USP 797 & USP 800

  • Sustainable Gowning Protocol
  • Is Your Process FDA Compliant?
  • USP 797 & USP 800 Sterile and Non-Sterile Products
WHAT IS APPROPRIATE FOR YOUR CLEANROOM?
SUSTAINABLE GOWNING PROTOCOL
REUSABLE VS. DISPOSABLE

Help drive sustainability programs by reducing consumable products (disposable coveralls, hoods, boots, masks, goggles, mops and sleeve covers) all items you throw away, and convert them to a reusable solution.

HIGH DENSITY ESD VS. TYVEK

Tensile Strength
HD ESD has a much higher tensile strength than the Tyvek. Testing shows that HD ESD is a significantly stronger fabric.

Body Box
At 0.3 microns, Tyvek released 21% more particles than HD ESD. The Body Box test is the best real world test to show filtration and particulation characteristics of a fabric. Explanation of Body Box Personnel engaged in predetermined exercise per IEST-RP-CC003. This test challenges the entire garment system for particle containment capabilities. The particles are collected at two different levels, the knee and the sub floor.

Comfort
Air porosity and Moisture Vapro Transmission tests show HD ESD to be much more comfortable than Tyvek. Employees who are more comfortable produce better work performance.

Non-Linting
HD ESD is a non-linting fabric made of continuous filament polyester. Tyvek has a propensity to lint. Gamma irradiated Tyvek also tends to out gas.

Sustainable Gowning Protocol - Surface View

Sustainable Gowning Protocol - Cross Section

THE SUSTAINABLE CHOICE

Reduce carbon footprint
Reduce waste and environmental liability
Reduced cost
Improve morale / comfort
Enhance compliance
DISPOSABLE GARMENT AND RELATED SUPPLIES SAVING
Projected Annual Savings >30% when switching to reusable supplies.

PROCUREMENT SAVINGS

Time and overall cost reduction.

CAPITAL INVESTMENT SAVINGS

We stock it for you; unlike a disposable program, where you have to purchase and frequently manage inventories.

INVENTORY MANAGEMENT SAVINGS

Validated Garment Tracking System.

FREIGHT SAVINGS

PCS routed deliveries.

REDUCTION OF WASTE COST

Disposable garments and related supplies.

CLEANROOM GARMENT FEATURES

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

Garment Tracking System

SUBLIMATED LABELS

Provides easy view sizing
sublimated-label

SUBLIMATED LABELS

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.

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.

Prudential Sterile Labeling

STERILE & PARTICULATE CERTIFICATIONS

 

USP 797 Recommended Gowning and Ancillary Items

HOOD

HE-11-79-LZ

  • Hood eyes only
  • Built in light weight tricot FM
  • Flared skirt
  • Hidden elastic back
  • Horizontal adjustment 1 female snap, 3 male snaps
  • Color: White
  • Size: Unisize

COVERALL

CR-11-79-A8

  • Mandarin Collar
  • Raglan sleeves
  • Tunneled elastic wrist with thumb loops
  • Zipper front
  • Three snap knee high boot attachment
  • Tunneled elastic leg opening
  • Color: White
  • Size: S – 4XL

COVERALL

CS-11-79-JT

  • Elastic wrist and thumb loop
  • Enter garment thru zipper from anklets to ankle thru groin area
  • Set in sleeves
  • Three snap knee high boot attachment
  • Tunneled elastic back of hood and vertical snap adjustment for fit
  • Tunnel elastic at waist
  • Color: White
  • Size: S – 4XL

BOOTS

BK-11-79-PR

  • Large top opening
  • Hypalon tan soft sole
  • Ankle strap with side release buckle
  • Extended toe straps with snaps
  • Elastic and snap adjustable tab top
  • Corona fender
  • Color: White
  • Size: S – 2XL
hood-new

HOOD

HF-11-79-LZ

  • Open face
  • Two snaps on each side of face
  • Over the shoulder bib
  • Horizontal and vertical snap adjustable back
  • Elastic encased back
  • Side snaps for face mask installations
  • Color: White
  • Size: Unisize

FROCK

FR-11-79-JX

  • Mandarin collar
  • Raglan sleeves
  • Extended sleeve length
  • Tunnelled elastic wrist with thumb loops
  • Zipper front
  • Color: White
  • Size: S – 4XL

GOGGLES

#GG008011

INNER WEAR SHIRT – LONG SLEEVE

US-20-44-EXA

  • ESD Micro Denier
  • Three snap front
  • Henley collar
  • Raglan sleeves
  • Color matched knit cuffs
  • Color: Navy Blue
  • Size: S-4XL

INNER WEAR SHIRT – SHORT SLEEVE

US-20-44-EXA-SS

  • ESD Micro Denier
  • Three snap front
  • Henley collar
  • Raglan sleeves
  • Color matched knit cuffs
  • Color: Navy Blue
  • Size: S-4XL

PANT

UP-20-44-MK

  • ESD Micro Denier
  • Elastic bac
  • Drawcord front
  • Color matched knit cuffs
  • Color: Navy Blue
  • Size: S-4XL

SLEEVE COVER

SL-11-79-TG

  • Tunnelled 3/8″ elastic closure at top and wrist end
  • Thumb loop at wrist
  • Color: White
  • Size: 19″

VALIDATED REUSABLE MICROFIBER FLAT MOP HEAD

HYDRAL-HP

  • Validated Sterile 10-6
  • Gamma Irradiated
  • Also available Non-sterile
  • Color: Grey
  • Size: 22″