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PRESENTATION ON CLEAN ROOM AND ITS PROTOCOLS
11/21/2008
KIRAN DESAI
1
CLEAN ROOM QUERRIES…………?
WHAT IS CLEAN ROOM? WHO ARE THE S OF CLEAN ROOM? WHY CLEAN ROOMS ARE REQUIRED IN THE PHARMACEUTICAL INDUSTRIES? WHAT IS THE DESIGN OF CLEAN ROOM HOW THE CLEAN ROOMS ARE MAINTAINED?
11/21/2008
KIRAN DESAI
2
CLEAN ROOM WHAT ARE THE PROTOCOLS TO ENTER IN TO CLEAN ROOM? HOW THE CLEAN ROOMS ARE MAINTAINED? WHAT QUALITY OF AIR TO BE USED IN CLEAN ROOM? WHAT QUALITY OF WATER TO BE USED IN CLEAN ROOM?
11/21/2008
KIRAN DESAI
3
CLEAN ROOM WHAT IS CLEAN ROOM
DEFINITION: • Federal Standard 209 Defines a Clean Room A Clean Room is an enclosed area employing control over the particulate matter in air with temperature, humidity and pressure control as required. To meet the requirements of a 'Clean Room' as defined by this standard, all Clean Rooms must not exceed a particulate count as specified in the air cleanliness class." This standard, first issued in 1963, has been used in the current version 209B amendment 1 since 1976. It is shortly to be re-issued, entitled "Airborne Particulate Cleanliness Classes for Clean Rooms and Clean Zones".
11/21/2008
KIRAN DESAI
4
CLEAN ROOM WHAT IS CLEAN ROOM
DEFINITION: BS 5295 Definition "A Clean Room is a room with environmental control of particulate contamination, temperature and humidity, constructed and used in such a way as to minimize the introduction, generation and retention of particles inside the room."
11/21/2008
KIRAN DESAI
5
APPLICATIONS
Industry
Applications
ELECTRONICS
Computers, TV-tubes, Magnetic Tapes
SEMICONDUCTORS
Integrated Circuits
MICROMECHANICS
Compact Disc Players, Miniature Bearings, Gyroscopes
OPTICS
Lenses, Photographic Film, Laser Equipment
BIOTECHNOLOGY
Antibiotics, Generic Engineering
PHARMACY
Sterile Pharmaceuticals, Sterile Disposable
MEDICAL DEVICES
Heart Valves, Cardiac by- Systems
FOOD AND DRINK
Brewery Production, Unsterilized Food and Drinks Immunodeficiency Therapy, Isolation of Contagious Patients, Operating Rooms
HOSPITALS
11/21/2008
KIRAN DESAI
6
CLEAN ROOM WHY CLEAN ROOMS ARE REQUIRED IN PHARMACEUTICAL INDUSTRIES ? CLEAN ROMS ARE REQUIRED TO AVOID THE SOURCE OF CONTAMINATIONS. TYPES OF CONTAMINATIONS 1. Particulate: dust, makeup, skin, hair, …
2. Chemical: oil, grease, perfume, … 3. Biological: bacteria, fungi, … 4. Radiation (ultraviolet light, …) 11/21/2008
KIRAN DESAI
7
SOURCES OF CONTAMINATIONS People (~ 75%) Ventilation (~ 15%) Room structure (~ 5%) Equipment (~ 5%)
11/21/2008
KIRAN DESAI
8
HOW TO CONTROL CONTAMINATIONS?
PERSONNEL CONTROL * DRESS CODES * Personal Hygiene * GARMENTS/GOWNING Hair cover , Hood , Shoe covers , Coverall, Gloves Face mask , Safety Glasses
11/21/2008
KIRAN DESAI
9
CONTINUED... ENVIRONMENTAL CONTROL
Access Cards
* ENTERENCE AND EXIT CONTROL---
Air shower while entering
* SUPPLY OF MATERIAL AND TOOLS CONTROL (Through Box) * ROUTINE CLEAN ROOM CLEANING AND MAINTENANCE
11/21/2008
KIRAN DESAI
10
GENERAL FEATURES OF CLEAN ROOM Protocol for clean room provides general guidance and basic awareness Successful clean room maintenance really relies on individual ’s understanding, participation and self discipline. Everyone, whether faculty member, student or staff engineer, is equally important to the success of the protocol. Trust, understanding and shared responsibility among all s ensures the success of every . 11/21/2008
KIRAN DESAI
11
PRINCIPLES OF CLEAN ROOM •Air is highly (HEPA) filtered (99.97% @ 0.3m) •Layout should minimize particle sources in filtered air stream •Air flow should remove most particles generated by process
11/21/2008
KIRAN DESAI
12
TYPES OF FILTERS HEPA
-
ULPA Filters-
HIGH EFFICIENCY PARTICULATE AIR FILTER ULTRA LOW PENETRATION AIR.
