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www.biopharminternational.com March 2021 eBook BioPharm International 17 water; and finally an inspection of the garment, which determines whether or not the garment is usable. The inventory of garments must be ac t ively cont rolled to account for service life for reus- able garments and for adequate availability of single use garments. Clean garments must be packaged in a way that facilitates the ulti- mate gowning process and main- tains the integrity of the garment. Ideally, the packaging can facilitate gowning through the fold or inclu- sion of various gown items (i.e., hood/mask combination). Packaging The packaging materials used for the gowns must be of an appro- pr iate desig n to w it hsta nd t he handling, 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 test- ing 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 typ- ically made of plastic film that does not generate particles. The final packaging must be durable enough to protect the gar ment and w ithstand any cleaning or sanitization requirements includ- ing exposure to strong cleaning s olut ion s suc h a s a lcohol a nd sporicidal agents. Transparent packages are help- ful 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 appli- cations require multiple layers of sealed package protection for each garment. This will allow for ease in transfer from the warehouse to crit- ical gown rooms where the process is to remove layers of packaging as the garments are transitioned from uncontrolled to controlled and then to classified areas. Lastly, the ship- ping containers must also serve to protect the packaged garment from damage during handling and not contaminate the packaged garment during opening or distribution into the gown rooms. Cardboard boxes pose a severe risk to contamination control. The cardboard materials can transfer mold, fibers, and insects into a facility or onto the products they contain. The containers for transfer must be assessed for cleanability, potential risk they could pose to the facility, as well as to the facil- ity's cleanrooms and controlled environments. This risk increases when the boxes are transported by common carriers or non-dedicated transport companies. Additionally, regulatory agen- cies recommend the use of plastic or synthetic pallets to prevent the transfer of contamination that is associated with use of wood pal- lets and shipping materials. The cleanroom user must assess these risks. Even if two different clean- room garments are equal in design, specification, and cleanliness, if the packaging that contains one of them has not been carefully designed, or the process for trans- ferring the garments to different parts of the facility has not been carefully controlled, it will still lead to cleanroom contamination. PARTICULATE TESTING A number of established tests are used to measure particles in and on ga r ments a nd eva luate t he cleanliness of the final packaged cleanroom garments (3–5). These tests (i.e., the American Society of Testing and Materials [ASTM] F51 and the Helmke Drum test) establish specific cleanliness lim- its for use in various classes of cleanroom. However, these lim- its only refer to a clean unworn garment and do not address the performance of a garment that is currently being used. PREVENTING VULNERABILITIES The cleanroom garment system is designed to protect the product, process, and cleanroom environ- me nt f rom op e rator-ge ne rate d contamination. Despite special training desig ned to ma ximize the level of protection afforded by cleanroom garments, operators can still unknowingly contaminate the cleanroom. When this happens, it's crucial to ask whether the prob- lem was caused by vulnerabilities in the garment system, or person- nel training issues. Data have been published on cleanroom garments, using stan- dardized methods to assess their ability to filter out particulates. The required tests subject clean- room garment fabric swatches to an aerosol suspension of particles. However, some of the published data were generated decades ago and are based on first-generation polyester taffeta garments, which have a mean pore size of up to 80 micrometers in diameter. In the tests described in this article, polyester garments were used that were made of StarShield ESD, a fabric that consists of 99% high density polyester with 1% car- bon fiber (used as an antistatic) a nd a mea n pore si ze of 3 –10 micrometers. This fabric can be cleaned to the highest cleanliness categories specified by the labora- Regulatory Sourcebook Operations