Category: Single Use Systems

MDI Single Use gamma sterilized bottle assemblies are suitable for the safe transfer, sampling, and storage of biopharmaceutical products and reagents. These Assemblies for inoculum transfer are gamma sterilized vented assemblies to transfer cell culture to bioreactors. These assemblies have been designed to provide a closed system to prevent extraneous contamination during inoculum transfer.

These assemblies are fitted with a self-supporting lightweight, sterilizing grade 0.2μm PVDF vent filter to prevent ingress of microorganisms during filling and removal of high-value products.

The unique bottle cap design allows easy opening without rotating the tubing and vent connections.

MDI Single Use Bottle Assemblies are available with 3 different materials of construction:

• Single Use Assembly for Inoculum Transfer (Polycarbonate Bottle)
• Single Use Assembly for Inoculum Transfer (LDPE Bottle)
• Vented Bottle Assemblies (PETG Bottle)
• Mixer Bottle Assemblies with PVDF Stirbar

Applications:

• Storage and transfer of Cell culture media
• Aseptic sampling
• Sterile filling and transfer
• Aseptic inoculum transfer to bioreactors

Customization:

MDI Vented Bottle assemblies can be customized to suit user requirements in terms of tubing, fittings, end connections, and connectors.

Process owners in biopharma manufacturing are concerned about leakages and contamination in single use systems. Annex1 also highlights that manual handling activities associated with single-use systems, such as assembly and connection of components require appropriate controls and must be verified during Aseptic Process Simulation (APS). Where there is a potential risk to product sterility, suitable system integrity testing should be implemented to demonstrate robustness.

Furthermore, Annex 1 emphasizes that closed systems should be intentionally designed to minimize manual interventions and the risks they introduce. Thus, SUS assemblies should be engineered with the minimum number of connections necessary, using robust, well-qualified connection technologies to reduce contamination risk and ensure consistent aseptic performance.