SPECIALIST CONTAMINATION-CONTROL SOLUTIONS

Clean Room Garments (CRG) is a world-class provider

of specialist contamination-control solutions for the
pharmaceutical, medical and food processing industries –
the company has been at the top of the industry’s rankings
for 40 years.

An Australian-based company established in 1970 and

owned by the large multinational group ALSCO with an
approximate net worth of A$205.5 million, putting CRG in
a strong financial position. CRG provides cost-effective,
innovative contamination control solutions including
ultraclean garment processing, cutting-edge cleanroom
garment design and specialised cleanroom products.
GARMENTS.................................................................................................................03

Garment Specifications........................................................................................ 04

Size Charts..................................................................................................................14

Easy Ordering............................................................................................................18

FABRIC SPECIFICATIONS........................................................................................19

Cleanroom Classification Comparisons..........................................................26

Garment Recommendations............................................................................... 27
01

PERFORMANCE & QUALITY MEASURES............................................................29

CLEAN ROOM GARMENTS | GARMENT GUIDE

Fabric Performance................................................................................................30

Performance Measurement.................................................................................. 32

Thermal Effects Of Clothing................................................................................34

Physical Characteristics Of Fabrics.................................................................. 35

Fabric Selection.......................................................................................................36

Bioburden Testing................................................................................................... 37

Water Testing............................................................................................................ 37

Particle Counting.....................................................................................................38

Sterilisation............................................................................................................... 40

Chipping & Barcoding ...........................................................Inside Back Cover

 At the bottom of all garment
specifications you will see the
following icons. These have been
developed as a quick reference
to establish the process class,
sterilisation and whether the
garment is available for rental or
purchase.

PROCESS CLASS B

POTENTIALLY CONTAMINATED
GARMENTS PROCESS CLASS
02
PROCESS CLASS D
CLEAN ROOM GARMENTS | GARMENT GUIDE

LOW BIOBURDEN PROCESS CLASS

LAUNDER PROCESS CLASS

STERILISED

RENTAL

PURCHASE
CLEAN ROOM GARMENTS | GARMENT GUIDE
 6418 UNDER GARMENT TOP 6422 UNDER GARMENT PANT
FABRIC FABRIC
UNDER GARMENT (WY)....... GSWY6418 UNDER GARMENT (WY)....... GPWY6422
04 100% polyester (knit) with ECF stripe 100% polyester (knit) with ECF stripe
SEAMS FEATURES
Overlocked seams
CLEAN ROOM GARMENTS | GARMENT GUIDE

Elasticised waistline
SIZES SEAMS
XXSM - 5XL Overlocked seams
COLOUR SIZES
WY Navy XXSM - 6XL
COLOUR
WY Navy
6411 UNDER GARMENT TOP 6412 UNDER GARMENT PANT
FABRIC FABRIC
UNDER GARMENT (ZC).................. GSZC6411 UNDER GARMENT (ZC).................. GPZC6412
100% polyester twill hi-stretch with moisture finish 100% polyester twill hi-stretch with moisture finish 05
FEATURES FEATURES
®® 100% continuous filament polyester sewing thread ®® 100% continuous filament polyester sewing thread

CLEAN ROOM GARMENTS | GARMENT GUIDE

and elastic and elastic
®® High grade stainless steel snaps ®® High grade stainless steel snaps
®® Knitted wrist cuffs
SEAMS
®® Raglan sleeves
Overlocked seams
SEAMS
SIZES
Overlocked seams
XSM - 4XL
SIZES
COLOUR
XSM - 4XL
ZC Navy
COLOUR
ZC Navy
 6731 COVERALL 6727 POCKET COVERALL
FABRIC FABRIC
ULTRASHIELD (US)................ GOUS6731 LOW BIO BURDEN (SL)........ GOSL6727
06 100% polyester with ECF stripe 100% breathable polyester with ECF stripe

INTEGRITY (IN)....................... GOIN6731 FEATURES

®® Cover front zipper
CLEAN ROOM GARMENTS | GARMENT GUIDE

100% polyester with ECF stripe

FEATURES ®® Adjustable stainless steel clips closure at the
®® Coverall with hood neck line

®® Knitted cuffs with thumb loop ®® Mandarin collar

®® Zip front with clip closure at neck ®® Knitted wrist

®® Adjustable stainless steel clip closure at ankle ®® Adjustable stainless steel clip closure at ankle

®® Neck tie ®®Action (elastic) back with adjustable stainless

steel clips
®® Suitable to wear when dealing with
cytotoxic drugs ®® Set-in sleeves
®® Left internal breast pocket and front hip pockets
SEAMS
Overlocked seams SEAMS
Overlocked seams
SIZES
XSM - 6XL SIZES
XXSM - 6XL
COLOUR
US Purple COLOUR
IN Navy SL Royal Blue, Aqua, Grey
  

6727 COVERALL
FABRIC
ULTRASHIELD (US)................ GOUS6727
100% polyester with ECF stripe 07

ULTRACLEAN (PE)................. GOPE6727

CLEAN ROOM GARMENTS | GARMENT GUIDE

100% polyester with ECF stripe
FEATURES
®® Cover front zipper
®® Adjustable stainless steel clips closure at the
neck line and ankles
®® Mandarin collar
®® Knitted wrist cuffs
®® Set in sleeves
®®Suitable to wear when dealing with
cytotoxic drugs (UltraShield only)
SEAMS
Double needle stitched seams
SIZES
XXSM – 6XL
COLOUR
US Lemon, Green, Purple
PE Blue, Navy, Lemon, White
 6432 STAT COAT 6431 LAB COAT
FABRIC FABRIC
CBRI (CB).................................. GCCB6432 ULTRASHIELD (US)................ GCUS6431
08 100% polyester with ECF stripe 100% polyester with ECF stripe
STAT CONTROL (SC)............. GCSC6432 POLYCOTTON (PC)................. GCPC6431
96% polyester, 4% carbon Filament Yarn
CLEAN ROOM GARMENTS | GARMENT GUIDE

65% polyester, 35% cotton

FEATURES FEATURES
®® Stainless steel clip front closure ®® Stainless steel clip front closure
®® Two piece notched lapel ®® Two piece notched lapel
®® Raglan sleeves ®® Raglan sleeves
®® Left breast pocket, two lower pockets ®® Left breast pocket, two lower pockets
®® Knit ESD cuff
SEAMS
SEAMS Overlocked seams
Overlocked seams
SIZES
SIZES XXXSM - 8XL
SM - 3XL
COLOUR
COLOUR US Green
CB Blue, White PC Blue, White
SC Blue, White
2189 GOWN 6426 SMOCK
FABRIC FABRIC
ULTRASHIELD (US)................ GDUS2189 ULTRASHIELD (US)................ GDUS6426
100% polyester with ECF stripe 100% polyester with ECF stripe 09
FEATURES ULTRACLEAN (PE)................. GDPE6426
®® Knitted cuffs

