Bespoke Remote Microbial Air Samplers Monitor Grade A Filling Environment

UK-based manufacturer of aseptically filled blood plasma products and part of NHSBT, Bio Products Laboratory (BPL) has further enhanced its environmental monitoring programme by installing bespoke remote SAS microbial air samplers from Cherwell Laboratories.

Since plasma products are administered intravenously, their microbiological safety is critical. Therefore, as part of an upgrade to BPL's Grade A aseptic filling suite, where glove ports have been installed to minimise any risk of operator contamination and ensuing downtime, remote air sampling was necessitated for environmental monitoring.

As aseptic filling of plasma products into individual vials following intermediate raw blood plasma processing stages involves many personnel, BPL considered it essential to minimise direct human contact and subsequent contamination risk. Prior to the installation of glove ports, all environmental monitoring was undertaken by fully gowned operators using hand held portable SAS air samplers. This required an intervention into the filling line by opening the screens to the line, causing downtime issues. Since operators no longer had direct access to the filling line, a remote air sampling system was required to provide the necessary critical environmental monitoring data for Quality Control purposes prior to batch release of final plasma products.

Following the assessment of a number of different samplers by BPL, the SAS microbial air sampler from Cherwell was selected for its accuracy, reliability, robustness and speed of sampling. 'We required an air sampler that could remotely monitor our filling line at the exact height of the point of fill of our final plasma product vials,' said Clare Leavy, Deputy Microbiology Manager at BPL. 'Since our requirements were so specific, we realised we required a bespoke system. We were already successfully using hand held SAS units, which are still used for background monitoring around our facilities, and as Cherwell offers a broad range of SAS air samplers, we approached them to see if they had the flexibility to meet our particular needs.'

Cherwell Laboratories has now custom built and installed to date four fixed point air samplers with control units situated externally to the Grade A area, thereby enabling remote control of the sampling. Air samples are taken at the point of fill and also at the vial in-feed area at the start and finish of every filling run. 'Since we have two shifts of 10 personnel operating in our filling suite, the air samplers also had to be quick and easy to use by a number of different operators,' continued Clare Leavy. 'Since the installation of the new remote SAS samplers, we have not had a single sampling error incident.'

'This also demonstrates the effectiveness of remote sampling and cuts down the time and resource costs associated with any sampling errors,' added Clare Leavy. Such is the success of the remote SAS air sampling systems that further installations at BPL are expected shortly. Due to the forthcoming revision to Annex 1 of EU GMP guidelines requiring over-sealing of vial stoppers under Grade A conditions, in addition to the point of fill, BPL will soon have to remotely monitor this section of the filling line too.

'Cherwell and its SAS samplers have completely met our stringent microbial air sampling needs', concluded Clare Leavy. 'Working with us to design the perfect microbial sampling solution for us, Cherwell's customer service and level of responsiveness has been excellent.' The SAS Super Isolator system that Cherwell adapted specifically for BPL is a specialist version of the hand held SAS portable units already used on site. The proven SAS method of sampling is retained, thereby ensuring full compatibility with the hand held units used for background room monitoring.

The SAS Super Isolator is part of the SAS family of microbial air sampling solutions. Its sampling head, located separately within the area to be remotely monitored, is stainless steel and compatible with disinfection systems such as Vaporised Hydrogen Peroxide (VHP). The control unit, including power source, is located externally. A simple power connection is made using high quality pressure and vacuum rated connectors which retain cabinet integrity. The control unit can also be used with more than one sampling head, so offering flexibility and lower capital investment for multiple sampling requirements. Individual components and connectors are available to achieve the most economical solution.