Healthcare Laboratories
With unrivalled expertise and decades of proven delivery, Total Clean Air builds world-class cleanrooms you can trust.
Manufacturing Healthcare Sector Cleanroom Solutions
Ensuring ISO-Classified, GMP-Compliant Environments for Hospitals, Clinics, and Medical Laboratories
Maintaining a sterile, controlled environment is vital in healthcare. Total Clean Air provides cleanroom solutions for healthcare, including bespoke cleanrooms and consultation services, tailored to hospitals, clinics, and medical research laboratories. Our solutions ensure ISO-classified cleanrooms and GMP-compliant standards for safe, efficient patient care and laboratory operations.
In healthcare settings, the link between environmental control and patient safety is clear and undeniable. Airborne pathogens, microbial contamination, and poor air quality are well-known factors in healthcare-associated infections (HAIs), surgical site infections, and the deterioration of sterile medicinal products. The cleanroom environments designed and delivered by Total Clean Air are more than just a regulatory obligation, they are a critical protective measure for the patients, staff, and wider communities those facilities support.
Total Clean Air works with NHS trusts, private hospitals, clinical commissioning groups, sterile services departments, and medical research organisations across the UK to deliver controlled environments that meet the requirements of the Medicines and Healthcare products Regulatory Agency (MHRA), NHS technical guidance including Health Technical Memoranda (HTMs), and applicable ISO 14644-1 classification standards.
Trusted Cleanroom Solutions for Healthcare Facilities
Healthcare organizations rely on Total Clean Air to maintain sterile, controlled environments that minimize infection and cross-contamination risks. Our bespoke and modular cleanroom solutions, advanced air filtration systems, and specialized equipment support hospitals, clinics, surgical areas, and diagnostic laboratories, ensuring ISO-classified and GMP-compliant standards. By enhancing workflow efficiency, protecting staff, and safeguarding patient care, we help healthcare facilities operate at the highest levels of hygiene, safety, and compliance.
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Minimised Infection Risk: HEPA/ULPA filtration protects patients and staff throughout the facility
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Custom Solutions: Modular cleanrooms for hospitals, laboratories, and surgical suites
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Compliance & Performance: ISO-classified, validated, and maintained for full regulatory adherence
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Operational Efficiency: Monitoring, specialised equipment, and custom furniture support smooth workflows
FAQ’s
What
ISO class is required for sterile compounding in hospital pharmacies?
ISO Class 5 is required for the critical zone where products are prepared, with ISO Class 7 for the surrounding buffer area and ISO Class 8 for the anteroom or gowning area. These requirements align with MHRA guidance and EU GMP standards applicable to aseptic preparation.
Can
cleanrooms be customised for existing hospital layouts?
Yes, our bespoke and modular cleanrooms for healthcare are fully adaptable and can be integrated into existing facilities with minimal disruption to ongoing clinical operations. We work closely with estates and infection control teams throughout the design and installation process.
Are
your cleanrooms GMP compliant?
Yes, all cleanrooms are designed and validated to meet ISO and GMP standards applicable to healthcare, including MHRA guidance for aseptic preparation units and EU GMP Annex 1 for sterile medicinal product manufacture.
How
long does it take to build a healthcare cleanroom?
Timescales vary depending on the size, complexity, and location of the project. Modular cleanroom solutions can be delivered and installed significantly faster than traditional construction, often within weeks rather than months, and with considerably less disruption to surrounding clinical areas. Our team will provide a realistic programme at the outset of your project.
What
ISO class is required for sterile compounding in hospital pharmacies?
ISO Class 5 is required for the critical zone where products are prepared, with ISO Class 7 for the surrounding buffer area and ISO Class 8 for the anteroom or gowning area. These requirements align with MHRA guidance and EU GMP standards applicable to aseptic preparation.
Can
cleanrooms be customised for existing hospital layouts?
Yes, our bespoke and modular cleanrooms for healthcare are fully adaptable and can be integrated into existing facilities with minimal disruption to ongoing clinical operations. We work closely with estates and infection control teams throughout the design and installation process.
Are
your cleanrooms GMP compliant?
Yes, all cleanrooms are designed and validated to meet ISO and GMP standards applicable to healthcare, including MHRA guidance for aseptic preparation units and EU GMP Annex 1 for sterile medicinal product manufacture.
How
long does it take to build a healthcare cleanroom?
Timescales vary depending on the size, complexity, and location of the project. Modular cleanroom solutions can be delivered and installed significantly faster than traditional construction, often within weeks rather than months, and with considerably less disruption to surrounding clinical areas. Our team will provide a realistic programme at the outset of your project.
