Cleanroom
Crowthorne Hi-Tec Services are not designers or builders of cleanroom or cleanroom equipment and therefore provide a completely unbiased report on the performance achieved.
Cleanroom facilities
Crowthorne Hi-Tec Services carry out commissioning and validation of all cleanroom facilities from small hospital pharmacies to multimillion pound pharmaceutical production or micro-electronics class 1 facilities.
All tests are undertaken in accordance with the latest standards [cGMP, National and International], using the latest test equipment calibrated to National Standards.
Orthopaedic operating theatres [HTM2025]
Crowthorne Hi-Tec Services also provides a commissioning and periodic validation service to NHS Trusts including operating theatres for orthopaedic work. Where UCV systems are operated these should be regularly maintained and tested in accordance with HTM 2025.
Documentation
Crowthorne Hi-Tec Services provide a comprehensive protocol writing service tailored to each client’s requirements from writing the initial URS (User Requirement Specification), IQ, OQ and PQ documentation to the execution of all on site checks and tests. All work is backed by our BS EN ISO registration and comes with full method statements and copies of the calibration certificates for all test instrumentation.
Scope of Work
Routine Service Checks
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Airflow balancing
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Setting room over pressure gradients
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Calibration of magnehelic gauges and
pressure sensors
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Airflow visualization
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Record light levels [were specified] |
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Noise level readings (inc. octave band
analysis as dB(lin), dB(A),‘NC’ or ‘NR’
curves)
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Check operation of control system
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Airborne particle counting (from 0.1 to
25mm)
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Inspect pre-filter [replace as required] |
- Filter integrity testing (including DOP, PSL
and ambient challenges)
- Temperature and humidity recording
(single point or data logging)
- Structural induction leak checking
- Issue a report of results.
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In fact any validation procedures associated with clean room commissioning for the micro-electronic, pharmaceutical and allied industries.
The above are generic specifications and can be tailored to suit customer requirements.
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