to the sterility assurance level required by the customer. It is also most
cost-effective to radiate the manufactured materials to the same sterility
assurance level. Therefore most suppliers of sterile cleanroom materials
validate their processes to deliver sterile cleanroom reusable or disposable materials at 10-6 SAL (sterility assurance level) to serve a broader,
What unmet needs are there for cleanroom apparel?
There are as many unmet needs for cleanroom apparel as there are products and processes performed in cleanrooms. As nanotechnology expands
worldwide and the size of components of cleanroom manufactured
products reduce, the control of potential viable and non-viable contamination will increase. The safety and security of food and food products
will increase the demand for cleanroom apparel worldwide. The use of
reusable sterile and non-sterile cleanroom apparel is one method of controlling contamination in a cost effective manner.
It is imperative that the complete supply chain of the disposable and/
or reusable cleanroom garments is audited for compliance to IEST-RP-
CC003.4 and to individual customer specifications. Routine scheduled
assessments assure that the cleanroom garments protect the process and
the product in the cleanroom.
The most important, universal specification for cleanroom disposable
and reusable apparel is that the cleanroom garment system is appropriate
to protect the cleanroom process or product manufactured in the cleanroom and that it is always worn correctly.
Jan Eudy is a technical resource for ESD, cleanroom, food, and healthcare
garments and products. She is President Emeritus and Fellow, Institute of
Environmental Sciences and Technology. Jan can be reached at janeeudy@