Sunday, 24 August 2014

CLEANROOM GARMENT INFORMATION

Recommendations for Cleanroom Clothing

For step by step gowning instructions, please contact CRG for a Sterile Gowning Chart today!
Dowload: Sterile Gowning Chart Adobe Acrobat Document
Ph: 02 9851 4600

See also:

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

CRG Garment Recommendations

Garment ServiceYour FacilityRoom GradeFabricGarment Cleaning ProcessGarment StyleChange Rate
Sterile Cleanroom GarmentsAseptic Filling and compounding (sterile)
Micro testing
Grade A in B

(Class 100 or ISO 5)
Ultraclean PolyesterProcess Class B and SterileCoverall, hood, overshoes, mask and glovesPer entry
Sterile Protective Cleanroom GarmentsAseptic filling and compounding of:
Hormones
Antibiotics
Antineoplastics
Grade A in B

(Class 100 or ISO 5)
Ultrashield PolyesterProcess Class B (PCG) and SterileCoverall, hood, overshoes, mask and glovesPer entry
Process Only Cleanroom GarmentsClass III medical device and other industrial applications

Class I and II medical device and other industrial applications
Grade C

(Class 10,000 or ISO 7)

Grade D

(Class 100,000 or ISO 8)
Ultraclean Polyester


Ultraclean Polyester
Process Class B



Process Class D
Coverall, hood, overshoes, mask and gloves

Smock, cap and shoecovers
Daily / Weekly


Daily / Weekly
Bioclean GarmentsTableting, creams, solutions and powders
Primary and secondary packaging
None specified (controlled environment)Breathable PolyesterProcess Low Bio Burdon (LBB)Coverall, shoecovers and headcover
or two piece suit, shoecovers and headcover
Daily
Statguard Dust CoatsStatic sensitive areas
Assembly
Test and repair
Packaging
N/APolycotton with Electro Conductive Fibre (ECF)Launder OnlyStatcoatWeekly
General UniformsLaboratories, workshops, warehouse, assemblyN/APolycotton or cottonLaunder OnlyCoverall, Labcoat, Shirt and PantsDaily

References:

NB: 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
Unltrashield Polyseter - Available for wet environments

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