IOM Clean Room Validation Service – part of our commitment to the healthcare sector
Many hospitals have Pharmacy manufacturing departments which require validation and regular maintenance checks of their air handling/ventilation systems. These include aseptic manufacturing suites and radiopharmacy departments. These clean rooms are classified according to ISO 14664-1 and the equivalent EU Good Manufacturing Practice (GMP) classification.
It is an essential requirement to ensure compliance with GMP Annex 1 (March 2009), and with Hospital Technical Memorandum (HTM) 03-01: Specialised ventilation for healthcare premises. IOM’s specialist hospital validation team carry out a range of tests to help ensure compliance with these standards. These tests include:
- Dispersed Oil Particulate (DOP) testing to determine the integrity of HEPA filters
- Air volume measurements by balometer, to determine air change rates within individual rooms
- Measurement of pressure differentials by micromanometer, to determine the pressure cascade between rooms, and to ensure that airflows are in the correct direction
- Particle classification using a laser diode discrete particle counter, to determine compliance with ISO 14664-1 classification or the equivalent EU GMP classification
- Microbiological sampling and analysis
In addition to the validation of manufacturing clean rooms, the IOM carries out validation and maintenance checks on standard and ultraclean operating theatres, positive and negative pressure isolation rooms and sterile service departments. These services were featured in a previous article - see
http://www.iom-world.org/featured_services/ventilation_systems.php
As estates departments and hospital engineers face ever increasing workloads, the IOM offers a compliance auditing service according to HTM 03-01 recommendations. This audit process assesses how the maintenance of critical ventilation systems is being managed and whether or not it is sufficiently robust.