There are many pros and cons to consider when deciding whether to purchasesingle-use or multiple-wear garments.

Introduction
One of the most important decisions facing any manufacturer of sterile fill pharmaceutical products is the selection of the garment system that will be utilized to support both initial validation and ongoing production. There are two basic types of systems; single-use and multiple-wear, each with a long history of use. This article has been prepared to compare and contrast each garment system against the following key attributes: functionality, sterility, economics, supply chain reliability, and comfort. Since cleanroom garments are not regulated, it is important that the garment user exercise effective controls in the selection and ongoing monitoring of a sterile garment supplier. The purpose of the article is to provide a good working understanding of the merits of both systems, enabling the reader to make an informed andappropriate choice for their particular applications.

When selecting a garment system, key considerations should include a reliable supply of sterile apparel with minimal amounts of particulate matter, produced in a cost-effective and traceable manner that meets or exceeds defined specifications. In support of this objective, the following requirements become important:

Consistent Functional Performance
The woven and non-woven materials used to construct garments are engineered textiles with specific technical attributes. Chief among these attributesare:

Barrier properties: the ability to withstand fluid and particulate matter penetration and pass-through that will protect the worker, process, and product.

Strength properties: the ability to withstand the mechanical stress associated with the manufacturing process.

Lint properties: the propensity of a material to generate loose particulate matter in response to mechanical stress and normal wear.

Although there are no universally recognized industry performance standards to meet these attributes, there are numerous evaluation methodologies (many borrowed from the plastic, textile, and paper industries) with which a garment supplier can characterize their product offerings. Test methods sponsored by ASTM (American Society for Testing Materials) and other standards agencies are commonly used. There are significant differences between the single-use and multiple-wear products. The single-use items are constructed from non-woven materials manufactured by high-speed processes that are then converted by manufacturers into finished goods. The suppliers of these non-woven materials typically utilize statistical process control and other techniques to assure that the product meets the technical specifications. Since the garments are worn only once, the physical and performance properties of the non-woven are consistent and well established.

Material degradation becomes a factor for multiple-wear garment systems. The product history of a multiple-wear garment consists of washing, drying, packaging, sterilization, and use, for a pre-determined number of cycles. The garment may not offer the same level of performance at use number 80 as it did when initially put into service. Sterilization is typically accomplished by gamma or electron beam radiation, Either radiation type is sufficiently energetic to ionize polymeric materials and cause degradation. Certain polymer types, such as polypropylene and polytetra- fluoroethylene (PTFE), are not compatible with radiation sterilization due to weakening and other effects. Other types of polymeric fibers are more durable with respect to radiation and each material and garment type will have a finite lifetime, expressed as either the number of "cycles" or the total radiation received, Suppliers of multiple-wear garments must use appropriate validation techniques to determine the usable life of the products. Multiple-wear garments are typically cycled through contracted laundry and sterilization operations. Given the finite lifetime of the garments, it is imperative that a reliable mechanism be established that can track the individual garments, and remove them from service at the end of their lifecycle.