Issue link: https://www.e-digitaleditions.com/i/1351840
Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 13 Design The design and construction of a gowning system is covered in great detail in the Institute of En- vironmental Science and Technology's (IEST's) RP-3 guidelines (1). Gowning design elements such as length of zipper, size of the sleeve and leg openings, and the type of sewing used in the seams can have a very large impact on the per- formance of the garments in the cleanroom. Ad- ditionally, concerns will include ease of donning and doffing of the garment, and the ability of the material to withstand the gowning process without becoming compromised or damaged. Other elements such as the ty pe of seam, zip- pers, and threads can be a source of contamina- tion. If these elements are not compatible with the gowning process, inferior in design, or ill- suited to the level of activity in the cleanroom, the garments may be ripped or damaged in the course of normal activities. A torn or damaged gown would require an immediate exit from the cleanroom and/or an evaluation of the product being produced. Processing/cleaning In addition, the process used to clean the garments must be considered. Every cleanroom garment, whether it is worn once or many times, must be cleaned before being introduced to the cleanroom. The cleaning process for a garment can include soil sorting garments (which groups like garments together); specialized wash processes using appro- priate detergent and purified water; and finally an inspection of the garment, which determines whether or not the garment is usable. The inventory of the garments must be actively controlled to account for service life (reusable gar- ments) or adequate availability for single use. Clean garments must be packaged in a way that facilitates the ultimate gowning process and maintains the integrity of the garment. Ideally, the packaging can facilitate gowning through the fold or inclusion of various gown items (i.e., hood/mask combination). Packaging The packaging materials used for the gowns must be of an appropriate design to withstand the han- dling, transportation, storage, and end use of the garment over a wide range of temperature and cleanliness conditions, including any sterilization processes. The package's seal integrity is critical to maintaining cleanliness and/or sterility, and should be selected to facilitate the inspection of the garment prior to use or storage. Providers of cleanroom garments must perform seal integrity testing to ensure that the bag is not breached and that the gowning items within the package have not been compromised (2). The packaging materials used for cleanroom garments are typically made of plastic film that does not generate particles. The final packaging must be durable enough to protect the garment and withstand any cleaning or sanitization re- quirements including exposure to strong cleaning solutions such as alcohol and sporicidal agents. Transparent packages are helpful when they can allow an initial inspection of garment integrity and cleanliness to be performed before the bag is opened in the gown room. Many cleanroom ap- plications require multiple layers of sealed pack- age protection for each garment. This will allow for ease in transfer from the warehouse to critical gown rooms where the process is to remove lay- ers of packaging as the garments are transitioned