Cleanroom Validation & Clean Room Consultants, Diamond Scientific
- Validation of cleanrooms to ISO 14644, EU GMP, IES-RP-CC 006.2 and other standards and in-house requirements.
- Validation of laminar flow devices to current standards.
- Validation of safety cabinets to BS EN 12469:2000 including containment using KI-discus equipment.
- Testing of fume cupboards to COSHH & BS7258:1994, BS7989:2001 including containment and gaseous phase testing.
- Testing of isolators to all current standards and recommended practices.
- Supply, fitting, sealing and integrity testing of Hepa filters.
- Testing of local exhaust ventilation (LEV's).
- Training courses tailored to client requirements. Contamination control, cleanroom protocols, maintenance of cleanrooms etc.
- Ultraclean and Orthopaedic Theatres commissioned and validated to HTM 2025.
- Temperature and humidity mapping.
This is carried out by the appropriate number of experienced and trained technical staff. After discussing the scope of work with the client and agreeing the procedures to be followed, the various tests will be carried out using the most accurate instruments available on the market.
Testing normally includes airborne particle counts, filter integrity testing, air supply and extract volumes and air change rate calculation, differential pressures, temperatures and relative humidity measurement.
Additional tests which are frequently carried out are airflow parallelism, enclosure test, recovery tests and airflow visualisation recorded on video.
All testing is governed by our operating procedures which form part of the Quality Manual. We are also registered to ISO 9001. Anything unusual or falling outside the clients' target for the validation will be reported to the client immediately and, wherever possible, steps taken to rectify the situation.
It is our policy to inform clients of their test results before leaving site.
Always follows the same format. Summary and Recommendations form Section 1 in which we summarise our test programme, highlight any deficiencies and recommend improvements or corrective actions.
Method Statements describe in detail the test methods employed for that particular test programme. Every validation is different and test methods vary accordingly, so the blanket inclusion of standard operating procedures is not sufficient. Above all, the method statements must comply with appropriate standards and be capable of close scrutiny by quality personnel, auditors and the regulatory authorities.
The Validation Report describes in detail the test programme and quantifies all results and measurements.
Test Reports include all the test sheets for laminar flow cabinets, safety cabinets, isolators and fume cupboards. Each sheet has been devised to cover all the requirements of the relevant standard.
Airborne Particle count sheets include printouts of all the airborne particle counts taken on site.
Test Certificates certify that the room or device which was tested meets the relevant standard. Each Certificate has a red legal seal to prevent duplication.
The Plans section will include drawings of all the areas surveyed, showing airborne particle count positions, differential pressures and other information appropriate to the validation.
Calibration Certificates are included for instruments used in the test programme.
Each page in the report is numbered consecutively and is embossed to prevent duplication. Reports are produced as soon as possible after the work is done and we are always looking for ways in which technology can speed up this process.