Category: Cleanroom Validation
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.
Cleanroom Validation Report
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. 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.
Valid8 UK Ltd can provide a comprehensive test and maintenance solution for virtually any clean air device or cleanroom facility. We are committed to our clients' needs and aim to be the preferred choice for cleanroom validation.
Why is the Valid8 UK Ltd validation service better?
- High calibre, professionally qualified site engineers
- Continual investment in staff training
- Concise, customised, professional test reports
- Latest test equipment
- Full engineering support service
We can validate to all international standards including ISO 14644: 1999, EEC GMP: 2002, Fed Std 209E: 1992, BS 5295:1989andIES-RP-CC006.2.
What test procedures are offered?
- Air velocity and volumetric flow rate measurement
- Room differential pressure testing
- Filter integrity leak testing (DOP method)
- Airborne particle counting
- Airflow visualisation and digital video analysis
- Construction joint integrity testing
- Recovery performance testing
- Airflow balancing
- Temperature monitoring
- Lighting levels checks
- Noise level checks
- Pressure and flow gauge calibration
Valid8 UK Ltd can also provide the following protocols to obtain MCA /FDA approvals.
- Design Qualification Protocol
- Installation Qualification Protocol
- Operation Qualification Protocol
Regular validation minimizes product defects, costly downtime & hence increases productivity. We are providing independent customer-friendly cleanroom validation service with sophisticated calibrated instruments.
Cleanroom Service includes:
- HEPA filter Leak Testing
- Velocity Measurement
- Airborne Particle Counts Monitoring
- Recovery Test
- Air Changes Calculations
- Air Direction / Air Flow Visualization Study & Videography.
Valid8 Uk Ltd experienced Validation Team can carry out all routine cleanroom testing, to meet the requirements of BS EN ISO 14644. Our in house team offer the service of creating the SOP's and test protocols for your facility, re-writing existing protocols to suit new demands on your facility or utilising your current site protocols.
Valid8 UK Ltd have experience in the following test procedures:
HEPA Filter Integrity Testing
The filter media and the housing will be checked to ensure that no airborne contamination passes into the cleanroom as a result of bypassing the filter installation.
Pressure Differential Tests
This test demonstrates that the airflow between areas in the cleanroom suite cascades in the correct direction and that the pressure differences are correct.
Air Velocity & Uniformity Tests
This test will demonstrate the effective unidirectional airflow for laminar flow workstations and rooms.
Air Volumes & Air Change Tests
Tests will show that the correct volume (turbulent ventilated cleanroom) or the velocity (unidirectional cleanroom) is entering the clean area. Further tests will show that the number of air changes within the area complies with the specification.
Containment Leak Tests
This test is carried out to demonstrate that airborne contamination does not enter from a higher pressure area adjacent to the cleanroom by means of leaks in the construction materials.
Airborne Particulate Counts
This test proves the classification of the area has been achieved with regards to the concentration of airborne particulate. See table below for selected ISO 14644-1 cleanroom classifications.
Clean-up & Recovery Tests
Demonstrates the ability of the room to remove particulate by purging the area with filtered air and that the room can change from a "dirty" to "clean" state within the specified time.
Airflow Visualisation and Smoke Tests
This test, usually with video evidence, will show the airflow patterns and movement within the cleanroom, to show good coverage of critical operator and / or machine areas and highlight any zones with poor air movement.
Other tests include:
- Temperature and Humidity Testing & Mapping
- Noise Tests
- Lighting Level Tests
A full comprehensive validation report will be issued to the client following each visit which will include confirmation that all testing equipment used by Valid8 UK Ltd is maintained and calibrated to national standards.
|Schedule of Tests to Demonstrate Continuing Compliance|
|Test Parameter||Class||Maximum Time Interval||Test Procedure|
|Particle Count Test||A, B <= ISO 5|
C, D > ISO 5
|6 Months||SO 14644 -1 Annex A|
ISO 14644 -1 Annex A
|Air Pressure Difference||All Classes||12 Months||ISO 14644 -1 Annex B5|
|Air Flow||All Classes||12 Months||ISO 14644 -1 Annex B4|
|Schedule of Additional Optional Tests|
|Test Parameter||Class||Maximum TimeInterval||Test Procedure|
|Installed Filter Leakage||All Classes||24 Months||ISO 14644-1 Annex B6|
|Containment Leakage||All Classes||24 Months||ISO 14644-1 Annex B4|
|Recovery||All Classes||24 Months||ISO 14644-1 Annex B13|
|Air Flow Visualisation||All Classes||24 Months||ISO 14644-1 Annex B7|
The key to providing maximum reliability with a minimum of shutdowns is a good preventive maintenance program.The first year of a clean room maintenance contract will usually reveal the personality of a particular building in both filter and equipment frequencies.
Monitoring how dirty the pre-filters are during service, and the changes in magnehelic readings on the bag (or box) filter housings, will ultimately determine the actual frequency of the filter changes.
In addition, working closely with the occupants of the clean room, as well as the facilities personnel, will help you discover the needed frequency of the equipment maintenance.