Customer

Celavie Biosciences | Oxnard, USA

Customer Challenge

Build a cGMP cell culture isolator for cryovials filling

User Requirements – Celavie Biosciences

The manufacturing process is a mixture of closed and aseptic manufacturing steps. Critical aseptic steps include the preparation of a master cell bank, a working cell bank, and final formulation and filling of drug product. These steps were identified as high risk steps for potential contamination through a comprehensive risk assessment.

Isolator technology has been identified as a mitigating action to reduce the potential of microbial contamination of master and working cell bank filling and final drug product formulation and filling processing steps.

Solutions Highlights

Cell Culture Isolator is an isolator designed for laboratory professionals who require aseptic conditions for handling sterile products.

It is specially designed for handling cell cultures in a pharmaceutical context that complies with the GMP guidelines, with marketing authorisation.

Inside the isolator are the standard laboratory instruments for analysing and handling cell cultures.

The isolator works in positive pressure relative to the laboratory.

The isolator comprises a pre-chamber, used for introducing the materials, and a main chamber, used for the handling of cell cultures.

The isolator is equipped with a VPHP (Vapore Phase Hydrogen Peroxide) generator for the decontamination of the work areas.

Highlights

• Laminar airflow
• Fully PLC controlled
• Software GAMP 5 compliant (21CFR Part 11 available upon request)
• Friendly operator interface (HMI)
• Integrated decontamination system (Vapor Phase Hydrogen Peroxide)
• Integrated customized CO₂ incubator
• High grade stainless steel AISI 316L internally and AISI 304 externally
• Fully welded chamber with 20 mm radius