Standardising cleanroom production line monitoring for microbial contamination
The SAS Pinocchio compressed air and bottled gas sampler
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 customers. Synergy’s microbiological laboratories offer a range of services within the medical device and pharmaceutical manufacturing industries, including environmental monitoring, sterilisation validation and bioburden analysis.
The introduction of the SAS Pinocchio is enabling Synergy to help customers meet their regulatory requirements more effectively.
The Bicester, UK-based firm has been supplying Redipor prepared microbiological media, plus SAS air samplers for use within Synergy’s environmental monitoring service offering for a number of years. Having recently introduced the SAS Pinocchio to its programmes, Synergy now enables 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
'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,' said Susan Finlay-Woods, Laboratory Manager, South Marston Labs, AST.
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.'
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.
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. Airborne 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.