Cherwell, specialists in cleanroom microbiology solutions for the pharmaceutical, healthcare and related industries, has published findings of a new impartial investigation into the impact of using pre-poured Petri dishes from different suppliers for air sampling in cleanroom environmental monitoring (EM) programmes. This extends Cherwell’s initial ‘plate choice’ investigation which found that size and form factor of plates can affect microbial air sampling accuracy.
The original study was very well received at recent industry events, instigating wider discussion around sterile medicinal product manufacturing safety and subsequent questions. These have been followed up by the latest study, providing useful additional insights of significance for EM regulatory compliance.
The updated study report - “Comparative analysis of Petri dish variation in flow rate for air sampling” - delves deeper into the flow rate variations in prepared media plates observed in the initial study. It analyses the potential contributing factors, such as fill volume, petri size and agar height, and provides recommendations for ensuring consistent and accurate air sampling. It also serves as a means to share findings and stimulate further investigation in the field of air sampling and Petri dish variation which can impact Annex 1 compliance and the safe manufacture of sterile medicinal products.
Our initial study was definitely appreciated, and discussions around it with delegates at recent industry events led to further questions being raised
-Hamish Hogg, Microbiology Product Specialist
The comparative investigation of Petri dishes from six different media suppliers identified the factors contributing to sampling variations by taking additional measurements from all plates. It highlights that pre-poured Petri dishes deviating from the recommended standards used for air sampling can cause flow rate variations. If these variations are not accounted for, then under- or over-sampling can occur, resulting in unreliable data.
The study report concludes that for compliance with industry guidelines, particularly the revised Annex 1, organisations must ensure the careful selection of appropriate Petri dishes and air samplers to achieve accurate and reliable air sampling results.
“Our initial study was definitely appreciated, and discussions around it with delegates at recent industry events led to further questions being raised. We didn’t want to leave these questions unanswered and so carried out further investigations detailed in our latest study report,” said Hamish Hogg, Microbiology Product Specialist, Cherwell. “These studies have generated such interest that our microbiology laboratory team now plans to carry out more investigations of a similar nature. We’re very open to suggestions of what to investigate so we can continue to share useful knowledge which can support the safe manufacture of sterile medicinal products."
The new microbial air sampling study - Comparative analysis of petri dish variation in flow rate for air sampling – can be downloaded on Cherwell’s website.