CLEAN ROOM GARMENTS | GARMENT GUIDE

100% polyester with ECF stripe
®® Clip closure at neck LOW BIO BURDEN (SL)........ GDSL6426
®® Tie at waist 100% breathable polyester with ECF stripe
®® Suitable to wear when administering FEATURES
cytotoxic drugs ®® Stainless steel clip front closure
SEAMS ®® Mandarin collar
Overlocked seams ®® Knitted wrist cuffs
SIZES ®® Raglan sleeves
SM - XL
®® Suitable to wear when dealing with
COLOUR cytotoxic drugs (UltraShield only)
US Purple
SEAMS
Double needle stitched seams
SIZES
XSM – 8XL
COLOUR
US Lemon, Green, Purple
PE Blue, White, Lemon, Navy
SL Royal Blue, Aqua, Grey
 6425 FACILITY TOP 6423 FACILITY PANT
FABRIC FABRIC
LOW BIO BURDEN (SL)........ GSSL6425 LOW BIO BURDEN (SL)........ GPSL6423
10 100% breathable polyester with ECF stripe 100% breathable polyester with ECF stripe
ULTRASHIELD (US)................ GSUS6425 ULTRASHIELD (US)................ GPUS6423
100% polyester with ECF stripe 100% polyester with ECF stripe
CLEAN ROOM GARMENTS | GARMENT GUIDE

FEATURES FEATURES
®® Zip front opening ®® Deep front pockets
®® Stainless steel clips at neckline ®® Elasticised drawstring waist
®® Mandarin collar SEAMS
®® Knitted wrist cuffs Overlocked seams
®® Raglan sleeves SIZES
®® Suitable to wear when dealing with XXSM - 6XL
cytotoxic drugs (UltraShield only) COLOUR
SEAMS SL Royal Blue, Aqua, Grey
Overlocked seams US Lemon, Green, Purple
SIZES
XXSM - 6XL
COLOUR
SL Royal Blue, Aqua, Grey
US Lemon, Green, Purple
6279 OPEN FACE HOOD 2190 SLEEVE PROTECTOR
FABRIC FABRIC
ULTRASHIELD (US)................ GHUS6279 ULTRASHIELD (US)................ GHUS2190
100% polyester with ECF stripe 100% polyester with ECF stripe 11

ULTRACLEAN (PE)................. GHPE6279 ULTRACLEAN (PE)................. GHPE2190

CLEAN ROOM GARMENTS | GARMENT GUIDE

100% polyester with ECF stripe 100% polyester with ECF stripe
FEATURES FEATURES
®® Adjustable stainless steel clip closure under the ®® Suitable to wear when dealing with cytotoxic
chin drugs (UltraShield only)
®® Adjustable stainless steel closure on the back ®® Elastic cuffs
of the hood SEAMS
®® Open face hood, skirt extends over the Overlocked seams
shoulders
SIZES
®® Suitable to wear when dealing with OSFA (One Size Fits All)
cytotoxic drugs (UltraShield only)
COLOUR
SEAMS US Purple
Double needle stitched seams PE Blue, Lemon, White, Navy
SIZES
XSM - 2XL
COLOUR
US Lemon, Green, Purple
PE Blue, Navy, Lemon, White
 6986 OVERSHOE 6987 OVERSHOE
FABRIC FABRIC
ULTRASHIELD (US)................ GFUS6986 ULTRASHIELD (US)................ GFUS6987
12 100% polyester with ECF stripe 100% polyester with ECF stripe
DURACLEAN (PE)................... GFPE6986 INTEGRITY (IN)....................... GFIN6987
CLEAN ROOM GARMENTS | GARMENT GUIDE

100% polyester with ECF stripe 100% polyester with ECF stripe
FEATURES FEATURES
®® Suitable to wear when dealing with cytotoxic ®® Suitable to wear when dealing with cytotoxic
drugs (UltraShield only) drugs
®® Vinyl sole ®® Vinyl sole
SEAMS SEAMS
Overlocked seams Overlocked seams
SIZES SIZES
XSM - 2XL XSM - 2XL
COLOUR COLOUR
US Purple, Lemon, Green US Lemon, Purple, Green
PE Blue, Lemon, Navy, White IN Navy
6988 OVERSHOE 6989 OVERSHOE
FABRIC FABRIC
ULTRASHIELD (US)................ GFUS6988 ULTRASHIELD (US)................ GFUS6989
100% polyester with ECF stripe 100% polyester with ECF stripe 13

DURACLEAN (PE)................... GFPE6988 DURACLEAN (PE)................... GFPE6989

CLEAN ROOM GARMENTS | GARMENT GUIDE

100% polyester with ECF stripe 100% polyester with ECF stripe
FEATURES FEATURES
®® Suitable to wear when dealing with cytotoxic ®® Suitable to wear when dealing with
drugs (UltraShield only) cytotoxic drugs (UltraShield only)
®® Aussie Tough sole ®® Aussie Lite anti static rubber moulded sole
SEAMS SEAMS
Overlocked seams Overlocked seams
SIZES SIZES
XSM - 2XL XSM, SM, M, M/L, L, XL
COLOUR COLOUR
US Lemon, Green, Purple US Lemon, Purple
PE Blue, Navy, Lemon, White PE Blue, Lemon, White
 C B A

