The best of both worlds

An international pharmaceutical manufacturer active in the field of anticancer treatments recently gave Bassaire the challenge of constructing a flexible cleanroom facility that would be easy to clean, yet resilient to disinfectant regimes.

Historically there have been two types of cleanroom: the "fully vinyled" room and the modular partition room, formerly of a wood laminate construction but now generally replaced by steel partitions. Our challenge was to provide the best characteristics of each system in one room. It has long been acknowledged that the fully vinyled cleanroom not only looks superior but also has the benefits of a homogeneous and hermetic surface; thus it provides a very cleanable, fully-welded surface that resists attacks from cleaning regimes using chemicals such as isopropyl alcohol and sodium hypochlorite. Internal finishes are smooth, impervious, with ledges and crevices kept to a minimum. The vinyl room has several dis-advantages, however: the walls are not modular; it requires a longer site installation time with wet trades; the cavities are not accessible for periodic cleaning; and the retrofitting of services is not easily achieved. Of greater concern are failures in the fabric, such as minuscule cuts that, if allowed to go undetected, can lead to the internal cavity becoming damp, thus promoting bacterial and fungal growth over long periods of time. This is usually not detected due to lack of access, and can lead to spurious particulate and cfu bursts from the structure that cause cGMP compliance failure, with the further complication that the cause is difficult to identify. In addition, the structure is not very resistant to mechanical impact. If damaged, the repair is difficult, time-consuming, requires wet trades and could cause the mass generation of particles resulting in further downtime for cleaning and revalidation.

Easy access For many years the alternative to a vinyl finish has been the modular steel panel system. However, despite excellent flexibility, there is generally a lack of access to the cavity for the addition of services. Site installation time is shorter, but the panels, if scratched, can rust. The general finish is powder-coated polyester that scratches easily; some panels can have a plastisol coat that does have better scratch resistance, albeit not perfect. Damaged panels can be replaced if the system is fully demountable and not the tongue and groove type of system that requires dismantling from one end. Another, advantage, often overlooked, is that the fully demountable system can (in the UK) attract a company tax rebate. After reviewing many different panel systems with the client, there was one system that seemed to offer a solution to all these issues – the Komfort CX cleanroom partition system. Bassaire has completed a number of successful cleanrooms utilising this system. In the early days teething problems did delay the installation process; but, just like with a new car model, the defects have been fully addressed and now the installation time is slightly longer than for a standard steel partition, and quicker than that for a vinyl system. The complex nature of the system means approved installers must be used for successful and timely completion; Bassaire fitters were given formal training by Komfort. Having completed this cytotoxic drug facility, we believe Komfort CX system offers the advantages of a combination of the two traditional systems. It has a factory-applied vinyl surface that offers improved quality compared with site-applied vinyl, and is highly scratch-resistant. Although it does not have the hermetic quality of a fully vinyled room, there is abundant flush fitting and coving detail. The factory-applied vinyl can be infused with Microban antibacterial protection, which inhibits continuously the growth and spread of harmful bacteria between cleanings and in hard-to-clean areas. While Microban protection is not a substitute for good cleaning practise, it does provide an added level of hygiene. In some instances customers may prefer that the people involved with the sanitisation of the rooms do not know about the antimicrobial's presence, in case it lowers cleaning standards. The Komfort CX system utilises a bi-panel partition system that can house return air ducts, electrical services and gases etc, within a void depth of 54-600mm. The system can also be used as a single-sided wall lining. Any side of the CX panel system can be removed individually, if there has been damage or additional services are required in the cleanroom. Such remedial work can be performed externally without disrupting the cleanroom cleanliness levels.

Demountable panels The system is fully demountable and relocatable, which allows the replacement of individual panels without affecting adjacent panels, and the reconfiguration of elevations and plans. The panel-to-panel fixing options are dry re-usable gasket; traditional silicone; or solvent weld gasket. The aluminium base is recessed to allow a flush height-adjustable vinyl floor cove detail to compensate for uneven floors, a factor traditionally overcome by the less aesthetic stepping of wall partition panels. The Komfort CX system does have structural capability to support walk-on ceilings, as used in this project, although Bassaire took the view to support the ceiling from the factory structure to increase the flexibility of the facility. In the pharmaceutical world, annex 1 – cGMP is an important factor. There are not many references within it to the structure of cleanrooms, but those that it does make are:- Premises • In clean areas, all exposed surfaces should be smooth, impervious and unbroken in order to minimise the shedding or accumulation of particles or micro-organisms and to permit the repeated application of cleaning agents, and disinfectants where used. • To reduce accumulation of dust and to facilitate cleaning there should be no uncleanable recesses and a minimum of projecting ledges. • False ceilings should be sealed to prevent contamination from the space above. • Pipes and ducts and other utilities should be installed so that they do not create recesses, unsealed openings and surfaces which are difficult to clean. Equipment • Fittings and services should be designed and installed so that operations, maintenance and repairs can be carried out outside the clean area. This cytotoxic drug facility constructed with Komfort CX panels is very close to the annex 1 ideal, which helped it greatly in obtaining MHRA approval.