Diamond Scientific’s test and certification engineers carry out extensive environmental performance tests for cleanrooms, operating theatres and containment suites, assessing and assuring initial and continued compliance to the required standards, guidelines and cGMPs.
All tests are carried out in accordance with client requirements, Diamond Scientific’s operating procedures and with reference to national, international and industry standards and guidelines.
Full comprehensive validation reports are issued following each visit and provide a valuable record of performance levels for the controlled environment and build up to comprehensive documentary evidence of cleanroom performance and trends, satisfying auditor requirements such as MHRA, FDA, internal or external client audits.
Validation reports always follow 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.
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.
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.