6727 POCKET COVERALL XSM SM M L XL 2XL

A CHEST 111.8 119.4 121.9 129.5 132.1 142.2

B SLEEVE 66.0 67.3 67.3 67.3 67.3 67.3

14
C LENGTH 156.2 160.0 161.3 162.6 167.6 170.2

D HIP 119.4 124.5 124.5 129.5 139.7 149.9

CLEAN ROOM GARMENTS | GARMENT GUIDE

E TARGET 71.1 124.5 124.5 129.5 139.7 149.9

F INSIDE LEG 73.7 73.7 76.2 77.5 82.6 83.8

6727 COVERALL XSM SM M L XL 2XL

A CHEST 109.2 114.3 116.8 121.9 127.0 132.1

B SLEEVE 62.2 62.2 63.5 63.5 66.0 66.0

C LENGTH 152.4 157.5 160.0 162.6 163.8 170.2

D HIP 111.8 116.8 121.9 127.0 132.1 137.2

E TARGET 72.4 73.7 76.2 78.7 80.0 81.3

F INSIDE LEG 48.3 50.8 53.3 53.3 55.9 61.0

6731 COVERALL XSM SM M L XL 2XL

A CHEST 111.8 116.8 119.4 124.5 129.5 134.6

B SLEEVE 67.3 68.6 68.6 68.6 69.9 69.9

C LENGTH 156.2 157.5 162.6 165.1 167.6 170.2

D HIP 111.8 116.8 121.9 127.0 132.1 137.2

E TARGET 77.5 77.5 78.7 81.3 83.8 86.4

F INSIDE LEG 48.3 50.8 53.3 55.9 58.4 61.0

ALL SIZING SHOWN IN CENTIMETERS (CM) | ADDITIONAL SIZES AVAILABLE ON REQUEST

 B

A
C

6279 HOOD OPEN FACE XSM SM M L XL 2XL

A BACK LENGTH 45.7 45.7 45.7 45.7 47.0 47.0

B TOP CIRCLE 16-17 17-18 18-19 18-19 19-20 20-22

C FACE WIDTH 12.7 12.7 13.3 14.6 15.9 16.5

C B A

15

CLEAN ROOM GARMENTS | GARMENT GUIDE

6431 LAB COAT XSM SM M L XL 2XL
A CHEST - 111.8 119.4 124.5 127.0 134.6

B1 SLEEVE - 78.7 78.7 78.7 78.7 81.3

C LENGTH - 96.5 99.1 100.3 101.6 102.9

2189 GOWN XSM SM M L XL 2XL

A CHEST - 127.0 147.3 157.5 172.7 -

B SLEEVE - 62.2 64.8 69.9 74.9 -

C LENGTH - 108.0 110.5 110.5 111.8 -

6426 SMOCK XSM SM M L XL 2XL

A CHEST 111.8 116.8 121.9 124.5 129.5 -

B1 SLEEVE 78.7 82.6 82.6 82.6 85.1 -

C LENGTH 99.1 104.1 105.4 105.4 106.7 -

6432 STAT COAT XSM SM M L XL 2XL

A CHEST (1/2 WIDTH) - 116.0 122.0 132.0 142.0 152.0

B1 SLEEVE - 78.0 79.5 81.5 83.5 85.5

C LENGTH - 108.0 112.5 114.5 116.0 116.5

ALL SIZING SHOWN IN CENTIMETERS (CM) | ADDITIONAL SIZES AVAILABLE ON REQUEST

 A

C B

6418 UNDER GARMENT TOP XSM SM M L XL 2XL

A CHEST 104.1 104.1 116.8 121.9 124.5 134.6

B SLEEVE 54.6 58.4 58.4 59.7 61.0 66.0

C LENGTH 66.0 68.6 71.1 71.1 71.1 73.7

6411 UM UNDER GARMENT TOP XSM SM M L XL 2XL

A CHEST 106.7 116.8 127.0 137.2 147.3 157.5

B1 SLEEVE 86.4 88.9 91.4 94.0 96.5 99.1

C LENGTH 76.2 76.2 76.2 76.2 76.2 76.2

6425 FACILITY TOP XSM SM M L XL 2XL

A CHEST 109.2 116.8 116.8 121.9 127.0 132.1

B1 SLEEVE 77.5 78.7 81.3 81.3 81.3 81.3

C LENGTH 63.5 64.8 67.3 68.6 69.9 69.9

B
16
CLEAN ROOM GARMENTS | GARMENT GUIDE

6422 UNDER GARMENT PANT XSM SM M L XL 2XL

A WAIST 58.4 68.6 78.7 88.9 96.5 109.2

B TARGET 64.8 66.0 67.3 74.9 76.2 80.0

C LENGTH 96.5 99.1 101.6 108.0 111.8 115.6

6412 UNDER GARMENT PANT XSM SM M L XL 2XL

A WAIST 68.6 78.7 88.9 99.1 109.2 119.4

B TARGET 25.4 27.9 30.5 33.0 35.6 38.1

C LENGTH 105.4 107.9 110.5 113.0 115.6 118.1

6423 FACILITY PANT XSM SM M L XL 2XL

A WAIST 66.0 76.2 76.2 78.7 83.8 88.9

B TARGET 69.9 72.4 73.7 74.9 77.5 77.5

C LENGTH 105.4 106.7 106.7 106.7 108.0 109.2

ALL SIZING SHOWN IN CENTIMETERS (CM) | ADDITIONAL SIZES AVAILABLE ON REQUEST

 B

2190 SLEEVE PROTECTORS OSFA

A LENGTH 42

B TOP DIAMETER 27

C OPENING DIAMETER 20

A1

D
17
6987, 6988, 6989 6986

CLEAN ROOM GARMENTS | GARMENT GUIDE

6986 | 6987 | 6988 | 6989 OVERSHOE XSM SM M L XL 2XL

A HEIGHT - 6987, 6988, 6989 47.0 47.0 50.8 50.8 57.2 57.2

A1 HEIGHT - 6986 34.3 35.6 36.8 38.1 39.4 39.4

B OPENING WIDTH - 6987, 6989 45.7 45.7 48.3 50.8 50.8 50.8

B OPENING WIDTH - 6988 48.3 48.3 48.3 53.3 53.3 55.9

B OPENING WIDTH - 6986 25.4 25.4 25.4 25.4 30.5 30.5

6989 AUSSIE LITE SOLE XSM SM M L XL 2XL

C LENGTH 25.7 25.7 30.3 32.5 34.0 37.0

D WIDTH 10.0 10.7 11.5 13.0 13.3 14.0

6988 AUSSIE TOUGH SOLE XSM SM M L XL 2XL

C LENGTH 26.0 28.0 30.0 32.0 34.0 36.6

D WIDTH 10.0 10.4 11.0 11.2 13.2 14.5

6986, 6987 VINYL SOLE XSM SM M L XL 2XL

C LENGTH 26.7 27.9 30.5 33.0 34.3 36.8

D WIDTH 10.0 10.4 11.0 11.2 13.2 14.5

ALL SIZING SHOWN IN CENTIMETERS (CM) | ADDITIONAL SIZES AVAILABLE ON REQUEST

 STERILISATION
PROCESS | CLASS

PURCHASE
CODE FABRIC DESCRIPTION SIZES

RENTAL

PAGE
PB PCG PD LBB LD

UNDER GARMENTS

GSWY6418 WY UNDER GARMENT TOP XXSM-5XL O O O P O O P P 04

GPWY6422 WY UNDER GARMENT PANT XXSM-6XL O O O P O O P P 04

GSZC6411 ZC UNDER GARMENT TOP XSM-4XL O O O P O O P P 05

GPZC6412 ZC UNDER GARMENT PANT XSM-4XL O O O P O O P P 05

COVERALLS

GOUS6731 US COVERALL WITH HOOD XSM-6XL O P O O O P P P 06

GOIN6731 IN COVERALL WITH HOOD XSM-6XL O P O O O P P P 06

GOSL6727 SL POCKET COVERALL XXSM-6XL O O O P O O P P 06

GOUS6727 US COVERALL XSM-7XL O P O O O P P P 07

GOPE6727 PE COVERALL XXSM-6XL P O P O O P P P 07

STAT COATS

GCCB6432 CB STAT COAT SM - 3XL O O O O P O P P 08

GCSC6432 SC STAT COAT SM - 3XL O O O O P O P P 08

LAB COATS

GCUS6431 US LABCOAT XXXSM-8XL O P O O P O P P 08

GCPC6431 PC LABCOAT XXXSM-8XL O O O O P O P P 08

GOWNS

GDUS2189 US GOWN SM-XL O P O O O P P P 09

SMOCKS

GDUS6426 US SMOCK XSM-8XL O P O O O P P P 09

GDPE6426 PE SMOCK XSM-8XL P O P O O P P P 09

18 GDSL6426 SL SMOCK XSM-5XL O O O P O O P P 09

FACILITY GARMENTS
CLEAN ROOM GARMENTS | GARMENT GUIDE

GSSL6425 SL TOP XXSM-6XL O O O P O O P P 10

GPSL6423 SL PANT XXSM-6XL O O O P O O P P 10

GSUS6425 US TOP XXSM-6XL O P O O O O P P 10

GPUS6423 US PANT XXSM-6XL O P O O O O P P 10

HOODS

GHUS6279 US HOOD OPEN FACE XSM-2XL O P O O O P P P 11

GHPE6279 PE HOOD OPEN FACE XSM-2XL P O P O O P P P 11

SLEEVE PROTECTORS

GHUS2190 US SLEEVE PROTECTOR OSFA O P O O O P P P 11

GHPE2190 PE SLEEVE PROTECTOR OSFA P O P O O P P P 11

OVERSHOES

GFUS6986 US OVERSHOE CALF HIGH XSM-2XL O P O O O P P P 12

GFUS6987 US OVERSHOE TOP STRAP XSM-2XL O P O O O P P P 12

GFIN6987 IN OVERSHOE TOP STRAP XSM-2XL O P O O O P P P 12

GFUS6988 US OVERSHOE AUSSIE TOUGH SOLE XSM-2XL O P O O O P P P 13

GFPE6988 PE OVERSHOE AUSSIE TOUGH SOLE XSM-2XL P O P O O P P P 13

GFUS6989 US OVERSHOE TOP | FOOT STRAP XSM-XL O P O O O P P P 13

GFPE6989 PE OVERSHOE TOP | FOOT STRAP XSM-XL P O P O O P P P 13

SC Stat Control Process Class D

PE Ultraclean Polyester PC Poly/Cotton Process Class B
PE Duraclean Polyester WY Under Garment Fabric IN Integrity
Low Bioburden Process Class
US UltraShield ZC Under Garment Fabric Potentially Contaminated
SL Low Bio Burden CB CBRI Garments Process Class Launder Process Class
CLEAN ROOM GARMENTS | GARMENT GUIDE
 ULTRASHIELD FABRIC (US)

