14-May-2010

A clean start for consumables

Abstract

The operators of pharmaceutical and medical cleanrooms increasingly demand a fast and flexible supply of consumables, produced to the highest standards of cleanliness. Shield Medicare’s newly openend £5m production and r&d facility at Baglan in South Wales, aims to be top in this class

The operators of pharmaceutical and medical cleanrooms increasingly demand a fast and flexible supply of consumables, produced to the highest standards of cleanliness. Shield Medicare’s newly openend £5m production and r&d facility at Baglan in South Wales, aims to be top in this class.

When making products for cleanrooms, companies need to be confident that their production facilities meet the highest GMP standards and that products are delivered sterile where required. This is why Shield Medicare – a division of Ecolab – has opened a new, purpose-built manufacturing facility at Baglan Energy Park, near Swansea, South Wales.

The new ‘Centre of Excellence for Contamination Control,’ specialises in meeting the requirements of pharmaceutical and medical cleanrooms. It covers almost 50,000ft2 (4,645m2) with a 16,000ft2 (1,486m2) production area – four times the size of the former production facility.

The two-storey building houses 80 employees in state-of-the-art cleanrooms and laboratories, together with some of the most innovative technology in the industry. This means that not only can the company carry out large volume production and single batch supply to major pharmaceutical companies, but also it can now devote more resources to research and development.

“This is a significant development for Ecolab,” said Susan Nestegard, Ecolab’s senior vice president and chief technical officer. “As the global leader in our field, we pride ourselves on our dedication to maintaining the highest standards, and the Baglan plant reflects this commitment.

“We chose this site, adjacent to the M4 motorway, because the location was convenient for the company’s skilled workforce and it provides us with good transport links,” said Nestegard. “The area available on this plot meant that we could build the facility to this large size and to such a high specification, while still having room for expansion in the future.”

The facility was designed around a U-shape workflow to optimise working efficiencies and to ensure best practice. In total, the production plant has five state-of-the-art Grade B and C cleanrooms, with laminar airflow at the point of fill in certain rooms and with 40 air changes per hour in the grade B production rooms and 25 air changes per hour in the grade C areas.

The cleanroom design incorporates several new features to minimise contamination risk from people traffic and airflow during the production process. These include interlocking hatches, which provide a means of passing products in and out of a cleanroom environment while maintaining correct air pressures. In addition, talk-through panels and the latest intercom systems enable two-way communication from either side of the cleanroom suite, reducing traffic and the need to open doors, cutting any contamination risk.

Even the change areas and preparation rooms have a high specification and make use of different coloured flooring to identify ‘clean’ and ‘dirty’ areas. The facility also has a 400,000-litre sprinkler system featuring specialist ‘hidden’ sprinklers in the cleanrooms that sit flush with the ceiling, making it easy to clean the cleanroom ceiling.

Automated equipment commissioned in the facility includes a four-head automatic liquid filler for sterile fill and a six-head automatic filling system for terminally sterilised products. Many of the handling features are also automated, such as the in-line and in-room conveying and loading systems, vacuum-lift palletisers, pallet shrink wrappers and bagging systems.

The blending suite is furnished with two 5,000-litre stainless steel vessels and two 5,000-litre PVC vessels and three 1,000-litre stainless steel blending tanks. The new facility can also produce 400 litres/hour of water for injection, and has provision to store the water once produced in a 10,000-litre tank. The annual production volume of consumables for Shield Medicare is 894,231 tons (908,338 tonnes) and with this new facility the company has a terminally sterilised product capacity of 12,600 litres per shift.

Clean Room Construction (CRC), of Rochester, UK, was the cleanroom contractor and was involved with the project right from conception in early 2006 through to successful validation and handover in 2008. CRC delivered a turnkey project from an outline user requirement specification by working in close partnership with the project team at Shield Medicare, who were also joined by experienced engineers and cleanroom experts from Ecolab, following Shield Medicare’s acquisition by Ecolab in June 2006. Ecolab is a leading global developer and marketer of premium cleaning, sanitising, pest elimination, maintenance and repair products for the hospitality, food service, healthcare and industrial markets.

The project was the first to utilise CRC’s new SB05 partitioning system, according to CRC director Richard Rowe. The partitioning system was colour co-ordinated to suit Shield Medicare’s corporate colours and included a high proportion of flush glazing to achieve operator comfort and enable prospective clients to witness the process first hand without having to go through gowning regimes.

The cleanroom included areas to standards ENISO 14644-1 ISO 5, 7 & 8, which were designed in a modular concept with walk on ceilings. The cleanroom services were routed outside the critical cleanroom areas and penetrated the clean envelope only where necessary. This means that lights, fan filters and process services can be easily moved or replaced, facilitating a flexible approach to cater for Shield Medicare’s future development. It also has the added benefit of minimising costly downtime, should future process requirements mean that services need to be relocated or added to at a later date.

Due to the nature of the substances stored it was necessary to segregate the cleanroom areas from the warehouse and storage areas so CRC undertook the installation of a 12m high 2-hour fire-rated wall covering an area of approximately 1000m2. The panels were constructed in one full height section and the erection was completed and certificated within two weeks.

Shield Medicare is currently working towards the 98/8/EC Biocidal Products Directive and operates to EC GMP. But in addition to its extensive processing capability, the company has a reputation for innovation and the new laboratory areas created specifically for research purposes are housed on the first floor level.

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