Final fill & storage, including sterile filtration
Fill and Finish processing comes after downstream purification. This is where the final product is of the greatest value and thus one of the most critical steps. Any product which is contaminated or packaged incorrectly can result in safety issues, production failure and loss of expensive product. Therefore, it is important to maintain the sterility and quality of the (bio)pharmaceutical product.
We offer both standard designs of Single use assemblies, dedicated for fill and finish applications and also customized assemblies. These assemblies can be placed into the filling machine or can be used as a complete single use filling line.
- Standard or custom single use transfer assemblies (barbed or molded) can be used for transferring the product to the filling machine.
- Standard or custom single use tubing sets, including filling needles, can be placed into the filling machine to fill the biopharmaceutical end product into vials, bottles or bags.
- Standard or custom single use bag assemblies can be used to fill bulk product into vials.
- Platinum cured silicone tubing
- Pump grade tubing
- Alternative to the sterile connector – Biopharmaceutical TPE tubing; to create a sterile closed system for transporting (bio)pharmaceutical product to the filling lines.
- Gamma sterilized 2D & 3D bags can be used as a starting point for the fill and finish line or can be used to storage the bio-pharmaceutical product.
- 2D Aramus single use cryo bags can also be placed at the end of the fill and finish application. These cryo bags with filled bio-pharmaceutical product can be stored at -85°C and can be transported to customers.
- Sterilizing grade filters from Parker can be used to perform a sterile filtration of your biopharmaceutical solution before going to the filling machine.
- The single use/multi use pump system with magnetically levitated bearingless motor technology can be very useful to fill the (bio)pharmaceutical end product into vials, bags or bottles.
Plastic Fittings & Connectors
- Alternative to welding with TPE tubing – Sterile connectors, up to 1.5”, can be useful to connect the bioreactor to the filling machine, while keeping the system closed and sterile. These connectors maintain the sterility of the liquids. The sterile connection can also be made outside a cleanroom.
- Pinch valves can be used to shut off some fluid paths.
- A single use pressure sensor can be placed in front of the sterile filter before filling. Pressure can be monitored to control the sterile filter’s capacity.
- Single use bottles are very useful to place at the end of the filling line. Depending on the required volume, you can fill these bottles and use them for storage of the biopharmaceutical product as well.
- Sampling bottle system available from 60mL bottles to take sterile sample of the product to check the quality.
- Sampling bag system from 50mL bags to take sterile samples of the product check the quality.