Specifications 100% Polyester with ECF strip

Colour range Green (GUS), Lemon (LUS), Purple (PUS)

Unit Weight 117 g/m2

Water Vapour Transmission Rate 44.72 g/hrs m2

5.3 cm2/cm2/s (toward airflow)

Air Permeability
5.3 cm2/cm2/s (away from airflow)

Abrasion Resistance 37,000 cycles

SURFACE RESISTIVITY (ESD)

3X10 -1X10 Ώ (Static Dissipative)

8 11
0 washes

250 washes 3X10 -1X1012 Ώ (Static Dissipative)

8

PARTICLE SHEDDING (HELMKE) 0.3um 0.5um

Particles/min (0 washes) 656 637

Cleanliness Category I I

Particles/min (250 washes) 325 209

Cleanliness Category I I

FILTRATION EFFICIENCY (%) 0.3um 0.5um 5.0um

0 washes 75.12 91.88 95.25

25 washes 95.57 96.79 97.46

50 washes 81.13 89.13 88.64

75 washes 87.27 96.23 72.01

100 washes 93.37 95.30 87.92

125 washes 86.45 96.90 100

150 washes 89.40 96.51 100

175 washes 88.32 95.12 95.87

200 washes 87.85 95.41 97.06

255 washes 86.01 97.18 100

20
250 washes 93.22 96.43 85.92

WATER REPELLENCY (%)

CLEAN ROOM GARMENTS | GARMENT GUIDE

0 washes 90.3%

25 washes 96.6%

50 washes 98.0%

75 washes 96.9%

100 washes 96.7%

125 washes 98.4%

150 washes 98.0%

175 washes 95.4%

200 washes 97.8%

225 washes 97.6%

250 washes 96.8%

INDIVIDUAL DRUG INFORMATION SHOULD BE CONSULTED FOR EXPOSURE LIMITS

CYTO PENETRATION | PURPLE US ONLY

0 Washes 10 Washes 50 Washes

Drugs 20 min 30 min 60 min 20 min 30 min 60 min 20 min 30 min 60 min

Ethanol Based(µg) <0.1 <0.1 <0.1 NA NA NA <0.1 <0.1 <0.1

Powder Based(µg) <0.1 <0.1 <0.1 NA NA NA <0.1 <0.1 <0.1

% Penetration 0 0 0 NA NA NA 0 0 0
 LOW BIO BURDEN FABRIC (SL)

Specifications 100% Polyester knit with ECF strip

Colour range Grey, Aqua, Blue, White

Unit Weight 69 g/m2

Water Vapour Transmission Rate 49.10 g/hrs

44.7 cm2/cm2/s (toward airflow)

Air Permeability
45.7 cm2/cm2/s (away from airflow)

Abrasion Resistance 45,500 cycles

SURFACE RESISTIVITY (ESD)

0 washes 1X108 - 3X108 Ώ (Static Dissipative)

250 washes 1X1012 Ώ (Static Dissipative)

PARTICLE SHEDDING (HELMKE) 0.3um 0.5um

Particles/min (0 washes) 1,084 1,058

Cleanliness Category I I
21

Particles/min (250 washes) 2,646 1,976

CLEAN ROOM GARMENTS | GARMENT GUIDE

Cleanliness Category II II

FILTRATION EFFICIENCY (%) 0.3um 0.5um 5.0um

0 washes 59.27 88.36 94.20

25 washes 89.24 94.30 97.73

50 washes 85.18 93.37 96.05

75 washes 83.16 95.86 90.62

100 washes 79.44 95.38 80.00

125 washes 76.65 95.70 92.11

150 washes 91.39 97.65 94.34

175 washes 83.85 91.39 98.98

200 washes 78.00 89.35 100

225 washes 96.26 98.85 98.49

250 washes 77.93 89.58 100

 ULTRACLEAN FABRIC (PE)

Specifications 100% Polyester with ECF strip

Colour range Blue (BP), White (WP), Navy (NP), Lemon (LP)

Unit Weight 106 g/m2

Water Vapour Transmission Rate 62.72 g/hrs m2

2.6 cm2/cm2/s (toward airflow)

Air Permeability
2.2 cm2/cm2/s (away from airflow)

Abrasion Resistance 91,250 cycles

PARTICLE SHEDDING (HELMKE) 0.3um 0.5um

Particles/min (0 washes) 2,093.92 2,185.00

Cleanliness Category II II

Particles/min (250 washes) 150.59 207.60

Cleanliness Category I I

FILTRATION EFFICIENCY (%) 0.3um 0.5um 5.0um

0 washes 76.96 89.05 92.63

25 washes 84.63 96.90 100

50 washes 80.68 88.52 92.96

75 washes 86.71 93.26 83.33

100 washes 81.11 90.06 85.72

125 washes 90.28 94.01 100

150 washes 84.79 93.41 100

175 washes 86.21 95.62 100

22 200 washes 80.97 92.50 58.83

225 washes 83.57 95.45 100

CLEAN ROOM GARMENTS | GARMENT GUIDE

250 washes 78.65 86.06 NA

DURACLEAN FABRIC (PE)

Specifications 100% Polyester with ECF strip

Unit Weight 109 g/m2

Water Vapour Transmission Rate 3.24 mg/hr/cm2

Air Permeability 9.8 ml/m2

Abrasion Resistance Good

Flammability Index 14 (Range 0-100/least to most flammable)

Melting Point 250 °C

SURFACE RESISTIVITY (ESD)

0 washes 10° Ohms per square

FILTRATION EFFICIENCY (%) 0.5um 0.7um 1.0um 5.0um

0 washes 15% 17% 19% 60%

 UNDER GARMENT FABRIC (WY)

Specifications 100% Polyester with ECF strip

Colour range Blue, White

Unit Weight 166 g/m2

Water Vapour Transmission Rate 45.31 g/hrs m2

>68 cm3/cm2/s (toward airflow)

Air Permeability
>68 cm3/cm2/s (away from airflow)

Abrasion Resistance 25,000 cycles

PARTICLE SHEDDING (HELMKE) 0.3um 0.5um

Particles/min (0 washes) 3,319.82 3,218.63

Cleanliness Category II II

Particles/min (50 washes) 3,496.92 3,241.62

Cleanliness Category II II

Particles/min (100 washes) 10,075.84 8,086.34

Cleanliness Category II II

Particles/min (150 washes) 7,628.18 5,425.70

Cleanliness Category II II

Particles/min (200 washes) 4,033.74 3,148.23

Cleanliness Category II II 23

Particles/min (250 washes) 3,862.62 2,929.74

CLEAN ROOM GARMENTS | GARMENT GUIDE

Cleanliness Category II II

UNDER GARMENT FABRIC (ZC)