Total Clean Air offers a complete turnkey package for all your cleanroom requirements
Cleanroom Solutions Across Healthcare Applications
Total Clean Air supports healthcare organisations across a broad range of clinical and laboratory environments. Our cleanroom solutions are applied throughout the healthcare sector:
In Hospital Pharmacy and Aseptic Units, we deliver ISO Class 5 cleanrooms for sterile preparation of intravenous drugs, TPN, and cytotoxics, designed to meet MHRA, HTM 01-01, and EU GMP standards while supporting future expansion.
For Operating Theatres, we design ultra-clean air (UCA) environments that minimise infection risk during surgical procedures, in line with HTM 03-01 and relevant British Standards.
Our Sterile Services solutions support compliant decontamination, sterilisation, and storage of medical instruments, ensuring they are returned to use in a verified sterile condition.
We also create controlled environments for Microbiology and Pathology Laboratories, including containment facilities with appropriate biosafety levels for diagnostic and research work.
In Medical Device Manufacturing, our ISO-classified cleanrooms support compliance with UK regulations and ISO 13485 for production and testing.
For advanced therapies, we deliver Cell and Gene Therapy Facilities with Grade A/B environments for ATMP manufacture, aligned with EU GMP Annex 1 and MHRA guidance.
Additionally, our Research and Clinical Trial Laboratories provide modular cleanroom solutions for investigational medicinal products and compliant clinical research.
Additionally, we offer Research and Clinical Trial Laboratories with modular, scalable cleanroom solutions that enable the compliant manufacture of investigational medicinal products and support clinical research activities.
Regulatory Standards for Healthcare Cleanrooms in the UK
Healthcare cleanrooms in the United Kingdom are subject to a range of regulatory and technical standards depending on the nature of the activities being carried out. Total Clean Air’s team is well-versed in the full landscape of applicable guidance and works closely with clients to ensure that every environment we deliver is fully compliant from day one.
Key standards and guidance documents relevant to healthcare cleanrooms include ISO 14644-1 for classification by airborne particulate cleanliness, NHS Health Technical Memoranda including HTM 03-01 for ventilation in healthcare premises and HTM 01-01 for decontamination, MHRA guidance on aseptic preparation and unlicensed medicines, EU GMP Annex 1 for the manufacture of sterile medicinal products, and ISO 13485 for quality management systems in medical device manufacture. Our consultancy team will identify the precise standards applicable to your facility and ensure that your cleanroom design, build, commissioning, and ongoing operation are fully aligned with each of them.
Environmental Monitoring for Healthcare Cleanroom Compliance
Continuous environmental monitoring is a regulatory requirement for the majority of healthcare cleanroom applications, and an essential component of any robust quality management system. Real-time data on airborne particle concentrations, viable microorganism counts, temperature, relative humidity, and differential room pressures provides the evidence base that regulatory inspectors, quality teams, and clinical governance bodies require.
Total Clean Air supplies and integrates environmental monitoring systems tailored to the specific requirements of each healthcare environment. Automated alerting flags any deviation from specification immediately, allowing your team to respond promptly and maintain the comprehensive audit-ready records that MHRA inspections and NHS governance processes demand. Our monitoring solutions can be configured to support the specific data integrity requirements of healthcare quality management systems.
Decontamination Solutions for Healthcare Environments
Effective decontamination is a critical requirement across a wide range of healthcare environments, from operating theatres and sterile services departments to isolation rooms and aseptic preparation units. Total Clean Air is an authorised supplier and installer of SteraMist®, an advanced ionised hydrogen peroxide (iHP®) decontamination system that delivers rapid, validated sterilisation of air and surfaces with no wet residue and minimal downtime.
SteraMist® is particularly well-suited to healthcare applications where rapid turnaround is essential. In operating theatres, the ability to achieve validated decontamination between cases without lengthy downtime has a direct impact on surgical throughput and patient access to care. In isolation rooms and high-dependency units, SteraMist® provides a reliable, evidence-based decontamination solution for environments that have housed patients with highly infectious or multi-drug-resistant organisms.
The Total Clean Air Approach to Healthcare Cleanroom Projects
Every healthcare cleanroom project begins with a thorough consultancy phase in which our specialists work closely with your clinical, estates, and quality teams to understand the precise requirements of your facility. We consider the full operational context, including patient flow, staff movement, infection control protocols, and the regulatory framework applicable to your specific activities, before any design work commences.
Our in-house design and engineering teams then develop a solution built precisely around your specification, considering everything from room pressure differentials and ventilation design through to cleanroom furniture, pass-through hatches, and gowning facilities. We ensure that the finished environment supports both clinical compliance and day-to-day operational efficiency.
Once construction is complete, our commissioning and validation team takes the facility through a structured qualification process, producing the comprehensive documentation packages required by the MHRA, NHS governance bodies, and your internal quality management system. Total Clean Air continues to support healthcare clients throughout the operational life of their cleanrooms, providing scheduled maintenance, filter replacement, periodic revalidation, and responsive technical support.