Tuesday, December 15, 2009

Valid8 UK Ltd - Cleanroom Site Validation, Temperature and Humidity Mapping, HVAC Equipment Maintenance

Cleanroom validation by Valid8 UK Ltd was founded in 2006 as a specialist independent cleanroom validation company based on the ethos of quality and service. Our long experience and knowledge of the demands of regulatory authorities such as the FDA and MHRA, and third party audits, enables us to provide a comprehensive high quality service to all cleanroom users.

Valid8 UK Ltd staff have experience of every type of clean air application, from a single cabinet to a large ISO Class 5 cleanroom.

In addition, we validate clean air devices such as laminar flow cabinets, safety cabinets, fume cupboards and isolators to current standards and our light engineering skills mean that filter changes and other alterations can often be carried out at the time of validation; our policy is wherever possible, to leave site with all systems working to the clients' design specification.

  • Cleanroom Validation
  • Validation and Testing of Clean Air Devices and LEV's
  • HEPA filter testing and replacement
  • Laboratory Services
  • Other Services

Cleanroom Site Validation

Cleanroom site validation 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.

CI500 Partical CounterTesting 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.

Temperature and Humidity Mapping

Airborne Partical CounterUsing the latest digital sensors we can record temperature and humidity readings at many locations over extended periods of time. The results can be presented in a number of different graphical or numerical formats.

  • Cleanroom Validation
  • Validation and Testing of Clean Air Devices and LEV's
  • HEPA filter testing and replacement
  • Laboratory Services

Cleanroom HVAC Maintenance

No matter how much capital investment is made in the design and construction of your new cleanroom or laboratory, unless a regime of regular preventative cleanroom HVAC maintenance is introduced, then this investment can very quickly deteriorate. We can provide all of your maintenance and revalidation requirements.Photometer

HVAC Equipment Maintenance

HVAC equipment maintenance on any non-redundant clean room equipment will usually require a planned shutdown. This allows a technician the time necessary to thoroughly inspect such things as the belts, sheaves, and bearings.

It's a good idea to keep a spare parts inventory on hand so replacement of a worn belt or contactor can be accomplished without a subsequent interruption to the operation of the room. The frequency of this work is best scheduled with the pre-filter maintenance, but is often times dictated by the clean room's restrictions.

Quality ManagementCleanroom Validation Services

  • 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.
  • Testing of fume cupboards to COSHH & BS7258:1994, BS7989:2001
  • 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).
  • Ultraclean and Orthopaedic Theatres commissioned and validated to HTM 2025.
  • Temperature and humidity mapping.
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