Active Member
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[China]
Address: LTPM CHINA 2nd Floor,Dongxin Road and 5th Development Road ,Caizhai Industrial Zone, Ruian City, Zhejing Province ,China
Contact name:Chan
Leadtop Pharmaceutical Machinery |
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Customized Class 100~100,000 Pharmaceutical
Sterile Operating Clean Room Production Workshop
Customized high quality pharmaceutical clean room
Specifications
Clean room - GMP Workshop Cleaning Series is suitable for the
pharmaceutical factory to lay out the pharmaceutical machineries
Clean room - GMP Workshop Cleaning Series is suitable for the
pharmaceutical factory to lay out the pharmaceutical machineries
and other related packaging machineries.
Definition of cleanse:
Smear exists during processing or handling objects will affect the
success rate, while controlling the smear on the processing object
will increase the success rate. Technology of cleanse and tarnish
control, usually called as tarnish control in international, is a
technique to control such smears (also including treatment and
isolation of harmful substances in the processing or handling
objects).
Manipulation of clean air:
Air from outdoor is processed by early effect segment, mixed with
indoor return air, and then filtrated by middle effect segment,
high effect segment to clean room, to control the number of
particles in the air below a certain number.
Air can also be manipulated by heating, cooling, humidification,
dehumidification, sterilization and et al, to receive certain state
like sterile, constant temperature and humidity.
According to the clean-level, indoor air can be organized in a
manner laminar, turbulent flow and mixing.
Clean possession of state:
Empty: Facilities have been completed, all connected to power
supply and run, but no production equipment, materials and staff
Dynamic: Facilities have been completed, production equipment has
been installed, operation under agree ment of business and vendors
agree, but no staff.
Static: Facilities run under stated condition, the presence of
stated person and work under promissory state.
Clean rank of suspended particles in air of clean room or clean area:
| ISO rank for air cleanness | Bigger or equal to maximum concentration limits in table (P/m3-air) | American federal 209E rank for cleanness | |||||
| 0.1um | 0.2um | 0.3um | 0.5um | 1um | 5um | ||
| ISOClass1 | 10 | 2 | |||||
| ISOClass2 | 100 | 24 | 10 | 4 | |||
| ISOClass3 | 1000 | 237 | 102 | 35 | 8 | 1 | |
| ISOClass4 | 10000 | 2370 | 1020 | 352 | 83 | 10 | |
| ISOClass5 | 100000 | 23700 | 10200 | 3520 | 832 | 29 | 100 |
| ISOClass6 | 1000000 | 237000 | 102000 | 35200 | 8320 | 293 | 1000 |
| ISOClass7 | 352000 | 83200 | 2930 | 10000 | |||
| ISOClass8 | 3520000 | 832000 | 29300 | 100000 | |||
| ISOClass9 | 35200000 | 8320000 | 293000 | 300000 | |||
Recommend for rank of clean workshop of related industry:
| Rank | 1 | 10 | 100 | 1000 | 10000 | 100000 | 300000 |
| Semiconductor Chip Manufacturing | √ | √ | √ | ||||
| Semiconductor Chip Package | √ | √ | |||||
| Electronic Components Production | √ | √ | |||||
| Precision Products | √ | √ | |||||
| Medical Injections | √ | √ | |||||
| Medical Oral Agent | √ | √ | |||||
| Aseptic Ward | √ | ||||||
| Operation Room | √ | √ | √ | ||||
| Aseptic Rearing Animals | √ | √ | |||||
| Precision Printing | √ | √ | √ | ||||
| Food Packaging | √ | √ | √ | ||||
| Food Canning | √ | √ |
