SPECIFICATIONS FOR CLEAN ROOM

General: Class 10, 000 clean room including four change rooms and two dynamic pass boxes as per architectural drawing attached herein. Conditions required include: Temp- 20+/- 2 DEG. CENT, RH- 50+5, and Successive differential pressure of 15 Pa between each area to be maintained with outside corridor to be at reference zero. Hence, the pressure in Clean Room is 60 Pa. The Clean Room facility is needed for manufacturing stem cells under GMP conditions for clinical use. Air Handling Unit 1. The facility should have a dedicated air-handling unit (AHU) of suitable capacity and comprising of fresh air section, mixing section, cooling section, blower section and filter section complete with pre-filters and micro-vee filters to maintain desired conditions of filtration, temperature, and positive pressure in the clean room area. 2. Its construction should be double skin type fabricated from aluminum extruded structure (Thermal Break & Coving type), the inner skin in GI plain and outer skin in GI pre-coated construction with 40 mm thick panels having PUF in between the two skins. 3. The blower and motor assembly of the AHU should be on a common base frame and mounted on vibration isolators within the blower section. The blower section should be provided with suitable inspection doors and illuminated. 4. Return air (RA) and Fresh air (FA) mixing sections should have aluminum Aerofoil dampers and there should have a 10-micron pre filter at fresh air connection. Total air changes inside the clean room should be 55-60 per hour. Fresh air quantity of 10-12%. per hour should be provided in the AHU mixing section. Exhaust damper on AHU with suitable ducting to exhaust fumes for Defumigation of the area, and main supply damper should be like Fire damper with fusible link and spring. 5. Filter section with pre filters (EU-3/4) and micro-vee filters (EU-7) on common filter frame. 6. Cooling coil section with 6 Row deep DX coil (copper tube with aluminum fins) with insulated drain tray made out of 18 G SS-304. 7. Electrical strip heaters ( In three bank construction ) should be provided at outlet of cooling coil, mounted on suitable frame. 8. Fan section should have reputed make DIDW centrifugal fans (Nikotra Comefri/Kruger make) statically and dynamically balanced, drive package with

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belts & pulleys, TEFC motor to drive the fan. Fan section should have GI/Al volume control damper at the outlet of AHU.

Air Conditioning Unit: 1. There should be one dedicated optimal 10-15 TR capacity Air-cooled Condensing Unit with scroll compressor (single or multiple, R22 as refrigerant) duly fitted with necessary controls along with control panel. 2. All refrigeration piping and fittings shall be included in the scope of work and refrigeration piping shall be routed upto AHU coil. 3. It should have a Humidistat (ON/OFF type) and a Thermostat. Air Circulation and Filtration: 1. Ducting: Its construction should be as per BIS 655, supply and return air ducting shall be made of GI sheet (120 gsm) as per BIS 277 with all duct supports of MS construction and primer painted and all joints sealed with silicon sealant. An optional quote for aluminium ducting (22/24G) should also be provided. 2. Insulation: All supply and return air ducting should be insulated with closed cell cross-linked polyethylene foam (Trolcellen), 13 mm on supply and 9 mm on return air ducts. All ducting (whether exposed or unexposed) must be factory foil laminated. 3. Return Air Riser: All return air (RA) risers should have GI Powder coated construction with joints between clean room wall panel and return air risers provided with aluminum coving and silicon sealant and inbuilt aluminum volume control dampers. Alternately, the return air risers may be in-built in the wall panels. 4. Hepa Terminal: All supply air terminals including four change rooms should have suitable number of HEPA filters of suitable capacity with an efficiency of 99.97 % down to 0.3 micron ( EU-12). A perforated and powder coated Al-sheet should be given below HEPA terminals. This MS Powder coated housing should have air volume control damper and the mechanism to operate the damper from bottom. It should also have DOP upstream concentration check port with dummy plug. Hepa size 610 x 610 x 150 mm for room and 305 x 305 x 305 mm for change rooms. Interiors and Finishes: 1. Wall Panels: Should be of 100 mm thick double skin progressive modular wall type made of 0.8mm thick powder coated GPSP sheets on both sides with 40 2 Kg/m density PUF as infill. The service panels should be covered with 0.8mm thick

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powder coated GPSP sheets and extruded aluminum profiles for fixing the service panels.
2. Ceiling: All conditioned areas should have 50 mm thick double skinned walk able

type clean room compatible false ceiling made of 0.8mm thick powder coated GPSP sheets on both sides with 40 2 Kg/m density PUF as infill. It should have sealed cutouts for HEPA filters & Light Fixtures installation and all the suspension material in Galvanized finish.
3. Covings: Should be extruded aluminum powder coated clip-on type for all wall to

wall and wall to ceiling joints but PVC coving for all wall to floor joints. 4. Light Fixture and Power Sockets: All conditioned areas should have suitable number of suitable capacity and clean room compatible light fixtures (bottom opening type) with clear glass at bottom. Lux level is NLT 400 at 1 meter from floor ( only WIPRO make). Power sockets for each equipment inside clean room should be provided. 5. Doors: The system should have optimal numbers of single leaf and double leaf type clean room compatible doors and accessories. They should be 44 mm thick both sides flush type made of 1.2mm thick CRCA / GPSP powder coated doorframes totally flush with the wall panels. Flush door leaves made of 0.8mm thick powder coated CRCA/ GPSP sheet with Honeycomb Kraft Paper / PUF as in-fill. 6. View Panels: Wall panels along the corridor should have double glass type rectangular (900/900 mm) and clean room compatible 4 view panels (silica gel in between the panels). 7. Change Rooms: 6 lockers and a wash basin to be provided in change room 1. Cross over bench to enter inside change room 2. Automatic dispenser for hand cleaning in change room 3. Door inter-lock facility to be provided in the change room doors.

8. Flooring: All conditioned areas should have scratch proof, fire proof, lab solvent resistant and clean room compatible vinyl flooring (2 mm thick vinyl sheet) with all joints thermally welded. (Tarkett make only). 9. Clean Room Testing: After complete installation and commissioning, the testing procedure should be provided and the clean room should be tested and validated for the following parameters .as per ISO 14644 -3 -Particle count in all classified areas -Temperature Page 3 of 5

-Humidity -Pressurization - ACPH - To include reports for DQ, IQ, PQ, and OQ. Miscellaneous: Two dynamic pass box (inner dimensions of 2X 2 X 2 size) in SS-304 construction with electrical interlocks and audio-visual communication. Each pass box should have hepa filter, UV tube with Hr. meter and magnehelic gauge. Electrical panel of 16 G CRCA coated Sheets with incoming ammeter, voltmeter, etc Copper bus bar and outgoing starter for AHU fan. Strip heater and outgoing feeder for condensing unit. Lighting and power DBs. Clean Room modular switches for lighting in all areas. Incomer cable from DG Panel to electrical panel for clean room including auto changeover facility. Copper earthing should be provided. Piping for CO2 and N2 supply to the incubators to be done at the site indicated in the lay-out. Temp, RH and pressure digital display units to be provided in all the rooms/areas. Smoke detection alarm system to be provided and it should be linked with the existing fire fighting system. All the required civil work should be done by the vendor.

Turn Key Project: The work has to be done as a turn-key project, in a maximum period of 12 weeks from the date of placement of the Order. Warranty: At least of 36 month from the date of handing over the system.

Note: Any vendor interested to visit the site, may contact Ms Pooja Bajpai, Project Asst, Dept. of Hematology, between 9.30 AM and 5 PM. Tel No: 2668700/2668800/2668900, Extn 3224, 3223

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