EFFECT OF EFFICIENCY: ULPA is more efficient than HEPA.
11/21/2008
HEPA
-
99.97% (To remove 0.3 micron particles)
ULPA
-
99.99% (To remove 0.1 micron particles)
KIRAN DESAI
13
HOW TO TEST THE EFFECIENCY?
DOP TEST (PENETRATION TEST) DOP
-
ADVANTAGE
-
Di-octyl-pthalate
TO DETERMINE % OF PARTICLE ING THROUGH FILTERS WHY IS THIS TEST PREFERRED? DOP PARTICLE SIZE IS 0.2 MICRON CONSISTANTLY.
11/21/2008
KIRAN DESAI
14
HOW SHOULD BE THE LAYOUT ………………..?
Production Plant Change Room
11/21/2008
KIRAN DESAI
Toilets
15
BUILDING FINISHES Not Acceptable
Acceptable
PVA Paint
Epoxy or Enamel paint
Window sills
Window view s
Exposed pipes
Smooth surfaces (Electro polished)
Horizontal pipes & services
Concealed services
Open floor drains
Hygienic drains
Floor cracks, flaking floor surfaces
Homogonous sealed floors – epoxy finish or welded vinyl
Ceiling cracks & ts
Smooth sealed ceilings
Exposed, open light fittings
Flush light fittings
Wooden furniture
11/21/2008
S/Steel mirror finished or Melamine furniture KIRAN DESAI
16
FLOOR FINISHING…………
Tiled Floor
Epoxy Floor
NOT ACCEPTABLE
11/21/2008
RECCOMMENDED
KIRAN DESAI
17
Poor Window
11/21/2008
NOT ACCEPTABLE
Good Windows
KIRAN DESAI
RECCOMMENDED
18
SERVICE DISTRIBUTION
Cleaning is easier Accessibility for cleaning is not there 11/21/2008
KIRAN DESAI
19
Where ever it is possible possible services should be located behind wall s.
Exposed services & pipes are very difficult to clean,
&
sometimes impossible to clean.
Equipment such as Film Coaters should be enclosed so that only the front face is in the GMP area. This makes cleaning much easier.
Make use of service corridors behind equipment (but must be under negative pressure)
Insulation of all the utility lines should be GI coated and enamel painted.
11/21/2008
KIRAN DESAI
20
ALWAYS ROOM SHOULD BE WITH POSITIVE PRESSURES. THE INTERNAL PARTICULATE GENERARTION TO BE CONTROLLED BY EPOXY FLOORING HARD SURFACED NON PORUS MATERIAL (PVC S) EPOXY PAINTED WALLS GLASS BOARD CEILINGS PROPER HVAC (HEATING VENTILLATION AIR CONDITIONING) PROPER DOOR CLOSURES
11/21/2008
KIRAN DESAI
21
Continued………
BOTTOM CLOSURES
COVING ON WALLS AND FLOORS TO AVOID ACCUMALATION OF DUST.
ENTRY FOR SPECIFIED PERSON WITH ACCESS CARDS
ALL THE ROOMS SHOULD HAVE FIRE ALARM SYSTEMS
CLEAN ROOM SHOULD HAVE TEMPERATURE AND HUMIDITY CONTROLLER SYSTEMS.
AIR LOCK SHOULD BE ROOMS.
11/21/2008
PROVIDED FOR ACCESSING TWO
KIRAN DESAI
22
AIR FLOW
11/21/2008
KIRAN DESAI
23
TYPES OF AIR FLOW
1. LAMINAR AIRFLOW 2. TURBULENT AIRFLOW
11/21/2008
KIRAN DESAI
24
LAMINAR AIR FLOW CLEAN ROOM
Laminar air flow is used when low airborne concentrations of particles or bacteria are required.
This air flow 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 air flow ventilated system relies on mixing and dilution to remove contamination.
11/21/2008
KIRAN DESAI
25
LAMINAR AIR FLOW CLEAN ROOM
11/21/2008
KIRAN DESAI
26
Any obstructions will cause the laminar air flow to be turned into turbulent air flow around the obstructions.
Higher contamination concentrations will be established in the turbulent areas.
Air changes per unit of time are related to the volume of the room and are many times greater than those supplied to a turbulent air flow Clean room.
11/21/2008
KIRAN DESAI
27
TURBULENT AIR FLOW
The general method of ventilation used in turbulent air flow clean rooms 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 diffs in the ceiling.
However, a clean room differs from an ordinary ventilated room in three ways. These are increased air supply, the use of high efficiency filters and room pressurization.
The increased air supply is an important aspect of particle control. A typical turbulent air flow clean room would have at least 10 air changes per hour and likely to have between 20 and 60.
11/21/2008
KIRAN DESAI
28
TURBULANT AIR FLOW CLEAN ROOM
11/21/2008
KIRAN DESAI
29
TURBULANT AIR FLOW CLEAN ROOM
This additional air supply is mainly provided to dilute to an acceptable concentration the contamination produced in the room.
