| 1. |
Name and layout for clean room: Names for various areas, process equipments layout, space and dimensions of construction area shall be specified in the drawings.
|
| 2. |
Cleanliness class for clean room: Required cleanliness class shall be specified (in case of regulatory requirement, design verification shall be made in parallel):
|
| 3. |
Detailed height of clean room shall include floor height above ground and locations of beam column, ceiling height of clean room, height under beam, height between tubing and room volume.
|
| 4. | Establishing requirement table for clean room equipments and cyclone equipments from proprietor, such as: |
| 1.Power consumption：____________KW |
| 2.Power supply type：__________phase__________Volt__________Hz |
| 3.Air exhaust：____________CFM |
| 4.Ice water flow：___________LPM |
| 7. | Heat production from process equipment/machinery：
Kcal/hr×__________unit， KW×__________unit， HP×__________unit、 |
||||||||||||
| 8. | Required exhaust (with gas type specified) ：
__________CFM，__________ CMM、__________ CFM，__________ CMM、 |
||||||||||||
| 9. |
Number of workers (maximum)：__________ persons.
|
||||||||||||
| 10. |
Required illuminance (with type of light source specified) ：__________Lux(70 cm above ground).
|
||||||||||||
| 11. | Positive pressure(airflow direction of each area specified)：
Cleanest area：__________mmAQ，Second cleanest area：__________mmAQ， |
||||||||||||
| 12. |
Noise value (with noise value before construction specified：less than__________dB
|
||||||||||||
| 13. |
Vibration(with vibration value before construction specified：vertical__________UM，lateral__________UM， side alternating__________UM.
|
||||||||||||
| 14. | Floor(with water content tested before construction)，for example： | ||||||||||||
|
|||||||||||||
| 15. | Insulation partition (with anti-erosion/salinization or anti-static materials for low humidity area，for example:： |
| □ | Nonflammable honeycomb metal plate （incombustible grade Ⅰ and grade） |
| □ | Fire-retardant PF foam metal plate（one hour fire-retardant） |
| □ | Mineral wool metal partition board（one hour fire-retardant） |
| □ | PU metal plate（incombustible grade Ⅰ and grade Ⅱ） |
16.Ceiling (with or without heat insulation slab)：
| □ | Ceiling Grid | □ | Calcium Silicate ceiling with hinted grid |
| □ | Metal plate identical to material of partition | □ | General light steel frame |
| □ | Others | ||
17. Personnel flow chart(with flow and shift number specified))：
| □ | Gowning room layout | □ | Layout and size of Air Shower |
| □ | Location of emergency exit | □ | Layout of shoes cabinet |
| □ | Layout of clothes cabinet | □ | Others |
18. Material flow chart (with volume and size for pass objects specified)：
| □ | Layout for Buffer room | □ | Layout and size for Air Lock |
| □ | Layout and size for PASS BOX | □ | Others |
19. Location and layout for control room(with floor height in building and construction area specified)：
| A. Location for cooling tower | B. Water chiller |
| C. AHU | D. Gas scrubber tower |
| E. Air compressor | F. De-ionized water room |
| G. Acid/alkali liquid storage tank | H. Gas cabinet |
| I. Vacuum pump | J. Switch box |
| K. Central control board | L. VOC |
| M. Socket | N. Others |
20. Type of sterile clean room (with industrial regulations specified):
| □ | Operation room（○Heart ○Brain ○phthalmology ○Embryonic transplant ○General） | ||||||||||||||||||||||
| □ | Burn ward（○Hydrotherapy ○peration room ○Hyperbaric oxygen ○Ward） | ||||||||||||||||||||||
| □ | TPN laboratory | □ | Embryonic culture room | ||||||||||||||||||||
| □ | Chemotherapy room | □ | Isolation room for respiratory (GI) infection | ||||||||||||||||||||
| □ | Negative pressure isolation ward | □ | TB laboratory | ||||||||||||||||||||
| □ | Bone marrow transplantation ward | □ | Sterile animal care room | ||||||||||||||||||||
| □ | P1~P4 laboratory(USA NIH standard) | □ | SPF animal laboratory | ||||||||||||||||||||
| □ | Non-SPF animal laboratory | ||||||||||||||||||||||
| □ | Food GMP or HACCP | ||||||||||||||||||||||
|
|||||||||||||||||||||||
| □ | Drug GMP or CGMP | ||||||||||||||||||||||
|
|||||||||||||||||||||||
| □ | Medical device GMP（ □ Invasive □ Non-invasive） | ||||||||||||||||||||||
| □ | Manufacturing procedures for purification, dispersion and etching of semiconductor wafer | ||||||||||||||||||||||
| □ | Lead frame itching and cut foot | □ | Surface treatment and metal evaporation | ||||||||||||||||||||
| □ | Assembly of lithium iron battery | □ | BONDING Bezel bonding | ||||||||||||||||||||
| □ | SMT | □ | PCB | ||||||||||||||||||||
| □ | LCD | □ | Gas/Solid state laser | ||||||||||||||||||||
| □ | Sputtering process | □ | Backlight plate, light guide plate | ||||||||||||||||||||
| □ | Optical lens | □ | Calibration and measurement laboratory(Secondary laboratory) | ||||||||||||||||||||
| □ | Precise printing | □ | Biochip | ||||||||||||||||||||
| □ | CD、VCD、tape | □ | Cementing room | ||||||||||||||||||||
| □ | LCM | □ | Precise coating | ||||||||||||||||||||
| □ | Seed storage | □ | Culture room(seed/tissue culture) | ||||||||||||||||||||
| □ | Capsule formation | □ | Coating room | ||||||||||||||||||||
| □ | Drying room | □ | Clean oven | ||||||||||||||||||||
| □ | Packing and storage room for missile and gun powder | ||||||||||||||||||||||
| □ | Aging Room (Burnin Room) | ||||||||||||||||||||||
21. Equipments to be provided by customer：
□ Water chiller__________RT
□ Vapor__________℃，__________㎏，Flow __________LPM
□ Cooling tower__________RT
□ Water pump__________HP × __________台
□ Other equipments