Albright Technologies will ensure your prototypes and part orders will come with a complete record of traceability; including processing, material specifications, and silicone supplier agreement. We provide a Certificate of Conformance with every order of parts we manufacture. This includes relevant information including customer’s purchase order number, silicone manufacturer, product number, silicone lot number, manufacture date, post bake details, colors (if used), tool number, and Albright’s lot number of the parts. For those customers that require additional information on their Certificate of Conformance, we can add that pertinent info to meet your quality requirements.
Below is an example of a supplier agreement that lists application restrictions and usage responsibilities:
Wacker Health Care Guidelines
These guidelines relate to the use of Silicone products in the manufacture of medical devices.
- We do not sanction the use of our products for and do not sell into long term implant applications defined as greater than 30 days.
- In no case will we sanction the use of our products for the following applications:
- Cosmetic reconstruction (e.g. plastic surgery, prosthetic devices)
- Devices for gynecological or obstetric applications (e.g. pessaries, tampons, vaginal stents) except for diagnosis and monitoring and surgical instruments.
- Contraceptive or reproductive devices (e.g. condoms, condom lubricants, intrauterine devices, cervical caps)
- Free injections including the use of silicone fluids where they can be introduced directly into tissues, body cavities or blood (e.g. syringe lubricants, intraocular fluids)
- We will sell our products for fabrication of most short term implant devices (30 days or less) but we reserve the right to exclude selected applications.
- For those applications defined as short term implant or where medical equipment results in tissue or blood contact, the Wacker Health Care products will be tested to USP Class VI testing requirements which include:
- Systemic toxicity
- Intracutaneous toxicity
- Muscle implantation
- We will sell our products other than Health Care products for use in medical equipment where there is no contact with blood or tissue (e.g. skin contact only devices such as electrocardiographs) and these products will not necessarily be tested to USP Class VI requirements.
- We will sell our non Health care products for use in the manufacture of products used to manufacture certain dental devices with a contact duration of less than 24 hours. These products however, will not necessarily be tested to USP Class VI requirements.
- It is the responsibility of the customer to adhere to the curing and post curing conditions as specified in our elastomer product technical brochures.
- It is the customer’s responsibility to determine material suitability for the specific application and to comply with all applicable statutory, regulatory and health care industry requirements and/or standards for testing, safety, efficacy and labeling requirements and to meet these requirements and/or standards – including the applicable provisions for the Federal Food, Drug and Cosmetic Act particularly as amended by the Safety Medical Devices Act of 1990, and the regulations issued under these laws before any Wacker product is used in any health care device or other application.