High efficiency filters are used to filter the supply air into a clean room to ensure the removal of small particles. The high efficiency filters used in clean rooms are installed at the point of air discharge into the room.
Room pressurization is mainly provided to ensure that untreated air does not from dirtier adjacent areas into the clean room. The clean room is positively pressurized with respect to these dirtier areas. This is done by extracting less air from the room than is supplied to it.
11/21/2008
KIRAN DESAI
30
APPLICATIONS LAMINAR AIR FLOW
FORMULATION
STERILE PLANTS
TURBULENT AIR FLOW
11/21/2008
NON STERILE PLANTS
KIRAN DESAI
31
PARTICLE CHARACTERISTICS OF CLEAN ROOM
50 micron particles are visible
Average human hair is about 100 microns
Time to fall 1 meter in still air •
33 seconds for 10 micron particle
•
48 minutes for 1 micron particle
Humans generate >1x105 particles per minute when motionless (fully gowned)
Humans can generate >1x106 particles when walking in the clean room
11/21/2008
KIRAN DESAI
32
GUIDELINES AND DESIGN PARAMETERS OF CLEAN ROOM
FUNDAMENTAL OF CLEAN ROOM DESIGN IS TO CONTROL THE CONCENTRATION OF AIRBORNE PARTICLES. A PROPER HVAC SYSTEM IS CRITICAL PART OF CLEAN ROOM DESIGN. PARTICULATE MATTER CAN BE CONTROLLED BY HEPA FILTERS WITH MIN EFFECIENCY OF 99.97% TESTED ON 0.3 MICRON NUMBER OF AIR CHANGES PER HOUR SHOULD BE IN THE RAGE OF 10 TO 20.
11/21/2008
KIRAN DESAI
33
CLASSIFICATIONS OF CLEAN ROOM • HOW ARE CLEAN ROOMS CLASSIFIED? CLEAN ROOMS ARE CLASSIFIED BASED ON CLEANLINESS OF AIR. STANDARDS OF CLEAN ROOM • Federal Standard 209D Class Limits • Federal Standard 209E Airborne Particulate Cleanliness Classes • British Standard 5295:1989 • BR 525 Environmental Cleanliness Classes • BS EN ISO Standard
11/21/2008
KIRAN DESAI
34
Federal Standard 209D Class Limits MEASURED PARTICLE SIZE (MICROMETERS)
CLASS
11/21/2008
0.1
0.2
0.3
0.5
5
1
35
7.5
3
1
NA
10
350
75
30
10
NA
100
NA
750
300
100
NA
1,000
NA
NA
NA
1,000
7
10,000
NA
NA
NA
10,000
70
100,000
NA
NA
NA
100,000
700
KIRAN DESAI
35
Federal Standard 209E Airborne Particulate Cleanliness Classes Class Name
SI
English
M1 M 1.5
1
M2 M 2.5
10
M3 M 3.5
100
M4 M 4.5
1 000
M5 M 5.5
10 000
M6 M 6.5
100 000
M7
11/21/2008
Class Limits 0.1m m
0.2m m
0.3m m
0.5m m
5m m
Volume Units
Volume Units
Volume Units
Volume Units
Volume Units
(m^3)
(ft^3)
(m^3)
(ft^3)
(m^3)
(ft^3)
(m^3)
(ft^3)
(m^3)
(ft^3)
350
9.91
75.7
2.14
30.9
0.875
10
0.283
--
--
1 240
35
265
7.5
106
3
35.3
1
--
--
3 500
99.1
757
21.4
309
8.75
100
2.83
--
--
12 400
350
2 650
75
1 060
30
353
10
--
--
35 000
991
7 570
214
3 090
87.5
1 000
28.3
--
--
--
--
26 500
750
10 600
300
3 530
100
--
--
--
--
75 700
2 140
30 900
875
10 000
283
--
--
--
--
--
--
--
--
35 300
1 000
247
7
--
--
--
--
--
--
100 000
2 830
618
17.5
--
--
--
--
--
--
353 000
10 000
2 470
70
--
--
--
--
--
--
1 000 000
28 300
6 180
175
--
--
--
--
--
--
3 350 000
100 000
24 700
700
--
--
--
--
--
--
10 000 000
283 000
61 800
1 750
KIRAN DESAI
36
BS 5295 ENVIRONMENTAL CLEANLINESS CLASSES Maximum permitted number of particles per m^3 (equal to, or greater than, stated size)
Class of environment al cleanliness
0.3 m m
0.5 m m
5mm
10 m m
25 m m
C
100
35
0
NS
NS
D
1 000
350
0
NS
E
10 000
3 500
0
F
NS
3 500
G
100 000
H
Maximum floor area per sampling position for clean rooms (m^2)
Minimum pressure difference*
Between classified areas and unclassifie d areas (Pa)
Between classified area and adjacent areas of lower classification (Pa)
10
15
10
NS
10
15
10
NS
NS
10
15
10
0
NS
NS
25
15
10
35 000
200
0
NS
25
15
10
NS
35 000
200
0
NS
25
15
10
J
NS
350 000
2 000
450
0
25
15
10
K
NS
3 500 000
20 000
4 500
500
50
15
10
L
NS
NS
200 000
45 00
5 000
50
10
10
M NS 11/21/2008
NS
NS
50
10
NA
450 000 50 000 KIRAN DESAI
37
ISO 209 airborne particulate cleanliness classes for clean rooms and clean zones. Numbers (N)
Maximum concentration limits (particles/m^3 of air) for particles equal to and larger than the considered sizes shown below 0.1m m*
0.2m m
0.3m m
0.5m m
ISO 1
10
2
ISO 2
100
ISO 3
1m m
5.0m m
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
* m m Micro Meter 11/21/2008
KIRAN DESAI
38
GRAPHICAL REPRESENTATION OF AIRBORNE PARTICLES
11/21/2008
KIRAN DESAI
39
GENERAL CLEAN ROOM REGULATIONS Below is a list of general regulations recommended as a minimum for the successful operation of a clean room. All professional cleaning personnel should be aware and follow these regulations at all times. •
All personal items such as keys, watches, rings, matches, lighters and cigarettes should be stored in the personal locker outside the gowning room.
