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. 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.
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: 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. 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.
Sterility Assurance: The desired Sterility Assurance Level (SAL) for garments to be used in pharmaceutical manufacturing is 1 Q-6. This level of sterility translates to a one-in-one-million probability of a garment being non-sterile.
Sterilization Dose Determination: Each product type requires a minimum quantity of radiation to achieve sterility. The quantity of radiation received is a function of the number and types of microbes present on the garment. Certain microbe types are more resistant than others.
Dose Auditing: Once a dose is established, its validity must be confirmed periodically through experimentation. Microbial populations can change in count and resistance from season to season, and it is possible that a dose determined in a particular season may not be effective throughout the year. These “dose audits” are commonly done on a quarterly basis. More apparel selection tips will be given in next week’s Cleanroom Tip!
From: “Apparel System Selection For Phamaceutical Cleanrooms”