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Nancy Baeten DuPont Protection Solutions BCW College Day - September 2017
UNDERSTANDING DIFFERRENT ASPECTS OF PROTECTIVE GARMENT SOLUTIONS IN CLEANROOMS & CONTROLLED ENVIRONMENTS
MARKETS AND APPLICATIONS
Pharmaceutical production Medical device production Cytotoxic handling Vaccine production Chemical Dipping Chemical Etching Cleanroom visitors Cleanroom start up Cleanroom construction Cleanroom maintenance Cleanroom cleaning Maintenance work
Pharma
Medical Device Manufacturing
Biotechnology
Other: Food processing, cosmetics
WHY DO WE WEAR PROTECTIVE GARMENTS IN CLEANROOMS?
WHAT DO YOU NEED TO PROTECT?
PEOPLE AGAINST HEALTH RISKS
Barrier: OUTSIDE to inside PRODUCT
AGAINST PEOPLE
Barrier: INSIDE to outside
LEGISLATIVE CLOTHING REQUIREMENTS
Directive 89/391/EEC Introduction of measures to encourage improvements in safety and health of workers at work Directive 89/656/EEC Minimum health and safety requirements for the use by workers of personal protective equipment at the workplace
GMP and IEST provide guidance on garment usage to maintain product quality and cleanroom environment.
DRESSING FOR THE RIGHT CLEANROOM TYPE
In general, IEST* says the lower the ISO number of the clean room, the more of the person that must be covered. Full Gowning – Entire body coverage is required by ISO Class 4/5.
*Institute for Environmental Sciences and Technology
Goggles
PROTECTING THE PRODUCT and process from contamination
e.g. microorganisms
PEOPLE REMAIN THE BIGGEST CONTAMINATION RISK IN A CLEANROOM
ENVIRONMENT
CONTAMINATION SOURCES
People 75% Ventilation 15% Room Structure 5%
Equipment 5%
Source: http://www.climet.com/library/particle_sources.htm
PEOPLE: SOURCE OF CONTAMIATION
Type of movement Particle / min . (> 0.5 m)
Sitting without moving 100 000
Moving hands, arms, head 500 000
Active hand/arm movement,
Fast turning of the head
1 000 000
Standing up from a sitting position or
vice versa
2 500 000
Rapid movement, climbing stairs, etc. 110 000 000
Source: Clean Room Primer, 1985, J. J. Nappi Jr. Liberty Industries Inc. USA
Contamination risk: particle creation by people movement
HOW TO CONTROL CONTAMINATION RISK BY PEOPLE? ORGANISATIONAL MEASUREMENTS Selection of personnel Education and training of personnel Safety aspects in cleanrooms Personnel practice and hygiene The medical condition of the personnel Which members or staff should enter the cleanroom Decisions on maximum occupancy Entry as well as exit procedures The passage in and out of a cleanroom ….
+ CLEANROOM CLOTHING PERFORMANCE
Garments should not contaminate the environment, shed low number of particles.
Helmke Drum Test – IEST-RP-CC003.4 • The garment under test is tumbled in a rotating drum to release particles from the
surface of the cleanroom garment in a controlled manner. An automatic particle counter is used to sample the air within the drum to determine the average particle concentration of the air during the initial ten minutes of the test
BodyBox Test - IEST-RP-CC003.4 • A Body Box simulates particle release of the person under real wear conditions. The
test person performs a series of defined movements ranging from still to walking, knee bands and arm movements in a cleanroom test cabin.
• Particle counters determine the quantity of particles generated by the wearer/garment that are emitted into the chamber. There are no limit values available for the absolute values.
• Due to the high variation in particle generation between individuals, one can only compare relative performance of garment systems if the test person and the test parameters are identical. A performance classification doesn’t exist.
PARTICLE EMISION
13
.
PROTECTING THE ENVIRONMENT FROM HUMAN CONTAMINATION
Garment fabric should act as a filter and keep the contamination inside the garment.
PARTICLE BARRIER EFFICIENCY TEST
Simulates filtration of cleanroom clothing fabric
Barrier against airborne Particles
VDI 3926
Crude gas
Air is pulled through the test fabric
“Transmitting Factor” is defined for every
measured particle size:
(Particle concentration of clean gas/particle
concentration of crude gas) x 100%
BACTERIAL FILTRATION EFFICIENCY
It is Important to make sure no bacteria from the wearer contaminates the cleanroom.
Bacterial Filtration Efficiency – ASTM F2101 measures the ability of the fabric to filter out bacteria (staphylococcus aureus) from a standard aerosol challenge.
9/5/2017 17
PROTECTING THE OPERATOR from on the job hazards like
chemical risks.
It is mandatory to equip the employees with the appropriate PPE whenever there is
potential risk of contamination.
CHEMICAL PROTECTION
In order to provide appropriate protection against a specific chemical, performance properties of the fabric such as PERMEATION DATA need to be consulted. Knowing the toxicity and consequences of short- or long-term exposure to a hazard is essential.
Permeation is the process by which a
chemical, in the form of a liquid, vapour or
gas, moves through protective clothing
material on a molecular level.
