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

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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.

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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 !