A. Cleanroom Latest Trends

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  1. 1. A presentation on New Trends in Modular cleanrooms
  2. 2. Flow of Presentation History of Clean Rooms Introduction to Clean Rooms Emerging Trends in Cleanrooms Need of Clean Rooms History of Clean Rooms in Healthcare
  3. 3. A cleanroom is an environment, typically used in manufacturing or scientific research, that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. More accurately, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. To give perspective, the ambient air outside in a typical urban environment contains 35,000,000 particles per cubic meter in the size range 0.5 m and larger in diameter, corresponding to an ISO 9 cleanroom, while an ISO 1 cleanroom allows no particles in that size range and only 12 particles per cubic meter of 0.3 m and smaller (see table below).
  4. 4. Class maximum particles/m FED STD 209E equivalent0.1 m 0.2 m 0.3 m 0.5 m 1 m 5 m ISO 1 10 2 ISO 2 100 24 10 4 ISO 3 1,000 237 102 35 8 Class 1 ISO 4 10,000 2,370 1,020 352 83 Class 10 ISO 5 100,000 23,700 10,200 3,520 832 29 Class 100 ISO 6 1,000,000 237,000 102,000 35,200 8,320 293 Class 1000 ISO 7 352,000 83,200 2,930 Class 10,000 ISO 8 3,520,000 832,000 29,300 Class 100,000 ISO 9 35,200,000 8,320,000 293,000 Room air
  5. 5. History of Cleanrooms The Clean-room is a recent technology coming to the age as part of the Atomic Age and greatly enhanced in the space-age. However, its roots go back hundreds of years to swiss watch makers who used to cover their precious watches with a small bell jars when they were not working on them to prevent dust from falling on them. The American Civil war (18611865) gave impetus to the next phase, when due to immense loss of life due to bullet wounds surgeons recognised the need for steps to prevent post traumatic infections. So, the methods were developed to achieve this and sterility became a watchword in operating suits and surgical tools. As a final step the development of HEPA (High efficiency Particulate Air) filter at Sandia Labs for Atomic Energy Commission after World War-II, in 1945 where deadly nuclear particles were isolated in process areas with HEPA filters while allowing air to circulate in them.
  6. 6. History of Clean-rooms in Healthcare sector The first Clean-rooms in Healthcare were found in hospitals It was after Pasteur, Koch, Lister and other pioneer microbiologists and surgeons over a 100 years ago established that bacteria cause wound infections It was discovered that elimination of bacteria from hospital and in particular Operating room should prevent infection This was the scientific basis for the first clean rooms Joseph Lister (1827 1912) British surgeon Heinrich Hermann Robert Koch (1843-1910) Prussian physician Lister's Operation Theatre (1869)
  7. 7. Why are Clean Rooms needed? Need To reduce contamination levels in the product or services performed To achieve compliance to world wide standards like cGMP, USFDA etc. the manufacturing has to follow certain standards (ISO standards) which makes clean-room a compulsion than a need. These standards cant be achieved without following contamination control technology, of which clean rooms are an important part. Contamination Control Technology : It deals with the removal of particles from the air and the levels of air cleanliness that can be achieved How items are handled, cleaned and stored What equipment is used and the method of its use. What materials are used in the process and what changes take place to that material, what are the contaminants, where do they come from and how can they be eliminated
  8. 8. Sources of Contamination 1. Facilities (building) Walls, floors and ceilingsPaint and coatingsConstruction material Air conditioning debrisRoom air and vaporsSpills and leaks 2. People Skin flakes and oilCosmetics and perfumeSpittle Clothing debris (lint, fibers etc.)Hair 3. Tool Generated Friction and wear particlesLubricants and emissionsVibrations Brooms, mops and dusters 4. Fluids Particulates floating in airBacteria, organics and moisture Floor finishes or coatingsCleaning chemicals Plasticizers (outgasses)Deionized water 5. Product generated Silicon chipsQuartz flakesCleanroom debris
  9. 9. Key Elements of Contamination Control Cleanroom Construction: Cleanrooms construction material should be non-shredding, Chemically stable/ resistant, with minimal places for dust-settlement. HEPA(High Efficiency Particulate Air Filter) They filter particles as smallas 0.3 microns with a 99.97% minimum particle-collective efficiency. Cleanroom Architecture: Cleanrooms are designed to achieve and maintain a airflow in which essentially the entire body of air within a confined area moves with uniform velocity along parellel flow lines (laminar flow). As, turbulence can cause particle movement. Filteration: In addition to the HEPA filters commonly used in cleanrooms, there are a number of other filtration mechanisms used to remove particles from gases and liquids. These filters are essential for providing effective contamination control. Cleaning: Cleaning is an essential element of contamination control.
