Transcript Document

BioNetwork Bioprocessing Center
1800G North Greene Street
Technology Enterprise Center (TEC)
Greenville, NC 27834
252.757.3759
252.757.3745 fax
www.bionetwork.org
Staff:
•William T. (Bill) Cooper, Manager
[email protected]
•Greg Smith, PhD, Curriculum Coordinator
[email protected]
•Vallere Shelton, Administrative Assistant
[email protected]
What is the Bioprocessing Center?
Pitt Community College has established a
Bioprocessing Center in conjunction with the
statewide BioNetwork initiative. It is one of six
specialized biotechnology centers developed by the
North Carolina Community College System. This
Center is a resource center created to promote
biotechnology workforce development. The ultimate
goal is to facilitate the growth of biotechnology firms
in North Carolina and the surrounding region. Start-up
funding for these centers was provided by Golden
LEAF.
Why Biotechnology?
•Biotechnology is the fastest growing sector
of the economy in the State of North
Carolina, a state where traditional jobs, such
as textiles and tobacco, are by and large
extinct.
•Biotechnology provides products made
from living cells that are useful to all of us.
•Biotechnology is the wave of the future as
scientific and technological discoveries are
made daily.
•Biotechnology jobs pay well.
Ranking of U.S. States in the
Number of Biotechnology Jobs
Rank
1
2
3
4
State
California
Massechusetts
North Carolina
Maryland
State Impact:
State Impact:
Growth in Protein Technology:
30000
Illustration of the Growth in Biotechnology using the
Growth in the Number of Structures Deposited and
Available in the Protein Data Bank
20000
15000
Protein Structures Deposited
Protein Structures Available
10000
5000
2003
2004
2001
2002
1999
2000
1997
1998
1995
1996
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1988
Year
1989
1986
1987
1984
1985
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0
1973
Number of Protein Structuress
25000
How does Industrial Systems fit in?
Because the nature of products created through
biotechnology is so valuable to industrial interests,
down-time can cost companies millions of dollars in
lost profits. Machinery that keeps this industry
running needs to be serviced, calibrated, maintained,
and cleaned on a regular, expeditious basis.
Technicians trained in the culture of biotechnology are
more valuable to a company than those that are not.
They understand the needs of the industry and have
the specialized training to keep the down-time to a
minimum. Additionally, they have the expertise to be
able to service the equipment without causing undue
contamination to the product and the
environment.
What is Contamination?
•The introduction of an unwanted substance
to a particular process or environment, either
intentionally or accidentally; that which has
been introduced to a controlled environment.
•Types of contaminants:
•Water
•Soil
•Air
•Radiological
What is Contamination?
Sources of contamination:
•Water (Pseudomonas Aeruginosa)
•Soil (Bacillus Subtilis)
•Air (any aerosolized form of
contamination)
•Radiological (any unwanted
electromagnetic radiation)
What is Contamination?
Prevention of contamination:
•Water (filtration or irradiation)
•Soil (sanitization and/or disinfection)
•Air (high efficiency particulate air filtersultrafiltration)
•Radiological (shielding or non-use)
What is Contamination?
Particles are measured in microns. If you
were to slice a 1-inch cube into 25,400 equal
size pieces, each slice would be 1 micron
thick (so thin that you could not see it).
Since cleanroom facilities contain invisible
particles that can cause defects, we need to
have a way to determine their sizes and
possible sources.
What is Contamination?
These particles cannot be seen with the
naked eye and yet may cause serious loss to
our client and to their ability to manufacture
devices without defects.
We measure the amount of particles in the air
with a device known as a particle counter.
This helps us to determine when to perform
or restrict certain activities.
What is Contamination?
To combat the tremendous amount of
particulate released by the human body,
cleanroom personnel are asked to wear
special garments that are restrictive and may
be uncomfortable if the working conditions
(temperature, humidity) are not carefully
controlled.
What is Contamination?
