Cleanroom Facilities
Crowthorne carry out commissioning
and validation of all cleanroom facilities
from small hospital pharmacies to
multi-million pound pharmaceutical
production and micro electronics
ISO class 1 facilities.
All tests are undertaken in accordance
with the latest standards [cGMP,
National and International, and
BS EN ISO 14644] using test equipment,
calibrated to National Standards.
Standard Operating Procedures
A comprehensive protocol writing service can
be tailored to each client’s requirements, from
producing the initial URS (User Requirement
Specification), IQ, OQ and PQ documentation,
followed by the execution of all on-site checks
and tests. All work is backed by our
BS EN ISO9001 registration and comes with
full method statements and copies of calibration
certificates for all test instrumentation.
In addition to your routine validation testing
procedures, such as measuring airflows, HEPA
filter integrity testing (including DOP, PSL and
enhanced ambient challenges) and particle
counting, we can also provide additional tests
such as airflow visualisation, compressed air
testing, recovery rate tests and microbiological
sampling.
Any validation procedures associated with clean
room commissioning for the micro-electronic,
pharmaceutical and allied industries can be
carried out, and the above generic specifications
can be tailored to suit your requirements.
