Information
Cytostatic isolator

A cytostatic isolator is a fully enclosed negative-pressure system that reliably protects the user from exposure to highly potent, carcinogenic, mutagenic or reprotoxic (CMR) substances. FASTER develops and manufactures cytostatic isolators in accordance with TRGS 525, DIN 12980 and EU GMP Annex 1 – TÜV NORD GS-certified, fully GMP-qualifiable, for hospital pharmacies, pharmaceutical production and oncology facilities.

Discover isolators

What is a cytostatic isolator and what is it used for?

A cytostatic isolator (also known as a negative-pressure isolator or CMR isolator) is a hermetically sealed work system that is operated continuously under negative pressure. The negative pressure principle ensures that, in the event of a glove failure or a leak, no highly potent substances, aerosols or particles escape into the environment – outside air flows inwards, not the other way round.

Unlike a Class II biological safety cabinet or an open fume cupboard, the cytostatic isolator provides a complete physical barrier: the operator has no direct contact with the work area. All operations are carried out exclusively via integrated glove ports whilst wearing certified protective gloves.

Cytostatic isolators are used wherever complete prevention of exposure to CMR substances is required by law or is essential for quality control – particularly in the preparation of cytostatic drugs in hospital pharmacies, in pharmaceutical HPAPI production and in oncological research.

How does a cytostatic isolator work? The negative pressure principle explained

At the heart of every cytostatic isolator is the active negative pressure system. During operation, a negative pressure differential of −75 Pa to −100 Pa relative to the surrounding room is continuously maintained inside the isolator. This constant negative pressure acts as an invisible safety barrier:

• If a glove is damaged: outside air flows in – no substance can escape.
• When the transfer lock is open: pressure equalisation occurs inwards – no contamination cloud enters the room.
• In the event of a seal failure: the same principle applies – the negative pressure prevents aerosols from escaping.

Unused gloves bulge outwards due to the negative pressure – providing an immediate visual check that the system is pressure-tight. An audible and visual alarm warns of a pressure drop outside the defined range.

HEPA exhaust air system: 100% outdoor air discharge to protect the surrounding environment
100% of the exhaust air from the cytostatic isolator is discharged to the outside via HEPA H14 filters – equivalent to a Type B2 biological safety cabinet system. There is no recirculation of air back into the installation room. This complies with the requirements of TRGS 525 (Technical Regulation for Hazardous Substances in Healthcare Facilities) and DIN 12980 (Laboratory Equipment – Safety Workbenches for the Preparation of Cytostatic Drugs).

The installation room must be connected to the isolator’s HEPA outlet via a suitable exhaust air system. FASTER provides advice on the design of the room-side connection system.

Transfer airlocks: Safe transfer in and out without risk of contamination
Materials are transferred into and out of the isolator via integrated transfer airlocks. The airlocks operate using pressure-equalisation cycles: before the inner airlock flap can be opened, the outer one must be closed and the negative pressure in the airlock chamber restored. This cascade principle prevents a direct air path between the interior and the surrounding environment.

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 high resistance 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 cytostatic isolator differ from the H₂O₂ and sterility test isolators?

All three types of isolator in the FASTER GloveFAST range offer the highest level of containment safety – yet they differ fundamentally in terms of their intended use, pressure operation, exhaust air management and regulatory framework. The following table provides clarity for system selection:

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

The cytostatic isolator (GloveFAST Cyto Pharma) is the right choice when the primary protection requirement is to prevent exposure to toxic, mutagenic or carcinogenic substances – rather than to maintain sterile conditions for the product. Typical applications: preparation of cytostatic drugs in hospital pharmacies, HPAPI synthesis in pharmaceutical production, and handling of radioactively labelled compounds.

The H₂O₂ isolator (GloveFAST Aseptic) is the right choice when the priority is validatable decontamination prior to aseptic processes – e.g. fill-and-finish, parenteral drug manufacture or research laboratories handling biological samples without CMR hazards.

The sterility test isolator is the right choice when sterility tests in accordance with Ph. Eur. 2.6.1 need to be carried out and a full ISO 5 cleanroom is to be replaced or supplemented for this purpose.

What standards and certifications apply to cytostatic isolators?