•
Valuable personal Items such as wallets may be permitted in the clean room provided they are NEVER removed from beneath the clean room garments.
11/21/2008
KIRAN DESAI
40
CONTINUED……… •
NO eating, smoking or gum chewing allowed inside the clean room.
•
Only garments approved for the clean room should be worn when entering.
•
NO cosmetics shall be worn in the clean rooms. This includes: rouge, lipstick, eye shadow, eyebrow pencil, mascara, eyeliner, false eye lashes, fingernail polish, hair spray, mousse, or the heavy use of aerosols, after shaves and perfumes.
•
•
Only approved clean room paper shall be allowed in the clean room.
•
Approved ball point pens shall be the only writing tool used.
11/21/2008
KIRAN DESAI
41
CONTINUED………
•
Use of paper or fabric towels are prohibited. Use of hand dryers equipped with HEPA filters are suggested.
•
Gloves or finger coats should not be allowed to touch any item or surface that has not been thoroughly cleaned.
•
Only approved gloves, finger cots (powder-free), pliers, tweezers should be used to handle product. Finger prints can be a major source of contamination on some products.
•
Solvent with the bare skin should be avoided. They can remove skin oils and increase skin flaking.
11/21/2008
KIRAN DESAI
42
CONTINUED……….
•
Approved skin lotions or lanolin based soaps are sometimes allowed. These can reduce skin flaking.
•
All tools, containers and fixtures used in the cleaning process should be cleaned to the same degree as the clean room surfaces. All of these items are a source of contamination.
•
NO tool should be allowed to rest on the surface of a bench or table. It should be place on a clean room wiper.
11/21/2008
KIRAN DESAI
43
CONTINUED………. •
Only clean room approved wipers are allowed to be used. The wipers must be approved for the Class of clean room being cleaned.
•
ALL equipment, materials and containers introduced into a sterile facility must be subjected to stringent sterilization prior to entrance.
•
NO ONE who is physically ill, especially with respiratory or stomach disorders, may enter a sterile room. This is a good practice in any clean room environment.
11/21/2008
KIRAN DESAI
44
HVAC DESAIGN CONSIDERATIONS 1. Temperature and Humidity 2. Pressurization 3. Ventilation and Make Up Air
11/21/2008
KIRAN DESAI
45
Temperature and Humidity Most clean room require year-round cooling as a result of the fan energy associated with high clean room 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 75 F, since workers frequently wear clean room garments over street clothes. 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% to 70% relative humidity 11/21/2008
KIRAN DESAI
46
Pressurization
A clean room 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 air flows 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.
11/21/2008
KIRAN DESAI
47
HOW IS AIR PRESSURE MEASURED? The pressure differential over the doorway is measured with a portable magnahelic gauge or micro manometer
11/21/2008
KIRAN DESAI
48
Ventilation and Make Up Air
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.
11/21/2008
KIRAN DESAI
49
HOUSE KEEPING Every is responsible for keeping the clean rooms clean. Always clean your workspace before leaving. Don’t leave or store items on or in equipment. Do not set liquids on any equipment. Properly store all materials before leaving the clean room Last one out should make sure the room is in a safe idle mode.
11/21/2008
KIRAN DESAI
50
CHEMICAL HANDLING IN CLEAN ROOMS
Chemical waste should be properly disposed of as outlined by EHS systems.
No chemicals may be poured down the drains
Waste containers should be properly marked as such and have a pink Hazardous Waste tag tied to them at all times.
