Cherwell Laboratories, specialists in cleanroom microbiology solutions for the pharmaceutical and related industries, has been assisting Portsmouth Pharmaceutical Manufacturing Unit (PMU) in their extensive environmental monitoring (EM) programme for over 20 years. Such is PMU’s confidence in Cherwell and its products, the facility has recently purchased an additional SAS Super 180 microbial monitoring air sampler. Cherwell has subsequently published a case study discussing PMU’s key considerations when purchasing a new active air sampler for an EM programme.
Portsmouth PMU specialises in the aseptic preparation of pharmaceuticals and parenteral nutrition, cytotoxics and patient-controlled analgesia in a variety of administration devices. With two aseptic rooms, eight isolators, two preparation rooms and a checking and labelling area; an extensive environmental monitoring programme (incorporating both active and passive air sampling, as well as contact plates) is in place to ensure the environment is free from microbial contamination.
Reliability, ease-of-use and sampling speed were all key considerations in Portsmouth’s selection process for a microbial air sampler. With a sampling rate of 180 litres per minute, the SAS Super 180 unit is the fastest sampler available, completing a cubic metre in less than 6 minutes - this saves on staff time and minimises disruption. In addition, the SAS is unique since it uses more readily available, and therefore less expensive, contact plates as the consumable. Furthermore, its portability allows PMU to easily conduct environmental monitoring across its various locations.
Julie Bowden, QA Releasing Officer, Portsmouth PMU commented, “When we were looking to buy a new unit, we didn’t look at any other air samplers on the market. We only considered Cherwell due to our positive experience of the product and their excellent customer service. Cherwell are always very accommodating and deal with any queries straight away, we don’t have to be passed on to someone else.”
The reliability and robustness of SAS air sampling equipment, combined with Cherwell’s technical expertise, were also key factors in Portsmouth’s decision to continue using SAS units. In addition to the newly purchased unit, PMU still uses another SAS Super 180 unit 12 years after the initial purchase, confirming the lifetime value of the units. This has been supported by Cherwell’s customer focused calibration service - operated by the Company’s own engineering department based in its Bicester facility - this also ensures a rapid turnaround time. Calibrations can also be arranged to fit in with customer requirements, further minimising downtime and inconvenience.
“Cherwell make it easy for us to arrange recalibration at a time that suits us and the turnaround time is very quick,” said Nicola Lightfoot, QC Technician, Portsmouth PMU. She added, “If any repairs are required, a quotation is always provided before the work is carried out and we are kept informed of progress.”
The long standing relationship between Portsmouth PMU and Cherwell has been based on providing the most appropriate product to fit the required application, alongside a flexible and reliable service. In fact, in addition to the portable SAS Super 180 units, PMU also uses SAS Super Isolator units for dedicated EM within isolators; it has also received regular and flexible delivery of Redipor® prepared culture media since 2006. Cherwell’s focus on customer support, high quality products and technical advice are all valued by Portsmouth PMU, who know their specific requests will be dealt with efficiently and effectively.
Through understanding the increasing regulatory requirements placed on pharmacy manufacturing units within the UK, Cherwell has been able to assist Portsmouth PMU in meeting these obligations. This has only been possible by having good knowledge of the industry sector and providing products and services that are fit for purpose.