Garments & Clean areas
ViéNnI
Working in AREAS OF PEOPLE & PROCESSES
Initiatives as Opportunities in Partnership with
VIENNI TRAINING & CONSULTING LLP
ViéNnI
Gap
Identification
Audit of Unit Gap Analysis
Operations & Closure
IMPLEMENTATION
Implementation
Process of Action Points
review for
Training
compliance activities
The results of the successful Implementation Initiative
Gain in average
performance
Original average New average
performance Performance
Number or
Percentage of
People
Poorest PERFORMANCE LEVEL Best
performance performance
Our Belief…
“Excellence is doing
ordinary things
extraordinarily well”
- John .W. Gardner
So, What are
Clean Areas?
Let us see……
ViéNnI
What is a Clean area?
A clean environment designed to reduce the
contamination of processes and materials.
This is accomplished by removing or reducing
contamination sources.
Purpose of Clean Protocol
• Promote Successful Cleanroom Operations
• Ensure Safety in the Clean Environment
• Provide Operational Conditions that Meet
Process & User Needs
Perspective
• The protocol provides basic awareness and general
guidelines for clean area users.
• Successful clean area operation relies on each user’s
understanding, participation and self discipline.
• The success of each user relies on trust, understanding
and shared responsibility among all users & vendors .
Historical Perspective
Why Clean areas?
◦ First in hospitals to prevent disease transmission and infection in
operating rooms (over 100 years ago!)
◦ Valuable tool to prevent particulate and bio contamination
◦ Well known use
◦ Semiconductor industry, Pharmaceuticals, Flat panel displays, Space program,
Photonics, Life sciences, industrial (painting, assembly), etc.
◦ Clean area itself is only part of the solution
Types of Contamination
• Particulate—encompasses most
contamination
• Chemical—films, vapors, etc.
• Biological—bacteria, viruses, etc.; for our
purposes, treat as particles
• Similar concerns for rooms & equipment as for
substrates
Sizes
mikro nano
Fiskeegg Cellekjerner Virus Fettsyrer
1m 1 mm 1 m 1 nm
Makroverden Hår Bakterier Insulin Atomer
Methods to Achieve Cleanliness
• Positive Pressure / Airflow
• Keeps contamination out of the work area
• Depends on clean air input
• Filtration
• Development of effective filtration revolutionized industry
• HEPA (High Efficiency Particulate Air) and ULPA (Ultra Low Particulate Air)
Filters
• Materials Selection
• Gowning & User Protocols
• Cleaning
• All are very important!
GARMENTS…….
Regulatory perspective
ViéNnI
Regulatory Guidelines in US/EU for environmental
monitoring of Clean Environments
Reference Document Details
21 CFR.211.42 Design and Construction features
21 CFR.211.46 Ventilation, Air Filtration, Air Heating and Cooling
21 CFR.211.113 Control of Microbiological Contamination
21 CFR.211.22 Responsibilities of Quality Control Unit
ASAP Guidance- Sep FDA Guideline of Sterile Products Produced by Aseptic Processing
2004
EU Guide to Good Annex 1 on the manufacture of Sterile Medicinal Products
Manufacturing Practice-
USP Chapter 1116 Microbiological evaluation of Clean Rooms and other controlled
environments
IEST-RP-CC027.2 Personnel Practices & Procedures in Cleanrooms and Controlled
environments
ISO-13408-1; Aseptic processing of health care products ;
ISO- 14644 Clean Rooms
USP <1116> MICROBIOLOGICAL EVALUATION OF CLEAN ROOMS
AND OTHER CONTROLLED ENVIRONMENTS
• “The environment should be sampled during
normal operations to allow for the collection
of meaningful data. Microbial sampling
should occur when materials are in the area,
processing activities are ongoing, and a full
complement of operating personnel is on
site.”
ISO 13408-1; Aseptic processing of health care products —
• 9 Gowning Part 1:General requirements
• 9.1 Gowning training
• 9.1.1 Employees shall be trained in appropriate gowning
procedures to minimize the introduction of contamination into the
APA.
• 9.1.2 Effectiveness of training for gowning procedures shall be
verified using microbiological methods.
• NOTE : Total particle methods may also be used to show
effectiveness of gowning.
• 9.1.3 Results of verification of gowning training shall be
communicated to employees.
• 9.2 Gowning requirements
• 9.2.1 Personnel shall wear dedicated factory clothing, including
shoes, prior to entering the gowning area.