Typical Pollutant Sizes That Cause Down Time
Smoke
.01 to 1.0 Microns
Bacteria
.25 to 10 Microns
Human Skin Flakes
0.4 to 10 Microns
Household Dust
0.5 to 100 Microns
Mold
2.0 to 20 Microns
Human Hair
70 to 100 Microns
Pollen
5 to 100 Microns
What is Contamination?
People are dressed in booties, gloves,
helmets, hoods and special facemasks that
are not part of a normal experience. You are
also asked to move slowly, to clean up dirt
you cannot see, and to follow practices and
procedures that may not immediately make
sense.
The approach to cleanrooms is designed in
steps so as to ensure that every effort has
been made not to introduce contaminants
into the cleanroom.
What is Contamination?
"Humans are walking, breathing, waste pits
from a microbiological perspective and there
is no indication we are going to evolve into
anything cleaner."
Human dust combined with sebum will
tenaciously adhere to and contaminate
surfaces, creating contamination problems
that are simultaneously bacterial, chemical
and particulate.
What is Contamination?
There is an additional complicating factor normal human activity. Humans breathe,
sneeze, cough, talk and move around. Body
and breath temperatures cause heat
turbulence in addition to air turbulence.
What is Contamination?
People slough off huge numbers of particles
a half micron and larger and these are
propelled around by air and body movement.
Some examples of how many 0.5 micron and
larger particles can be released by simple
movement are shown below. Vast amounts of
contamination need to be controlled in a
cleanroom environment.
What is Contamination?
Activity
0.3µm Particles Released
Seated
100,000 particles per minute
Head, arm, neck, and leg motion
500,000 particles per minute
All of the above with foot motion
1,000,000 particles per minute
Standing to sitting position
2,500,000 particles per minute
Moving 2 miles per hour
5 million particles per minute
Moving 3.5 miles per hour
7.5 million particles per minute
Moving 5 miles per hour
10 million particles per minute
What is Contamination?
Humans also release elemental chemicals that can cause
contamination:
* Spittle (saliva): potassium, chloride, phosphorus,
magnesium, and sodium
* Dandruff: calcium, chloride, carbon, and nitrogen
* Perspiration: sodium, potassium, chloride, sulfur,
aluminum, carbon, and nitrogen
* Fingerprints: sodium, potassium, chloride, and
phosphorus
Consequently, a critical component of cleanroom
management is strict adherence to protocol. Cosmetics are
prohibited because in addition to their gross particle
generation, cosmetics release iron, aluminum, silicone,
carbon, titanium, magnesium, potassium, sulfur, and
calcium.
What is Contamination Control?
Just as humans are the greatest potential
contamination risk, they are also the greatest
resource for contamination control. A
thorough, comprehensive training program
detailing all aspects of cleanroom
management will empower the cleanroom
operators to control the degree of
contamination during the production
process.
What is Contamination Control?
Just as all operators must be thoroughly trained in
occupational skills, knowledge of the product, and all
aspects of the production process, they must also be
trained in the unique practices and behaviors required
for working in the cleanroom environment. Testing
and certification of cleanroom operators and
subsequent observation of operators after training
assures that the training has been implemented and is
effective. Training is mandatory for all personnel
(including Management), regardless of frequency of
entry or job classification.
What is Contamination Control?
Personal health and hygiene begins at home
with daily bathing or showering, shaving,
brushing of teeth and hair, and application of
silicone-free skin moisturizers to reduce skin
flakes. Make-up, hair gels, hair sprays,
aromatic after-shave lotions or body lotions
are not cleanroom-compatible. While at work,
all employees must wash hands after eating
and/or using the toilet. Cleanroomcompatible hand cream may be applied prior
to gowning.
What is Contamination Control?
As mentioned earlier, any activity by the
cleanroom operator generates millions of
viable and non-viable particles.
Consequently, it is imperative to limit talking
and actions in the cleanroom to only those
required for the manufacture of the product.
Running, horseplay, and other nonprofessional activities are not permitted.
What is Contamination Control?
