EU GMP Annex 1 revision triggers growing requirement to protect agar plates and prevent spoiled samples
Bicester, UK, 21st May 2020: : Cherwell Laboratories, specialist suppliers of environmental monitoring and process validation solutions for the pharmaceutical and related industries, has increased the breadth of its range of stainless-steel prepared media accessories for use within cleanroom environmental monitoring programmes, in response to customer demand. This is due to the increasing importance and need for continuous microbial monitoring in line with updated GMP regulations for the manufacture of sterile medicinal products.
The GMP regulatory inspectorate’s focus on the revised EU GMP Annex 1 - continuous viable monitoring and data integrity - has elevated the humble agar settle plate and active air sample plate to delivering very high value data points. The agar plate costs only pence, but as soon as it is allocated a time and location its loss or damage can delay batch release of sterile products and require expensive, time-consuming investigations.
Andrew Barrow, Sales Manager, Cherwell Laboratories, explains, “Due to the recent Annex 1 revisions, we have seen a renewed and growing interest in simple, well designed accessories to reduce the risk of accidents involving agar plates through the whole cycle - from receipt of sterile wrapped agar plates, to the final counting and identification of colonies in the laboratory. So, we have sought to support our customers fully by expanding our prepared media accessories range.”
Cherwell’s growing range of stainless-steel accessories includes Settle Plate stands offering a defined sample point and reducing the risk of a spoilt sample. Holding either one or two plates, the stainless-steel stand’s two-shelf configuration provides a place for both the exposed plate as well as its lid, preventing it from becoming separated or accidentally damaged. The twin plate stand offers a practical solution where two types of agar (usually TSA and SDA for bacteria and fungi separately) are used.
A tall version, for placement near to critical points, has recently been introduced. This floor standing model of the settle plate stand can be placed in an optimal position for environmental monitoring, whilst being sited in a non-intrusive location so as not to disturb workflow. Based on the existing design, the settle plate stand is mounted on a single rod, with a robust, circular base for stability, all in stainless-steel. Cherwell now offers the stand at 800mm and 1,000mm heights, but is also able to make the stand to a customer specified height, as well as a twin plate version on request.
Also ensuring crucial agar plate protection and complementing the plate stands, Cherwell manufactures stainless-steel contact plate and petri dish carriers to aid safe handling and transportation and efficient use of incubator space. Holding up to 20 plates, each carrier is 100% stainless-steel with no fixings or difficult corners to clean, providing a cleanroom compatible finish that is easily cleaned and/or autoclaved. For additional practicality, the units feature a handle for transportation, which moves to enable unobstructed loading of the carrier.
Cherwell initially developed its range of settle plate stands to meet specific environmental monitoring requirements following an approach by a pharmaceutical manufacturer. “We pride ourselves on our ability to offer customers bespoke solutions to meet their specific requirements,” adds Andrew Barrow. “We have an on-site Engineering Team and experts that keep up to date with regulatory requirements, such as the latest revision of the EU GMP Annex 1. This means we can work closely with our customers to find the best possible solution to meet their individual environmental monitoring needs; we can also fully understand how our solutions can be used to support all of our customers.”
Cherwell’s product range has developed over the years to meet changing customer and regulatory requirements. Its Redipor® range of prepared culture media offers a vast selection of contact plates and Petri dishes, plus liquid media in a variety of formats. It also supplies microbial air samplers for a range of environmental monitoring applications, including cleanroom, compressed air/gas and isolator monitoring. Supported by an experienced in-house engineering department, Cherwell’s SAS air samplers offer a convenient, robust, and reliable solution to environmental monitoring needs.