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 De-
fumigation 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
Page 1 of 5
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/m³
density PUF as infill. The service panels should be covered with 0.8mm thick
Page 2 of 5
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/m³ 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 2’X 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
Page 4 of 5
------------------------------------------------------------------------------------------------------------
Page 5 of 5