Other behavioral requirements include, but
are not limited to, the following:
•Smoking is not allowed inside the
manufacturing facility including all
cleanroom areas. Smokers release particles
for at least one-half hour after smoking one
cigarette.
What is Contamination Control?
Nothing is allowed inside the cleanroom
complex which is not required in the
cleanroom manufacturing process. This
includes personal items such as jewelry or
keys, cosmetics, tobacco or matches in any
form, and food or drink in any form.
Hair may not be combed in the cleanroom
gowning area.
What is Contamination Control?
•Only cleanroom compatible ball-point pens
are allowed inside the cleanroom for
recording data on cleanroom compatible
paper and clipboards.
•While working in the cleanroom,
mannerisms such as scratching or handrubbing. Cleanroom personnel may not
access the inside of the cleanroom uniform.
What is Contamination Control?
The use of facial tissues is prohibited in the
cleanroom. If one must use a cleanroom
compatible non-linting tissue, it must be
used only in the gowning area and disposed
appropriately in waste receptacle.
All doors must remain closed when not
entering or exiting. Emergency doors may be
alarmed with a visual and audible alarm to
enforce compliance.
What is Contamination Control?
An integral piece of the cleanroom
management program is cleaning of the
cleanroom. It is important for all personnel
who may work in a cleanroom to understand
the critical aspects of maintaining this clean
environment.
What is Contamination Control?
Below is a partial list of some of the
commonly known contaminants that can
cause problems in some cleanroom
environments. It has been found that many of
these contaminants are generated from five
basic sources. The facilities, people, tools,
fluids and the product being manufactured
can all contribute to contamination.
What is Contamination Control?
•Facilities
•Walls, floors and ceilings
•Paint, caulk and coatings
•Construction material (sheet rock, wood,
saw dust etc.)
•Air conditioning debris
•Room air and vapors
•Spills and leaks
•Rust
What is Contamination Control?
•People
•Skin flakes and oil
•Perspiration
•Cosmetics and perfume
•Spit or saliva
•Coughing or sneezing
•Clothing debris (lint, fibers etc.)
•Hair
•Gum, Cough Drops
•Food or drink
What is Contamination Control?
•Tool Generated
•Friction and wear particles
•Lubricants and emissions
•Vibrations
•Brooms, mops and dusters
•Paper
•Cardboard
•Duct tape
•Permanent Markers
•Non-clean room pens
What is Contamination Control?
•Fluids
•Particulates floating in air
•Bacteria, organics and moisture
•Floor finishes or coatings
•Thinners or solvents
•Cleaning chemicals
•Plasticizers (outgases)
•Deionized water
What is Contamination Control?
•Product generated
•Silicon chips
•Quartz flakes
•Cleanroom debris
•Aluminum particles
•Packing material
•Aerosols and smoke
Monitoring Contamination?
Airborne Particulate Cleanliness Classes (by cubic meter)
CLASS
Number of Particles per Cubic Meter by Micrometer Size
0.1 um
0.2 um
0.3 um
0.5 um
ISO 1
10
2
ISO 2
100
ISO 3
1 um
5 um
24
10
4
1,000
237
102
35
8
ISO 4
10,000
2,370
1,020
352
83
ISO 5
100,000
23,700
10,200
3,520
832
29
ISO 6
1,000,000
237,000
102,000
35,200
8,320
293
ISO 7
352,000
83,200
2,930
ISO 8
3,520,000
832,000
29,300
ISO 9
35,200,000
8,320,000
293,000
Monitoring Contamination?
Air Monitoring
Class
Areas
Colony forming
units per volume
Frequency
Class 100 and
Class 1000
Critical processing
areas for product
and containerclosures
<0.1 cfu per ft3
of air or 3 cfu
per m3
Each Shift
Class 10,000
Less critical
processing areas
for product and
container-closures
<0.5 cfu per ft3
of air or 20 cfu
per m3
Daily
Class 100,000
Controlled Support
Areas
2.5 cfu per ft3 of
air or 100 cfu
per m3
Twice/week
(product/compone
nt contact areas)
and once/week
(other support
areas)
Monitoring Contamination?
