INDUSTRIAL CLEANING PROCESS

COMPARISON VALIDATION OF THE CINTAS INDUSTRIAL CLEANING PROCESS OF
CLEANROOM GARMENTS VERSUS THE CINTAS CLEANROOM CLEANING PROCESS
OF CLEANROOM GARMENTS USED IN FOOD PROCESSING INDUSTRIES
I. Purpose
This trial is one component of the complete validation of the industrial
cleaning process of Cleanroom garments for food processing companies
and services provided by Cintas Corporation. The purpose of this trial is to
compare the final viable (microbial) bioburden of Cleanroom laundering of
Cleanroom garments used in the food processing industry with the final
viable (microbial) bioburden of industrial laundering of Cleanroom
garments used in the food processing industry.
Cleanroom laundering of Cleanroom garments is typically performed for
reusable garments used in all contamination controlled manufacturing in
such industries as aerospace, semiconductor, microelectronics, disc drive,
medical device, pharmaceutical and now food processing.
The Cleanroom laundering process at Cintas Cleanroom Resources is fully
validated. Documented evidence of validation is available for review at the
facility.
II. Background
Each Cintas Cleanroom Resources facility has validated their Cleanroom
processing cycles. Each facility adheres to Cintas Corporate policies,
Cleanroom Division policies and procedures, the Cleanroom Division
Quality Manual, and location-specific standard operating procedures. All of
these documents are available for review at each facility.
The “six-log microbial reduction industrial wash process” used in Cintas
industrial locations is validated for non-cleanroom garments used in food
processing industries. This process is known to be deleterious to the
physical properties of many Cleanroom fabrics and components. Over the
years, Cintas has tested and validated the fabrics and components of the
Cleanroom garments to determine the most durable, Cleanroom
compatible, gamma compatible Cleanroom garment system. Over time,
the fabric and components will degrade.
The purpose of this trial was to compare the final microbial bioburden of the
Cleanroom garments laundered in each process.
The scope of this validation was to determine the final microbial bioburden
of Cleanroom laundered Cleanroom garments versus industrial laundered
Cleanroom garments used in a typical food processing manufacturing
scenario.
NOTE: This trial does not evaluate the two processes for garment integrity
over the life of the garment.
IV. Procedure
A. Specifications
NOTE: The following specifications are based on historical device
bioburden results for Cleanroom garments at Cintas Cleanroom
Resources.
1. < 47 CFU (colony forming units)/garment.
B. Materials
Five Integrity-1800 coveralls processed at Cintas Loc# 342, Normal, IL.
Five Integrity-1800 coveralls processed at Cintas Loc# 236, Greenville,
SC.
Tryptic Soy Agar (TSA) with Lecithin and Polysorbate 80 (Tween 80),
Rodac™ plates, Catalog # P3500, Lot# 46106-1, Expiration date: July 14,
2004. Supplied by PML Microbiologicals, 27120 SW 95th Avenue,
Wilsonville, OR 97070,
(800) 547-0659.
C. Methods
1. Integrity 1800 coveralls were Cleanroom processed per the
validated Cleanroom laundering process at Cintas Cleanroom
Resources, Greenville, SC.
2. Integrity 1800 coveralls were industrially processed per the “sixlog
microbial reduction” wash formula at Cintas, Normal, IL.
3. The Integrity 1800 coveralls processed at Greenville, SC were
individually packaged in Cleanroom compatible, gamma
compatible antistatic Cleanroom bags inside the ISO Class 3
cleanroom.
4. The Integrity 1800 coveralls processed at Normal, IL were
placed in a plastic bag and shipped to the Greenville, SC facility
for microbial testing.