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.
Mdi has introduced overmolded platinum cured silicone connections to minimize tube to fitting connections in critical single use fluid management systems such as PUPSIT and filling line assemblies. Overmolding of platinum cured silicone tubing provides seamless robust connections that eliminate risk of leakages and liquid entrapment in inner bore. These also help mitigate the possibility of any particulate contamination during manufacture of these critical single use systems.
A wide range of overmolded connections such as T and Y connections, Cross connections, straight step-up or step-down connections are available (see images above).
The impact of such overmolded connections is significant. For example, in Figure 1 (a typical assembly) , the total number of connections is 56, whereas in Figure 2, in which overmolding technology is adopted, there are only 13 connections.
Overmolding of platinum cured silicone tubing provides the flexibility to autoclave the single use liquid transfer assemblies and reduces the probability of leaks after autoclaving.
Overmolding also helps minimize risks associated with container closure systems for autoclavable bottle assemblies such as breach of sterility and loss of high value process fluids. Overmolded silicone cap adapters integrated with autoclavable bottle assemblies ensure aseptic sealing of bottle assemblies.
To learn more about how overmolding can optimize your single-use system design and reduce contamination risk, connect with our team or explore our full range of solutions. Email: info@mdimembrane.com to learn more.
Please note: mdi manufactures a wide range of platinum cured silicone (PCS) and Thermoplastic Elastomer (TPE) tubing for various applications such as transfer of fluid; high pressure tubing to replace braided tubes in PUPSIT; pump tubing; and accurate dispensing tubing for filling lines.
The PCS tubing assembly can be offered with a diverse selection of overmolding connections such as T and Y connections, Cross connections, straight step-up or step-down connections.