-How is the Indian market for Clean Rooms and their components shaping up?
Market for Clean Rooms in India is increasing day in and day out. With increase in individual requirements the market for each and every product is bound to increase thereby increasing the Shop Floor Areas, in turn increasing the Clean Room requirements.
The increased awareness along with regulatory attention and the frequent production of higher value products are key drivers of advances for Clean Room technologies.
The shift in pharmaceutical and biotechnology industry from big molecule drugs to smaller and more flexible manufacturing facility for regional market requirements increases the Clean Room requirements. Targeted therapies, wide range of smaller volumes and niche products are the new trend setters for newer Clean Rooms.
Pharmaceutical including Safety Labs, Animal Supply Facility etc., themselves are expected to add more than 5% Growth Rate to the Clean Room Industry.
Safety of Working Personnal, Environment & Recent Focus for Safety of Healthcare Products has led to Product Innovation and Automation of Clean Rooms.
How is the opportunity in the international arena?
particle control is a global requirement. With the opening of new markets in India and in line with the Prime Minister’s ‘Make in India’ dream, the opportunity in India has left the global market far behind.
As a manufacturer of Clean Rooms, what are the areas where you feel maximum focus is needed?
As a manufacturer in India for Clean Rooms, probably focus is required to see Clean Room as an industry in itself. Clean Room is a combination of:
a. Construction (includes Walls/ Terminals/ Cabinets/ Pass Thrus…)
b. Equipment (includes Heating & Ventilation Systems, Filters Laminar Air Flows…)
c. Consumables (includes Cleaning Materials..).
– Incentives on development of new products suitable for Indian ambient conditions.
– Simpler and clearer laws governing particle count.
-What are the main challenges in contamination control?
a. The selection of construction materials should be made on the basis of durability, whether the material’s surfaces can be cleaned and sanitized and how easy it is to do so, resistance to chemicals, and location.
Construction materials come in two basic types, hard shell and soft shell. Soft-shell (flexible, plastic materials) Clean Rooms are not as durable as hard- shell Clean Rooms and have surfaces that are usually more difficult to clean and sanitize; therefore, they should be considered only for temporary purposes.
b. Typical specifications for defining a hard-shell Clean Room are as follows:
- Walls may be modular, having locking panels with all joints sealed or epoxy-coated wallboard. All coverings and sealing materials shall be resistant to cleaning and sanitizing agents.
- The wall panels will be extruded aluminium grid sections with honeycomb core of varying thickness (from 6 mm to 50 mm), which will be of modular construction. These wall panels will be of zero out-gassing type, either anodized or powder epoxy coated finish.
- The walls and ceiling must have smooth, cleanable surfaces. The interface with the floor and ceiling should be sealed with– approved materials and coved to facilitate cleaning.
- Raised flooring can be of die-cast aluminium tiles with perforations for the return passage, installed over a grid work of robust die-cast aluminium pedestals. All the utility and service pipes can be brought into the Clean Room through these flooring tiles at pre-determined locations. Heavy equipment can also be installed over these flooring tiles at predetermined locations with adequate passage for the return air movement. The floor void beneath the raised floor will act as the return air plenum and has to be designed as a Clean Room floor.
- Where return is drawn from lower floor levels, the floor shall be covered with sheet vinyl that is heat sealed or thin-set epoxy resin. The floor surface shall be seamless and cleanable. All coverings and sealing materials shall be resistant to cleaning and sanitizing agents. Materials should be FDA and USDA approved.
- The ceiling grids are of extruded aluminium, either anodized or powder coated, which can be ceiling suspended and firmly fixed on to the side walls. The ceiling grids will have built in recesses for light fixtures and terminal filters. The liquid gel sealant will make all the joints perfectly leak right. Commercially available ceiling grids consume approximately 18% of ceiling as dead zone as attic.
- Architectural details, such as windows, doors, pass-through, and utility penetrations, shall be as ledge free as possible. Window and door frames are to be constructed with double panes and flush frames.
- The ceiling shall be constructed of epoxy-coated gypsum board or in-laid panels. If the inlaid panel option is chosen, the panels must be impregnated with material that makes them impervious and hydrophobic. Panels are to be sealed or gasketed to the frame and tied down. The frame materials of construction shall be epoxy coated or anodized.
