamination cycle. The integrable sterility test pump enables membrane filtration tests to be carried out directly within the closed isolator – without disrupting the aseptic environment. This version completely eliminates the need for a conventional ISO 5 cleanroom for sterility testing.

In which areas are H₂O₂ isolators used?

FASTER’s H₂O₂ isolators are used wherever validatable, residue-free decontamination of the work area prior to the start of the process is required by regulations or is beneficial in terms of quality:

• Aseptic pharmaceutical manufacturing: fill-and-finish processes for parenteral preparations, eye drops, ampoules and pre-filled syringes in accordance with EU GMP Annex 1
• Sterility testing: Conducting sterility tests in accordance with Ph. Eur. 2.6.1 without a conventional cleanroom – more efficient, space-saving and GMP-compliant
• Research & Development: Aseptic laboratory work with biological samples, cell cultures or pathogenic microorganisms, where validatable decontamination is required between experiments
• Hospital pharmacies: Preparation of patient-specific sterile formulations (e.g. parenteral preparations, eye drops) under aseptic conditions
• Veterinary medicine & diagnostics: Sterile work with biological samples where cross-contamination must be ruled out
• Medical device manufacturing: Aseptic packaging and testing of medical devices in accordance with ISO 13485