Furnished with steel for hygiene and compliance

8-Sep-2015

Flexibility for future change in operations is important when designing new labs and work areas. Teknomek highlights a project where GMP compliant but flexible work surfaces were key

When designing a cleanroom for any aspect of drug manufacture, a clean and safe environment is the top criterion. To meet Good Manufacturing Practice (GMP) and national regulations, it is important that cleanrooms are designed with appropriate consultation and with contamination prevention and control practices front of mind. To support this, furniture and equipment must withstand thorough cleaning.

Stainless steel furniture and equipment can help pharmaceutical and life science companies meet the exacting hygienic audits set by the regulatory authorities. It is also offers flexibility in design and is very robust.

By bringing in the suppliers early on, you can use their expertise to help define the optimal products for specific cleaning routines

It is common practice for stainless steel furniture providers to work with customers in delivering tailor-made solutions that comply with regulatory criteria. Teknomek has been working with Oxford BioMedica, a leading developer of gene and cell based medicines and investigational medicinal products (IMPs), which has expanded into manufacturing and required a set of cleanrooms for production. The Oxford-based company’s work addresses diseases for which there is either currently no or inadequate treatment, including ocular diseases, neurodegenerative disorders and cancer. All require rigorous controls.

The cleanroom brief was for a common format and bespoke furniture which could be flexible in terms of use of space, would comply with GMP standards, cleanability as well as adaptability, and would withstand the company’s harsh cleaning processes. The use of freestanding stainless steel furniture meant the cleanroom would be future-proof – the use of space could be adjusted by placing furniture where it is needed as the room’s function evolves over time. The material also lends itself well to bespoke designs and for requirements such as rapid decontamination using vaporised hydrogen peroxide.

Francois-Xavier Toubhantz, Production Manager at Oxford Biomedica, explains: ‘It’s important to establish, early in the planning stage, how the cleanroom design will assist us in adhering to GMP. By bringing in the suppliers early on, you can use their expertise to help define the optimal products for specific cleaning routines. We collaborated with the designers for our new cleanroom months before it went live, enabling us to have leading-edge furniture that is robust for our rigorous cleaning routines and GMP.’

Austenitic steels (e.g. 304 grade steel) not only provide excellent resistance to corrosion, but they are also easily cleaned and disinfected without loss of robustness.

Crevice-free design

Furniture and equipment that comes into contact with materials with an acidic or alkaline pH can become pitted and this pitting can harbour bacteria and contaminants. As 304 stainless steel is essentially inert to most acids/alkali, corrosion, the creation of contamination traps is avoided. If the use dictates, austenitic 316 grade steel includes even more nickel and molybdenum, offering additional resistance to ultra-rigorous cleaning routines using products with chloride contents of up to 500mg/l.

The 304 stainless steel withstands mechanical, thermal and chemical cleaning

The removal of weld marks also reduces dirt traps and the wiping action when washing further enhances the bacterial cleanability of stainless steel. The 304 stainless steel withstands mechanical (e.g. high bar pressure), thermal (high temperature) and chemical (detergent) cleaning. For example, this grade of steel furniture and equipment maintains its structural integrity even at 870°C and chloride content up to 200mg/l.

Sue Springett, Commercial Manager, Teknomek, said: ‘Whether our customers’ priority is longevity through modular or bespoke design or supporting their GMP standards, we quickly adapt or design furniture and equipment from scratch which means we can help our clients meet specific challenges.’

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