GMP Cell Preparation Station

Controlled Environment and Integrated Equipment

In accordance with specific User Requirement Specifications (URS), the critical equipment necessary for cell processing is integrated into a localized Grade A (ISO 5) environment. This configuration may include:

• Centrifuges

• Shakers

• RTP (Rapid Transfer Port) incubators

• Dry bath incubators (metal baths)

• Microscopes

The station features an ergonomic design and simplified operational controls, ensuring high-efficiency workflows within the controlled environment.

Aseptic Process Integrity

The system provides a comprehensive aseptic guarantee during the entire cell preparation cycle. It enables the seamless execution of the following operations within a closed or protected environment:

• Cell separation and extraction

• Activation and sampling

• Cultivation and media exchange

• Observation, monitoring, and harvesting

These processes are managed in combination with a proprietary GMP cell preparation management system, ensuring data integrity and process repeatability.

Applications and Regulatory Compliance

This station provides a practical, ergonomic, and fully compliant solution for the production of cell therapy medicinal products (ATMPs). It is engineered for: