Sunday, 24 August 2014

CLEANROOM INFORMATION

Training & Monitoring Kits

The largest source of contamination in the cleanroom is from people entering, moving about, operating and cleaning. Controlling contamination from people related sources is achieved by training operators to follow validated procedures. How do you know a procedure is being followed and not contributing to contamination?
Ecolab Training & Monitoring kits can help you confirm that your operator’s competence and techniques are not adding to your contamination risk.

See also:

3056560 - Klercide UV Validation Torch

A high intensity UV light to instantly identify contamination
Instant cleaning validation
The Klercide UV Validation Torch enables you to identify immediately if a cleaning procedure has not been carried out effectively. Any contamination remaining will show clearly under the 35W UV light.
Technician training
The Klercide Validation Torch can be used to demonstrate to technicians correct surface disinfection techniques and the effectiveness of them.
Identify contamination risks
Klercide UV validation Torch can be used to identify contamination risks, for example difficult to clean areas, or poorly cleaned surfaces with clearly visible results.
Easy to use
The equipment does not require any special training to operate and is supplied with full instructions.
Cost effective
The Klercide UV Validation Torch will highlight any non-visible contamination improving contamination control techniques and reducing the risk of costly errors in production.
Literature Adobe Acrobat Document

CLEANROOM STATIONARY

Stationary


Paper and Notebooks

Cleanroom paper is an integral component in critical environments. BCR® Cleanroom Bond and Notebooks provide a flexible way for you to record information throughout the production process without causing contamination.
SHARED COMPOSITION & ATTRIBUTES 
  • Minimises particle contamination
  • Cellulose base sheet with a synthetic latex binder for optimal smoothness and cleanliness
  • High tear resistance to withstand long periods of use
  • Autoclavable (with the exception of the blue coloured bond)
  • High opacity
  • Easy to write on
  • Fine cut edges reduces particle contamination
Item NumberProduct DescriptionUOMMOQ
5812
PHOTO BOND 1040 A4
250 sheets
10 Packs
5813
BCRBOND PAPER680 A4WHITE 250Pg
250 sheets/Pk
10 Packs
5813B
BCR BOND PAPER680 A4BLUE 250Pg
250 sheets/Pk
10 Packs
5813G
BCR BOND PAPER 720 250PG GREEN
250 sheets/Pk
10 Packs
5813P
PHOTO BOND 680 - PINK 250SHTS
250 sheets/Pk
10 Packs
5813Y
BCR BOND PAPER 680 250PG YELLO
250 sheets/Pk
10 Packs
5818
NOTEBOOK SPIRAL 22x28cm 50page
1 book
10 books/ctn

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

Sunday, 17 August 2014

Cleanroom garments- Knowledge Sharing

Why necessary?

Humans are broad-spectrum particle and aerosol
generator
Prevent contamination of cleanroom by cleanroom worker
(barrier-function)
 

Danger :

Garments can shed particles (linting)
Garments can damage microelectronic components
through ESD events