GMP Technical Provides Clean Room Trends

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GMP Technical Solutions manufactures and providing partitions, doors and equipments in the Indian Sub-landmass. GMP is the innovation pioneer in the range of Clean Room innovation and gives Turnkey clean room arrangements around the globe.

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Presentation Transcript

Slide 1:

A presentation on New Trends in Modular cleanrooms

Flow of Presentation:

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

What is a Clean Room:

What is a Clean Room 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 μm 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 μm and smaller (see table below).

ISO 14644-1 clean room standards:

ISO 14644-1 clean room standards Class maximum particles/m³ FED STD 209E equivalent ≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥1 µm ≥5 µm 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

History of Cleanrooms:

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 (1861–1865) 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.

History of Clean-rooms in Healthcare sector:

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)

Why are Clean Rooms needed?:

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 can’t 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

Sources of Contamination:

Sources of Contamination 1.     Facilities (building) Walls, floors and ceilings Paint and coatings Construction material Air conditioning debris Room air and vapors Spills and leaks 2.    People Skin flakes and oil Cosmetics and perfume Spittle Clothing debris (lint, fibers etc.) Hair 3.   Tool Generated Friction and wear particles Lubricants and emissions Vibrations Brooms, mops and dusters 4.    Fluids Particulates floating in air Bacteria, organics and moisture Floor finishes or coatings Cleaning chemicals Plasticizers ( outgasses ) Deionized water 5.    Product generated Silicon chips Quartz flakes Cleanroom debris

Key Elements of Contamination Control:

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.

Key Elements of Contamination Control:

Key Elements of Contamination Control Laminar Air-Flow Turbulent Air-Flow

Pharma Industry Dynamics:

Pharma Industry Dynamics Pharma Industry Development

Disadvantages of Brick-walls:

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.

Emerging trends in Cleanrooms:

Emerging trends in Cleanrooms

Types of Cleanroom Construction :

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

Slide 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 doesn’t 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

Slide 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

Slide 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

Slide 18:

Pre-Engineered Panels

Slide 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 doesn’t have any supporting profile/ frame 80 mm Partitions Normal Partitions

Slide 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 panels, so no chance of any bacterial growth.

Slide 21:

Truss Hanging ROOF HANGING Rod Hanging Truss Type Hanging Normal Partition

Slide 22:

RETURN AIR RISER Inbuilt Risers In 80 mm Panels Advantages of In-built risers: Smooth surface of wall, as internal ducts acts as risers. Proper space utilization is possible, as no obstacles are there in the rooms in terms of external riser ducts. Easy duct connections at the top. More clear area inside the rooms. Easy cleaning of rooms is possible as wall surfaces are in straight lines.

Slide 23:

RETURN AIR RISER Projected Type Risers Normal Partitions Disadvantages of Projected risers: Non-Smooth surface of wall, as the externs ducts creates a many projections in the wall. Proper space utilization is not possible, as many obstacles/ projections are there in the rooms in terms of external riser ducts. Duct-connection at the top of riser is difficult. It decreases clear area inside the rooms. Cleaning of rooms is difficult due to presence of projected risers as wall surfaces are in not in straight lines.

Slide 24:

80 mm pre-engineered partitions Normal Partitions Paint Quality Paint Type: Pure Polyester Method: Powder coating , oven baked Paint Thickness: 70 to 90 Microns Gloss level: 25 % Maximum Cross-cut/ Paint Adhesion Test: Done Paint Peal-off test: Done Impact/ Drop Test : Done Chemical Resistance: Yes ADVANTAGES: Better final finish Low fatigue in working (low gloss) More life Better Scratch and Chemical resistance Paint Type: Wet PU paint Method: pre-painted sheets used to make partitions Paint Thickness: 20 to 25 Microns Gloss level: above 35% Paint Adhesion Test: Not Done Paint Peal-off test: Not Done Drop Test : Not Done Chemical Resistance: Very low DISADVANTAGES: Poor final finish Higher fatigue due to higher gloss Lower life Poor Scratch and Chemical resistance

Slide 25:

Chemical Resistance chart of Powder Coating

Bend Test:

Bend Test Different tests for powder coating Scratch Test Weight drop Test

Gloss level test (20±5%):

Different tests for powder coating and bar coding Gloss level test (20±5%) Dry film thickness test (70-90 micron) Bar coding for easy identification

Slide 28:

Factory Made cut-outs with conduits fitted in factory: With and Without Lip cut-outs possible for ceiling Conduits are fitted in factory in wall cut-outs All cut-outs are covered with channels fitted inside them, which are welded These results in proper sealing (i.e. Infill is not in touch with wires/ connections. Hence less fire hazards) Proper welding of channels results in higher strength. Machine made cut-outs give better finishing. 80 mm Pre-engineered Partitions Wall/ Ceiling Cut-outs and Conduits

