Amna bedri-interview-el-gazette-published-issue375-april2011
Clean Rooms-Classification-by Amna Saeed
-
Upload
amna-saeed -
Category
Science
-
view
543 -
download
8
Transcript of Clean Rooms-Classification-by Amna Saeed
![Page 1: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/1.jpg)
CLEAN ROOMS &CLASSIFICATION OF CLEAN ROOMS
by: Amna Saeed
Pharm.D(2009-2014) (L.C.W.U)
![Page 2: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/2.jpg)
A clean room (or cleanroom) is an enclosed space in which airborne particulates, contaminants, and pollutants are kept within strict limits.
CLEAN ROOM
![Page 3: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/3.jpg)
WHY WE NEED CLEAN ROOM???
![Page 4: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/4.jpg)
TO AVOID “CONTAMINATION”
![Page 5: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/5.jpg)
CONTAMINATION
Contamination is a process or act that causes materials or surfaces to be soiled with contaminating substances.
Sources of Contamination:1:Facilities2:People3:Tool generated4: Fluids5: Product generated
![Page 6: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/6.jpg)
1. FacilitiesWalls, floors and ceilingsPaint and coatingsConstruction material (sheet rock, saw dust etc.)Air conditioning debrisRoom air and vaporsSpills and leaks
2. PeopleSkin flakes and oilCosmetics and perfumeClothing debris (lint, fibers etc.)Hair
![Page 7: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/7.jpg)
3. Tool GeneratedFriction and wear particlesLubricants and emissionsVibrationsmops and dusters
4. FluidsParticulates floating in airBacteria, organics and moistureFloor finishes or coatingsCleaning chemicalsDeionized water
![Page 8: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/8.jpg)
5. Product generatedSilicon chipsQuartz flakesCleanroom debrisAluminum particles
![Page 9: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/9.jpg)
HOW TO CONTROL CONTAMINATION???
![Page 10: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/10.jpg)
![Page 11: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/11.jpg)
Key Elements of Contamination Control
•HVAC system•HEPA•CLEANROOM ARCHITECTURE•LAMINAR FLOW CABINET•FILTERATION•CLEANING•CLEANROOM GARMENTS•HUMANS IN CLEANROOM•COMODITIES•COSMETICS•MEASUREMENTS & INSTRUMENTATION•ELECTROSTATIC DISCHARGE(ESD)
![Page 12: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/12.jpg)
HVAC SYSTEM (heating, ventilation & air-conditioning) What can HVAC do?HVAC system performs four basic functions:
1. Control airborne particles, dust and micro-organisms – Thru air filtration using high efficiency particulate air (HEPA) filters.
They filter particles as small as 0.3 microns with a 99.97% minimum particle-collective efficiency
![Page 13: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/13.jpg)
2. Maintain room pressure (delta P) –Areas that must remain “cleaner” than surrounding areas must be kept under a “positive” pressurization,
This is achieved by the HVAC system providing more air into the “cleaner” space than is mechanically removed from that same space.
![Page 14: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/14.jpg)
3: Maintain space moisture (Relative Humidity) Humidity is controlled by cooling air to dew point temperatures or by using desiccant dehumidifiers.
![Page 15: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/15.jpg)
4. Maintain space temperature –
Temperature can affect production directly or indirectly by fostering the growth of microbial contaminants on workers.
![Page 16: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/16.jpg)
CLEANROOM ARCHITECTURE
This air flow is called laminar flow. The more restriction of air flow the more turbulence. Turbulence can cause particle movement.
![Page 17: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/17.jpg)
Laminar flow cabinet
•Laminar flow principle involves double filteration of air through coarse Pre-filters (upto 5 microns) and HEPA filters (down to 0.3 microns) for filteration of Biological & Particulate contaminants.
•A constant uni-directional air flows either Horizontally or Vertically, is drawn from atmosphere and passed through pre and Hepa filters on to the work surface.
![Page 18: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/18.jpg)
COMPONENTS OF LAMINAR FLOW CABINETPrefilters : Made of Washable synthetic material.Hepa Filters : Made of Microglass fibre with corrugated aluminium foil separators. Blower Units : A motor,with dynamically balanced blowers making the unit least vibrant with minimum noise level.Lighting : Fluorescent tube lights.Sterilization : Germicidal Ultra Violet (UV) tube.manometer : Pressure measuring device
![Page 19: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/19.jpg)
TYPES OF LAMINAR FLOW CABINETS
![Page 20: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/20.jpg)
CLEANROOM GARMENTS
The requirements for cleanroom garments will vary from location to location.