Surface Monitoring
Class 100 and
Class 1000
Critical processing
areas for product
and containerclosures
3 per 2 inch
square (25 - 30
square cm.)
RODAC Plate
Each Shift
Class 10,000
Less critical
processing areas
for product and
container-closures
-5 per 2 inch
square (25-30
square cm.)
RODAC Plate
-10 per 2 inch
square (25-30
square cm.)
RODAC Plate
for the floor
Daily
Class 100,000
Controlled Support
Areas
Not Applicable
Not Applicable
Monitoring Contamination?
Personnel Monitoring
Class 100 and
Class 1000
Critical processing
areas for product
and containerclosures
-3 Gloves (25 –
30 square cm.)
-5 Gloves (25 –
30 square cm.)
Each Shift
Class 10,000
Less critical
processing areas
for product and
container-closures
-10 Gloves (25 –
30 square cm.)
-20 Gloves (25 –
30 square cm.)
Daily
Class 100,000
Controlled Support
Areas
Not Applicable
Not Applicable
Safety in Controlled Environments:
Cleanroom safety is as important (if not
more) than any other facility having
laboratories. Workers in these critical
environments must be conscientious
about not only their own safety, but the
safety of the people benefiting from the
products produced in the environment.
Safety in Controlled Environments:
Everything one learns about safety in a
general safety course is applicable in
cleanrooms and the responses would
be the same. However, in cleanrooms
the product is treated with much more
respect and the way one behaves is
more critical than anywhere else.
Safety in Controlled Environments:
Exposure to chemicals and biologics
is a risk in cleanrooms just as it is in
any laboratory setting, but less likely
to occur in controlled environments
because of the likelihood of operations
ceasing when maintenance or
calibration procedures are being
performed.
Design Considerations and Operation:
The method most easily understood and
universally applied is the one suggested by
the Federal Standard 209E in which the
number of particles equal to or greater than
0.5 microns measured in a cubic foot of air
designates the class number. For example, a
class 100,000 cleanroom limits the
concentration of airborne particles equal to
or greater than 0.5 microns to 100,000
particles in a cubic foot of air.
Design Considerations and Operation:
Cleanrooms have evolved into two major
types which are differentiated by their
method of ventilation - turbulent airflow and
laminar airflow cleanrooms. The general
method of ventilation used in turbulent
airflow cleanrooms is similar to that found in
buildings such as offices, schools, malls,
manufacturing plants, auditoriums, shops,
etc. The air is supplied by an air conditioning
system through diffusers in the ceiling.
Design Considerations and Operation:
A cleanroom differs from an ordinary
ventilated room in three ways:
•increased air supply
•the use of high efficiency filters
•room pressurization
Design Considerations and Operation:
Increased air supply:
The increased air supply is an important
aspect of particle control. A typical turbulent
airflow cleanroom would have at least 10 air
changes per hour and likely have between 20
and 60. This additional air supply is mainly
provided to dilute to an acceptable
concentration the contamination produced in
the room.
Design Considerations and Operation:
High efficiency filters:
High efficiency filters are used to filter the
supply air into a cleanroom to ensure the
removal of small particles. The high
efficiency filters used in cleanrooms are
installed at the point of air discharge into the
room.
Design Considerations and Operation:
Room Pressurization:
Room pressurization is mainly provided to
ensure that untreated air does not pass from
dirtier adjacent areas into the cleanroom. The
cleanroom is positively pressurized with
respect to these dirtier areas. This is done by
extracting less air from the room than is
supplied to it.
Design Considerations and Operation:
Laminar airflow is used when low airborne
concentrations of particles or bacteria are required.
