Standardising Cleanroom Production Line Monitoring for Microbial Contamination

Synergy Health’s Applied Sterilisation Technologies (AST) laboratory services are using Cherwell Laboratories’ SAS Pinocchio compressed air and bottled gas sampler to deliver an enhanced service to its customers. Synergy’s microbiological laboratories offer a wide range of services within the medical device and pharmaceutical manufacturing industries, including environmental monitoring, sterilisation validation and bioburden analysis. The introduction of Cherwell’s SAS Pinocchio is enabling Synergy to help their customers meet regulatory requirements more effectively. 

Cherwell have been supplying Redipor® prepared microbiological media, plus SAS air samplers for use within Synergy’s fully accredited environmental monitoring service offering for a number of years. Having recently introduced the SAS Pinocchio to its monitoring programmes, Synergy can now enable their customers to demonstrate enhanced monitoring of product contact air on the production lines within their manufacturing cleanrooms. 

Compressed air and bottled gas sampling has traditionally used sterile tubing to spray air across the surface of a media plate. However, this process is not quantitative as the volume of compressed air used is unknown and, since it is also highly pressurised, any microbes may be killed when hitting the plate. “Using the SAS Pinocchio not only lowers the flow rate to maintain viability of organisms, but also provides quantifiable results as it uses a known volume of air sample. This enables our customers to set microbial limits and meet the increasingly stringent requirements of regulatory auditors,” explained Susan Finlay-Woods, Laboratory Manager, South Marston Labs, AST. 

Susan Finlay-Woods continued, “We selected the SAS Pinocchio for compressed air sampling due to our positive long-term experience with Cherwell and its SAS Super hand held microbial samplers that we use routinely for air monitoring. Therefore, we were confident that SAS technology was the most effective and easy to use.” 

Importantly, Synergy technicians also find SAS Super and SAS Pinocchio microbial samplers highly portable, being very simple to assemble, use and dismantle into an individual carrying case - essential when visiting clients’ manufacturing sites. “We have an excellent working relationship with Cherwell who are always very helpful, meet our specific needs and ensure reliability, just like their products. The SAS Pinocchio provides another example of this,” concluded Susan. 

Cherwell’s SAS air sampling units use the multi-point impaction (single stage sieve) sampling technique and sample air at a fixed rate to give quantifiable results. Air borne particles are impacted onto the agar surface of a standard Contact plate, with Petri dish versions also available. The SAS Pinocchio is a non-powered air sampling unit, which provides a controlled method for bioburden monitoring of compressed air and other gases. Regulating air flow from the compressed supply before passing through a traditional head, it forms part of a compatible environmental monitoring programme when used alongside other air samplers within the SAS monitoring range, as demonstrated by Synergy AST. 

more about SAS Pinocchio microbial samplers

more about Cherwell Laboratories

more news from Cherwell Laboratories