Increasing pressure from regulatory agencies, including continuing changes in the ISO guidelines for cleanrooms, has driven higher demand for environmental monitoring and the validation of sterilisation processes in the pharmaceutical and related industries. A key factor in ensuring successful completion of building projects is a thorough understanding of the specific requirements of the client
With demand for environmental monitoring and sterilisation validation processes rising, prepared media company Cherwell Laboratories is expanding its facilities in two phases. The company describes the successful completion of phase one.
Increasing pressure from regulatory agencies, including continuing changes in the ISO guidelines for cleanrooms, has driven higher demand for environmental monitoring and the validation of sterilisation processes in the pharmaceutical and related industries. As a supplier of microbiological media and instruments, UK-based Cherwell Laboratories has responded to the growing demand for its Redipor range of contact and settle plates by expanding its own cleanroom facilities in two main phases. A key factor ensuring successful completion of the first phase of the project was a thorough understanding of the specific requirements of the media manufacturing company. The second phase of the expansion is due for completion during 2013.
The company has been in the business of environmental monitoring and process validation for more than 40 years and its expertise has been passed on to numerous companies to ensure the effectiveness of their cleanroom and sterilisation techniques. The company has witnessed a 25% increase in sales over the past year, with 70% of the business originating from the Redipor prepared media range of products, which includes contact and settle plates used to measure microbial contamination in the pharmaceutical industry.
The drive behind the expansion of the cleanroom was the need for greater space and increased flexibility, says managing director Andy Whittard: “Our current facility was under considerable space constraints, particularly for the final inspection and packaging area. Expansion was our only option, providing increased capacity to match our higher sales figures. We also wanted to introduce automated flow-wrap packaging, plus a new labelling system, to increase throughput, while having space left for manual packaging.”
Although the company has fully automated aseptic plate filling machinery capable of processing more than 5,000 plates per batch, it can also produce small batches from 50 plates for selective or investigational media. The emphasis, therefore, is placed on being able to provide individual, bespoke solutions to customers and the new cleanroom design needed to accommodate this flexibility.
“Alongside routine mass production, a key strength of the company is the ability to work with customers to design bespoke solutions that fit their validation needs. The aim for us is to combine high volume efficiency with small volume flexibility. The new cleanroom facility gives us the ability to react quickly to our customers’ specific needs, which has strengthened our long-term relationships with them: as they grow, we grow,” says Whittard.
A blank canvas – the new facility in February 2012
Phase I of the expansion, which covers 270m2 was completed in July 2012 by Envair, a manufacturer of clean air and containment facilities for the pharmaceutical and biotechnology industries, research laboratories and healthcare. Envair’s managing director Andrew Cockcroft was in charge of the previous cleanroom design and construction, and Cherwell Laboratories chose to rely on his expertise once again for the expansion.
The basic design included floors, walls and ceilings made of a smooth, impervious material to ensure no particle shedding and easy cleaning. The unit is also hermetically sealed, with no ingress of air, to reduce contamination. Nevertheless, Envair was able to tailor its design to produce a bespoke solution that matched the company’s specific needs.
“One of the main factors to consider was the layout of the cleanroom to ensure a good workflow of both products and personnel to prevent cross-contamination,” says Cockcroft.
The expanded unit includes a new packing room, which allows for the automated packaging requirements as previously mentioned. Personnel gowning areas have also been expanded to help reduce contamination risks within the core cleanroom space. The final solution was based on a model of “high quality combined with cost-effectiveness” according to Whittard.
The new packaging areas, designed and installed with flexibility in mind
Increased warehouse space was provided for storage of finished goods, including other products in the company’s range, such as biological indicators and hand-held air sampling equipment. The efficiency and organisation of the company also relies on the provision of ample warehouse space, which allows increased stock holding.
The new installation was dovetailed around an existing and fully operational production facility so that Phase I caused minimal disruption to production. Having a good knowledge and understanding of the company’s production processes was key to the smoooth running of the project. “Having worked with Cherwell Laboratories for more than 14 years we had a good understanding of the production methods, protocols and design requirements,” said Cockcroft.
Envair Projects followed the User Requirement Specification (URS) – the document produced jointly with the client that gives detailed information on the needs of the project.
Each phase of work had to be fully commissioned and validated prior to the moving of any equipment and personnel. The new production areas were designed and installed in line with Good Manufacturing Practice (GMP) guidelines and recommendations.
The validation was carried out using Cherwell’s own products, such as air samplers and gamma irradiated TSA settle plates and contact plates, as well as SDA plates. Validation continues on a daily and weekly schedule to ensure the cleanroom was fit for purpose.
The new automated flow-wrap packaging line, plus a new labelling system, increases throughput, while ensuring space is left for manual packaging
“Having knowledge of, and confidence in, our own validation products made it easy for us to validate the cleanroom environment,” said Whittard. For environmental monitoring, the ISO 14644 standard for cleanrooms is applied and, although the cleanroom at Cherwell Laboratories is not GMP certified, many of the principles are taken on board, with the equivalent of a grade C applied for the level of airborne particulates allowed.
Phase II of the cleanroom expansion is to begin in 2013. The facility will then more than double from the original 440m2 to 940m2 to allow additional space for media preparation and support areas. This will allow production volumes to exceed the current 5.5 million agar plates produced every year, allowing the company to delve further into the export market. It seems that a lot of hard work, plus a good relationship with customers, is the formula for success for Cherwell – but not without the help of a well-designed cleanroom.