OPEN RABS Conforming to FDA/GMP/ PIC/S
The filling operation of injections and Ampoule agents must be conducted in a clean and aseptic environment conforming to the specifications of FDA/GMP/PIC/s. Therefore a clean booth able to correspond to the high precision inspection requirements is required. The body is made of rust-proof stainless steel materials with strong pollution resistance property. It is applicable to operation sites with frequent applications of chemical solution and of high humidity. The materials and surface processing of this equipment can be duly changed in accordance with client requirementsAseptic Therapy Room
- The down flow manner is adopted, with cleanness at ISO5 (Class 100). Booths of other cleanness classes can also be planned.
- The average air blowing speed is 0.45m/sec±20%.
- The PAO particles for HEPA filter and inspection is provided to inspect if dust is outspread.
- The specifications of main parts are standardized and inventory-oriented to shorten the delivery period.
- Various cleaning equipment with multiple functions are provided to be used for clean rooms of various fields. Clients can choose according to the service environment, objectives, etc.
- Specifications such as PVC curtain, polycarbonate board, or SUS plate, etc. can be selected for the equipment side.
- A client can choose to buy products conforming to the specifications of FDA/GMP/PIC, of designated material (SUS304, 316, etc.), and surface grinding treatment(hair-line surface treatment, polishing and grinding). Products of special sizes can also be customized according to client requirements.
|Cleanliness||GRADE A(US.FED.STD.209DCLASS 100)|
|Filter Efficiency||0.3μm particle above 99.99%|
|Dust collection||Main filter:HEPA filter|
|Element||Pre filter: non-woven fabric filter|
|About 84 m3/min|
|About 0.45 m/sec±20%|
|Air change||About 664 times/hour|
|Power supply||0.51 M/S
(As the height of the operation opening is at 200mm)
|Poewr consumption||Galvanized steel plate coating with painting|
|Illumination||T5 14Wx4 units|
|Bactericidal lamp||10W×6 units|
|Structure||Body: SU304 hair-line surface treatment Column, cross beam
SUS304 hair-line surface treatment
|Side: Electricity-proof PVC curtain Ventilation punched plate SUS304|