  10. 10. Key Elements of Contamination Control Laminar Air-Flow Turbulent Air-Flow
  11. 11. Pharma Industry Dynamics Pharma Industry Development
  12. 12. Disadvantages of Brick-walls It shreds particles and Gets chemically effected very fast Paint peals off very fast leading to high maintenance cost (frequent painting) Absorbs moisture expediting the paint peal-off and particle shreding. No modularity. In case of any change required the area will need to be shut down for weeks together. Re-validation will be required after any changes. More down time due to maintenance reasons.
  13. 13. Emerging trends in Cleanrooms
  14. 14. Types of Cleanroom Construction Trends in clean room partition materials 1900 s 1980 s 2000 s 2006 Plaster / Blockwork Plasterboard /Studwork /paint Solid core panel monoblock+factory applied paint finish Hollow core/ 2 part panel /factory applied finish GI & HPL Pre- Engineered Panels GRP Panels
  15. 15. It is a general partitioning system, which is being used in pharmaceutical cleanrooms just because of lower price. These panels are not Pre-engineered & all cut-outs, conduits, view-panels are done manually at site. This drastically reduces the final finish quality. Thickness of 50mm is not very sturdy and doesnt allow many utilities and switch-boards to fit into it. The paint is wet type and paint thickness is just 20-25 microns. So, the scratch resistance is very poor as compared to powder coating. CRC sheets used in making panels instead of GI. This increases the risk of rusting at later stage. C-Type floor-track is used to fix the panel on the floor. This leads to a direct contact between the panel and any kind of seepage/ spillage/ leakage of water etc. Resulting in bacteria formation. Removal of partition is very difficult after installation. Hanging system is used for ceiling (load-bearing capacity of 70-80 Kg/m2) and very less movement space over ceiling. Also the ceiling cut-outs are done at site and covered with channels from outside (not welded), hence reduced strength of panels with cut-outs. PVC covings and corners in standard colours is provided Overall final finish is not very good Disadvantages of thin pre-painted panels
  16. 16. Major highlights: Integrated system specially designed for Pharmaceutical industries. Pre-engineered system (panels, cut-outs, conduits, view-panels are designed and manufactured in factory) as per design requirements. Inbuilt risers for low-level air discharge resulting in better aesthetics and better space utilization. Raised type floor-track can be provided to accommodate epoxy coving. This results in total flushing of epoxy coving with walls. Truss system used for ceiling hanging for sturdy ceiling (load-bearing capacity of 150 Kg/m2) and more movement space over ceiling. Aluminium Powder coated covings and corners to match colour, gloss as of partitions and for better life. Doors and accessories are specially designed to suit the clean-room requirements. Pre-engineered Partitioning System
  17. 17. Pre- Engineered, Pre-Designed (different sized panels as per requirement) Progressive / Non-Progressive (Both types) are provided as per layout requirement. (Please see an Example of Pre- Engineered panels in next slide) Pre-Engineered Panels Standard Design Standard Length and Width panels are supplied and are cut at site to make any changes Pre-engineered 80 mm Partitions Normal Partitions
  18. 18. Pre-Engineered Panels
  19. 19. - Panels have a profile all around and channels are welded to the sheet to give more strength - The wall panels supports the load- bearing ceiling. i.e. Panels are self- supporting - Stiffeners are provided where-ever required in ceiling panels and hence more strength. - Better chemical resistance due to 70- 90 microns of powder coating. Panels Having more strength Panels are made of sheets pasted on the frame of GI or Aluminium resulting in lower strength Also some panels doesnt have any supporting profile/ frame 80 mm Partitions Normal Partitions
  20. 20. Raised Floor Track Raised type Floor Track C Type Floor Track 80 mm Partitions Normal Partitions Disadvantages of C-Type Floor Track: PVC or Al. Coving is only option in this case. Since panels are resting just on the C Channel; Any seepage of water will enter the area behind coving and also panels bottom and create bacterial formation/ Contamination Advantages of Raised Floor Track: This allows total flushing of Epoxy coving with wall panels thus giving total flush surface and also avoids Water contact with the pan