This airflow pattern is in one direction, usually
horizontal or vertical at a uniform speed of between 60
to 90 ft/min. and throughout the entire space. The air
velocity is sufficient to remove relatively large
particles before they settle onto surfaces. Any
contaminant released into the air can therefore be
immediately removed by this laminar flow of air,
whereas the turbulent airflow ventilated system relies
on mixing and dilution to remove contamination.
Design Considerations and Operation:
Because airflow is such an important aspect
of particle control, the design of a cleanroom
requires careful consideration of air motion
and airflow patterns. Depending on the
degree of cleanliness required, it is common
for air systems to deliver considerably more
air than would be needed solely to meet
temperature and humidity design.
Design Considerations and Operation:
Airborne particles can be organic or
inorganic. Most contamination control
problems concern the total contamination
within the air. Particles of different sizes
behave differently as air moves through a
room. For example, in an eight-foot high
room, a particle in the 50 micron range might
take 60 seconds to settle, while a 1 micron
particle might take 15 hours to settle.
Design Considerations and Operation:
Before any methods of contamination
control of airborne particles can be
applied, a decision must be made as to
how critical this particulate matter is to
the process or product. The quantity of
the particles of a given size that might be
present within the area must be
considered. The source of the
contamination is divided into external
sources and internal sources.
Design Considerations and Operation:
For any given space, there exists the external
influence of gross atmospheric contamination.
These sources include air pollution in general
and dust storms. External contamination is
brought in primarily through the air
conditioning system. Also, external
contamination can infiltrate through building
doors, windows and cracks. The external
contamination is controlled primarily by the
type of filtration used and space
pressurization.
Design Considerations and Operation:
People and the production process are
some of the greatest sources of internal
contamination. People in the workspace
generate particles in the form of skin
flakes, lint, cosmetics, and respiratory
emissions. Industry generates particles
from combustion processes, chemical
vapors, soldering fumes, and cleaning
agents.
Design Considerations and Operation:
Other sources of internal contamination are generated
through the activity of manufacturing equipment.
Although airflow design is critical, it alone does not
guarantee that cleanroom conditions will be met.
Construction finishes, personnel and garments,
materials and equipment, and building entrances and
exits are other sources of particulate contamination that
must also be controlled. Room construction and
material finishes are an important part of cleanroom
design. Room construction is important to provide an
enclosure that will house a process to exclude outside
contaminants and that the material finishes will not
contribute to particle generation in the space.
Design Considerations and Operation:
Walls, floors, ceiling tiles, lighting
fixtures, doors, and windows are
construction materials that must be
carefully selected to meet cleanroom
standards. People must wear garments to
minimize the release of particles into the
space.
Design Considerations and Operation:
The types of garments depend on the level of
cleanliness required by a process. Smocks,
coveralls, gloves, and head and shoe covers
are clothing accessories commonly used in
clean spaces. Materials and equipment must
be cleaned before entering the cleanroom.
Room entrances such as air locks and pass
trough’s are used to maintain pressure
differentials and reduce contaminants. Also,
air showers are used to remove contaminants
from personnel before entering the clean
space.
Design Considerations and Operation:
The ability of a filter to remove
particles from the air is reflected by its
efficiency rating. The American
Society of Heating, Refrigerating, and
Air Conditioning Engineers (ASHRAE)
have developed a standard for
measuring filter effectiveness. The
standard describes test procedures to
classify filters in terms of arrestance
and efficiency.
Design Considerations and Operation:
Arrestance is the amount of dust
removed by the filter, usually
represented as a percentage. Since
large particles make up most of the
weight in an air sample, a filter could
remove a fairly high percentage of
those particles while having no effect
on the numerous small particles in the
sample. Thus, filters with an
arrestance of 90 percent have little
application in cleanrooms.
Design Considerations and Operation:
Efficiency measures the ability of the
filter to remove the fine particles.
ASHRAE efficiencies of between 10
percent and 40 percent should remove
20 percent to 40 percent of the 1
micron particles in the air, but hardly
any of the 0.3 to 0.5-micron particles.
