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