Medical Device Qualified Supplier Directory
Apple Rubber Products Company Profile
Qualifications: ISO 9001, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe, Worldwide
Apple Rubber Products Inc.
Apple Rubber’s custom medical sealing solutions will meet your exact specifications, no matter the shape or size. From simple seals to the most complex parts, Apple Rubber utilizes a host of sophisticated technologies and processes – including LSR capabilities – to consistently manufacture the high quality components you demand, directly in our USA plant. We offer sealing solutions for applications such as seals for medical appliances, medical pump seals, IV components, feeding devices, implant materials, O-rings for dialysers, and more.
Our USA-based manufacturing facility features an ISO Class 7 (10,000) clean room, utilizing the highest quality standards. We deliver in weeks, not months for large and small runs. With parts and seals available in American or metric sizes, complete part traceability and full documentation is standard. Apple Rubber has the experience, the products and the design engineering capabilities to deliver the exact sealing solution for your medical applications.
Medical Grade Elastomers
Apple Rubber’s Medical Grade Elastomers are available in all shapes and sizes – and feature improved chemical resistors, excellent heat resistance, and low permeability to gases.
- Silicone (-85° to +400°F)
- Viton® Fluoroelastomer (-13° to +446°F)
- Ethylene Propylene (-60° to +275°F)
Medical Seals and Parts
From simple seals to the most complex parts, Apple Rubber utilizes a host of sophisticated technologies and processes – including LSR capabilities – to consistently manufacture the high quality components you demand.
- Seals for medical appliances
- O-rings for dialysers
- Medical pump seals
- IV components
- Feeding devices
- Implant materials
- Seals for non implantable
- Certification to USP Class 6 medical devices and ISO 10993 available
Apple Rubber’s ISO Class 7 (10000), Certified Cleanroom
Our cleanroom certification at Apple Rubber Products corporate headquarters in Lancaster, NY reflects our commitment to meeting our customers’ increased demands for cleanroom processing.
- Air handling system supplying the cleanroom area has recently been certified to ISO 14644-2-2000.09.15 (Testing and Monitoring). This corresponds to FS 209E Class 10,000.
- Air systems for the following areas have met ISO 14644-1-1999.05.10 guidelines to quality for the following cleanliness classifications:
- Main Cleanroom – Class 7 (10000) in an “As-Built” Mode of Operation at .5 microns
- Inspection (Gown) Room – Class 7 (10000) in an “As-Built” Mode of Operation at .5 microns.
Within the ISO Class 7 (10000) cleanroom we provide:
- Dedicated mold inspection area
- Complete processing, including production, washing and packaging area
- Multiple injection molding machines primarily for Liquid Silicone Rubber, and available for plastic and rubber
- Separate, fully automated ultrasonic parts cleaning area
Why Apple Rubber?
- Buy direct from our USA facility
- More than 30 years of seal experience
- Lot traceability
- Expert prototyping and fast turnaround
- Advanced production systems
- ISO 9001-2008 certified
- Durometer range of 10-80 Shore A
- Implantable-grade silicone available
- 3-D CAD design capabilities and full engineering assistance
- Restriction of Hazardous Substances (RoHS) compliance
- Leader in small-scale application
- FDA, ISO 10993 or USP Class 6 grades available
- Extensive range of silicone seals and parts: o-rings, gasket seals, face seals, housing seals, filter seals, custom shapes, and more
- Wide variety of colors available
Click HERE to link to Apple Rubber's Inspection Specifications.
Look into the future of sealing at applerubber.com
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O-rings (AS568 or ISO 3601)
Apple Rubber offers the seal industry's largest inventory of o-rings, which includes every standard AS568 and ISO 3601 size, and the following: Inside Diameter from 0.031 in (0.794 mm) to 26.0 in (66.04cm)Outside Diameter from 0.094 in (2.38 mm) to 26.5 in (67.31cm)Cross Section from 0.031 in (0.79...