ASHRAE efficiencies of 80 percent to
95 percent can remove 50 percent to
70 percent of the 0.3-micron particles.
Design Considerations and Operation:
A HEPA filter, i.e., high efficiency
particulate air filter, is defined by its
particle removal efficiency and its
airflow rate. A HEPA filter is rated by
its efficiency in removing small
particles from air and has a minimum
efficiency of 99.97 percent. These high
efficiency filters are usually designed
to remove particles of 0.3 microns and
larger.
Design Considerations and Operation:
An ULPA filter, i.e., ultra low
penetration air, is a filter that has
efficiencies higher than those of a
standard HEPA filter. An ULPA filter
will have efficiency greater than 99.99
percent. These filters are constructed
and will function the same way as a
HEPA filters. They differ in that the
filter medium that is used has a higher
proportion of smaller fibers and is
hence more efficient.
Design Considerations and Operation:
Most cleanrooms require year-round cooling
as a result of the fan energy associated with
high cleanroom airflow as well as the heat
generated by the process, people, and lighting
within the facility. Temperature control is
required to provide stable conditions for
materials, instruments, and personnel comfort.
Human comfort requirements typically call for
temperatures in the range of 72F to 75F, since
workers frequently wear cleanroom garments
over street clothes.
Design Considerations and Operation:
Humidity control is necessary to
prevent corrosion, condensation on
work surfaces, eliminate static
electricity, and provide personnel
comfort. The human comfort zone is
generally in the range of 30 percent to
70 percent relative humidity.
Design Considerations and Operation:
A cleanroom facility may consist of multiple rooms
with different requirements for contamination
control. Rooms in a clean facility should be
maintained at static pressures higher than
atmospheric to prevent infiltration by wind. Positive
differential pressures should be maintained
between the rooms to ensure airflows from the
cleanest space to the least clean space. The only
exception to using a positive differential pressure is
when dealing with specific hazardous materials
where governmental agencies require the room to
be at a negative pressure. Pressure differentials
must be 0.05 in WC higher in an adjacent clean area
from the less clean area. This makes airflow critical.
Design Considerations and Operation:
Ventilation and makeup air volumes are
dictated by the amount required to maintain
indoor air quality, replace process exhaust and
for building pressurization. This provides
assurance that carbon dioxide and oxygen
remain in balance, that formaldehyde and other
vapors given off by building materials and
furniture are diluted, and that air changes occur
with sufficient frequency to minimize the
chance for high concentration of airborne
pollutants within the building. Typically,
makeup air must be 15% of all air per air
change.
Hygiene and Specialized Attire:
Cleanroom environments require people
and they also require that those people
are clean.
• Shower or bath- All employees should
shower or bath before coming to work.
This help to reduce the amount of dead
skin cells that are shed when the
employee arrives to work.
• Clean hair is important for reducing
flaking from the scalp
Hygiene and Specialized Attire:
• Clean shaven faces will reduce the
potential of contamination from hair that
may be exposed in some cases.
• Smoking before entering a cleanroom will
create contamination and should not be
done at least thirty minutes before
entering.
• Clothing should be newly cleaned and free
of lint. Efforts should be made to reduce
contact with animals while wearing
clothing that will be worn to work.
Hygiene and Specialized Attire:
• Hands should be clean and disinfected per
the company protocol.
• Shoes and socks must always be worn.
Never wear sandals or open-toed shoes.
