Garment Recommendations

At CRG we guarantee that the Ultraclean Garment Processing System we provide for your controlled environment will comply with the appropriate Australian Standards and Good Manufacturing Practice (GMP) requirements.

YOUR FACILITY	GARMENT SERVICE	ROOM GRADE	FABRIC	CLEANING PROCESS	GARMENT STYLE	CHANGE RATE
Aseptic Filling & compounding (sterile), Micro testing	Sterile Cleanroom Garments	Grade A in B Class 100 / ISO 5	Ultraclean Polyester (PE)	Process Class B & Sterile	Coverall, hood, overshoes, mask & gloves	Per entry
Aseptic filling & compounding of: Hormones, Antibiotics and Antineoplastics	Sterile Protective Cleanroom Garments	Grade A in B Class 100 / ISO 5	Ultrashield Polyester (US)	Process Class B (PCG) & Sterile	Coverall, hood, overshoes, mask & gloves	Per entry
Class III medical device and other industrial applications	Process Only Cleanroom Garments	Grade C Class 10,000 / ISO 7	Ultraclean Polyester (PE)	Process Class B	Coverall, hood, overshoes, mask & gloves	Daily / Weekly
Class I and II medical device & other industrial applications	Process Only Cleanroom Garments	Grade D Class 100,000 / ISO 8	Ultraclean Polyester (PE)	Process Class D	Smock, cap & shoecovers	Daily / Weekly
Tableting, creams, solutions and powders	Bioclean Garments	None specified Controlled environment	Breathable Polyester (LBB)	Process Low Bioburden (LBB)	Coverall, shoecovers & headcover	Daily
Primary & secondary packaging	Bioclean Garments	None specified Controlled environment	Breathable Polyester (LBB)	Process Low Bioburden (LBB)	Coverall, shoecovers & headcover or two piece suit, shoecovers & headcover	Daily

References

Garment Cleaning Process refers to the surface cleanness level of the garment as specified in IEST-RP-CC003.4 Garment System Considerations for Cleanrooms and Other Controlled Environments
Room Grading referenced from PIC/S GMP Guide Pg 8 item 44
PCG – Process for Potentially Contaminated Garments
UltraShield Polyester – Available for wet environments

Standard Launder Service VS Clean Room Garments

The type of garment, where and how it is processed are ALL important in achieving compliance and controlling particulate borne contamination. The table below emphasizes the difference between CRG’s specialized service and a standard laundry service.

Standard Laundry Service
Washing using town water
Dried in a drier in uncontrolled environment using unfiltered air
Garment design and fabric maybe compliant for the grade of area but likely to be covered in particles from the way and where it was processed. Now a potential source of contamination for your business
ISO 9001: 2015 accredited, controlled by documented procedures and validated processes

Specialised Service Provider (CRG)
Washed using filtered, purified water in pass through washing machine
Dried in a controlled environment (B Grade) using drier with HEPA filtered air
Garment suitable for use for A/B grade or lower, reduced risk of contamination from where and how the garment was processed. Sterilisation of the garment via ETO as required, also in a controlled environment
ISO 9001: 2015 accredited, controlled by documented procedures and validated processes

Garment Guide

DOWNLOAD THE CRG GARMENT GUIDE

Download a copy of our Garment Guide for everything you need to know about our garment range, from fabric specifications to performance and quality measures.

CONSIDERATIONS

Points to consider when deciding on the most appropriate garments and quantities for your facility:

GRADE OF CLEANROOM
In what Class of Cleanroom is the garment used?

What surface cleanliness level is required?
TYPE OF OPERATION
Is the manufacturing process wet?

Is static discharge a concern?

Is the product potentially hazardous?

Will physical abrasion on the garment surface be an issue?

STERILE OR NON STERILE
Do the garments need to be sterilised?
QUANTITY REQUIRED
How many operators do you have?

How many shifts do you operate?

What is the garment change rate?

How many days worked?

How much buffer stock is required?

By asking these important questions, we can take the guess work out of garment selection, providing the fabric, style, process and quantities most appropriate to your needs.

Sterile Gowning Procedure and Cleanroom Process (Lead-Times)

DOWNLOAD OUR STERILE GOWNING CHART

DOWNLOAD OUR CLEANROOM PROCESS