The biopharmaceutical and healthcare industries continuously innovate to keep up with aging populations, long-term care needs, and people living with increasing diseases, such as diabetes. And the biopharmaceutical industry requires high-performance materials to keep up with new medical advances and regulations.
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 Silicone for Biopharmaceuticals
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. Here are some of the ways silicone is used in biopharma:
Medical Devices
Silicone is used in the production of medical devices, such as catheters, tubing, and personal protection equipment (PPE), due to its biocompatibility and flexibility. It can be molded into various shapes and sizes and withstand repeated sterilization without losing its physical properties.
Drug Delivery Systems
Silicone is used in controlled-release devices and drug delivery systems, such as hoses, tubing, and drug pumps. It can be designed to release drugs at a specific rate over time and for sustained drug delivery.
Parenteral Packaging
Silicone is used in parenteral packaging, such as vials and syringes. It provides a barrier to moisture and oxygen, ensuring the stability and shelf life of the drug product.
Bioreactors
Silicone is used in constructing bioreactors for cell culture and fermentation processes. It is used as a sealing and tubing material due to its biocompatibility and ability to withstand high temperatures for long pump life capabilities.
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 reduce friction for a higher-slip surface while meeting complex health-care healthcare-device designs.
Biocompatible: USP Class VI and ISO 10993 (parts 5, 6, 10, 11) compliant
Low extractables
Maintains physicals properties at low temperatures
Self-bonding properties to thermoplastics
No Primer required
Outstanding aging stability
Improved productivity for multi-component molding processes by eliminating the need for assembling
This product offers biocompatibility, improved tear resistance, longer-lasting lubricating benefits for molded parts, and delayed lubricant surface bloom while lowering the coefficient of friction.
Momentive High Consistency Rubber (HCR)
Momentive High Consistency Rrubber (HCR) is a material that is 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 sSilicone ensures that the process is sterile and free from contamination.
This is a two-component platinum cured, Shore 50A durometer silicone elastomer. This grade provides biocompatibility and low hysteresis for extruded silicone tubing.
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, Eethylene oxide (EtO), or gamma radiation. The graphs below show the performance of the silicone rubber post-sterilization.
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.
Conditions
EtO concentration
600 mg/L
Chamber temperature
54.4ºC
EtO pressure
26.6 psia
Exposure time
2 h
Pre-humidification time at 60% RH
30 min
Post vacuum
1.45 psia
Pre-vacuum
1.5 psia
Air washes
3
Summary
Talk to one of our technical specialists today about which Momentive grade would work best for your biopharmaceutical applications.
