Spare
and replacement parts for our Laminar
Air Flow equipment.
Validation
Aim: Micro-organisms and other particulate contaminants
are the cause for concern in any sterile air. These
airborne contaminants are controlled mainly using HEPA
filtration systems. Periodic validation of the filtration
systems and the early remedial action ensures that the
sterile / clean area is within the standard or safe
design limits. The Institute Of Environmental Sciences
and Technology have recommended practices for test procedure
for HEPA filtration systems. HEPA filters have to be
tested as per these standards. Apart from this test,
periodic checking of airflow velocity, uniformity, static
pressure etc., has to be done. Data gathered from these
tests serve as baseline information to determine the
current operational status and as justification for
corrective action.
Nature of Tests:
Velocity Test
Pressure Test
HEPA integrity (D.O.P)
test
Particle Count Test
Air Flow Pattern
etc.
Standards:
ISO 14644 - 1
IEST - RP - CC -
002 - 2
Validation
The performance of your equipment or
facility is critical to the protection of the product,
and in certain applications the end user. It is therefore
necessary that your equipment is maintained in a fully
functional and serviceable condition.
Our in-house capability can offer to
validate:
Laminar flow equipment
Biological safety
cabinets
All of the above
will be validated with DQ, IQ, OQ, PQ documentation.
