This article appears in the January 2006 Controlled Environments by Mike Groesbeck V.P of Quality Operations for Cardinal Health. He addresses the question of single use vs. multiple use garments by first listing the necessary attributes of the materials • Barrier properties • Strength properties • Lint properties He points out that material degradation becomes a factor for multiple wear garments. The desired Sterility Assurance Level( SAL) is 10(6) insuring a one in one million probability of a garment being non sterile.. This requires more radiation which reduces the life of multi wear garments. The supply chain for multiple use garments is complicated and generally requires contracts with processors of 1 to 5 years. Supply chain for single use garments is less complicated There are two general approaches that a pharmaceutical company can use to assure the quality of incoming garments. • Use internal personnel to monitor and periodically audit • Third party verification of supplier quality system Third part verification requires a certification system ( e.g two ISO standards and or EC Certification) Comfort is another factor . the non woven tyvek used in single use garments is lighter than woven materials used in multiwear garments. Tyvek is comparable in air permeability but is stiffer. Comfort is typically quantified through air permeability water vapor transmission rates and material stiffness.

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• Cardinal Health

• Cleanroom

• Garment

• Contamination Control

• Article