USP 797

CLEANROOM GARMENT FEATURES

HOOD

Snaps to adjust sizing

GOGGLES – VALIDATED STERILE REUSABLE GOGGLE PROGRAM

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! All reusable goggles are validated at SAL 10-6. “A game changer for reusable sterile goggle programs”

COVERALL

Provides maximum contamination control, comfort and mobility. PCS requires the over locking/surging of cut or raw edges. This helps to minimize the potential of a cut panel fraying and protruding through the seam. Since cleanroom polyester fabric is made from long continuous filament yarn, there can be an “angel hair” type fraying that is a result of fiber separation at the edge of a cut panel. If over locked/surged, the cut panel is encapsulated by the thread. The typical size (IN-STOCK garment sizing) for the PCS coverall is generous. It is at the high or generous end of the industry standards for coverall sizing. This should insure a more comfortable fit for the end wearer. These same statements can be made for all of our garments.

BOOTS

Available in many sizes with flat, molded soles or soft hypolon soles.

PCS has been a long time innovator in boot design. While most of our competition uses a single ankle strap design, we provide a better fitting boot by adding extra webbing. The extra webbing (refer to styles TW, D3) makes the outer boot more comfortable to wear since it holds to the shoe more efficiently. In addition, we invest in the longevity of the boot by using a corona fender material on most hard sole designs. Many of our competitors choose to not add a corona fender which will lead to a shorter boot life span and a faster replacement charge.

BARCODES

Garment Tracking System

SUBLIMATED LABELS

Provides easy view sizing
sublimated-label

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/ mustache 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 sterilized 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.

STERILE & PARTICULATE CERTIFICATIONS

For customers manufacturing aseptically, PCS provides labeling with lot traceability, the expiration date and the dosimeter dot that indicates exposure to irradiation.