Specifications 100% Polyester Twill Hi-Stretch 288T P/D + Moisture Finish

Colour range Blue

Unit Weight 117 g/m2

Dimension stability to washing +/- 3%

Useable width 140 cm

Tensile strength Warp (kg) 20 kg

Tensile strength Weft (kg) 20 kg

Tear strength Warp (g/f) 1200

Tear Strength Weft (g/f) 1200

Washing fastness 3-4

 CBRI FABRIC (CB)

Specifications 100% Polyester with ECF strip

Colour range Blue, White

Unit Weight 103 g/m2

Water Vapour Transmission Rate 44.57 g/hrs m2

4.0 cm2/cm2/s (toward airflow)

Air Permeability
4.1 cm2/cm2/s (away from airflow)

Abrasion Resistance 92,500 cycles

SURFACE RESISTIVITY (ESD)

0 washes 1X106- 1X108 Ώ (Static Dissipative)

1X10 - 1X10 Ώ (Static Dissipative)

7 12
250 washes

PARTICLE SHEDDING (HELMKE) 0.3um 0.5um

Particles/min (0 washes) 2462.40 2238.01

Cleanliness Category II II

Particles/min (250 washes) 720.59 505.20

Cleanliness Category I I

FILTRATION EFFICIENCY (%) 0.3um 0.5um 5.0um

0 washes 95.61 97.57 97.56

25 washes 82.56 90.04 76.75

50 washes 94.21 98.17 100

75 washes 82.22 94.72 100

100 washes 93.33 98.09 97.25

24 125 washes 94.03 97.91 98.45

150 washes 85.87 95.17 91.38

CLEAN ROOM GARMENTS | GARMENT GUIDE

175 washes 86.10 93.18 96.70

200 washes 94.48 96.92 99.28

250 washes 86.88 97.31 90.57

250 washes 76.38 85.24 96.97

STAT CONTROL FABRIC (SC)

Specifications 99% Polyester + Carbon Fibre 1%

Colour range Blue, White

Unit Weight 95 g/m2

Useable Width 153.7 cm

1.0 ft3/ft2 per min @ 125 Pa

Air Permeability
1.6 ft3/ft2 per min @ 200 Pa

Filtration Efficiency 92% @ 0.5um

Water Vapour Permeability 1100 g/hrs m2

Hydrostatic Resistance 80cm (min)

Surface Resistivity 1x108 - x109

Static Decay 0.01 (sec)

Tensile strength Warp (kg) 86.18 kg

Tensile strength Weft (kg) 47.63 kg

 INTEGRITY 2000 FABRIC (IN)

Specifications 100% Polyester with ECF strip

Colour range Navy Blue

Unit Weight 107 g/m2

Water Vapour Transmission Rate 76.51 g/hrs m2

0.3 cm2/cm2/s (toward airflow)

Air Permeability
0.3 cm2/cm2/s (away from airflow)

Abrasion Resistance 71,000 cycles

SURFACE RESISTIVITY (ESD)

0 washes 3X108-1X1010 Ώ (Static Dissipative)

250 washes 8
1X10 -1X10
12
Ώ (Static Dissipative)

PARTICLE SHEDDING (HELMKE) 0.3um 0.5um

Particles/min (0 washes) 162.10 173.90

Cleanliness Category I I

Particles/min (250 washes) 214.20 191.99

Cleanliness Category I I

FILTRATION EFFICIENCY (%) 0.3um 0.5um 5.0um

0 washes 66.80 77.87 82.38

25 washes 84.63 96.90 100

50 washes 80.68 88.52 92.96

75 washes 88.41 94.76 73.80

100 washes 84.23 96.16 100

25
125 washes 88.85 94.85 100

150 washes 93.32 97.42 98.85

CLEAN ROOM GARMENTS | GARMENT GUIDE

175 washes 83.72 93.09 90.38

200 washes 70.68 84.74 91.67

250 washes 91.63 97.01 98.89

250 washes 80.11 92.47 97.62

WATER REPELLENCY (%)

0 washes 99.8%

25 washes 99.0%

50 washes 99.5%

75 washes 99.3%

100 washes 99.7%

125 washes 99.5%

150 washes 99.3%

175 washes 99.7%

200 washes 99.3%

225 washes 99.5%

250 washes 99.5%

 CLEANROOM
CLASSIFICATION
COMPARISONS
®® The pharmaceutical industry in Australia is regulated by GMP standards or the PICS
code (class A to D)
®® The ISO 14644-1 standard (classes 1 to 9)

26
®® The US Federal standard 209E (classes 1 to 100 000)
CLEAN ROOM GARMENTS | GARMENT GUIDE

maximum particles/m3
FED STD 209E
Class equivalent
≥0.1um ≥0.2 um ≥0.3 um ≥0.5 um ≥1 um ≥5 um

ISO 1 10 2

ISO 2 100 24 10 4

ISO 3 1,000 237 102 35 8 Class 1

ISO 4 10,000 2,370 1,020 352 83 Class 10

ISO 5 100,000 23,700 10,200 3,520 832 29 Class 100

ISO 6 1,000,000 237,000 102,000 35,200 8,320 293 Class 1000

ISO 7 352,000 83,200 2,930 Class 10,000

ISO 8 3,520,000 832,000 29,300 Class 100,000

ISO 9 35,200,000 8,320,000 293,000 Room Air

 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.

GARMENT
GARMENT SERVICE YOUR FACILITY ROOM GRADE FABRIC CLEANING GARMENT CHANGE
PROCESS STYLE RATE

Aseptic Filling &

compounding (sterile)
Coverall, hood,
Sterile Cleanroom Grade A in B Ultraclean Process Class B
overshoes, mask & Per entry
Garments Class 100 / ISO 5 Polyester & Sterile
gloves
Micro testing

Aseptic filling & Coverall, hood,

Sterile Protective Grade A in B UltraShield Process Class B
compounding of: Hormones overshoes, mask & Per entry
Cleanroom Garments Class 100 / ISO 5 Polyester (PCG) & Sterile
Antibiotics Antineoplastics gloves

Grade C Coverall, hood,

Class III medical device and
Class 10,000 / Process Class B overshoes, mask &
other industrial applications
ISO 7 gloves
Process Only Ultraclean
Cleanroom Garments Polyester
Daily / Weekly 27
Class I and II medical Grade D
Smock, cap &
device & other industrial Class 100,000 / Process Class D
shoecovers
applications ISO 8

CLEAN ROOM GARMENTS | GARMENT GUIDE

Coverall,
Tableting, creams, solutions shoecovers &
and powders None headcover
specified Process
Breathable
Bioclean Garments Low Bioburden Daily
Controlled Polyester
(LBB) or two piece suit,
environment
Primary & secondary shoecovers &
packaging headcover

Polycotton
Static sensitive areas
with Electro
Statguard Dust Coats Assembly Test & repair N/A Launder Only Statcoat Weekly
Conductive
Packaging
Fibre (ECF)

Laboratories, workshops, Polycotton or Coverall, Labcoat,

General Uniforms N/A Launder Only Daily
warehouse, assembly cotton Shirt & Pants

®® 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 Polyseter - Available for wet environments

22 / CLEAN ROOM GARMENT GUIDE
CLEAN ROOM GARMENTS | GARMENT GUIDE
 Cleanroom clothing is intended to prevent substances
released off the wearer’s body from contaminating
the environment. It is also important that the clothing
does not itself release particles or fibres into the
environment. Cleanroom personnel contribute about
25% of airborne particulate contamination. Skin, hair
and other substances are released from the body and
clothing with each person releasing about 25,000
particles per minute (p/min). Emission rates in normal
clothing range from about 100,000 p/min when sitting
or standing motionless, 500,000 p/min during hand,
forearm and head movement and up to 5,000,000
p/min during normal walking. The particles released
are generally greater than 0.3um. In addition, many
particles emitted from the body can be contaminated
by bacteria.

