UNDERSTANDING DIFFERRENT ASPECTS OF PROTECTIVE GARMENT SOLUTIONS

Transcription

1 UNDERSTANDING DIFFERRENT ASPECTS OF PROTECTIVE GARMENT SOLUTIONS IN CLEANROOMS & CONTROLLED ENVIRONMENTS Nancy Baeten DuPont Protection Solutions BCW College Day - September 2017

2 MARKETS AND APPLICATIONS Pharma Medical Device Manufacturing Biotechnology 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 Other: Food processing, cosmetics

3 WHY DO WE WEAR PROTECTIVE GARMENTS IN CLEANROOMS?

4 WHAT DO YOU NEED TO PROTECT? PEOPLE AGAINST HEALTH RISKS Barrier: INSIDE to outside Barrier: OUTSIDE to inside PRODUCT AGAINST PEOPLE

5 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.

6 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

7 Goggles

8 PROTECTING THE PRODUCT and process from contamination e.g. microorganisms

9 PEOPLE REMAIN THE BIGGEST CONTAMINATION RISK IN A CLEANROOM ENVIRONMENT

10 CONTAMINATION SOURCES People 75% Ventilation 15% Room Structure 5% Equipment 5% Source:

11 PEOPLE: SOURCE OF CONTAMIATION Contamination risk: particle creation by people movement Type of movement Particle / min. (> 0.5 m) Sitting without moving Moving hands, arms, head Active hand/arm movement, Fast turning of the head Standing up from a sitting position or vice versa Rapid movement, climbing stairs, etc Source: Clean Room Primer, 1985, J. J. Nappi Jr. Liberty Industries Inc. USA

12 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

13 PARTICLE EMISION 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. 13

14 PROTECTING THE ENVIRONMENT FROM HUMAN CONTAMINATION Garment fabric should act as a filter and keep the contamination inside the garment.

15 PARTICLE BARRIER EFFICIENCY TEST Simulates filtration of cleanroom clothing fabric Crude gas Barrier against airborne Particles VDI 3926 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%

16 BACTERIAL FILTRATION EFFICIENCY Bacterial Filtration Efficiency ASTM F2101 measures the ability of the fabric to filter out bacteria (staphylococcus aureus) from a standard aerosol challenge. It is Important to make sure no bacteria from the wearer contaminates the cleanroom.

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. 9/5/

18 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 longterm 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.

19 PERMEATION DATA Permeation data against cytostatic drugs 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.

20 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.

21 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 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

22 S I N G L E - U S E S O L U T I O N S SMS MPF Tyvek AFTER 10 CYCLES OF ABRASION AFTER 10 CYCLES OF ABRASION AFTER 10 CYCLES OF ABRASION 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.

23 BARRIER TO LIQUID BARRIER TO SOLID PARTICULATES COMFORT Permeation test EN ISO 6529 Method A Hydrostatic Head EN ISO 6529 Method A INSIDE (protecting people) The suit inward leakage test EN ISO (1&2) OUTSIDE (protecting the processes) Dry linting propensity BS 6909 Water vapour Resistance Ret Before abrasion After abrasion* Before abrasion After abrasion* Tyvek 5 MPF SMS 1 * 10 cycles of abrasion - simulating 1-day use Great performance Medium performance Limited performance 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.

24 To re-use or not to re-use? That is the question...

25 OVER THE ENTIRE LIFE CYCLE.

26 DETAILS OF DUPONT STUDY ON REUSABLE GARMENTS

27 RELEVANT FINDINGS POLYMER CHANGES 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.

28 RELEVANT FINDINGS PARTICLE SHEDDING Body Box Test Particle Shedding for all activities; particles 0.5 mm, in particles/minute. 0 Garment A Garment B Cycle 20 Cycle 30 With increased gamma exposure and laundering, the amount and variability of particle generation increased.

29 RELEVANT FINDINGS TEAR STRENGTH 9 MD Trapezoidal Tear strength Garment A Garment B Cycle 0 Cycle 15 Cycle 20 Cycle 25 Cycle 30 Increased gamma radiation and laundering exposure reduces tear strength.

30 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.

31 OTHER ASPECTS OF SELECTING THE RIGHT SOLUTION FOR CLEANROOM USE Documentation Packaging Donning-doffing procedures

32 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 to provide a Sterility Assurance Level of 10-6 Certificate of compliance Certificate of irradiation ISO 9001 Certificate ISO Certificate Etc.

33 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.

34 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.

35 Thank you!

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