GMP Cell Preparation Workstation-Cell and gene therapy（ATMP）-SRI (Jiangsu) Biological Equipment Co., Ltd.

GMP Cell Preparation Workstation

The GMP cell preparation workstation is suitable for process scenarios related to cell and gene therapy (ATMP), and can be project-based integrated around equipment interfaces, operating methods, and validation requirements.

The system supports customization based on on-site space and upstream and downstream processes, taking into account operational safety, convenient maintenance, and stable operation.

Product features

Customized and modular design builds cell production platforms adapting to various cell drug preparation processes and production schedules
Positive pressure vertical unidirectional flow design complies with GMP standards
Fast VHP sterilization transfer technology realizes rapid sterilization and delivery within 8 minutes
Superior airtightness with hourly leakage rate below 0.5%vol/hr
Built-in hydrogen peroxide resistant particle and airborne bacteria detectors support in-situ sterilization to reduce incomplete sterilization risks of sampling pipelines
Split glove design combining gloves and sleeves fits hands perfectly for precise operations
Optional wireless glove integrity tester enables wireless transmission and storage of test data
Siemens control system satisfies GAMP 5 and FDA 21CFR PART 11 specifications for electronic records and electronic signatures
Professional VHP sterilization cycle development and validation services (CD/CV) are available

Technical parameters

Cleanliness Class

A-level

Airflow form

Vertical unidirectional flow

Airflow velocity

0.45m/s±20%

Illuminance

Working height ≥ 500LUX

Noise

≤75dB

Door sealing method

Adopting inflatable sealing and tempered glass with a thickness of ≥ 15mm

Fresh air volume

≥ 1200m ³/h during sterilization

Power supply

220V/380V 50Hz

Common Medium

Clean compressed air 0.6Mpa ≤ P ≤ 0.8Mpa

Power supply

220V/380V 50Hz