- Ceiling penetrations are to meet the following requirements: (a) sprinklers should be flush mounted, (b) lighting fixtures should be flush mounted, with smooth, sealed, airtight, exterior-mounted lens surfaces, and (c) utility penetrations are to be caulked or sealed with approved materials.
- The Clean Room design should contain a pass-through for materials entering the room from the anteroom. This reduces the potential for contamination by lessening traffic between the two rooms.
- Lighting fixture for the Class 100 and better Clean Rooms, shall be tear-drop type or flush mounting type (recess type), which can be made leak tight with liquid sealant. Flame-proof and explosion-proof type light fixtures are also available, which are wall mounting type, because of their size and weight.
-What kinds of tests are conducted for Clean Rooms and their components?
Recommendations for Clean Room include:
- Only authorized personnel should enter the Clean Rooms. Nobody should be allowed into the Clean Room without wearing Clean Room garments including cap and Clean Room shoes.
- Always stay in the ‘air shower’ for a specified time before entering Clean Rooms.
- After the use of garments and shoes, these used Clean Room attire should be kept at a properly designated place. Never go into ‘non-clean’ areas from change room with garments or shoes.
- Do not walk into a Clean Room unless necessary.
- Do not take contamination producing materials like tobacco, food, match boxes, purses, cosmetics, card boards and unnecessary papers inside the clean areas. Also, do not apply cosmetics in the clean area.
- Do not sharpen pencils in the Clean Room and use a ball point pen only.
- Wear gloves and finger cots whenever required.
- Do not touch contaminated articles or surfaces after wearing finger cots/ gloves.
- Do not scratch your head or rub your nails inside the Clean Room or change room and keep finger nails clean.
- Do not take personal items into Clean Room, keep them in lockers provided.
- Keep your work table clean.
- Clean / change filters in the air conditioning system as and when required.
- Never sweep the Clean Room floor, vacuum them or wet mop them as per frequency specified.
- Clean walls, ceilings and furniture as per frequency specified with wet mop.
- Garments should be washed as per frequency specified.
- Clean all furniture, equipment and raw material packages etc. properly before taking into Clean Room.
- Do minimum maintenance of equipment inside the Clean Room. Take the equipment outside the Clean Room for maintenance.
- Unpacking of the machinery required for the clean areas should be done outside the Clean Room.
-How meticulously do you focus on Research & Development (R&D)?
Our field team members are one of the main sources of inspiration for feed back and product improvement.
Every sixth product inherits a new change.
Our focus remains on product improvement and end user satisfaction.
Apart from the Long Tunnel Type Air Showers, we have developed New Product (Work Bench) for Blood Bank. Here the Work Bench has Controlled Temperature on the Surface to maintain Good Quality of RBC & WBC. The Room Temperature could vary from 21°C to 30°C, while the Temperature required for Good Quality Blood Storage is 4°C to 8°C.
Another feather in our cap is the Door Interlock System for Rooms under various Air Pressures connected to BMS and suitable for Operators returning from Hazardous Conditions.
This year our team members also developed Special Garment Storages Cabinet suitable for Disposal of Garments used in Highly Infectious Pathogens.
Please tell me about some of your significant in-house developments through R&D.
One of our clients discussed a problem with us during one of our visits. The product is lead based. Lead being in powder form floats in the air and settles on the operator’s dress while working at the shop floor. Thus, while having his meals at the canteen, the lead dust would fall on his meals and the same would be consumed by him.
Our team developed a new air shower wherein we delivered 45m/s of air at the nozzles.
We probably ended up making the longest air shower (25 feet) in the country of stainless steel sheet 304 grade. The high turbulence of air in the walkway assisted to reduce the lead content on the operator’s dress. The air shower was placed after the shop floor and before entry to the canteen.
The reduction of lead was huge, even the operators were happy with the results. The new development assisted in a big way, saving precious human lives.
What are your short-term future plans?
We at SAM PRODUCTS are preparing for the ‘Make in India’ challenge. Increase in Production Floor Space, Add New Machines, Technology Transfer, May be a Joint Venture, Hiring More Skilled Staff.
We are already adding more products to our list of Items.