Is Apple Rubber ISO 13485 certified?

No, Apple Rubber is a component manufacturer. We do not manufacture or assemble medical devices. Apple Rubber is ISO 9001 and AS 9100 certified. Our quality system is continuously audited by customers to the ISO 13485 standard. These customer audits typically yield only opportunities for improvement. We welcome all customers to tour our facility and audit our quality system.

Do you have a certified clean room?

Apple Rubber has an ISO 14644-1 Class 7 (FS209E class 10,000) clean room used for molding, cleaning, inspecting and packaging medical product. Testing and monitoring of cleanroom areas to prove continued compliance is conducted in accordance with the Recommended Practices detailed in IEST-RP-CC006.3 and in accordance with ISO 14644-2 specifications.

How do we control Particulate/FM?

Apple Rubber has clean room facilities for processing medical product. Regular particle counts are performed to ensure the clean room is performing to expectation. In addition, a FOD (Foreign Object Debris) program is in place in all critical processing areas.

What type of cleaning capabilities does Apple Rubber have?

Apple Rubber has a detergent based Ultrasonic Cleaning System within our clean room facility. We also have detergent based cleaning capability for products prior to going into our clean room.

Do we have a Cleaning Validation?

Apple Rubber has created and executed cleaning validations based on specific customer requirements. These requirements may specify part processing and cleaning, and then testing a sample for: 3 category bioburden (Aerobic, Spore, Fungal), 4 category bioburden (Aerobic, Spore, Fungal, anaerobic), cytotoxicity, bacterial endotoxin concentration, particle counts, etc. Please contact us to discuss your particular cleaning validation requirements.

What type of validation activities has been performed at Apple Rubber?

Apple Rubber performs many different types of part validations for our customers. This varies from basic first article inspection reports (FAIR) through the production part approval process (PPAP) and full IQ / OQ / PQ creation and execution. Common documentation includes: master validation plans (MVP), installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ), validation summary reports (VSR), as well as other bespoke validation documents that can be used to build objective evidence showing that our manufacturing processes can create rubber parts that consistently meet specific component specifications. Every application and component has a different level of risk associated with it, which drives the need for a custom validation strategy. Apple Rubber is familiar with a wide variety of validation approaches and will work with you to create the most efficient and cost effective validation effort.

Is Apple Rubber qualified as GMP factory?

No, Apple Rubber is only a rubber component manufacturer. As such, we are not directly connected to the FDA and are not required to hold ISO 13485 registration. We are however registered to ISO 9000 and AS 9100. We manufacture rubber components for many major medical device manufacturers around the world.

What levels of medical grade materials do you offer?

We work with all major providers of medical grade silicones. In addition, we have compounds tested that are EP and FKM. It is up to the customers to approve these materials. ISO 10993 is just a testing protocol from materials used in medical devices. There is no certification to ISO 10993. Materials are just tested to the various listed test in the standard. UPS Class VI is another testing protocol for materials used in pharmaceutical applications. See our Free eBook “The complete guide to medical-grade rubber.”

What is an FDA rubber compound?

Typically in the rubber industry, FDA materials are rubber compounds that comply with FDA 21 CFR 177.2600 which is for rubber in contact with food. FDA USP Class VI is a designation for medical grade for parts used in pharmaceutical applications. We highly recommend making sure when purchasing parts to be clear what level you require for your applications.

Do you offer colored medical grade silicones?

Yes, we have pigments that have been tested and certified for medical use.

Are there external coatings for o-rings to lower friction?

We will send out our o-rings to be parylene coated and other medical grade coatings as a service for our customers where friction is an issue.