The use of cytostatic isolators is subject to a strict regulatory framework that governs both the protection of the operator and GMP compliance of the manufacturing process:

• TRGS 525 – Technical Regulation on Hazardous Substances: Mandatory protective measures for handling hazardous substances in healthcare facilities. TRGS 525 requires the use of suitable, technically tested protective equipment when preparing cytostatic drugs – the isolator is the technically superior solution compared to safety cabinets.
• DIN 12980:2017 – Laboratory equipment: Safety fume cupboards for the preparation of cytostatic drugs. Defines minimum requirements for air flow, HEPA filtration, exhaust air extraction and airtightness for cytostatic drug containment systems.
• TRGS 818 / GESTIS: Limit values and assessment criteria for hazardous substances in the workplace. Authoritative for risk assessment in accordance with the GefStoffV.
• EU GMP Annex 1 (2022): The requirements of the revised Annex 1 apply to cytostatic isolators in GMP-regulated facilities (e.g. hospital pharmacies, pharmaceutical manufacturers). The isolator must ensure ISO Class 5 (EU-GMP Class A) within the working area.
• ISO 14644-1 / ISO 14644-7: Cleanroom classification and requirements for containment devices. FASTER cytostatic isolators achieve ISO Class 5 or better in the working area.
• EN ISO 10648 (Parts 1 & 2): Design and leak testing of glove boxes. Regular leak testing of the gloves is mandatory in accordance with ISO 10648-2.
• TÜV NORD GS certification: Equipment safety of the GloveFAST Cyto Pharma – confirms the negative pressure containment system, HEPA exhaust air ducting and mechanical safety.

FASTER provides comprehensive qualification documentation for all GloveFAST models: DQ, IQ, OQ (PQ on request), FAT and SAT – in German and English, ready for direct integration into existing quality management systems.

What features does a FASTER cytostatic isolator have, and what accessories are available?

FASTER cytostatic isolators are manufactured from high-quality stainless steel (AISI 316L) with rounded, cleaning-optimised internal contours. The modular design allows for complete adaptation to the facility’s structural and process requirements.

Standard equipment GloveFAST Cyto Pharma:

• AISI 316L stainless steel housing with a closed surface (RA ≤ 0.8 µm), optimised for cleaning
• Active negative pressure system (−75 to −100 Pa), continuously regulated and monitored
• HEPA H14 filtration of exhaust air (100% fresh air supply, no recirculation)
• Integrated transfer airlock system (cascade pressure principle)
• Glove port system with GMP-certified butyl/neoprene gloves (various sizes)
• Touch control panel with pressure monitoring, alarm management and status display
• Energy-efficient LED lighting, low-shadow daylight spectrum
• Safety glass viewing window (laminated safety glass, shatterproof)

Optional extras:

• NHP module (Nebulised Hydrogen Peroxide): Retrofittable H₂O₂ decontamination system for validatable sterilisation between preparation cycles.
• Easy Click system: Quick , contamination-free glove change without opening the system – based on the FASTER patent, TÜV-certified.
• Glove testing system: Automated glove leak testing in accordance with ISO 10648-2 – for GMP-compliant routine logging.
• Lead shielding: For radiopharmacy and nuclear medicine applications (radiation protection in accordance with the Radiation Protection Ordinance).
• Iso-Footrest and ergonomic height adjustment: For sustained ergonomic working whilst standing or seated.
• Arm cuffs: Extended arm protection for deeply recessed work areas.
• Remote access interface: Remote monitoring of pressure, alarms and filter status – for centralised building automation or external service management.
• Audit trail (compliant with FDA 21 CFR Part 11): Complete electronic logging of all operating parameters for GMP documentation.

In which areas are cytostatic isolators used?

FASTER cytostatic isolators are used in all areas where CMR substances are handled and the highest level of protection for the operator is required:

• Hospital pharmacies and oncology facilities: preparation of patient-specific cytostatic formulations in accordance with the German Medicines Act (AMG), the Pharmacy Operating Regulations (ApBetrO) and TRGS 525. The cytostatic isolator is the only solution that enables complete body protection without the need for special protective clothing.
• Pharmaceutical HPAPI production: synthesis , formulation and filling of highly potent active pharmaceutical ingredients (HPAPI, OEB 4–5) under GMP conditions.
• Radiopharmacy and nuclear medicine: Manufacture and handling of radioactively labelled compounds (e.g. ¹⁸F-FDG, Lu-PSMA). Special versions of the GloveFAST Cyto Pharma are available with lead shielding for radiation protection.
• Oncological research and pre-clinical studies: Working with cytotoxic substances in research laboratories, animal testing facilities and CROs (Contract Research Organisations).
• Veterinary medicine: Preparation of veterinary cytostatic agents – a growing sector with increasing regulatory requirements.
• Industrial chemistry and specialised processes: Handling highly toxic, pyrophoric or mutagenic substances where a hermetic containment system is required.