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Objective
To determine that the HVAC systems model #
perform as intended by running the
sys- tem as-built, at rest, and operational, for 20 consecutive working days each and monitoring
and re- cording all relevant information and data. Results must demonstrate that performance
consistently meets pre-determined specifications under normal conditions, and where appropriate
for worst case situations.
Scope
To be performed after the OQ has been completed and approved. Any equipment or system
serving this HVAC system must be fully validated before HVAC validation begins.
a)
For new installation, modification, replacement, or relocation of any component of the
HVAC
system.
b)
Annual re-validation
c)
If there is a contamination
problem.
Responsibility
Facility engineer is responsible for writing the protocol, supervising the performance of the PQ,
verify- ing the data and writing the PQ report.
QA is responsible for approving the protocol and reviewing and approving the data and
conclusions and for scheduling re-validations
Materials,
Documents
Equipment
and
Materials required are all the items which will be routinely used to test air quality for particulates
and microbial counts, the manual operations or computer-programme controlling the facility
temperature, humidity, airflow, make-up air, etc.
Documented calibration is required before using the following to measure the facility
air: Micromanometer or Differential Pressure Gauge
Thermal Anemometer
Vane-type
Anemometer
Micro-ohmmeter
with
Airflow
Hood
Particle Counter
Microbiological Air Sampler and Media
plates
Charts for
recording.
the time,
temperature
and pressure
SOPs for each test method, for the operation and calibrations of the equipment used, the data to
be recorded, and the criteria for acceptance must be prepared and approved before beginning the
perfor- mance qualification.
Reference Documents:
IES: Contamination Control Division Recommended Practice 006.2 Testing Cleanrooms.
WHO/VSQ/97.02
WHO/VSQ/97.02