FACTORS LIMITING
30

CLOTHING &
CLEAN ROOM GARMENTS | GARMENT GUIDE

FACE-MASK
PERFORMANCE
Penetration and leakage can reduce the protective performance of cleanroom clothing.
Penetration can be regarded as passage of materials through holes in the protective equipment.
Such holes can occur in fabrics, filters, seams or fasteners. Leakage can occur at any point
at which there is a gap between the equipment and the wearer’s body or face. Face-mask
performance can similarly be limited by penetration of the filter and leakage between mask and
face.

Clothing penetration and leakage result from pressure differences between the inside and outside
which are generated by body movement. For example, when raising and lowering arms, voids
open up between the body and the clothing. Airflow into the garment can contaminate the body
and airflow out of the garment can contaminate the environment. The pressure differentials
generated, and thus the transfer of contaminants, depend on both the air permeability of the
garment and the goodness of fit.
FABRIC PENETRATION
Conventional clothing fabrics such as cotton, nylon, terylene or spunbond have numerous small
holes through the fabric. Objective tests of such fabrics using respirable asbestos fibres or small
particles indicate that over 50% of such particles penetrated through the fabrics. Fabrics giving
such test results are essentially “transparent” to fine aerosols such as bacteria, skin scales or
other contaminants and are therefore unsuitable unless only marginal performance is required.

WOVEN FABRICS
MADE FROM 100% CONTINUOUS FILAMENT POLYESTER FIBRE

The fibres of the garment must be fine and tightly woven, which reduces the air permeability of
the garment. The air permeability is a function of the space between the woven fibres. Polyester
is a synthetic fibre that is hydrophobic which means it will not absorb moisture and will not
allow moisture such as perspiration to evaporate. Natural fibres such as cotton are hydrophilic,
this means they absorb moisture and are more comfortable to wear but shed high levels of
contaminants. Polyester garments are durable, wash well, dry quickly and are the most suitable
fabric for the cleanroom environment.

GARMENT MANUFACTURE
Unsealed stitched seams and fasteners such as Velcro or conventional zips offer little resistance
to either airflow or aerosol penetration. In many garments, the air permeability of seams and
fasteners is much greater than that of the fabrics. Consequently, although the area of seam and
fastener is typically less than 1% of the total area of a garment, the total flow of contaminated air
through seams and fasteners can be much greater than that through the fabric, particularly if the
fabric is relatively impermeable to air.

Clean Room Garments manufactures its garment seams to exacting standards to help prevent
this happening. Seams are “French Seam” stitched; the seams are overlocked, stitched again to
encase the overlock, then stitched down onto the garment.
31
LEAKAGE

CLEAN ROOM GARMENTS | GARMENT GUIDE

Many garments have gaps between the clothing and the body, most commonly at the neck.
Contamination can readily pass through such gaps. Penetration through seal gaps can permit
unhindered passage of large particles that would otherwise be unable to pass through the fabrics
of construction, so contamination of the body can occur even when the clothing worn is effectively
impervious to the contaminant. A garment that permits inward leakage will just as easily permit
outward leakage. Cleanroom garments using the same fabrics and construction techniques as
protective clothing will be equally poor at keeping contamination inside the clothing as they
are at keeping environmental contamination outside the clothing. A garment constructed from
an efficient fabric with well sealed seams and fasteners may therefore fail to provide effective
protection for either the body or the environment unless it is well sealed to the wearer’s body.

Studies of cleanrooms have shown this to be a common occurrence. For example, when a
cleanroom is occupied by personnel, microbial contamination increases greatly even when
personnel wear surgical masks in addition to cleanroom clothing. Coveralls, hoods and boots
worn as a set only reduce by half the airborne contamination produced when just smocks and
boots are worn, and gowns worn with head covers reduce the contamination level by only 19%.

From the above it will be appreciated that it is not adequate to specify cleanroom clothing in
terms of fabric performance only, it is necessary to specify fabric, seam and fastener penetration
and suit-seal leakage. While it might appear that protective performance could be increased
by providing better seals, sealing can cause thermal discomfort or heat strain by preventing or
reducing air exchange.
 FILTRATION EFFICIENCY
Filtration efficiency of fabrics is the main method by which the particle exclusion performance
of fabrics can be measured. Fabric is placed on a fabric holder with the inside surface up, pulled
flat and clamped into place with an o-ring and the top of the holder. A pump draws air through
the fabric and particle count samples of air are taken from the air outside and inside the fabric
holder. The filtration efficiency is the amount of particles filtered from the air by the fabric when
compared to unfiltered “control” air, expressed as a percentage. A brief explanation of these
results follows the table below:

SAMPLE FILTRATION EFFICIENCY TABLE

32
FABRIC FILTRATION EFFICIENCY %
0.3um 0.5um 1.0um 5.0um
CLEAN ROOM GARMENTS | GARMENT GUIDE

Fabric A 70 79 88 95

Fabric B 69 74 87 99

The four columns indicate each of the particle sizes

the APC is capable of monitoring. The two sizes
that are most important are 5um and 0.5um (um
is a micrometre (micron), or .001mm). 0.5um is the
size that most cleanroom classifications AS/NZS
ISO 14644 are based around. The percentage result
shows how many particles the fabric excludes.
Particle penetration is often quoted in place of
filtration efficiency in documentation. It is the direct
opposite of filtration efficiency; for example Fabric
A above allows 21% (100%-79%) of 0.5um particles
through.
AIR PERMEABILITY
Air permeability is an indicator of the “breathability” of a fabric, or how much air will pass
through it under pressure. Fabrics with low air permeability will allow less contamination
to pass through them (either from operator to environment or vice versa), but with the
resultant trade off in comfort. The lower the air permeability of the fabric, the more attention
must be paid to the fit and seal of the garments, as air pressure will always escape via the
easiest path.

The air permeability test is carried out by clamping fabric into a sealed holder, then creating
a constant pressure gradient across it. Once the desired pressure is reached and has become
stable, the volume of air required to be pumped into the “upstream” side of the fabric to
maintain this pressure gradient is measured, in ml of air per second. Then, with the area of
fabric clamped into the holder taken into account, the mean air permeability is calculated,
expressed as ml of air per square cm of fabric per second (ml/cm2.s)

WATER VAPOUR TRANSMISSION

This test is one of the best indicators of the likely “comfort factor” of a fabric as it measures
how quickly water vapour – for example, in the form of sweat – passes through fabric. It is a
more important factor to consider in garments such as hoods, or for those worn by workers
who do not move around much as airflow is not generated in the garment to help heat
loss. In some of the highest performance fabrics, there is also a “wicking” effect – the fabric
actively draws moisture away from the body.

