Biopharmaceutical Silicone Solutions

One of the most important applications of silicone in biopharma is in the production of biopharmaceutical drugs, which are large, complex molecules manufactured using living cells. Silicone tubing is often used to transfer these living cells between different parts of the production process, and silicone gaskets and seals ensure that the process is sterile and free from contamination. Momentive's comprehensive portfolio of silicone elastomers does not require plasticizers or additional organic additives and is qualified as ISO 10993 and USP Class IV compliant. Overall, Momentive's biopharmaceutical silicone can be utilized in injection molding, closed molding, and extrusion manufacturing.

Momentive performance silicone is a widely used material in the biopharmaceutical industry due to its unique properties, such as biocompatibility, chemical inertness, and thermal stability. Below are some of the ways silicone is used in biopharma.

Momentive Liquid Silicone Rubber  (LSR)

Momentive liquid silicone rubber (LSR) is a commonly used material in the medical industry due to its biocompatibility, chemical resistance, and durability.

One of the key advantages of Momentive LSR in biopharmaceutical applications is its ability to be molded into complex shapes with high precision, making it ideal for devices where accuracy and consistency are important and allowing for complex systems to be easily bent and manipulated to route fluid through a variety of devices. Furthermore, Momentive performance LSR offers self-lubricating and self-bonding advantages that aid in reducing assembly steps and friction for a higher-slip surface while meeting complex healthcare device designs.
 

• Biocompatible: USP Class VI and ISO 10993 (parts 5, 6, 10, 11) compliant
• Low extractables
• Maintains physical properties at low temperatures
• Self-bonding properties to thermoplastics
• No primer required
• Outstanding aging stability
• Improved productivity for multicomponent molding processes by eliminating the need for assembling

Momentive  High Consistency Rubber (HCR)

 
Momentive high consistency rubber (HCR) is a material often used in the biopharmaceutical industry due to its unique combination of properties that make it well suited for a range of applications. Momentive performance high consistency rubber silicone can be used in the molding of medical tubing to transfer living cells and fluids between different parts of the bioprocessing production process, and silicone ensures that the process is sterile and free from contamination.

Effects of Sterilization

Momentive performance silicone offers high thermal stability, making it an excellent product for biopharmaceutical and healthcare applications requiring sterilization by steam autoclave, ethylene oxide (EtO), or gamma radiation. The graphs below show the performance of the silicone rubber poststerilization.

Sterilization Resistance 

Momentive performance materials offer the strength of a silicon-oxygen backbone which offers high stability when various sterilization resistance is required. Because of their inherent chemical properties, silicone elastomers are excellent materials for biopharmaceutical and medical applications that require not only sterilization but even repeat sterilization processes. The charts below depict the performance of various Momentive silicone products against exposure to various sterilization tactics. 
 

Summary

Talk to one of our technical specialists today about which Momentive grade would work best for your biopharmaceutical applications.