HVAC
and Clean Rooms
Introduction
HVAC systems are an intrinsic
part of any pharmaceutical production facility and clean rooms. The
HVAC system performs many functions including providing clean
air quality, removing particulate contamination, providing the
correct temperature and humidity for operator comfort and process
requirements, and room pressure control.
The HVAC system can be used to provide a ultra-clean environment
using positive pressure cascades or provide a containment facility
using negative pressure to prevent the release of harmful substances.
Approach
The validation of the system including filter integrity testing,
particulate monitoring and airflow checks is vital for a controlled
environment.
We measure the airflows at the filters and measure the air change
rates within the cleanrooms.
We measure the room pressures to establish the correct cascade
of pressures from the critical working areas back to the lobbies
and changing rooms and confirm the correct pressure is maintained
from ambient to prevent contamination entering (or leaving in containment)
the facility.
We perform integrity testing of the HEPA filters to insure the
air quality is not compromised by particles penetrating the filters.
We perform airflow visualisation to demonstrate there are no still
air areas within the cleanrooms.
We measure particle levels at the working area
to demonstrate the air quality meets the required classification.
Our testing is comprehensive and designed to satisfy the requirements
of US (FDA), UK (MHRA) and European regulatory authorities.
Experience
PEV staff are experienced in the validation of HVAC systems, clean
rooms and containment facilities.
We understand the requirement for ISO 14644, EU cGMP, ACDP and
US Federal Standard 209E guidelines for all room classifications.
We are able to assist in the qualification of GMP, Clean rooms
and CL2, 3 and 4 containment facilities.
We can provide operational resources and assistance
with the generation of User Requirement Specifications (URS),
through Commissioning and Installation Qualification (IQ), Operational
Qualification (OQ) and Performance Qualification (PQ). We
work can work closely with the HVAC installation engineers to
ensure the design will met the user requirements
We are able to carry out routine re-qualification
to demonstrate continued conformance is achieved
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