Performance of Cleanroom Garment Fabrics When Processed in an Industrial Laundry, Comparing Irradiation and Autoclave Sterilisation

Abstract

EU GMP Annex 1 requires that “reusable garments should be replaced based at a set frequency determined by qualification, or if damage is identified.” [1] In the UK, most cleanroom garments supplied to the pharmaceutical and healthcare sectors are washed and sterilised by gamma irradiation. This study compares cleanroom garment fabric performance across the lifespan of multiple fabrics. Previous research has shown that cleanroom garment fabrics terminally sterilised by gamma irradiation remain suitable for use for up to 50 processes, however, these studies often focus on a limited number of samples. This study uses a large sample set, analysing the performance up to 100 processes and compares the performance effects of gamma irradiation vs autoclaving, as an alternative sterilisation method. Multiple market leading cleanroom garment fabrics were washed and dried using a standard industrial cleanroom laundry process and sterilised by either gamma irradiation or autoclave. They were tested for particle barrier efficiency, abrasion resistance, pore size, and tensile strength as new, then at set process counts throughout their life, 10, 20, 30, 50, 70 and 100 processes. A process is equal to one wash/dry/sterilisation cycle. The results show that not all cleanroom garment fabrics deteriorate equally and that some market leading fabrics may not provide adequate performance throughout life, even if they are suitable when new. They also show that autoclaving is comparable with irradiation in durability and performance over a fabric’s life, in some cases performing better than irradiation above process counts of 50.