If you have questions about disposal a staff member.
11/21/2008
KIRAN DESAI
51
VOILATION OF RULES First time
Warning
Report to Advisor
Second time
Suspension of access
Report to Advisor
Retraining may be required
Third Offense
Suspension of access
Report to Advisor
Access will not be renewed until an acceptable resolution is reached between Advisor and Clean room Manager
11/21/2008
Clean room Protocol re-training will be required. KIRAN DESAI
52
HVAC SUPPLY CLEAN ROOM DOORS
FLUSHED LIGHTING
FALSE CEILING
FLUSHED WINDOWS
EPOXY FLOORING
COVING 11/21/2008
KIRAN DESAI
53
11/21/2008
KIRAN DESAI
54
11/21/2008
KIRAN DESAI
1
CLEAN ROOM QUERRIES…………?
WHAT IS CLEAN ROOM? WHO ARE THE S OF CLEAN ROOM? WHY CLEAN ROOMS ARE REQUIRED IN THE PHARMACEUTICAL INDUSTRIES? WHAT IS THE DESIGN OF CLEAN ROOM HOW THE CLEAN ROOMS ARE MAINTAINED?
11/21/2008
KIRAN DESAI
2
CLEAN ROOM WHAT ARE THE PROTOCOLS TO ENTER IN TO CLEAN ROOM? HOW THE CLEAN ROOMS ARE MAINTAINED? WHAT QUALITY OF AIR TO BE USED IN CLEAN ROOM? WHAT QUALITY OF WATER TO BE USED IN CLEAN ROOM?
11/21/2008
KIRAN DESAI
3
CLEAN ROOM WHAT IS CLEAN ROOM
DEFINITION: • Federal Standard 209 Defines a Clean Room A Clean Room is an enclosed area employing control over the particulate matter in air with temperature, humidity and pressure control as required. To meet the requirements of a 'Clean Room' as defined by this standard, all Clean Rooms must not exceed a particulate count as specified in the air cleanliness class." This standard, first issued in 1963, has been used in the current version 209B amendment 1 since 1976. It is shortly to be re-issued, entitled "Airborne Particulate Cleanliness Classes for Clean Rooms and Clean Zones".
11/21/2008
KIRAN DESAI
4
CLEAN ROOM WHAT IS CLEAN ROOM
DEFINITION: BS 5295 Definition "A Clean Room is a room with environmental control of particulate contamination, temperature and humidity, constructed and used in such a way as to minimize the introduction, generation and retention of particles inside the room."
11/21/2008
KIRAN DESAI
5
APPLICATIONS
Industry
Applications
ELECTRONICS
Computers, TV-tubes, Magnetic Tapes
SEMICONDUCTORS
Integrated Circuits
MICROMECHANICS
Compact Disc Players, Miniature Bearings, Gyroscopes
OPTICS
Lenses, Photographic Film, Laser Equipment
BIOTECHNOLOGY
Antibiotics, Generic Engineering
PHARMACY
Sterile Pharmaceuticals, Sterile Disposable
MEDICAL DEVICES
Heart Valves, Cardiac by- Systems
FOOD AND DRINK
Brewery Production, Unsterilized Food and Drinks Immunodeficiency Therapy, Isolation of Contagious Patients, Operating Rooms
HOSPITALS
11/21/2008
KIRAN DESAI
6
CLEAN ROOM WHY CLEAN ROOMS ARE REQUIRED IN PHARMACEUTICAL INDUSTRIES ? CLEAN ROMS ARE REQUIRED TO AVOID THE SOURCE OF CONTAMINATIONS. TYPES OF CONTAMINATIONS 1. Particulate: dust, makeup, skin, hair, …
2. Chemical: oil, grease, perfume, … 3. Biological: bacteria, fungi, … 4. Radiation (ultraviolet light, …) 11/21/2008
KIRAN DESAI
7
SOURCES OF CONTAMINATIONS People (~ 75%) Ventilation (~ 15%) Room structure (~ 5%) Equipment (~ 5%)
11/21/2008
KIRAN DESAI
8
HOW TO CONTROL CONTAMINATIONS?
PERSONNEL CONTROL * DRESS CODES * Personal Hygiene * GARMENTS/GOWNING Hair cover , Hood , Shoe covers , Coverall, Gloves Face mask , Safety Glasses
11/21/2008
KIRAN DESAI
9
CONTINUED... ENVIRONMENTAL CONTROL
Access Cards
* ENTERENCE AND EXIT CONTROL---
Air shower while entering
* SUPPLY OF MATERIAL AND TOOLS CONTROL (Through Box) * ROUTINE CLEAN ROOM CLEANING AND MAINTENANCE
11/21/2008
KIRAN DESAI
10
GENERAL FEATURES OF CLEAN ROOM Protocol for clean room provides general guidance and basic awareness Successful clean room maintenance really relies on individual ’s understanding, participation and self discipline. Everyone, whether faculty member, student or staff engineer, is equally important to the success of the protocol. Trust, understanding and shared responsibility among all s ensures the success of every . 11/21/2008
KIRAN DESAI
11
PRINCIPLES OF CLEAN ROOM •Air is highly (HEPA) filtered (99.97% @ 0.3m) •Layout should minimize particle sources in filtered air stream •Air flow should remove most particles generated by process
11/21/2008
KIRAN DESAI
12
TYPES OF FILTERS HEPA
-
ULPA Filters-
HIGH EFFICIENCY PARTICULATE AIR FILTER ULTRA LOW PENETRATION AIR.
