Manufacturing

In any pharmaceutical production environment, highstandards of cleanliness are paramount. A failure toaddress this issue properly can lead to product wastageand have potentially fatal consequences. This articlewill look at the latest advances in cleanroom garmentsand laundry operations in preventing contamination.

Cleanroom garments are designed to prevent foreignparticles and bacteria from operatives contaminating theproduction process. Particular attention must be paid,therefore, to the selection, design, preparation andcleaning of these garments to ensure they are providingan optimal service.

In the past, pharmaceutical companies have chosendisposable garments but this thinking is now changing,and advances in reusable garments and the availability ofhi-tech specialist cleanroom laundries are making non-disposable clothing a more cost-effective option.

STERILISATION

To remove any potentially harmful microbes, garmentsmust undergo a sterilisation process. This is usuallycarried out by subjecting the garments to gammaradiation, which kills off any bacteria. However, use ofthis method can cause items such as zips and elastic cuffs

to deteriorate rapidly – drastically reducingthe useful life of the garment. At Origin, wehave developed a special process, whichremoves the need for radiation yet providesthe same standards of sterilisation. Thisprocess not only ensures that garments last forlonger, but it also offers more scope in terms ofgarment design. It allows the use of zips andstud fastenings instead of elastic, and featuressuch as penholders can also be incorporated.Another benefit of this approach is that the fitof garments can be improved, further reducingthe potential for contamination. Regulartesting for microorganisms on garments isessential; garments need to be swabbed and thesamples then cultivated on a petrie dish.

Garments are normally cleaned at a specialistcleanroom laundry to international cleanroomstandards. Key criteria to consider here are:

� Garments for pharmaceutical use should becleaned under ISO 14644-1, ISO Class 4and tested to AST 51-00 standards

� The supplier should carry out regularindependent audits of the air and water quality standards within thecleanroom laundry

� Water used to clean garments should be 18 mega-ohm ultra-pure de-ionised toeliminate the risks of contamination through impurities found in normal water

� Garments should be double-bagged at the laundry

� Sets of garments should be individuallypackaged and uniquely identified to employees

Advances in reusable garments and the availability of hi-tech specialist cleanroom laundries are makingnon-disposable clothing a more cost-effective option.

92 Innovations in Pharmaceutical Technology

By John Anderson at Origin Outsourcing

Cleanroom Clothing: Factors to Consider

Figure 1: Specialistcleanroom laundries havemade reusable garmentsa more cost-effectiveoption

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Three key methods are employed to test garments oncethey have been through the cleaning process:

� Garments are put into a Helme drum where anairborne particle counter is used to determinethe number of particles over 0.3 microns in sizeper cubic foot of air

� The ASTM 51-00 test involves drawing airthrough a filter on certain parts of the garment;this tests for loose particles and fibres in and onthe surface of the garment

� Static dissipation tests are used to check howwell the garment can resist static charges

GARMENT SELECTION

In selecting garments, operator comfort is veryimportant. Garments should integrate seamlessly withother items such as hats, gloves and footwear. A goodfit is essential to ensure operator comfort and theoperational efficiency of the garment. Carrying out ameasuring exercise will ensure that each employee feelscomfortable wearing the garment, and the lifespan ofthe garment is maximised. Poorly fitting garments willwear out more quickly, adding to the total cost ofownership. When sourcing garments from overseas,especially the US and Asia, it should be borne inmind that these countries have specific bodycharacteristics. Choice of footwear is particularlyimportant, as overshoes tend to suffer the worstwear and tear. Skimping in this area can be afalse economy.

The fabric from which the garments areconstructed is also important. There are a number of well-established brands – but new fabrics emerging from the Far East offer comparable performance andfunctionality at a reduced cost.

MONITORING

Careful monitoring and management of thestock of garments is vital. Each garment should bebarcoded so it can be tracked and also traced shouldany contamination issues arise. Key factors to considerinclude the following:

� How many sets of garments will be required foreach employee? It is essential that contingencystock is held at the site for emergencies, and

that spare garments are ready to hand shouldexisting garments be contaminated or damaged.

� Each garment should be thoroughly inspectedfor any damage when returned to the supplier;the stage at which a garment should be replacedrather than repaired should be agreed inthe contract.

� What service levelagreements are inplace to ensure thatresponse times,collections anddeliveries are in line with operationaland commercialobjectives?

Innovations in Pharmaceutical Technology

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� Does the supplier have sophisticatedManagement Resource Planningsystems in place to manage the flow of garments and to make sure that theright garments are in the right place at the right time?

� Are coats, hats, gloves and overshoespackaged together and assigned to each individual?

� Traceability is vital if anything goeswrong – can the supplier provide adetailed audit trail so that cleanedgarments can be identified by batch number?

� What policies and procedures are in place toenforce frequency of garment changes? Detailedmanagement reports should be supplied to showemployee compliance and monitoring of thegarment lifecycle.

CONCLUSION

The importance of cleanroom garments to the safe andefficient operation of a pharmaceutical manufacturingplant cannot be overestimated. How garments aresourced, designed and cleaned can have a significantimpact on operational efficiency and operator comfort.

94 Innovations in Pharmaceutical Technology

John Anderson is Business Development Manager of the Cleanroom Services Division of Origin OutsourcingSolutions Limited, a UK supplier of support services to thecleanroom sector. He has extensive experience in thecleanroom support services having previously been UKService Manager for Critical Environment Solutions Ltd (CES– formerly AIS Countdown). During his 13 years with the

company, he gained substantial experience working with a blue chip clientbase that included GSK and Philips Electronics. At Origin, John is responsiblefor driving forward sales and technical operations within the Origin CleanroomServices division, with a specific emphasis on the pharmaceutical sector.Email: john.anderson@origin-outsourcing.com

Figure 3: Garments arecleaned to internationalcleanroom standards

Figure 2: Garments arebarcoded and scannedto aid traceability

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