Preparation to Enter a Cleanroom:
•Personal Considerations
•Hygiene
•Illness
•Clean Shaven
•Smoking
•Jewelry
•Make-up
•Material Considerations
•Material of Construction
•Minimal Amounts of Materials
Preparation to Enter a Cleanroom:
•Disinfection
•Tools and Supplies
•Dedicated Tools
•Hand Washing
•Material Transfers
•Flow (separate)
•Disinfection
•Multiple Coverings
Gowning (Supplies and Technique):
Hand Disinfectant
Safety Glasses
Alcohol
Beard Cover
Gown
Surgical Mask
Hair Net
Sterile Sleeves and
Gloves
Dedicated Cleanroom
Shoes or Boots
Hood
Goggles
Shoe Covers
Gowning (Supplies and Technique):
•Always follow protocols
•Disinfect hands prior to gowning
•Obtain gowning supplies according to protocol
•Don cleanroom attire from head to toe (literally) except
footwear
•Disinfect hands
•Aseptically don sterile gloves
•Obtain footwear
•Don while crossing over bench
•Disinfect gloves with alcohol
•View gowned self in mirror
•Obtain any other garments before entering (such as sterile
sleeves)
Cleanroom Behavior:
Hygiene- Good basic hygiene is a necessity
when working in cleanrooms. Shedding skin
cells from unclean workers is the most
common contaminant. Bacterial
contaminants can also thrive on shed skin
cells. Workers who have exudative lesions
on their bodies (open wounds with blood or
pus) must exclude themselves from
cleanroom environments or appropriately
and completely cover the sores.
Cleanroom Behavior:
Coughing or sneezing sometimes cannot be
avoided, but it is important to exclude
oneself from working in a cleanroom if the
cough or sneeze is from and illness or
allergy. When coughing or sneezing, always
turn away from the area where cleanliness is
desired most. Above all, always wear
protective masks.
Cleanroom Behavior:
Facial hair can be shed easily and should
be completely covered when working in
cleanrooms. Beard covers can be utilized
to accomplish this with beards and
mustaches. All masks and beard covers
are porous and can still allow
contaminants to pass through.
Cleanroom Behavior:
Motion- All behaviors in cleanroom environments
should be performed at a moderately slow pace. Quick
movements in the cleanroom or any sterile area stir up
the particle counts where they can be easily detected
and frequently out-of-specification. Slow, deliberate
movements are always best to avoid the turbulence
that is created that will stir up particles. Scratching
oneself through the cleanroom garments, running,
jumping, and even handshakes, are all forbidden
practices. It goes without saying that eating, drinking,
or smoking is also forbidden.
Cleanroom Behavior:
Contact- Contacting surfaces is an easy way to
transmit bacteria, viruses, yeast, and molds. If
touching any area within a cleanroom by
necessity, be sure that you evaluate what you may
have “picked-up” and transferred to another area.
For example, you may open a door knob or handle
and then touch a stopper on a vial that will in
theory contain a sterile product. A good practice is
to regularly and frequently disinfect your gloves
with sterile alcohol between processes. Even a
routine disinfection of gloves is appropriate.
Cleanroom Behavior:
Processes- Obviously, contamination can be
generated by the work we do. For technicians
Who are maintaining or repairing equipment,
Every mechanical operation performed creates
a potential for contamination. Sawing,
grinding, fastening screws, hammering,
cleaning, drilling, all are sources of
contamination. Flames used in cleanrooms,
whether being used for sterilization or not,
create turbulence which in turn stirs up
particles. Even the removal of tools to perform
This work will create high particle counts.
De-gowning:
Reverse the order of gowning and refer to
protocol for reuse or disposal of materials.
Documentation:
•Laboratory Notebooks- Any procedure or
protocol that is not part of a standard
operating procedure should be documented
in a laboratory notebook so that it can be
referenced at a later time what activities took
place and the results that were obtained.
Documentation:
•Data Collection Forms- Provided an SOP is
in place that describes the environmental
monitoring procedures employed, a data
collection form can be used. This form
should be referenced in the SOP and
designed in an orderly format that allows the
manual recording of data and activities that
occur during the monitoring procedures
Documentation:
•Electronic Data Collection and Part 11
Compliance- Any electronic data that is
obtained as part of the monitoring process
must be Part 11 complaint to ensure that data
integrity is maintained. Written
documentation should be double-checked for
accuracy and completeness. All printed
materials must be intact and maintained so
that they can be archived for future
reference. Printed data on thermal paper
must be photocopied to preserve the original
data that will fade otherwise.
Questions?
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