ISO 13408-1; Aseptic processing of health care products — Part 1:General requirements
• 9.2.2 Personnel in support areas shall wear garments which meet the
particulate requirements specified for the area.
• NOTE A mesh hair net and beard cover, if required, are donned in the
airlock. Disposable shoe covers may be used in addition to dedicated
shoes.
• 9.2.3 Personnel entering the APA shall wear garments that are processed
to render them free from viable microorganisms and that minimize particle
generation.
• NOTE 1 Sterile, flexible goggles are often worn over the hood to cover the
eyes and eyebrows. Care must be taken to assure that, at the areas where
clothing meet areas such as the lower leg, wrist and neck, no gaps or
exposed skin are apparent.
• Some cleanroom operations use arm covers, extra-high boots and double
gloves to minimize the likelihood of gaps or tears occurring during
movement.
• NOTE 2 After a garment has been tested for microbial contamination (see
4.4), it should not be worn in the APA until cleaned.
ISO 13408-1; Aseptic processing of health care products —
Part 1:General requirements
• 9.3 Control of gowned personnel
• 9.3.1 Written procedures shall be implemented to assure that personnel
do not compromise the aseptic processing environment.
• 9.3.2 Gloves and gowns shall be checked regularly for proper fit and
integrity.
• 9.3.3 Operators working in support areas outside the APA shall not have
access to the APA without undergoing appropriate training and gowning
procedures (see 4.2).
• NOTE Personnel conducting filling operations should not routinely be
exchanged during a shift with employees performing other functions
within the APA.
EC GUIDE TO GOOD MANUFACTURING PRACTICE
ANNEXURE 1
Grade D: Hair and, where relevant, beard
should be covered. A general
protective suit and appropriate
shoes or overshoes should be worn.
Appropriate measures should be
taken to avoid any contamination
coming from outside the clean
EC GUIDE TO GOOD MANUFACTURING PRACTICE
ANNEXURE 1
Grade C: Hair and where relevant beard and
moustache should be covered. A
single or two-piece trouser suit,
gathered at the wrists and with high
neck and appropriate shoes or
overshoes should be worn. They
should shed virtually no fibres or
particulate matter
EC GUIDE TO GOOD MANUFACTURING PRACTICE
ANNEXURE 1
Grade A/B: Headgear should totally enclose hair and,
where relevant, beard and moustache; it
should be tucked into the neck of the suit; a face mask
should be worn to prevent the shedding of droplets.
• Appropriate sterilised, non-powdered rubber or plastic
gloves and sterilised or disinfected footwear should be
worn. Trouser-legs should be tucked inside the
footwear and garment sleeves into the gloves.
• The protective clothing should shed virtually no fibres
or particulate matter and retain particles shed by the
body.
EC GUIDE TO GOOD MANUFACTURING PRACTICE
ANNEXURE 1
20. Outdoor clothing should not be brought into
changing rooms leading to grade B and C
rooms.
• For every worker in a grade A/B area, clean
sterile (sterilised or adequately sanitised)
protective garments should be provided at
each work session.
• Gloves should be regularly disinfected during
operations.
• Masks and gloves should be changed at least
for every working session.
Clean Room Garments
• URS
• Qualification
• Storage
• Usage Cycle
• Launderability
• Retiring
Activity and Contamination
(from Ramstorp)
Clean Room Garments – Design URS
• A minimum of seams. The seams must firmly
envelop the edge of the material.
• Be loose fitting to eliminate abrasion
• Absence of pockets, belts, and pleated or
tucked areas.
• Tight fabric weave to minimize the passage of
dust.
• Fabric must reduce static electricity generation
and still remain non-linting.
• Garments should cover as much of the person
as possible, especially around the neck area.
Clean Room Garments - Qualification
• Filtration efficiency – % for 0.1μm
• Lint control – No. Of particles generated
• Worker comfort – MVTR gm/m2/day
• Electrostatic discharge control - Static decay
time
• Launderabilty – No. Of cycles, washing
instructions
• Durability and repairs – impact on filtration
efficiency, Lint control, MVTR
Filtration Efficiency
• Fabric is cut into pre-determined size.
• Fabric is stretched into a drum, with controlled
environment, using HEPA filters.
• One side of the drum is fitted with a particle
generator of specific size.
• Other side of the drum is fitted with a probe
(ABPC) to detect particles which may pass
through the fabric.
• Background particles are tare to remove their
impact on analysis.
Lint Control Test
• Helmke Drum Tumble test.
• A garment is placed in a rotating stainless steel
drum supplied with HEPA-filtered air.
