Under the latest draft revision of EU GMP Annex 1, environmental monitoring is more important than ever before. As pressures mount to increase efficiency while lowering risk of any contamination, in process environmental monitoring is now recommended.
Cherwell Laboratories supply all the specialist materials and equipment you need to ensure your cleanroom standards are maintained to meet the most stringent regulations. We can also help you create an EM program specifically for your premises.
For best practice, a combination of static and active air samplers, together with accessories to ensure precise data collection is required. Regular instrument calibration maintains top performance levels and your data remains 100% reliable.
Used in cleanrooms, isolators, operating theatres, offices, factories and waste processing sites
Petri dishes are widely used to collect air samples passively and also in air samplers. Contact plates for environmental monitoring contain raised agar for surface sampling and in air samplers. Make sure your media is quality tested.
These air samplers draw air onto a poured media plate. Used widely in areas of various grades
Air samplers that actively draw air over culture media are widely used in conjunction with settle plates and other methods for more accurate data. These instruments should be calibrated regularly.
Reproducibility is everything. Use accessories to make sure your poured media are placed accurately
Appropriate location for environmental monitoring equipment and static air sampling is critical for accurate, reliable results. Stainless steel stands are ideal for use in critical areas.
Yes. We have almost thirty years' experience with helping pharmaceutical and associated industries deliver environmental monitoring processes critical to the manufacture of heavily regulated products.
We supply every component you need to create environmental monitoring processes. We also offer bespoke formulations, accessories and even packaging solutions for organisations with very particular needs.
Get in touch today. Let's discuss your requirements.
The majority of our prepared media can be stored in ambient conditions, not exceeding 25ºC. There are only a small number of very specialist products that require different storage conditions.
We have never specified refrigeration as a storage condition for our general media as this causes excess condensation and can result in very wet agar, rendering it impossible to use.
Settle plates are used to monitor the level of viable particles in the environment through a process of passive air sampling. A viable particle settles on agar plates at a rate dependent on its characteristics and the airflow in the environment.
EU GMP Guide Annex 1 has recommended that 90mm settle plates can be exposed in cleanroom environments for up to 4 hours. However, agar plates may dry out during long exposures where the rate of air exchange is high. So, it might be necessary to use deep filled settle plates, or replace the settle plate after a shorter time to ensure satisfactory growth promotion after exposure.
Typical requirements suggest 1,000 litres per air sample in high risk areas, such as: grade A filling lines, grade B clean rooms, operating theatres etc. As the criticality of the area reduces, the sample size can be reduced. The aim is to achieve a representative sample; so where higher counts would be expected, a smaller sample produces a more realistic number of cfu to count.
SAS samplers were originally designed for Contact plates, however, a Petri dish option has been available for a number of years. It is really a personal choice, although this should be decided at time of purchase, as the sampler will be specifically configured for the plate type chosen. There are advantages for each version and we would be happy to discuss your specific needs.