The water vapour transmission test is done by weighing an amount of water into a container,
sealing the fabric to be tested over the mouth of the container (normally using hot melt
33
glue), then placing the container and fabric into an environment with controlled temperature
and humidity for a length of time. The amount of water, in the form of evaporating water

CLEAN ROOM GARMENTS | GARMENT GUIDE

vapour, that passes through the fabric barrier can be measured by the amount of weight
that is lost over time from the container. The result is expressed as grams water lost per
hour per square metre of fabric (g/hr.m2).

WATER REPELLENCY (SPRAY RESISTANCE)

Testing for water repellency forms part of CRG’s routine testing on barrier fabrics, to ensure
that it retains this property for its entire lifespan. The procedure involves weighing a piece of
blotting paper, clamping it behind a surface of the test garment at a 450 angle and running
500ml of water over the fabric through a shower head from a constant height (61cm). Any
water that penetrates the fabric will be absorbed by the blotting paper, which is removed
from behind the fabric and reweighed after the test has finished. The weight of the blotting
paper after testing is compared to the pre-test weight, and the result is expressed as a
percentage.
Although the testing procedure is extremely simple, it must be done very carefully as small
variations in the weight of the blotting paper after testing can cause a failure. For example,
touching the paper with wet fingers will cause a large discrepancy in the results.
 The human body converts energy derived from food into work with
typical conversion efficiencies ranging from about 25% for a fit person
carrying out exercise with the major muscle groups down to almost
zero when carrying out static work such as holding weights above the
head. All energy which is not converted into useful work will be lost
as heat. The higher the work load, the greater the amount of heat to
be lost. Heat can be lost by convection, radiation, conduction, sweat
evaporation and by heating and humidifying air that is breathed in.
It should be appreciated that only a few joules per gram is lost by
sweat dripping off the body whereas the evaporation of 1 gram of
sweat in contact with the body can lose about 2,400 joules. Heat is
more easily lost in light, open clothing than in well sealed clothing and
more easily lost in cold environments than in hot environments. Well
sealed garments exhibiting poor air and water vapour permeation can
substantially reduce sweat evaporation as sweat evaporation is much
reduced in the high humidities present within the garments. Such well
sealed garments can cause significant heat storage for moderate or
harder work in other than cold environments. Garments which cause
thermal discomfort or heat strain are often misworn in an attempt to
reduce discomfort, i.e. the fastener may be opened to permit easier flow
34
of air. Any such miswear substantially reduces the protection provided
by the clothing.
CLEAN ROOM GARMENTS | GARMENT GUIDE

If sufficient heat cannot be lost, heat is stored in the body and the
body’s core temperature rises. Moderate heat storage can cause
thermal discomfort, which although not directly health threatening, can
cause loss of attention which could result in reduced quality of product.
Severe heat storage can progressively result in cramps, coma and death.

Cleanroom workers often have to wear coveralls, hoods, gloves and face
masks which substantially reduce the area of skin off which heat can be
lost by convection, radiation or sweat evaporation. In 15°C environments,
wearing gloves and headcovers reduces the body’s ability to lose heat
by 10 to 50%. In addition, face masks absorb heat and moisture from the
exhaled air which is transferred to the inspired air, thus reducing heat
loss by breathing.

Well fitted, high performance garments, particularly when worn in

conjunction with face masks, can therefore so reduce heat loss from
the body that heat strain may be much more common than is presently
reported.
 There are three general zones of performance for
ELECTRICAL RESISTIVITY materials measured for electrical resistivity. Less
100% polyester is almost entirely insulative, that is, than 105Ω (ohms) is regarded as conductive, 105Ω
it does not conduct electricity – static or otherwise. to 1012Ω as static dissipative, and greater than 1012Ω
However, it generates a great deal of static as insulative. Clean Room Garments’ Aussie sole has
electricity through friction with clothing and other a resistivity of 108Ω to 109Ω, making it a good static
surfaces. This can result in anything from a mild dissipater in environments where this property is
shock as the charge is dissipated on contact with important.
a metal or other conductive surface that is earthed, A related test is static decay, where a static charge
to complete destruction of a sensitive electronic is applied to a fabric held in an insulative clamp and
component or an explosion or fire hazard in an area the time taken for it to decay by a set amount is
containing flammable vapours. measured. This test is quite common in countries
The common solution to this problem is to run where a significant proportion of the cleanroom
conductive fibres, usually carbon-based, through market is involved in integrated circuit manufacture
the fabric to pick up these static charges and and is static sensitive.
direct them to where they can be discharged in a
controlled fashion. These conductive fibres produce ABRASION RESISTANCE
the distinctive check or stripe appearance of Two types of test are usually specified when
cleanroom fabric. The quantity, type, weave pattern measuring abrasion resistance. These are the 35
and thickness of these conductive threads will all Taber test and the Wyzenbeck test, although the
have an effect on the static properties of fabric. Wyzenbeck test is rarely used for anything but

CLEAN ROOM GARMENTS | GARMENT GUIDE

For example, fabric with conductive fibres woven in upholstery. Both of these tests measure either the
a tight check pattern will have much better static appearance of fabric (fibre breakage, hole formation,
properties than one with wide stripes between etc) after a given amount of cycles (rubs), or at what
the fibres. Fibre thickness is important as thicker point destruction of the fabric (broken threads)
conductive fibres offer less electrical resistance and occurs. The Taber test also measures the mass of
therefore allow better conductivity, but also create material lost (in grams) after the specified amount
larger holes in a tightly woven fabric through which of cycles. A number of different test loads and
particles can penetrate. abradants can be specified for these tests, usually
To measure the static dissipative performance of agreed upon with the customer before the testing
a fabric, its resistance to the flow of an electrical commences.
current is measured. The results are expressed High abrasion resistance in fabric indicates better
as ohms (the unit of resistivity) per square. In durability, but this is often at the cost of a heavier
the measurement of surface resistivity, the same weight fabric that is not as comfortable to wear and
numerical result is obtained regardless of the size more difficult (and therefore costly) to manufacture
of the square. into a complex garment.
 FABRIC
SELECTION
Selection of fabric type must be a careful balance between the
customer’s contamination control needs and those of their production
staff. The cleaner the environment that must be achieved, the higher
the performance of the fabric that must be used. But with very clean
environments comes greatly increased running costs, as a much cooler
36
and less humid environment needs to be maintained in order to allow
production staff to operate in relative comfort.
CLEAN ROOM GARMENTS | GARMENT GUIDE

How rigorous is the environment? Do the operators continually come

into contact with sharp or abrasive surfaces? Do staff need to be
protected from liquid spills? Is static sensitive equipment involved?
BIOBURDEN
TESTING
There are no national or international standards that specify levels of
micro-organisms on cleanroom garments. On the other hand, almost all
standards and guidelines concerning the pharmaceutical, medical and food
industries state that “micro-biological tests have to be done” on garments.
They just do not explain how these tests have to be performed or what the
acceptance criteria are.