• An automatic particle counter samples the air
for particles of specific sizes generated by the
tumbling action.
Worker Comfort
• The comfort level of a garment depends on its thermal insulation
and the rate at which it allows passage of moisture vapour.
• One way to test comfort is to measure moisture vapour
transmission rates, or MVTRs.
• MVTR is a measurement of how much water vapour passes through
a clean room garment fabric in a 24-hour period.
• The test requires to expose one face of each fabric to carefully
controlled humidity and temperature conditions. The opposite face
of each fabric was placed in contact with a drying agent, which was
weighed before and after the test to determine moisture vapour
transfer rate through the fabric to the agent.
Electrostatic Discharge Control
• Static decay time is a measurement of the
time it takes for a static charge on a material
to decay to a certain level following
grounding.
• Test results indicate the material's
compatibility in an Electrostatic Discharge-
sensitive environment.
• Acceptable Results of Federal Standard 101B
Method 4046 are <0.01 seconds.
Launderability, Durability and Repairs
• Regular review of Tear & Punctures.
• Tears and punctures are repaired to original
effectiveness with a hot iron and GORE-SEAM® tape
patches.
• After tear and/ or puncture perform Filtration
efficiency, Lint control, MVTR & ESD tests again.
• Check from vendor number of Laundry cycles garment
is qualified.
IEST – RP – CC003: Garment System Considerations for Clean rooms and Other Controlled Environments.
Cleanroom Garment Storage
• Provision for hanging garment storage under HEPA or
ULPA filters.
• Panels directly beneath the garments should be non-
perforated.
• Panels in front of and behind the hanging garments,
should be perforated.
• This arrangement forces the clean air to form a zone of
protection around hanging garments.
• Hanged garments should be spaced at-least 1.5 in
(37.5mm), center to center.
IEST-RP-CC027.2, Personnel Practices and Procedures in Clean rooms and Controlled Environments.
Retiring/Tracking of Garments
• There should be a method for determining
traceability of all garments, repairs, size changes, re-
work.
• Current technologies like bar code or RFID (Radio
Frequency identification) chip.
• Tracking reports should point life-cycle of garment.
History of repairs, inventory, usage, re-qualification.
• Packing & Labeling should be done as per IEST-STD-
CC1246. ESD bags are not recommended, due to high
metallic content.
Design consideration – Gloves URS
• Curved fingers and
contoured palm.
• Anti-slip finish in palm
and fingers area.
• Smooth chlorinated
internal surface.
• Does not contain any
powder, silicone or
paraffin wax.
Qualification tests
• Fibres: Sanitized Goggles are placed, in a
shaker water bath for 10 minutes. The purified
water in the shaker is filtered on a membrane
for any fibers.
• Particle Generation: Goggles are placed in a
tumbling drum (containing ULPA or HEPA air
filters) for 10 minutes and, the particles
generated are counted (tare background
particles).
Clean Room Hygiene, Gowning & Doffing
Cleanroom Gowning Sequence
• Shoe covers
• Cap
• Hood
• Face mask
• Coveralls
• Boots
• Safety glasses
• Gloves
De-gowning (Doffing)
• “During the doffing procedure, improper
garment handling can cause at least as much
contamination as the initial gowning.”
IEST-RP-CC027.2, Personnel Practices and Procedures in Clean rooms and Controlled Environments
• Clean room garments should be regularly
inspected for and damage.
• Damaged garment should be placed in a
separate bin, where it can be collected and
repaired.
• Emergency exit!!!!
Auditing of clean room gowning
• Indicators:
• No. of garments used, per day per week per month
• Usage of consumables, caps, shoe cover etc. per
day per week per month.
• Inspection of wear & Tear of garment, per day per
week per month.
• Frequency of no. of personnel observed per day per
week per month
• Frequency of fixing or adjusting masks, snaps,
zippers, goggles etc. per day.
• Visible contamination on tack mat sheets, per day.
INCORRECT
1 2
3 4
SUMMARY
What is a Cleanroom?
A clean environment designed to reduce the
contamination of processes and materials.
This is accomplished by removing or reducing
contamination sources.
Purpose of Clean Protocol
• Promote Successful Cleanroom Operations
• Ensure Safety in the Clean Environment
• Provide Operational Conditions that Meet
Process & User Needs
Where Companies Have Difficulty with garments
At customer spaces
Effectivenes
Implement s Check
Review
Verify
Analyz
e
In-house
Closing
“It is not enough to do your best; you must know what to
do, and THEN do your best.”
W. Edwards Deming
Thank You
Question time!
ViéNnI
