Information
Pharmaceutical isolators
A pharmaceutical isolator (also: glovebox, glove box or isolator system) simultaneously protects the user, the product and the surrounding environment from contamination and hazardous substances in critical working environments. FASTER develops and manufactures pharmaceutical isolators in accordance with international standards (GMP, ISO 14644, EU-GMP Annex 1) – ranging from compact gloveboxes for research laboratories to fully automated production isolators for aseptic pharmaceutical manufacturing.
What is a pharmaceutical isolator and what is it used for?
A pharmaceutical isolator is a fully enclosed, hermetically sealed working system that creates a physical barrier between the operator and the interior of the working area. Unlike open or semi-open laboratory workstations such as biological safety cabinets, the isolator enables complete contamination control: neither hazardous substances nor micro-organisms can escape into the environment – and the ultra-pure atmosphere inside remains unaffected by external influences.
Access to the working area is exclusively via integrated glove ports, to which sterile rubber or plastic gloves are attached. Materials are transferred in and out via transfer locks (airlocks). A defined atmosphere – filtered air or inert gas – can be generated and maintained inside the enclosure.
Pharmaceutical isolators are used wherever complete protection against biological, chemical or microbiological hazards is required – or where the highest standards of cleanliness are essential for sterile products.
How does a pharmaceutical isolator differ from a glovebox?
This question often arises in laboratory practice. Both systems are based on the principle of physical separation – but differ fundamentally in terms of technology, scope of application and validability:
Gloveboxes are fully sealed enclosures without active air circulation or pressure control. They are primarily operated using inert gases (argon, nitrogen, helium) to create a controlled, moisture-free and oxygen-free atmosphere for reactive or sensitive substances. Typical areas of application include battery and semiconductor research, metal powder processing and specialised metallurgy.
Pharmaceutical isolators, on the other hand, feature integrated HEPA/ULPA filtration, controlled air flow and active pressure regulation (positive or negative pressure). They are fully validatable in accordance with GMP, ISO and FDA standards and are suitable for sterile manufacturing processes and the handling of toxic or highly potent substances.
| Feature | Glovebox | Pharmaceutical isolator |
|---|---|---|
| Airflow | No active air circulation | HEPA/ULPA filtration (ISO 5) |
| Pressure control | No active pressure equalisation | Overpressure or underpressure |
| Decontamination | Manual / none | Automated (H₂O₂, VHP) |
| Validation | Limited | Full (GMP, ISO, FDA) |
| Applications | Reactive/sensitive substances | Sterile production, cytostatic drugs, BSL |
| Atmosphere | Inert gas (argon, N₂, He) | Filtered air, optional inert gas |
How does a pharmaceutical isolator work? The principles of negative and positive pressure explained
The operating principle of a pharmaceutical isolator is based on two key mechanisms: the hermetic sealing of the housing and active pressure control. Depending on the application, either negative pressure (a negative pressure differential) or positive pressure (a positive pressure differential) is used.
Negative-pressure isolator – personal protection against toxic substances
When working with radioactive, carcinogenic, mutagenic, reprotoxic or otherwise highly hazardous substances – such as cytostatic drugs or hormones – a constant negative pressure of approximately -80 Pa to -100 Pa is maintained inside the isolator. If outside air enters through a leak or a defect in the gloves, it flows inwards – the hazardous substance cannot escape to the outside. Unused gloves bulge outwards, thereby making the negative pressure visible.
Positive-pressure isolator – product protection in sterile processes
For the aseptic manufacture of sterile medicinal products, parenteral preparations or other processes where purity is critical, a positive pressure of between +80 Pa and +120 Pa is generated inside the isolator. Any leak causes air to flow outwards – meaning that ambient air, particles and germs cannot enter the working area. The ultra-pure, HEPA-filtered air inside is thus maintained.
H₂O₂ decontamination – Validatable sterilisation prior to the start of the process
A key advantage of modern pharmaceutical isolators over traditional cleanroom solutions is their integrated decontamination capability. FASTER isolators are optionally equipped with automated H₂O₂ decontamination systems (also known as VHP, or vapourised hydrogen peroxide). The internal surfaces are fumigated with vapourised hydrogen peroxide before the process begins – a fully validatable and documentable sterilisation method recognised under EN ISO 14937.
Applications and atmosphere: Filtered air or inert gas?
The areas of application for pharmaceutical isolators and gloveboxes range from basic research through to industrial production and nuclear facilities. Depending on the process requirements, the atmosphere inside the isolator is defined on a case-by-case basis:
- Filtered air (HEPA/ULPA): For biological, medical and pharmaceutical applications – e.g. the manufacture of cytostatic drugs, aseptic filling, sterility testing and microbiological research. The air is purified to ISO Class 5 (EU GMP Class A) or better.
- Inert gas (argon, nitrogen, helium): For the processing of substances sensitive to oxygen or moisture – e.g. lithium battery production, halogen lamps, semiconductor manufacturing and specialised metal powder processing. These systems are operated as inert gas systems, often in conjunction with external gas purification systems.
The decision as to which atmosphere is required inside the isolator is closely linked to the material being processed and the intended protection. FASTER advises laboratory planners and process engineers on selecting the appropriate system.
