“A game changer for reusable sterile goggle
|Prudential sells top-notch cleanroom validated reusable sterile goggles! Find non garment reusable cleanroom products from our website and spend less.|
PCS has developed a sustainable reusable validated (SAL 10-6) rental goggle program with zero degradation, creating exponential increase in the life of your sterile goggles!
Contact your PCS professional for more information.
IS YOUR PROCESS FDA COMPLIANT?
A STUDY OF STERILE VS. SANITIZED GOGGLES GUIDANCE
The proper operation of an aseptic cleanroom has always required the greatest attention to every detail. The highest standard of operation and control must be maintained. One of these controls has long been the use of a sterile cleanroom garment gowning system.
The standard aseptic gowning configuration calls for the use of goggles to contain contamination from the operator’s eyes and face. Historically, goggles have been sanitized at the point of use which may not meet the traditional definition of sterile.
The current “Guidance for Industry Sterile Drug Products produced by Aseptic Processing-Current Good Manufacturing Practice” has attempted to extend this control. This issue for industry comment is being followed by many companies who wish to achieve compliance prior to the document becoming a regulation. The Agency recommends “gowns that are sterilized and non shedding, and cover the skin and hair (face-masks, hoods, beard/moustache covers, protective goggles, and elastic gloves are examples of common elements of gowns).” This document if left unchanged will require all garment elements including eye wear to be sterile if used in the aseptic cleanroom. The historical methods for sanitizing goggles, solvent wipe, UV cabinets etc. are not likely to be able to meet these enhanced requirements.
In order to help address this concern, Prudential Cleanroom Services provides a validated reusable sterlized goggle. PCS sterile goggles will ensure that every operator will comply with the most recent industry guidelines.
Prudential Cleanroom Services’ sterile goggles are tested to insure that their composition and properties remain intact after repeated sterilization.
A Prudential Cleanroom Services Validated Sterile Goggle Program delivers sterile goggles in accordance with the guideline!
*U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Regulatory affairs (ORA) September 2004 Pharmaceutical CGMPs
The FDA does not specifically endorse Prudential’s goggle program.