Gloves, face masks and head covers are standard in nearly every cleanroomenvironment
![Page 21: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/21.jpg)
![Page 22: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/22.jpg)
HUMANS IN CLEANROOMS
People are a major source of contamination in the cleanroom.
1. Body Regenerative Processes-- Skin flakes, oils, perspiration and hair.2. Behavior-- Rate of movement, sneezing and coughing.3. Attitude-- Work habits and communciationbetween workers.
![Page 23: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/23.jpg)
Notice the number of particles produced per minute during these activities.
PEOPLE ACTIVITY NUMBER OF
PARTICLES/MIN(0.3 micron
and larger)
Motionless (Standing or
Seated)
100,000
Walking about 2 mph 5,000,000
Walking about 3.5 mph 7,000,000
Walking about 5 mph 10,000,000
Horseplay 100,000,000
![Page 24: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/24.jpg)
COMMODITIES - Care is taken when selecting and using commodity items in cleanrooms. Wipers, cleanroom paper and pencils and other supplies that service the cleanroom should be carefully screened and selected
![Page 25: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/25.jpg)
COSMETICS - Many cosmetics contain sodium, magnesium, silicon, calcium, potassium or iron. These chemicals can create damaging particles. Cleanroom managers may ban or restrict cosmetics in the cleanroomA recent mirror on a space telescope was fogged up from the cologne that was present in the cleanroom.
![Page 26: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/26.jpg)
MEASUREMENT AND INSTRUMENTATION -
Some important measurements related to contamination control are particle count, air flow & velocity, humidity, temperature and surface cleanlinessELECTROSTATIC DISCHARGE (ESD)Moving air creates a charge. People touching surfaces or walking across the floor can create an electric charge.Special care is taken to use ESD protective materials to prevent damage from ESD. Cleaning managers should work with their personnel to understand where these conditions may be present and how to prevent them.
![Page 27: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/27.jpg)
CLASSIFICATION OF CLEAN ROOMS
Clean rooms are classified by the cleanliness of their air.
•The method most easily understood and most universally applied is the one suggested in the earlier versions (A to D) of Federal Standard 209 of the USA.
•In this old standard the number of particles equal to and greater than 0.5 m m is measured in one cubic foot of air and this count used to classify the room.
![Page 28: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/28.jpg)
Federal Standard 209This standard was first published in 1963 in the USA and titled "Cleanroom and Work Station Requirements, Controlled Environments“
![Page 29: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/29.jpg)
Pharmaceutical Clean Room ClassificationFor the manufacture of sterile medicinal products four grades are given
![Page 30: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/30.jpg)
Grade A: The local zone for high risk operations, e.g.filling zone, stopper bowls, open
ampoules and vials, making aseptic connections.Normally such conditions are provided
by a laminar air flow work station. Laminar air flow systems should provide an homogeneous air speed of 0.45 m/s +/- 20% at the working position.
![Page 31: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/31.jpg)
Grade B: In case of aseptic preparation and filling, the background environment for grade A zone.
Grades C and D: Clean areas for carrying out less critical stages in the manufacture of sterile products.
![Page 32: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/32.jpg)
Examples of operations to be carried out in the various grades are given in the table below
![Page 33: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/33.jpg)
Additional microbiological monitoring is also required outside production operations, e.g. after validation of systems, cleaning and sanitization.
(NOTES: a) These are average values.(b) Individual settle plates may be exposed for less than 4 hours.(c) Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. If these limits are exceeded operating procedures should prescribe corrective action.
![Page 34: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/34.jpg)
REFERENCES:1:http://www.mssl.ucl.ac.uk/www_cleanroom/cleanroom/cr_standards.html#pcc2:http://whatis.techtarget.com/definition/clean-room3:http://www.coastwidelabs.com/Technical%20Articles/Cleaning%20the%20Cleanroom.htm4:http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070342.pdf
![Page 35: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/35.jpg)
![Page 36: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/36.jpg)
![Page 37: Clean Rooms-Classification-by Amna Saeed](https://reader031.fdocuments.in/reader031/viewer/2022031817/55a3f2321a28ab3d168b4824/html5/thumbnails/37.jpg)