EFFECT OF EFFICIENCY: ULPA is more efficient than HEPA.
11/21/2008
HEPA
-
99.97% (To remove 0.3 micron particles)
ULPA
-
99.99% (To remove 0.1 micron particles)
KIRAN DESAI
13
HOW TO TEST THE EFFECIENCY?
DOP TEST (PENETRATION TEST) DOP
-
ADVANTAGE
-
Di-octyl-pthalate
TO DETERMINE % OF PARTICLE ING THROUGH FILTERS WHY IS THIS TEST PREFERRED? DOP PARTICLE SIZE IS 0.2 MICRON CONSISTANTLY.
11/21/2008
KIRAN DESAI
14
HOW SHOULD BE THE LAYOUT ………………..?
Production Plant Change Room
11/21/2008
KIRAN DESAI
Toilets
15
BUILDING FINISHES Not Acceptable
Acceptable
PVA Paint
Epoxy or Enamel paint
Window sills
Window view s
Exposed pipes
Smooth surfaces (Electro polished)
Horizontal pipes & services
Concealed services
Open floor drains
Hygienic drains
Floor cracks, flaking floor surfaces
Homogonous sealed floors – epoxy finish or welded vinyl
Ceiling cracks & ts
Smooth sealed ceilings
Exposed, open light fittings
Flush light fittings
Wooden furniture
11/21/2008
S/Steel mirror finished or Melamine furniture KIRAN DESAI
16
FLOOR FINISHING…………
Tiled Floor
Epoxy Floor
NOT ACCEPTABLE
11/21/2008
RECCOMMENDED
KIRAN DESAI
17
Poor Window
11/21/2008
NOT ACCEPTABLE
Good Windows
KIRAN DESAI
RECCOMMENDED
18
SERVICE DISTRIBUTION
Cleaning is easier Accessibility for cleaning is not there 11/21/2008
KIRAN DESAI
19
Where ever it is possible possible services should be located behind wall s.
Exposed services & pipes are very difficult to clean,
&
sometimes impossible to clean.
Equipment such as Film Coaters should be enclosed so that only the front face is in the GMP area. This makes cleaning much easier.
Make use of service corridors behind equipment (but must be under negative pressure)
Insulation of all the utility lines should be GI coated and enamel painted.
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ALWAYS ROOM SHOULD BE WITH POSITIVE PRESSURES. THE INTERNAL PARTICULATE GENERARTION TO BE CONTROLLED BY EPOXY FLOORING HARD SURFACED NON PORUS MATERIAL (PVC S) EPOXY PAINTED WALLS GLASS BOARD CEILINGS PROPER HVAC (HEATING VENTILLATION AIR CONDITIONING) PROPER DOOR CLOSURES
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Continued………
BOTTOM CLOSURES
COVING ON WALLS AND FLOORS TO AVOID ACCUMALATION OF DUST.
ENTRY FOR SPECIFIED PERSON WITH ACCESS CARDS
ALL THE ROOMS SHOULD HAVE FIRE ALARM SYSTEMS
CLEAN ROOM SHOULD HAVE TEMPERATURE AND HUMIDITY CONTROLLER SYSTEMS.
AIR LOCK SHOULD BE ROOMS.
11/21/2008
PROVIDED FOR ACCESSING TWO
KIRAN DESAI
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AIR FLOW
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TYPES OF AIR FLOW
1. LAMINAR AIRFLOW 2. TURBULENT AIRFLOW
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LAMINAR AIR FLOW CLEAN ROOM
Laminar air flow is used when low airborne concentrations of particles or bacteria are required.
This air flow 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 air flow ventilated system relies on mixing and dilution to remove contamination.
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LAMINAR AIR FLOW CLEAN ROOM
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Any obstructions will cause the laminar air flow to be turned into turbulent air flow around the obstructions.
Higher contamination concentrations will be established in the turbulent areas.
Air changes per unit of time are related to the volume of the room and are many times greater than those supplied to a turbulent air flow Clean room.
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TURBULENT AIR FLOW
The general method of ventilation used in turbulent air flow clean rooms 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 diffs in the ceiling.
However, a clean room differs from an ordinary ventilated room in three ways. These are increased air supply, the use of high efficiency filters and room pressurization.