CRG tests for bioburdens on garments twice a week. 2 sample customer

garments of each of the following fabrics are chosen at random: Blue
Polyester, Purple UltraShield, and Integrity. Once laundered and dried, the
front of the garment (hip area) and back of the garment (seat area) are
selected for sampling and coding. A sample is taken by briefly placing
the agar surface of a contact plate in contact with the chosen area of the
garment. Once samples are collected, garments are sent for rewash. Test
plates are incubated at 32°C for 5 days. Plates are inspected after this period
for any bacterial growth and the total CFU counted. We try to achieve an
action limit of 5cfu (colony forming units).

The types of organisms found can tell us a lot about the source of the
contamination on the fabrics, as most of them are found almost exclusively
in water, people or just general dust. High counts of the water types may
indicate that the garments were not dried properly, or that the water is not
particularly clean, while high counts of organisms associated with people
may indicate that the garments were not washed particularly well, or that our
operators were not isolated well enough from the environment.
37

CLEAN ROOM GARMENTS | GARMENT GUIDE

WATER
TESTING
The water system consists of the following:

1. storage tank pre filtration

2. carbon filters - coarse and fine to remove gross contamination and

chlorine

3. bag filters 10um

4. pump to compensate for lost pressure

5. a three stage unit consisting of a 3um, 1um and a 0.35-0.5um absolute

filter

We have a limit of 100cfu per ml, which is based on the USP guidelines for
process water at point of use.
 38
FABRICS
AS1807.19 is based on a method developed by the ASTM (American Society for Testing and
CLEAN ROOM GARMENTS | GARMENT GUIDE

Materials) in 1968, and has remained basically unchanged over the last 30 years. In simple terms,
the method involves sucking or vacuuming particles from a set portion of the garment surface
onto a filter membrane clamped into a holder. The membrane is then placed under a microscope
and the particles on it are counted according to a statistical formula to arrive at a result per
0.1m2. The process is laborious, but provides a very accurate indication of the level of particle
contamination on the garment in question.

An alternative method for determining particle contamination on materials is the Helmke Drum
method, which is also called the tumbling or rotating method. Garments are placed in a rotating
drum that is open at one end and tumbled to release particles from the fabric. An automatic
particle counter samples the air within the drum to determine the particle density of the air.

There are arguments for and against each method. The Helmke Drum test is much simpler to
perform than the AS1807.10-2000 method, but is only useful in tracking the performance of
the laundering process, or to compare similar materials. It is no indication of the quality of the
garment itself. Garments, especially larger ones like smocks and coveralls, also have a tendency
to “ball” in the drum, which results in less particles being released by the tumbling process and a
lower than expected count.

The AS method is more subjective, as the operator must determine what is or isn’t a particle on a
membrane surface that is often covered with various creases, shadows and other imperfections.
There is also a limit to the size of the particles that are visible at the magnification used. Even
at 100x, particles smaller than 5um are effectively invisible, hence the standard’s reliance on this
size level for specifications. As the Helmke Drum classifications are based on 0.5um particles, the
results of the two tests have no correlation at all.
CLEANROOM MONITORING
To assess the cleanliness of clean cabinets, isolators, and rooms, particle concentration
larger than a given size is determined by either microscopy (for larger sizes) or an optical
particle counter. For speed, cost and statistical validity, assessments are usually carried out
with an optical particle counter.

Modern optical particle counters provide data on a number of different sizes simultaneously
which are displayed on an internal screen and may be saved using a printer, or downloaded
to a PC and manipulated by a spreadsheet program into tables to be interpreted at a later
date.

CRG’s cleanroom is a vertical flow room and classed as a Grade B PIC’s guide to good
manufacturing for medicinal products (GMP) (ISO Class 5).

The facility is certified annually by a third party NATA certified testing service to Australian
Standards. The testing service verifies that the airflow velocity changes the air in the room
often enough (air change rate), that there are no pinholes in the filters (filter integrity),
and that the pressures being maintained in the room is enough to prevent particles from
entering (room integrity).

We also monitor all rooms with continuous particle counters (FMS). Results are compared
to AS/NZS14644.

FACILITY MONITORING
Although it is necessary for a clean area to be regularly tested, such testing only indicates
the level of cleanliness at a point in time, often when normal (particle producing) operations
are not taking place.

Many of CRG’s customer’s clean manufacturing environments often need to be more

39
rigorously monitored to ensure that there is a constant awareness of conditions, including
logging particle “spike” events which could be catastrophic if missed. This need is being

CLEAN ROOM GARMENTS | GARMENT GUIDE

driven by the desire to reduce operational costs, improve production yields and quality, to
increase confidence in good manufacturing practices or to fulfill regulatory requirements.

One way of achieving more regular monitoring is to install a Facility Monitoring System. A
Facility Monitoring System is an arrangement of instruments linked to a central monitoring
computer. The computer controls the intake of data from the various devices and logs and
displays the information, reporting to the operator any changes in conditions or trends.

The inputs to the Facility Monitoring System may be from numerous sources. In clean areas
the optical particle counter data may be transferred to the computer. Alternatively, particle
counters linked to scanning manifolds (an array of tubes connected to a single APC) may be
installed. Environmental conditions such as differential pressure, airflow velocity, temperature
and relative humidity often play an important part in ensuring quality. These may also be
monitored using appropriate sensors and the data collected via the PC/software.

Such automated, computer controlled Facility Monitoring Systems provide increased

vigilance whilst decreasing the labour requirements on these activities. If the system is well
planned, then a fast detection of potential problems in operating conditions should occur,
enabling counter measures to be taken rapidly. Over the longer term any significant trends
in operating conditions can be monitored and statistical analysis of data allows for closer
control and identification of normal and abnormal conditions.
 STERILISATION
We find that ETO is the best method for sterilising polyester. Autoclaving causes
these materials to shrink or become badly creased, and gamma causes cross-
linking in the polymers, leading to brittleness and reduced lifespan.
We sterilise in-house, and our method is revalidated annually using an ‘overkill’
method. This involves loading a steriliser chamber with garments, placing biological
indicators (BI’s) in multiple locations and running a half length cycle. The method is
in accordance with the AS ISO 11135 Medical devices - Validation and routine control
of ethylene oxide sterilisation.
The cycle is validated to a SAL of 10^ -6. Copies of the validation packs are available
40 if required. We conventionally release using BIs.
Sterile garments are packed in gas permeable bags. Each bag is individually
marked with the batch number and expiry date, so every garment is traceable to an
CLEAN ROOM GARMENTS | GARMENT GUIDE

individual cycle. The gas permeable bags have an ETO chemical indicator printed
on them so we have a visual indication that the bag has been through the steriliser.
Proof of sterilisation for us is having all of the cycle parameters met (temperatures,
pressures, gas weights, times, clear BI’s, etc.). This is documented on an approved
cycle record by a QA Representative.
Certificates of Sterilisation are available for all cycles on the CRG website
www.cleanroom.com.au. Written procedures exist for non-conforming lots, where
the cycle is re-processed or recalled in the unlikely event it has already left.
CHIPPING &
BARCODING
CRG aims to identity chip all garments and mops going through our
cleanroom processing facility. This provides CRG and clients with the
ability to track where their garments are and how many times they have
been returned to CRG for washing and/or sterilisation. This information
is then stored on CRG’s database and can be accessed by a customer’s
Key Account Manager.
This removes the risk of barcodes being damaged or unreadable. The
chips are sewn into the garment / mop so there will be no change in
comfort or quality standards of the item.
Where chips can not be offered, a barcode is used.

CLEAN ROOM GARMENTS | GARMENT GUIDE