Medical Grade Elastomers: Understanding the Basics
Definition and Testing Protocols
Medical grade rubbers are a specialized group of compounds typically tested to FDA USP Class VI standards and ISO 10993 test protocols. These rigorous testing procedures ensure the safety and biocompatibility of materials used in medical applications.
FDA Rubber vs. Medical Grade Rubber
- FDA Rubber typically refers to food contact rubber complying with FDA 21 CFR 177.2600
- Specifies allowable ingredients in rubber formulations
- Requires extraction testing in water and oil
- Medical Grade Rubber meets more stringent biocompatibility and safety standards for medical use
For more detailed information, refer to our comprehensive guide: "The Complete Guide to Medical Grade Rubber."
Key Properties of Apple Rubber's Medical Grade Elastomers
Our medical grade elastomers offer improved chemical resistance, excellent heat resistance, and low permeability to gasses
Featured Medical Grade Elastomers
- Liquid Silicone Rubber (LSR)
- Temperature Range: -85°F to +400°F
- Key Benefits: Excellent biocompatibility, resistance to extreme temperatures
- Fluoroelastomer (FKM)
- Temperature Range: -13°F to +446°F
- Key Benefits: Outstanding chemical resistance, high-temperature performance
- Ethylene Propylene (EPDM)
- Temperature Range: -60°F to +275°F
- Key Benefits: Excellent resistance to steam, hot water, and polar solvents
Medical Parts and Seals: Applications and Manufacturing
Manufacturing Capabilities
Apple Rubber employs advanced technologies and processes to ensure consistent, high-quality production:
- LSR (Liquid Silicone Rubber) manufacturing capabilities
- Class 10000 ISO-07 Clean Room for contamination-free production
- All manufacturing conducted in our USA-based plant
- Rubber Injection, Compression and Transfer Molding
- Automated Cleaning system with controlled water to tested bio-burden levels
Range of Medical Applications
Our sealing solutions cater to a wide array of medical applications, including:
- O-Rings for medical testing consumables
- Seals for medical appliances
- Ventilator components
- Medical pump seals
- IV components
- Feeding devices
- Implant materials
Material Compliance
We offer materials that meet the most stringent medical standards, including:
- USP Class VI compliant materials
- ISO 10993 compliant materials
- Sterilizable materials: ETO, Gamma, Autoclave
The Importance of Precision in Medical Sealing
In medical applications, the margin for error is virtually non-existent. Precision in sealing components is crucial for several reasons:
- Patient Safety: Ensures that medical devices function as intended, protecting patient well-being
- Device Reliability: Contributes to the longevity and consistent performance of medical equipment
- Contamination Prevention: Helps maintain sterile environments in critical medical procedures
- Regulatory Compliance: Meets strict industry standards and regulations, full IQOQPQ documentation and qualification for new part designs
Apple Rubber's Capabilities in Medical Sealing
Precision Molding
Apple Rubber's molding capabilities meet the highest industry standards for precision. We excel in:
- Custom-designed parts and seals
- Microminiature sealing solutions
- Producing o-rings in various sizes, durometers, and materials
Our custom molding expertise complements our vast inventory, allowing us to provide comprehensive sealing solutions for the medical industry.
Innovation in Medical Rubber Sealing
Apple Rubber continues to innovate in the field of medical rubber sealing:
- Development of new, biocompatible compounds
- Advancement in microminiature sealing technologies
- Cold drop molds for low material scrap and flash extension
For more information on medical parts and seals, or to discuss your specific medical sealing needs, contact Apple Rubber today.