Garments under threat

IEST-RP-CC-003-2 (currently under revision) is widely recognised by the cleanroom sector as the industry standard for all aspects of garment protocol, but its advice on recommended frequency of garment changes to meet room classifications has over recent years become one of the least adhered-to guidance papers within the cleanroom field. While an aseptic area is obliged by the nature of its product to follow a change-on-entry regime, the remainder of the recommended usage chart is often 'thrown out of the window', particularly by new entrants to cleanroom technology.

There is no doubt that the suggested change regime is often viewed as being on the 'overkill' side, and it's a fact of life that the cleanroom garment consultant sitting opposite procurement and proposing an increase in the number of changes per operative per week (together with its resultant cost implications) would be viewed, at the very least, with suspicion. Such a proposal in today's economic climate becomes more difficult as we see less informed personnel, with little or no knowledge of the 'raison d'etre' for cleanroom garment systems, being responsible for selection of a service provider.

Why is this? Is it a carry-over from standard industrial workwear practice, where a monochange per week is the benchmark? Is it the case that the higher costs of cleanroom apparel and processing in comparison to standard workwear schemes produce shock waves? If the latter reason is the case, then there is a need for the cleanroom garment field to better educate the end-user as to why cleanroom garments are an essential ingredient towards maintaining room classification, and that initial cost is only the tip of the iceberg.

Rather than the end-user posing the question 'how much'? and in 'what colour'?, the garment professional should be educating his customer as to the potential dangers of not operating a sensible garment regime.

A straightforward defect detected while still in the production area is bad enough, but a 'walking wounded' product, which is delivered to the end-user and subsequently fails, creates a whole new cycle of customer dissatisfaction, costly replacement and loss of prestige in the market place.

It will be seen that the minimum change pattern for cleanroom garments recommended in IEST-RP-CC-003.2, is every other day or shift. Reality is often very different. Cleanrooms well up the scale of the new Air Classification 14644-1 will house operatives who have changed but once during their whole week of shifts.

Theoretical savings gained by this practice are ill-advised and can often be proved to be short-term and fragile. A garment worn for a notional five-shift week, will carry a particle burden increasing with a non-linear impetus by the hour, creating problems for filter and air-handling controls within the cleanroom. Most importantly it will directly influence the bottom line yield figures when the end product - often carrying heavy replacement or reworking costs would be affected.

It could almost be argued that in lower specification cleanrooms, there is a case for a level of body filter protection greater than that recommended. The body temperature differential of an operative causes emitted fibres and particles to rise by convection and circulate within the room. High grade laminar flow configurations, together with ULPA and HEPA filters can normally deal with this challenge. However, in lower airflow specification rooms the contamination will take longer to dispel and could migrate to settling points - often corners of the room - ready to re-activate again when staff or materials enter the area. From an aesthetic point of view, residual staining due to prolonged wear presents a major problem. In cleanroom garment processing, the lack of abrasion in polyester, allied to the fact that normal detergents cannot be used in decontamination makes removal of the stain very difficult.

Sensible garment levels in a system will allow an appropriate number of changes to be made, prolonging garment life and integrity of seams and fastenings. In addition, in these days of bar-coding and transponder technology the laundry can monitor garment processing cycles and replace when necessary.

In the early days of cleanrooms, the operator contamination level was estimated as high as 80% of all total cleanroom pollution. We have since seen this figure almost halved. We should not now lose sight of how this reduction has been achieved. Operator training and cleanroom protocol have been important factors, but the overriding single cause of the reduction has been the improvement in quality and application of cleanroom fabrics and garment construction. There is evidence that this emphasis on good quality garments and fabrics, together with adequate change patterns has become diluted and that all too often apparel is seen as a cosmetic addition to cleanroom practice.

Most companies contract out their garment supply and processing services to specialist providers. In-house facilities are rapidly being condemned by inspectorates as being unable to meet ever more demanding Federal and European standards, or are perceived as not being part of a company's core business. The depth of service and advice available to the cleanroom industry is impressive, with contractors providing:

• Choice of fabrics including static dissipative and antimicrobial polyesters
• Field-tested garment designs
• Choice of systems, including on-site management and dispensers
• Latest barcode and transponder technology aiding stock control
• Thermal disinfection
• Antistatic and microbiological treatment and monitoring
• Fitting and repair service
• Certificates of particle count conformity and sterilisation if required

With this wealth of quality services readily available to end users, it is difficult to understand why recommendations are not followed more closely.

Without doubt it is the responsibility of cleanroom garment manufacturers and processors, together with experienced professionals within the field of human-source contamination, to provide the necessary guidance and present a solid case illustrating a direct, practical and financial correlation between sensible garment procedures and end-product quality.