Slide 29:

Cut-outs are done manually at site Only Through cut-outs possible for ceiling Conduits are fitted at site in wall cut-outs, which are also done at site Only ceiling cut-outs are covered with external covering channels. These are just put on cut-out in pieces with no welding etc. No covering channels in the wall cut-outs results in no sealing (i.e. Infill is in touch with wires/ connections. Hence more fire hazard) No welding of channels results in lower strength. Man made cut-outs results in poor finishing. Normal Partitions Wall/ Ceiling Cut-outs and Conduits

Slide 30:

Load bearing capacity of 150 kg/m2 Load Bearing Ceiling 80 mm Pre-engineered Partitions Truss system for hanging and self-supported system (Wall panels supports the ceiling panels and are rested on it)

Slide 31:

Load Bearing Ceiling Load bearing capacity of 90-100 kg/m2 Normal Partitions Turn- Buckle system for hanging is used; This results in poor mobility space over ceiling and lower load bearing capacity

Slide 32:

VIEW PANELS Factory fitted View Panels Advantages of Factory fitted view panels : View-Panels are fitted in factory in controlled environment and hence no dust/ moisture etc. Is present. Cavity is made on CNC machines resulting in high quality and finish. SS channels inside the two glasses gives even better finish.

Slide 33:

DOOR FIXING Door Fixing in partitions Advantages of Pilaster joints in doors: Easy Removal of door is possible by removing both sides pilasters. This is extremely useful in case any big machine/ item needs to be transferred to/ from the room. After removing the door the height and width of open space is increased. Conduits for Door-interlocking/ Access control etc. Can easily be accommodated inside the plaster joints on both sides of the door.

Slide 34:

Aluminium frame cut in parts and fixed at site DOOR FIXING Normal Partitions Disadvantages of Aluminium frame in doors: Removal of door is not possible or is very difficult. Even if the door is removed the door over panel (DOP) can’t be removed. So, any removal/ shifting of bigger machines becomes very difficult.

Slide 35:

Factory Fitted View-panels Different sheet thickness of door frame and door leafs is considered for better strength. Press fit type door seal is used resulting in better finish and low maintenance. Powder coating on doors and frames for better appearance (same colour for frame and door leafs) and life. Good quality of accessories are used (door closure ( Dorma ), SS ball bearing hinges, SS handles, Drop seals etc.) DOOR Features Pre-engineered Partitions Normal Partitions Site Fixed View-panels Aluminium frame (generally without paint) and same thickness pre-painted sheet (as of the partitions) is used to make door leafs resulting in poor strength. Pasted type door seal is used resulting in poor finish and more maintenance. Pre painted sheet for doors and bare frames results in poor appearance/ life. Normal accessories are used instead of specially designed clean-room accessories, which results in frequent failures and poor performance.

Slide 36:

COVING Normal Partitions Pre-engineered Partitions Advantages of Aluminium Powder Coated covings and corners: Aluminium powder coating of covings have very good strength and life. Exactly same colour and gloss level as of partitions is maintained resulting in better look and finish. If required to remove and re-fix, it will not break-up as in case of PVC covings. Disadvantages of PVC covings and corners: PVC covings have poor strength and life. Colour as not possible to match resulting in poor look and finish. If required to remove and re-fix, it will break-up, as it becomes brittle after some time.

Slide 37:

Pre-engineered Partitions- Final Finish

Slide 38:

Advantages of HPL Partitions Panel skin is non-metallic and hence no static charge. So it is suitable for areas requiring low static charge. HPL is having very good scratch resistance due to melamine coating done on the skin. The panel skin is having very good mechanical properties i.e. no denting or breaking due to impact. Final finish of the project is excellent and there is no waviness in panels. No rusting/ deformation in due course of time

Slide 39:

HPL Installation photos

Slide 40:

Advantages of GRP partitions Panels are molded out of resins with reinforcement of fibers. Material is virgin in nature. Chemical resistance of GRP is very high. Even can withstand high potential acids. One service panel after each solid panel. Inbuilt / molded covings. High capacity return-air risers (150mm depth) are provided within wall. Bigger view-panels provided. Mechanical strength of product is very high. Repairable at site in case of any kind of damage.

Slide 41:

GRP Installation photos

Slide 42:

CRUX of the presentation 80mm Pre-engineered partitions system design is most suitable for pharmaceutical cleanrooms . However GRP partitions are best suited for more critical facilities like Oncology, H ormones etc . which needs frequent fumigation by using harsh chemicals. Thanks !

Slide 43:

Presented by: GMP Technical Solutions Pvt. Ltd. Works: Gunai Road, Mandhala , Via Barotiwala , Distt . Solan , Himachal Pradesh, India Website: www.gmpcleanrooms.com E-mail: ajaymehta@gmptech.net

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