PERMEATION DATA
A permeation rate indicates
the mass of the chemical in
micrograms (μg), which can be
transferred through one square
centimetre (cm2) of the fabric in
one minute (min).
Some suppliers like DuPont offer
online tools to check permeation
data for a specific fabric e.g.
www.safespec.dupont.co.uk
Permeation data against cytostatic drugs
CORRECT PROTECTIVE SOLUTIONS SHOULD BE SELECTED AS A RESULT OF A RISK ASSESSMENT
specific for individual end-user and cleanroom application, to protect the products/processes and the operators.
C O M M O N P R O T E C T I V E FA B R I C S AVA I L A B L E O N T H E M A R K E T
S I N G L E - U S E S O L U T I O N S • Microporous film (MPF)
• Spunbound/meltblown/spunbound(SMS)
• Tyvek®
R E U S A B L E S O L U T I O N S • Textile e.g. Polyester garments
SMS MPF Tyvek®
AFTER 10 CYCLES OF ABRASION
AFTER 10 CYCLES OF ABRASION
AFTER 10 CYCLES OF ABRASION
S I N G L E - U S E S O L U T I O N S
Abrasion resistance (EN 530 Method 2) Abrasion is the physical destruction of fibers, yarns, fabrics resulting from the rubbing of thetextile surface over an abrasive glass paper. It ultimately affects the appearance of the fabric and results in the loss of performance properties after a number of cycles.
BARRIER TO LIQUID BARRIER TO SOLID PARTICULATES COMFORT
Great performance
Medium performance
Limited performance
* 10 cycles of abrasion - simulating 1-day use
5 1
Tyvek®
MPF
SMS
Before abrasion
Permeation test EN ISO 6529 Method A
Hydrostatic Head EN ISO 6529 Method A
INSIDE (protecting people) The suit inward leakage test EN ISO 13982-(1&2)
OUTSIDE (protecting the processes) Dry linting propensity BS 6909
Water vapour Resistance Ret
Before abrasion
After abrasion*
After abrasion*
Protective suits may look the same, but only from a distance.
Independent testing according to normative requirements shows that the Tyvek® material offers superior protection in terms of permeation, comfort and durability when compared with Microporous Film and SMS.
To re-use or not to re-use? That is the question...
OVER THE ENTIRE LIFE CYCLE.
DETAILS OF DUPONT STUDY ON REUSABLE GARMENTS
RELEVANT FINDINGS – POLYMER CHANGES
0
5000
10000
15000
20000
25000
Molecular weight data – PET polymers (Garment A+B combined)
Cycle 0 Cycle 15 Cycle 20 Cycle 30
After exposure to gamma radiation, chain
scission was the primary mechanism of
degradation in garment PET polymers.
With increased gamma exposure and
laundering, the amount and variability of
particle generation increased.
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
Garment A Garment B
Cycle 20 Cycle 30
Body Box Test – Particle Shedding for all activities; particles ≥0.5 mm, in particles/minute.
RELEVANT FINDINGS – PARTICLE SHEDDING
Increased gamma radiation and laundering
exposure reduces tear strength.
0
1
2
3
4
5
6
7
8
9
Garment A Garment B
Cycle 0 Cycle 15 Cycle 20 Cycle 25 Cycle 30
MD Trapezoidal Tear strength
RELEVANT FINDINGS – TEAR STRENGTH
BOTTOM LINE
EVIDENCE OF DAMAGE IS OFTEN INVISIBLE TO THE NAKED EYE Cleanroom operators should have their “eyes open” when
making decisions about their garment systems.
OTHER ASPECTS OF SELECTING THE RIGHT SOLUTION FOR CLEANROOM USE
Documentation Packaging Donning-doffing procedures
PRODUCT DOCUMENTATION EXAMPLE OF A DOCUMENTATION SET NEEDED FOR GARMENT QALIFICATION AND VALIDATION
• CE Certificate
• CE Declaration of Conformity
• Instructions for use
• Certificate of sterility - sterilization
process must be validated as per
ANSI/AAMI/ISO 11137-1 to provide a
Sterility Assurance Level of 10-6
• Certificate of compliance
• Certificate of irradiation
• ISO 9001 Certificate
• ISO 14001 Certificate
• Etc.
PACKAGING Double bagging with validated, cleanroom bags is a key element for contamination risk reduction when transferring apparel into clean areas. The validated dual barrier packaging system serves both as an additional sterility risk management component.
Example of dual barrier validated packaging system Tyvek® IsoClean ® garment model 183 B option DS.
The garment is individually packed in a dual barrier validated packaging system, consisting of an inner and outer easy
tear, validated, cleanroom bag. The box quantities are packed in a cardboard box with two polyethylene liners.
GOWNING PROCEDURES
Operators must know how to properly gown
the coverall in order to minimize the
contamination risk and not transfer
contamination into clean areas.
The suppliers should be able to provide an
easy to follow documented guidance that could
serve as training for operators e.g. video
instruction when entering specific grades of
cleanrooms.
Thank you !
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