The increased air supply is an important aspect of particle control. A typical turbulent air flow clean room would have at least 10 air changes per hour and likely to have between 20 and 60.
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TURBULANT AIR FLOW CLEAN ROOM
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TURBULANT AIR FLOW CLEAN ROOM
This additional air supply is mainly provided to dilute to an acceptable concentration the contamination produced in the room.
High efficiency filters are used to filter the supply air into a clean room to ensure the removal of small particles. The high efficiency filters used in clean rooms are installed at the point of air discharge into the room.
Room pressurization is mainly provided to ensure that untreated air does not from dirtier adjacent areas into the clean room. The clean room is positively pressurized with respect to these dirtier areas. This is done by extracting less air from the room than is supplied to it.
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APPLICATIONS LAMINAR AIR FLOW
FORMULATION
STERILE PLANTS
TURBULENT AIR FLOW
11/21/2008
NON STERILE PLANTS
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PARTICLE CHARACTERISTICS OF CLEAN ROOM
50 micron particles are visible
Average human hair is about 100 microns
Time to fall 1 meter in still air •
33 seconds for 10 micron particle
•
48 minutes for 1 micron particle
Humans generate >1x105 particles per minute when motionless (fully gowned)
Humans can generate >1x106 particles when walking in the clean room
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GUIDELINES AND DESIGN PARAMETERS OF CLEAN ROOM
FUNDAMENTAL OF CLEAN ROOM DESIGN IS TO CONTROL THE CONCENTRATION OF AIRBORNE PARTICLES. A PROPER HVAC SYSTEM IS CRITICAL PART OF CLEAN ROOM DESIGN. PARTICULATE MATTER CAN BE CONTROLLED BY HEPA FILTERS WITH MIN EFFECIENCY OF 99.97% TESTED ON 0.3 MICRON NUMBER OF AIR CHANGES PER HOUR SHOULD BE IN THE RAGE OF 10 TO 20.
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CLASSIFICATIONS OF CLEAN ROOM • HOW ARE CLEAN ROOMS CLASSIFIED? CLEAN ROOMS ARE CLASSIFIED BASED ON CLEANLINESS OF AIR. STANDARDS OF CLEAN ROOM • Federal Standard 209D Class Limits • Federal Standard 209E Airborne Particulate Cleanliness Classes • British Standard 5295:1989 • BR 525 Environmental Cleanliness Classes • BS EN ISO Standard
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Federal Standard 209D Class Limits MEASURED PARTICLE SIZE (MICROMETERS)
CLASS
11/21/2008
0.1
0.2
0.3
0.5
5
1
35
7.5
3
1
NA
10
350
75
30
10
NA
100
NA
750
300
100
NA
1,000
NA
NA
NA
1,000
7
10,000
NA
NA
NA
10,000
70
100,000
NA
NA
NA
100,000
700
KIRAN DESAI
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Federal Standard 209E Airborne Particulate Cleanliness Classes Class Name
SI
English
M1 M 1.5
1
M2 M 2.5
10
M3 M 3.5
100
M4 M 4.5
1 000
M5 M 5.5
10 000
M6 M 6.5
100 000
M7
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Class Limits 0.1m m
0.2m m
0.3m m
0.5m m
5m m
Volume Units
Volume Units
Volume Units
Volume Units
Volume Units
(m^3)
(ft^3)
(m^3)
(ft^3)
(m^3)
(ft^3)
(m^3)
(ft^3)
(m^3)
(ft^3)
350
9.91
75.7
2.14
30.9
0.875
10
0.283
--
--
1 240
35
265
7.5
106
3
35.3
1
--
--
3 500
99.1
757
21.4
309
8.75
100
2.83
--
--
12 400
350
2 650
75
1 060
30
353
10
--
--
35 000
991
7 570
214
3 090
87.5
1 000
28.3
--
--
--
--
26 500
750
10 600
300
3 530
100
--
--
--
--
75 700
2 140
30 900
875
10 000
283
--
--
--
--
--
--
--
--
35 300
1 000
247
7
--
--
--
--
--
--
100 000
2 830
618
17.5
--
--
--
--
--
--
353 000
10 000
2 470
70
--
--
--
--
--
--
1 000 000
28 300
6 180
175
--
--
--
--
--
--
3 350 000
100 000
24 700
700
--
--
--
--
--
--
10 000 000
283 000
61 800
1 750
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BS 5295 ENVIRONMENTAL CLEANLINESS CLASSES Maximum permitted number of particles per m^3 (equal to, or greater than, stated size)
Class of environment al cleanliness
0.3 m m
0.5 m m
5mm
10 m m
25 m m
C
100
35
0
NS
NS
D
1 000
350
0
NS
E
10 000
3 500
0
F
NS
3 500
G
100 000
H
Maximum floor area per sampling position for clean rooms (m^2)
Minimum pressure difference*
Between classified areas and unclassifie d areas (Pa)
Between classified area and adjacent areas of lower classification (Pa)
10
15
10
NS
10
15
10
NS
NS
10
15
10
0
NS
NS
25
15
10
35 000
200
0
NS
25
15
10
NS
35 000
200
0
NS
25
15
10
J
NS
350 000
2 000
450
0
25
15
10
K
NS
3 500 000
20 000
4 500
500
50
15
10
L
NS
NS
200 000
45 00
5 000
50
10
10
M NS 11/21/2008
NS
NS
50
10
NA
450 000 50 000 KIRAN DESAI
37
ISO 209 airborne particulate cleanliness classes for clean rooms and clean zones. Numbers (N)
Maximum concentration limits (particles/m^3 of air) for particles equal to and larger than the considered sizes shown below 0.1m m*
0.2m m
0.3m m
0.5m m
ISO 1
10
2
ISO 2
100
ISO 3
1m m
5.0m m
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
* m m Micro Meter 11/21/2008
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GRAPHICAL REPRESENTATION OF AIRBORNE PARTICLES
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GENERAL CLEAN ROOM REGULATIONS Below is a list of general regulations recommended as a minimum for the successful operation of a clean room. All professional cleaning personnel should be aware and follow these regulations at all times. •
All personal items such as keys, watches, rings, matches, lighters and cigarettes should be stored in the personal locker outside the gowning room.
