Device Testing & Validation

Validation of Clean Air & Containment Devices

Cleanrooms, Bio Safety facilities and any forensic laboratory will utilise varied clean air and containment devices, such as Laminar Flow Cabinets, Microbiological Safety Cabinet, Pharmaceutical Isolators and Fume Cupboards to conduct critical activities which require the highest air contamination control.

Clean Air Technologies validation technicians are trained and internally accredited in the testing of all types of these critical devices. Testing and certification is carried out in accordance with such standards as ISO14644, BSEN12469, BS7258, ISOLATOR STANDARD, and cGMP Annex 1, with the associated documentation and certification.

Microbiological Safety Cabinets

In accordance with ACDP3 containment regulations, the manipulation of hazardous pathogens, within bio-safety labs and similar facilities will be conducted in Microbiological Safety Cabinets.

The safe performance of these devices must be certified in accordance with BSEN12469 and will include such tests as: –

• Operator Protection Factor (KI Discus Test)
• Air Inflows
• HEPA Filter Testing
• Breach Velocity Testing

Certification will need to be provided to any HSE or MHRA inspection.

Pharmaceutical Isolators

These mission-critical mini environments provide air contamination control through their own independent air filtration system, operating under a positive or negative pressure, they will comply to ISO14644 or ACDP containment guidelines.

Clean Air Technologies have developed bespoke documentation to reflect the diverse nature of these clean air solutions.

Downflow Booths / Powder Control Booths

Many pharmaceutical cleanrooms will utilise downflow booths to provide air contamination control during the dispensing of powders and pharmaceutical ingredients. Evidence of testing and certification of these devices will need to be provided during regulatory audits, such as MHRA inspection.

Clean Air Technologies validation technicians are trained and internally accredited in the testing of all types of these critical devices. Testing and certification is carried out in accordance with such standards as ISO14644 and cGMP Annex 1, with the associated documentation and certification. Tests will include: –

• HEPA Filter Integrity Testing
• Measurement of Airflows through HEPA Filters
• Verification of containment of powders
• Magnahelic Gauge Calibrations

Laminar Flow Cabinets

Localised air contamination control is often provided by the use of Laminar Air Flow devices, which utilise HEPA Air Filters to limit airborne particles and offer maximum product protection. As part of the routine cleanroom monitoring process, supporting data from testing and certification of these devices will need to be provided during regulatory audits, such as MHRA inspection.

Clean Air Technologies validation technicians are trained and internally accredited in the testing of all types of these critical devices. Testing and certification is carried out in accordance with such standards as ISO14644 and cGMP Annex 1, with the associated documentation and certification. Tests will include: –

• HEPA Filter Integrity Testing
• Measurement of Airflows through HEPA Filters
• Working Height Airflow Velocity
• Non-viable Airborne Particle Counting

Depyrogenation Ovens & Tunnel Sterilisers

Aseptic pharmaceutical production techniques often require the use of HEPA Filtered depyrogenation ovens and tunnel sterilisers to ensure sterility of the product containers. Air contamination control is critical within these devices, with assessment of the air filtration system and the use of particle counting to establish the absence of airborne contaminants.

Clean Air Technologies have developed and implemented bespoke techniques to address the nuances of these specialist devices.