Garment Recommendations for Cleanroom Clothing

For step by step gowning instructions, please contact CRG for a Sterile Gowning Chart today! Ph: 02 8437 4600

CLEAN ROOM CLASSIFICATIONS

The following table will assist you in your garment selection:

AIRBORNE PARTICULATE CLEANLINESS CLASS COMPARISON
ISO 14644-1	USA FED STD 290D	AUST AS1386-1989
1
2
3	1	0.035
4	10	0.35
5	100	3.5
6	1000	35
7	10000	350
8	100000	3500
9

Source: AS1386-1989 Superseded by AS/NZS ISO 14644.1:2002

AUSTRALIAN CODE OF GMP FOR MEDICINAL PRODUCTS

The sterile medicinal manufacturer must meet the requirements of Annex 1 of the above Code of GMP. This code includes recommendations on garment requirements.

Cleanroom clothing should "shed virtually no fibres or particle matter".

SUMMARY OF GARMENT RECOMMENDATIONS
Grade¹	Class	Garment Type
A/B	100/ISO 5	Coverall, hood, mask, gloves, overshoes, undergarments
C	10000/ISO 7	Coverall or two piece suit, overshoes or dedicated shoes, undergarments²
D	100000/ISO 8	Protective suit - coverall or smock, dedicated shoes or overshoes

1. Australian Code of GMP for Medicinal Products - Annex 1 - Manufacture of Sterile Medicinal Products - Page 44, item 19
2. "Outdoor clothing should not be brought into changing rooms leading to Grade B&C rooms" - EU Guide for Medicinal Products - Page 44 item 20.

Ultraclean Garment Processing

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.

APPLICATION OF GARMENT STYLE AND PROCESSING CLASS TO MANUFACTURING ENVIRONMENT

GARMENT SERVICE	YOUR FACILITY	ROOM CLASS	FABRIC	GARMENT PROCESS	GARMENT STYLE	CHANGE RATE
Sterile Cleanroom Garments	Aseptic filling & Compounding (sterile) Micro Testing	5 in 7	Polyester (95% efficient)	Class B & sterile	Coverall, hood, overshoes, mask & gloves	Per entry/Daily
Sterile Protective Cleanroom Garments	Aseptic filling & compounding of: Hormones Antibiotics Antineoplastics	5 in 7	Ultrashield Polyester (94% efficient)	Class B (PCG) & sterile	Coverall, hood, overshoes, mask & gloves	Per entry/Daily
Process only Cleanroom Garments	Class III Medical Device & other industrial applications	7	Polyester (95% efficient)	Class B	Coverall, hood, overshoes, mask & gloves	Daily/ 3 Day
	Class I & II Medical Device & other industrial applications	9	Polyester (95% efficient)	Class D	Smock, cap & shoecovers	Daily/Weekly
Bioclean Garments	Tableting, creams, solutions & powders Primary & Secondary Packaging	None specified (Controlled environment)	Breathable polyester	LBB	Coverall, shoecovers & headcover, or two piece suit, shoecovers & headcover	Daily
Statguard Dust Coats	Static sensitive areas Assembly Test & Repair Packaging	N/A	Polycotton with ECF Fibre	LD	Statcoat	Daily
General Uniforms	Laboratories, Workshops, Warehouse, Assembly	N/A	Polycotton or cotton	LD	Coverall, Labcoat, Shirt & Pants	Daily

N.B: Garment Process refers to the surface cleanness level of the garment as specified in AS 2013-2. - ie Class B and Class D
PCG - process for potentially contaminated garments.

LBB - low bio burden processing.

LD - Launder only

ECF - Electro Conductive Fibre

Water repellent polyester is available for wet areas.

Fabric efficiency is at 5.0 micron.