In parenteral drug manufacturing, maintaining a sterile environment is critical to ensure the safety and efficacy of the final product. The United States Pharmacopeia (USP) General Chapter 788 provides guidelines for measuring visible particles in injections, parenteral infusions, and ophthalmic solutions. The guidelines require that injectable drug products contain no more than 6000 particles per container equal to or greater than 10 microns in size and no more than 600 particles per container equal to or greater than 25 microns. Therefore, it is essential to minimize the presence of particles greater than 30 microns that are shed from sterile cleanroom wipers during the manufacturing process.
Cleanrooms designed for parenteral drug manufacturing typically use sterile wipers for cleaning and disinfection. These wipers are usually manufactured from nonwoven Polycellulose or polypropylene, or circular knit polyester fabrics. However, these fabrics typically score low on tabor abrasion measurements. Tabor abrasion measures the mass loss of materials exposed to an abrasive wheel, and a lower score indicates a lower likelihood of shedding particles during use. Microfiber fabric-based wipers have been shown to score higher on tabor abrasion measurements and are a better option for contamination control.
Multiple foreign particle assessments in parenteral manufacturing sites have shown that “lint-free“ wipers are the major source of fiber-based contamination.
MiraWIPE is an example of a microfiber fabric-based wiper designed to shed fewer particles during use. It has been designed to shed less than 0.6 grams, significantly less than the typical shedding of knitted polyester wipers (1-3 grams) and nonwoven fabrics (more than 20 grams) under tabor abrasion testing. Using the PolyCHECK particle identification process, multiple aseptic cleanrooms have confirmed that fabric-based mops and wipers are the number one source of fibers and particles larger than 30 microns.
See below, post-cleaning inspection of wipers conforms to the results generated by ASTM tabor abrasion test methods.
Polycellulose Before & After
Polyester Before & After
MiraWIPE Before & After
Using microfiber fabric-based wipers can significantly improve contamination control in cleanroom environments. Shedding fewer particles during use helps reduce contamination risk and ensure compliance with USP 788 and other regulatory requirements. Furthermore, reducing the shedding of opaque particles in appearance reality eases complicated visible inspection procedures.
In conclusion, using sterile wipers is critical in maintaining a clean environment in parenteral drug manufacturing cleanrooms. However, shedding particles from these wipers can pose a risk to the final product. The use of microfiber fabric-based wipers, such as MiraWIPE, can significantly reduce the shedding of particles and improve contamination control in these environments. As a result, these wipers should be considered part of any contamination control program in cleanroom environments.
MiraWIPE Cleanroom Microfiber Wipes
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