Testing the integrity of HEPA/ULPA absolute filters installed in HVAC systems is one of the most important tests for cleanroom qualification. In the new edition of Annex1 of the European cGMPs related to pharmaceutical manufacturing, the frequency of HEPA filter integrity testing according to cleanroom classification levels is indicated, as well as the requirement to perform the test in cases of plant modifications, maintenance and qualification with out-of-specification findings.
Problems with Emery Oil's hot-run generators.
It is well known that one of the main problems in the use of hot Emery Oil generators is in fact the contamination of the filters under test, contamination due to the large amount of aerosol required for reading with traditional photometers.
The use of a particle counter, required by ISO 14644-3 standards, allows the use of an extremely small amount of contaminant, an amount not capable of damaging the filter media. This technique is, by the way, the only one possible for testing PTFE filters.
The AM team uses Lighthouse ScanAir PRO, developed to provide operators with a viable alternative to using photometers and hot Emery Oil generators to perform HEPA/ULPA filter integrity tests.
ScanAir Pro: operation
Based on the use of the SOLAIR 3100 particle counter, the ScanAir PRO system uses a dilution device and a special scanning probe that allows operators complete control of the counter for capturing the upstream contaminant concentration and measuring the penetration rate.
The operator will be able, at any leaks in the filter media, to acquire the measurement and, at the end of the test, obtain a printed report directly from the connected particle counter.
When the use of the ScanAir PRO system is terminated, the SOLAIR 3100 particle counter becomes a traditional particle counter, which can then be used for cleanroom qualifications as provided in ISO14644-1 and EuGMP standards.
ScanAir Pro and Solair 3100 System
The ScanAirPRO system with the Solair 3100 counter allows:
- Optimize spending on instrumentation by allowing two tests ( cleanroom qualification and integrity testing) to be performed with a single investment
- Make it easier to carry out the integrity test by limiting the generation of aerosols and avoiding the use of hot generators and connected gas cylinders, thus preserving the terminal filters
- Have a very reliable and practical system (downstream filter scanning is done by the meter also powered by internal rechargeable battery)
