Microbial Testing
Testing for Microbial Contamination
Camfil Farr NZ Ltd offers air sampling and analysis for purposes of testing for microbial contamination.
Testing involves air sampling with a P100 MicroPortable Air Sampler and analysis of the exposed agar plates by an accredited microbiological test laboratory.
Testing may be necessary in any of the following air systems:
1. Cleanrooms
Where protection from microbial contamination is required for products and processes, limits for allowable concentrations of micro-organisms, frequency of monitoring, and state of room during monitoring should be established. Regular monitoring of representative sites within the cleanroom, using recognised microbiological testing techniques, is necessary to assure compliance with the specified limits.
NOTES:
Airborne micro-organisms are particulate in nature and are included in the total particulate count of air cleanness classes.
In the setting of limits for allowable microbial levels, cognisance must be given to the relevant statutory requirements.
It is recommended that quantitative air sampling techniques be used for monitoring. A large quantity of air must be sampled so as to achieve meaningful test results, and results should be expressed as colony-forming-units (cfu) per cubic metre.
When protection from microbial contamination is required, Camfil Farr NZ Lab’s microbial testing service is a suitable quantitative air sampling technique.
2. Operating Theatres and other Hospital Areas
Microbial contamination is obviously an issue in hospital operating theatres, intensive care units and infectious wards.
Generally, hospitals will regularly check for microbial contamination with settle plates and/or swabs and have the exposed plates analysed by the hospital micro-laboratory. It may be useful to utilise a more quantifiable air sampling method as a comparison with the regular in-house monitoring.
As well as the standard cleanroom test described above, testing can be customised to produce results comparable with the in-house monitoring results. Agar plates can be prepared, supplied and analysed by the hospital micro-laboratory for consistency and lowest cost.
3. Isolators
AS/NZS 4273:1999,Australian/New Zealand Standard for Pharmaceutical Isolators specifies microbial testing of isolators. Included in the test regime is analysis of airborne samples of 2 m3. Airborne viable organism counts should be conducted monthly in the case of manufacturing and preparation operations, and quarterly for dispensing.
4. General Indoor Air Quality
Microbial testing within a building may be required as part of a routine Indoor Air Quality audit or as part of testing to isolate the cause of sick building syndrome complaints.
Testing for specific bacteria can be arranged.
Hire of P100 MicroPortable Air Sampler
Our Air Sampler is available for hire to our regular clients on a daily basis. Bookings in advance are essential.