You can reach us for consultation at
+49 (0) 7641-468819-0
Standards and certifications for pharmaceutical isolators
The use of pharmaceutical isolators in the manufacture of medicinal products is strictly regulated. Validation and compliance with standards are not optional features, but fundamental requirements for GMP-compliant operation. The most important applicable regulations are:
- EU GMP Annex 1 (2022): Mandatory requirements for the manufacture of sterile medicinal products. Annex 1 stipulates the highest cleanliness classes for aseptic processes (ISO 5 / EU-GMP Class A in the working area) and expressly recommends the use of isolator technology as a superior alternative to conventional cleanroom technology.
- DIN EN ISO 14644-1: Classification of clean air environments and air cleanliness classes. Pharmaceutical FASTER isolators achieve ISO Class 5 or better in the working area.
- ISO 14644-7: Separative devices (clean-air hoods, gloveboxes, isolators, mini-environments) – standard specifically for separation devices and closed systems.
- ISPE Baseline Guide – Sterile Product Manufacturing Facilities: Industry guideline for the design and validation of sterile production facilities – authoritative for international pharmaceutical engineering.
- EN ISO 10648 (Parts 1 & 2): Requirements for the design and testing of glove boxes, including leak testing.
Important: Pharmaceutical isolators must be qualified (IQ/OQ/PQ) following installation, after any modification and at regular intervals. FASTER offers comprehensive qualification documentation as well as Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
Overview of FASTER isolator features and accessories
FASTER isolators are manufactured from high-quality stainless steel (AISI 316L) and are designed for intensive, continuous operation in pharmaceutical and industrial environments. Their modular design allows for flexible adaptation to specific process requirements.
Standard features of the FASTER GloveFAST range:
- Stainless steel housing (AISI 316L) with rounded, cleaning-optimised internal contours
- HEPA H14 or ULPA U15 filtration (ISO Class 5 or better)
- Active pressure maintenance system (positive or negative pressure, precisely controlled)
- Integrated transfer airlocks for contamination-free material transfer
- Glove port system with certified cleanroom gloves (various materials and sizes)
- Touch-screen control panel with status display, pressure monitoring and alarm system
- Energy-efficient LED lighting (white light, low shadow)
- Safety glass viewing window (shatterproof, clear)
Optional extras:
- H₂O₂ decontamination system (NHP technology) for validatable sterilisation
- Easy Click system for quick, contamination-free glove changes
- Glove testing system for regular leak testing in accordance with ISO 10648
- Inert gas supply and gas purification systems for argon/nitrogen operation
- Iso-Footrest for ergonomic working at standing workstations
- Arm sleeves for extended arm protection with deeply recessed glove boxes
- External HMI connection, remote access and data logger for 21 CFR Part 11 compliance
- Special dimensions and customised openings for the integration of robotics or automation
In which sectors are FASTER isolators used?
FASTER’s GloveFAST range covers a wide spectrum of industrial and scientific applications:
- Pharmaceutical production and aseptic manufacturing (parenteral preparations, biotechnological products, biologics)
- Hospital pharmacies and oncology facilities (cytostatic drug preparation and monitoring)
- Biotechnology research and production laboratories (cell cultures, fermentation, upstream/downstream)
- Nuclear medicine and radiopharmacy (manufacture and handling of radioactive substances)
- Chemical and petrochemical industry (processing of reactive, pyrophoric or toxic substances)
- Battery and semiconductor manufacturing (lithium cells, thin-film technology, electroplating)
- Food and cosmetics industries (formulations and filling processes requiring high levels of cleanliness)
- Research and development (universities, research institutes, CROs)
Frequently asked questions about pharmaceutical isolators
What is the difference between a pharmaceutical isolator and a biological safety cabinet?
Biological safety cabinets (BSCs) are semi-open systems with a front opening and laminar airflow – they protect users and products through filtered air, but are not fully enclosed systems. Pharmaceutical isolators are hermetically sealed systems with no direct access – the operator works exclusively through gloves. Isolators therefore offer a higher level of protection and are mandatory for GMP-regulated processes with the highest purity or safety requirements.
When do I need a vacuum isolator, and when do I need a positive pressure isolator?
Negative-pressure isolators protect the user: they are used when working with highly potent, toxic or hazardous substances (e.g. cytostatic drugs, hormones, radioactive materials). The negative pressure prevents hazardous aerosols from escaping to the outside. Positive-pressure isolators protect the product: they are used in sterile manufacturing processes (aseptic filling, parenteral preparations) where particles and germs must be kept out.
What standards must pharmaceutical isolators comply with?
Pharmaceutical isolators must comply with various standards depending on their application: EU GMP Annex 1 (2022) for the manufacture of sterile medicinal products, ISO 14644-1 (cleanroom classes), ISO 14644-7 (separation devices) and EN ISO 10648 (glove boxes, leak testing). FASTER isolators are designed for full GMP validability and can be supplied with complete IQ/OQ/PQ documentation.
What is a cRABS, and when is it the better choice compared to a full isolator?
A cRABS (Closed Restricted Access Barrier System) is a compromise between a biological safety cabinet and a fully enclosed isolator: it offers a high level of protection whilst providing more flexible access and easier operation. cRABS are the preferred choice when process flexibility is more important than absolute contamination isolation, or when the conversion of an existing cleanroom to isolator technology is to be carried out in stages.
Does FASTER also offer bespoke designs and mock-up studies for isolators?
Yes. FASTER develops bespoke isolator systems for specific process requirements, including integrated isolators for robotics, multi-station systems and production isolators. Prior to manufacture, FASTER offers mock-up studies in which ergonomics, glove reach and workflows are validated using a model – ensuring maximum process reliability and ease of use.
