Validated Reusable Goggle Program

Is your process compliant?

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 sterile cleanroom garment configuration.

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 recent "Guidance for Industry Sterile Drug Products Produce by Aseptic Processing-Current Good Manufacturing Practice" (FDA September 2004* p.14) 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)."

*A Study of Sterile vs. Sanitized Goggles
Recent Guidance

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 goggles that have been sterilized via a validated irradiation process. PCS sterile goggles will ensure that every operator will comply with the most recent industry guidelines.

Prudential Cleanroom Services' gamma irradiated 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.