Low Cyclic Silicone for Medical Packaging
Medical-grade silicone packaging materials must maintain sterility while meeting strict regulatory requirements for extractables and leachables. Current formulations show extractable turbidity levels above 0.3 NTU and can release unwanted residual compounds during sterilization processes at temperatures reaching 150-190°C.
The fundamental challenge lies in developing silicone compositions that combine low extractables with the mechanical properties needed for medical packaging—particularly elongation, tear strength, and dimensional stability through sterilization cycles.
This page brings together solutions from recent research—including modified crosslinking systems, optimized vinyl-terminated polymers, specialized filler technologies, and surface treatment approaches. These and other developments focus on achieving medical-grade performance while meeting increasingly stringent regulatory requirements for extractables and biocompatibility.
1. Silicone Compositions with Carbon-Based Backbone and PDMS-PEO/PPO Side Chains
MITSUBISHI CHEM CORP, 2023
Silicone compositions, films, and articles that have reduced protein adhesion and improved biocompatibility compared to traditional silicone materials. The compositions contain a polymer with a carbon-based backbone, side chains of polydimethylsiloxane (PDMS), and side chains of polyethylene oxide (PEO) or polypropylene oxide (PPO). The specific composition of side chains helps concentrate the polymer at surfaces, reducing protein adhesion compared to traditional silicone. The silicone films and articles made with this composition show reduced protein fouling in medical devices, foods, and sanitary products.
2. Crosslinked Silicone Compositions with Alkoxysilane Additive and Post-Crosslinking Water Immersion Treatment
WACKER CHEMIE AG, 2022
Crosslinked silicone compositions with low surface friction suitable for medical devices like catheters and syringes. The compositions are made by a process that involves crosslinking a specific silicone elastomer composition containing an alkoxysilane additive. After crosslinking, the material is allowed to rest for at least 30 minutes, then immersed in water for at least 30 minutes. This treatment reduces the surface friction compared to unmodified crosslinked silicone. The process steps of crosslinking, resting, and immersion are critical for achieving low friction properties.
3. Curable Liquid Silicone Rubber Composition with Reactive Terminal Groups and Fillers
ELKENN SILICONE CO, 2022
Curable liquid silicone rubber composition for drug delivery devices that improves active ingredient efficacy. The composition contains reactive groups like terminal alkenes, fluorides, or seleniums in the silicone chains. This allows better release of drugs like progestogens from the silicone elastomer after curing. The composition also has fillers like silica and resins. It cures at temperatures up to 220°C. The resulting molded silicone rubber is used as a drug delivery device like an intravaginal ring.
4. Organic Silicon Material with Enhanced Wear Resistance and Specific Composition for Medical Devices
CHANGZHOU NUOPOO NEW MAT CO LTD, 2021
Wear-resistant and long-life organic silicon material for medical devices that can address the shortcomings of current silicone medical products in terms of wear resistance and mass production. The material is made by combining specific amounts of silicone rubber, organosiloxane, fillers, molding aids, reinforcing aids, and crosslinking aids. The optimized composition enables improved wear resistance for medical devices like tubing compared to standard silicone rubber. The material can be prepared by mixing and molding the components.
5. Silicone Rubber Composition with Shellac Resin for Enhanced Gas Barrier Properties
SHIN ETSU POLYMER CO LTD, 2021
Lightweight, odorless silicone rubber with improved gas barrier properties for applications like food packaging, medical devices, and sensors. The rubber is made by adding small amounts of shellac resin (less than the silicone amount) to the silicone curable composition. The shellac melts during curing while the silicone crosslinks. The resulting rubber is lighter, almost odorless, and has better gas barrier properties compared to regular silicone.
6. Silicone Article Comprising Vinyl-Terminated Polymer and Fumed Silica Filler with Controlled Turbidity Levels
SAINT GOBAIN PERFORMANCE PLAST, 2015
Silicone article with low extractable turbidity levels suitable for medical applications. The article is made from a silicone composition containing a silicone matrix, fumed silica filler, and a vinyl-terminated silicone polymer with a viscosity of 500-5000 cP. This composition allows forming silicone articles like tubes with turbidity below 0.3 NTU. The low turbidity is achieved by using the specific vinyl-terminated silicone polymer with optimized viscosity.
7. Radiation-Stable Silicone Rubber Composition with Dispersed Antioxidant and Polydimethylsiloxane
TERUMO KABUSHIKI KAISHA, 2013
Silicone rubber composition for medical devices that can be sterilized by radiation without hardening. The composition contains an antioxidant dispersed in the silicone rubber, along with polydimethylsiloxane. The antioxidant and PDMS prevent radical crosslinking during radiation sterilization, limiting hardening of the silicone rubber.
8. Silicone Formulations with Polar Radiation Resistant Component for Gamma Irradiation Sterilization
SAINT-GOBAIN PERFORMANCE PLASTICS CORP, 2012
Radiation resistant silicone formulations for medical devices that can be sterilized using gamma irradiation without adversely affecting device performance. The formulations contain a small amount (0.1-20 wt%) of a polar radiation resistant component in the non-polar silicone matrix. The polar component has low viscosity (<70,000 cP) and prevents adhesion between contact surfaces of sterilized devices. The formulations enable sterilization of medical devices like valves without lubricants, reducing costs and simplifying manufacturing. The devices have good sealing and burst pressure after irradiation.
9. Composite Silicone Material with Reinforcing Silica and Block Copolymer for Barrier Coating
FEDERALNOE GOSUDARSTVENNOE UNITARNOE PREDPRIJATIE GOSUDARSTVENNYJ ORDENA TRUDOVOGO KRASNOGO ZNAMENI NAUCHNO-ISSLEDOVATELSKIJ INSTITUT KHIMII I TEKHNOLOGII EHLEMENTOORGANICHESKIKH SOEDINENIJ, 2009
Biocompatible composite silicone material for barrier coating applications like medical implants that minimizes penetration of uncrosslinked gel components through the coating. The composite contains a reinforcing silica-filled silicone rubber with low vinyl group content, along with a block copolymer containing both phenylsiloxane and organosiloxane segments. The organosiloxane segment has functional groups to chemically bind to the rubber binder. This composite has reduced swelling under the influence of uncrosslinked silicone gel compared to regular barrier layers.
10. Silicone Rubber Medical Devices with Homogeneously Dispersed Micron-Scale Antimicrobial Preservatives
BAYER INNOVATION GMBH, 2009
Silicone rubber medical devices like catheters with improved antimicrobial properties for preventing infections. The devices contain homogeneously dispersed preservatives with small particle sizes in the silicone rubber matrix. The preservatives are suspended in a medium like a silicone polymer or solvent. The suspension is mixed into the rubber formulation before curing. The dispersed preservatives provide long-term antimicrobial effectiveness against bacteria and fungi on the device surface. The preservatives have average particle sizes of 1-30 microns and a distribution of 0.1-30 microns.
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