Medical Air Technology | Tel: +44 (0)844 871 2100
Life Sciences
Containment Laboratories, Aseptic Suites and Cleanrooms
Medical Air Technology’s solutions for cleanrooms, aseptic areas and containment laboratories help hospitals and universities move forward to fulfil their vision of developing healthcare technologies to diagnose, treat and combat diseases.
Whether you want a total turnkey design-and-build installation, an upgrade, refurbishment, reclassification or conversion, MAT can apply its expertise to designing and installing the right specialist environment for your needs.
Protecting People, Preparation and Products
Designing the controlled environment of a cleanroom, aseptic suite or laboratory is a complex challenge that requires a detailed understanding of the rules and restrictions governing operation and validation.
It must also be a comfortable workplace for operatives – despite the need for increased air changes and greater airflow, no one in the room should be working in a draft or other situation causing discomfort.
MAT has an advanced understanding of the importance of room structure and the way airflow operates. This is vital when conceptualising and designing safe and compliant facilities including:
- MHRA licenced aseptic suites (radiopharmacies, stem cell laboratories, cytotoxic pharmacies, gene therapy, TPN, IVF, etc)
- ACDP compliant containment laboratories built to CTSA and LPS1175 security standards (microbiology, forensic science, tropical disease research, immunology and vaccinology, biotechnology, veterinary medicine, etc)
- BS EN ISO 14644-1 compliant cleanrooms (pharmaceutical manufacturing, electronics, aerospace, optical and research)
Containment Laboratories – Containment Level/Category 2 and 3
Category 2 (CAT2) or Containment Level 2 (CL2) is the biosafety level required by laboratories working with agents associated with human diseases that pose a moderate health hazard. Examples include Legionella pneumophila and Pseudomonas aeruginosa.
Category 3 (CAT3) or Containment Level 3 (CL3) is the highest containment level in common use in the UK. This level of containment is required when handling human pathogens that may be transmitted via inhalation, that often have a low infectious dose to produce effects and that can cause serious or life-threatening disease. These pathogens include HIV, hepatitis B, yellow fever and rabies.
Features of CAT2 and CAT3 laboratories:
CAT2
- Microbiological safety cabinets
- Access restrictions and security
- Surfaces impervious to water, acids and agents
- CO2 incubators
- Safe storage of biological agents
- Optional mechanical ventilation
- Air management systems
- Centrifuges, fridges and freezers
CAT3
- Fully sealed environments
- Constant negative pressure
- Security and IT legal requirements
- Controlled fumigation process
- Safe storage of biological agents/pathogens
- Motorised isolation
- HEPA extract and change facilities
- UPS power supply
- Lone worker safety systems
- HSE observation requirements
Aseptic Suites
An aseptic suite is a type of cleanroom used for the manufacture of pharmaceutical drugs. It has to be a microorganism-free space to avoid contamination. It achieves this through specialist HVAC and room design.
Radiopharmacies, stem cell laboratories, cytotoxic pharmacies, gene therapy, total parenteral nutrition (TPN) and in vitro fertilisation (IVF) all require aseptic conditions.
Features of aseptic suites:
- Bespoke air conditioning systems
- GRP and specialist finished doors
- BMS integration
- Double framed light fittings, IP65 seals
- Pharmacy isolators with grade A airflow
- Security, storage and SOP-compliant
- Interlocked system doors/pass throughs
- Specialist finishes
Cleanrooms
The design, layout and placement of cleanrooms has a significant impact on processes, behaviours and communications. A good design proactively supports processes such as flow, visual management, standard work, and excellence in workplace organisation, whereas a bad design may actually create waste and make flow more difficult.
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