Testing & Verification

TESTING & VERIFICATION

Our qualified test and certification engineers undertake extensive environmental performance tests for cleanrooms, operating theatres, containment suites, LEVS and workstations. As well as assessing and assuring initial compliance, we ensure continued compliance to all the required standards, industry guidelines and cGMPs. Validair is a UKAS ISO17025 certified testing laboratory: Lab No. 4264

Testing and verification provide assurance that the national standards and industry guideline requirements, relating to the performance of the clean air facilities and equipment, have been met.

We carry out tests in accordance with client requirements while adhering to our own stringent operating procedures that reference applicable national and international standards. Our engineers have experience of every type of clean air application, from a single clean air cabinet to the largest ISO Class 4 cleanroom in Europe.

Comprehensive validation reports are issued after each visit from our certification and testing team. These provide a helpful record of performance levels for the controlled environment and build-up to create a valuable repository of documented evidence relating to every critical aspect of your cleanroom performance and trends. Importantly, this fully satisfies auditor requirements such as MHRA and FDA as well as supplying a useful resource to internal and external client auditors.

CLEAN AIR TESTING & VERIFICATION

Where the cleanliness of customers’ products and processes are critical, our unrivalled experience enables us to provide a comprehensive scope of testing and monitoring on these critical clean air facilities and equipment:

• Cleanrooms
• Pharmaceutical Isolators & RABs
• Unidirectional Flow Workstations
• Safety Cabinets
• IVF Clean Laboratories

Testing is carried out in accordance with national and international standards such as BS EN ISO 14644 Parts 1, 2, 3, 4 and 7 and BS EN 12469 as well as industry guidelines such as EU GMP Annex 1.

VERIFICATION OF OTHER CONTAMINATION-CONTROLLED ENVIRONMENTS

Certain contamination-controlled equipment and systems will be categorised as Local Exhaust Ventilation (LEV). These require thorough examination and test to comply with CoSHH regulations and HSG258.

• Local Exhaust Ventilation Systems
• LEV Cabinets, Capture Hoods and Workstations
• Ducted and Recirculatory Fume Cupboards

Safety cabinets and negative pressure isolators can also be considered LEV equipment.

All of this testing provides the assurance that health & safety is suitably addressed.

VERIFICATION OF HOSPITAL CRITICAL VENTILATION

COMPRESSED GASES AIR QUALITY TESTING

Compressed gas systems used within cleanrooms require verification that the supply air quality will not compromise the cleanliness of the cleanroom, the product or the processes. We provide an air quality testing service for particles, oil and moisture for a variety of compressed gases.

Tests give consideration to ISPE good practice guidelines, BS EN ISO 8573 and European Pharmacopoeia.

TEMPERATURE & HUMIDITY MAPPING

We carry out mapping validations using digital sensors to record temperature and humidity readings at multiple locations over extended periods. The MHRA and FDA expect product and sample storage areas to meet stringent conditions. These critical storage areas include:

• Refrigerators
• Freezers
• Cold Rooms
• Incubators
• Warehouse Storage