•
Valuable personal Items such as wallets may be permitted in the clean room provided they are NEVER removed from beneath the clean room garments.
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CONTINUED……… •
NO eating, smoking or gum chewing allowed inside the clean room.
•
Only garments approved for the clean room should be worn when entering.
•
NO cosmetics shall be worn in the clean rooms. This includes: rouge, lipstick, eye shadow, eyebrow pencil, mascara, eyeliner, false eye lashes, fingernail polish, hair spray, mousse, or the heavy use of aerosols, after shaves and perfumes.
•
•
Only approved clean room paper shall be allowed in the clean room.
•
Approved ball point pens shall be the only writing tool used.
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CONTINUED………
•
Use of paper or fabric towels are prohibited. Use of hand dryers equipped with HEPA filters are suggested.
•
Gloves or finger coats should not be allowed to touch any item or surface that has not been thoroughly cleaned.
•
Only approved gloves, finger cots (powder-free), pliers, tweezers should be used to handle product. Finger prints can be a major source of contamination on some products.
•
Solvent with the bare skin should be avoided. They can remove skin oils and increase skin flaking.
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CONTINUED……….
•
Approved skin lotions or lanolin based soaps are sometimes allowed. These can reduce skin flaking.
•
All tools, containers and fixtures used in the cleaning process should be cleaned to the same degree as the clean room surfaces. All of these items are a source of contamination.
•
NO tool should be allowed to rest on the surface of a bench or table. It should be place on a clean room wiper.
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CONTINUED………. •
Only clean room approved wipers are allowed to be used. The wipers must be approved for the Class of clean room being cleaned.
•
ALL equipment, materials and containers introduced into a sterile facility must be subjected to stringent sterilization prior to entrance.
•
NO ONE who is physically ill, especially with respiratory or stomach disorders, may enter a sterile room. This is a good practice in any clean room environment.
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HVAC DESAIGN CONSIDERATIONS 1. Temperature and Humidity 2. Pressurization 3. Ventilation and Make Up Air
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Temperature and Humidity Most clean room require year-round cooling as a result of the fan energy associated with high clean room 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 75 F, since workers frequently wear clean room garments over street clothes. 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% to 70% relative humidity 11/21/2008
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Pressurization
A clean room 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 air flows 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.
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HOW IS AIR PRESSURE MEASURED? The pressure differential over the doorway is measured with a portable magnahelic gauge or micro manometer
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Ventilation and Make Up Air
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.
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HOUSE KEEPING Every is responsible for keeping the clean rooms clean. Always clean your workspace before leaving. Don’t leave or store items on or in equipment. Do not set liquids on any equipment. Properly store all materials before leaving the clean room Last one out should make sure the room is in a safe idle mode.
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CHEMICAL HANDLING IN CLEAN ROOMS
Chemical waste should be properly disposed of as outlined by EHS systems.
No chemicals may be poured down the drains
Waste containers should be properly marked as such and have a pink Hazardous Waste tag tied to them at all times.
If you have questions about disposal a staff member.
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VOILATION OF RULES First time
Warning
Report to Advisor
Second time
Suspension of access
Report to Advisor
Retraining may be required
Third Offense
Suspension of access
Report to Advisor
Access will not be renewed until an acceptable resolution is reached between Advisor and Clean room Manager
11/21/2008
Clean room Protocol re-training will be required. KIRAN DESAI
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HVAC SUPPLY CLEAN ROOM DOORS
FLUSHED LIGHTING
FALSE CEILING
FLUSHED WINDOWS
EPOXY FLOORING
COVING 11/21/2008
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11/21/2008
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