IMeBIO, a pioneer in Europe to produce a GMP grade B in a container for Biopharma production
IMeBIO manufactures GMP and cGMP compliant facilities (Current Good Manufacturing Practice). Our modular cleanrooms are available in multiple configurations to suit a wide variety of cGMP product development applications. Each facility is designed and built to meet or go beyond current Good Manufacturing Practices.
IMeBIO's mobile/modular production unit serves the pharmaceutical industry, responding to production needs and easily integrated and deployed. This allows clinical trials to be conducted without a conventional CAPEX commitment, making it an attractive economic model.
The cGMP environment is configurated into standard transportable modular structures, designed with the appropriate airlocks for the flow of people and materials, and a dedicated and separate technical room.
IMeBIOs stand-alone, mobile/modular production unit serves the pharmaceutical industry, answering to the production needs and easy to integrate and deploy, allowing clinical trials without a conventional CAPEX commitment becoming then an attractive economic model.
This unit allows the implementation of new technologies for emerging therapies such as CAR-T and CGT or vaccine production as mRNA technology containerized factories.
IMeBIO manufactures innovative facilities that are always tailored to your needs.
Clearoom Classification Standards (ISO)
| ISO 14644-1 | FED STD 209 E | |
| ISO Class | English | Metric |
| 1 | ||
| 2 | ||
| 3 | 1 | M1.5 |
| 4 | 10 | M2.5 |
| 5 | 100 | M3.5 |
| 6 | 1,000 | M4.5 |
| 7 | 10,000 | M5.5 |
| 8 | 100,000 | M6.5 |
| Grade A | ISO 5(100) | Grade B | ISO 5(100) |
| Grade C | ISO 7(10,000) | Grade D | ISO 8(100,000) |
| CLASS | Number of Particles per Cubic Meter by Micrometer Size | |||||
| 0.1 µm | 0.2 µm | 0.3 µm | 0.5 µm | 1 µm | 5 µm | |
| ISO1 | 10 | 2 | ||||
| ISO2 | 100 | 24 | 10 | 4 | ||
| ISO3 | 1,000 | 237 | 102 | 35 | 8 | |
| ISO4 | 10,000 | 23,700 | 1020 | 352 | 83 | |
| ISO5 | 100,000 | 237,000 | 10,200 | 3,520 | 832 | 29 |
| ISO6 | 1,000,000 | 102,000 | 35,200 | 8,320 | 293 | |
| ISO7 | 352,000 | 83,200 | 2,930 | |||
| ISO8 | 3,250,000 | 832,000 | 29,300 | |||
| ISO9 | 35,200,000 | 8,320,000 | 293,000 | |||
