Microbial air monitoring success in Grade A filling environment for plasma products
Bicester, UK, 1st November 2010: Following the previous successful installation of bespoke remote SAS microbial air samplers from Cherwell Laboratories, UK-based manufacturer of aseptically filled blood plasma products and part of NHSBT, Bio Products Laboratory (BPL) has now installed additional SAS samplers on a second plasma product aseptic filling line.
This additional installation means that no direct human contact is required within BPL's Grade A filling lines for environmental monitoring purposes. The SAS Super Isolator remote air sampling system can be operated through glove ports to provide the necessary critical environmental monitoring data for Quality Control purposes prior to batch release of final plasma products.
A planned refurbishment of the second BPL plasma product filling line provided the ideal opportunity for BPL to request that Cherwell and the new in-feed conveyor manufacturer, Bausch & Ströbel, work together. This ensured that the correct mounting pillars were installed on the new line by Bausch & Ströbel to enable efficient and effective installation of the new SAS remote samplers by Cherwell.
BPL required minimal downtime on their production line for the bespoke SAS sampler installation and by working closely together, Cherwell completed install, IQ and OQ work to fit within BPL's tight timeline. "With this install we are very pleased to be able to demonstrate Cherwell's attention to detail and customer service," said Andy Whittard, Managing Director at Cherwell. "By working in conjunction with all necessary parties, we really can offer total flexibility and bespoke solutions to meet our customers' needs as required."
Cherwell Laboratories has now custom built and installed to date eight fixed point air samplers with control units situated externally to the Grade A area, thereby enabling remote control of the sampling of both of BPL's plasma product filling lines. 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.
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.
Bio Products Laboratory (BPL) is a not-for-profit organisation which is part of NHS Blood and Transplant (NHSBT) and wholly owned by the UK Government's Department of Health. Its research, development, manufacturing and UK and overseas marketing departments are all based at Elstree on the outskirts of London. (BPL) provides a continuous and competitive supply of high quality plasma-derived products to patients throughout the UK and in more than 40 countries worldwide through investing in the latest research, technology and manufacturing methods.
BPL operates in the global health market with security and stability, giving its customers a high degree of confidence in its integrity and its services. Dealing with BPL gives an assurance that all personnel are experts and highly experienced in their field and that the organisation as a whole is totally committed to providing an unparalleled level of service, while delivering the right solutions at the right time for health professionals throughout the world.
ABOUT CHERWELL LABORATORIES:
Cherwell Laboratories, established in Bicester since 1974, is a leading supplier of prepared microbiological media and environmental monitoring instrumentation for pharmaceutical and related industries. This family owned company specialises in the manufacture of the Redipor range of prepared microbiological media products. Its product portfolio is extensive and includes Petri dishes, contact plates and gamma irradiated media, as well as bottled broths and diluents and Dipslides. Cherwell also supplies environmental monitoring solutions, including an extensive range of portable microbial air samplers, fixed microbial sampling systems and a range of hand held, or portable particle counters, as well as the DataTrace® datalogger range.
The Company is extremely customer focused and fully recognises the need for excellence in customer service and support, a fact that is confirmed by its ongoing commitment to ISO9001:2008 registration. What also sets Cherwell Laboratories apart is its ability to respond to customer demand. Cherwell has fully automated aseptic plate filling machinery capable of processing over 5000 plates per batch, but can also produce small batches from 50 plates for selective or investigational media. This enables the provision of the smaller batches required for validation of changes to media formulations for example.
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