How do medical and pharmaceutical grade silicones contribute to Healthcare?
Silicones are used as essential components in life-enhancing and life-saving medical technologies. Below, we respond to key FAQs regarding silicones in healthcare.
What do the terms “medical and pharmaceutical-grade silicones for healthcare” mean?
The various terms – medical-grade, pharmaceutical-grade, and healthcare silicones – are used in the Life Sciences industry to qualify silicone materials that have been produced and tested to specific standards and/or in accordance with requirements for use in human healthcare applications, which typically include Class VI USP and/or select sections of the ISO 10993 standards. They are constantly monitored and inspected to make sure they are safe and efficacious. The control process is also applied in how these products interact with other materials, such as metals, glass or plastics and the people involved in healthcare are carefully trained to make sure they use the products properly for their intended purpose. The main characteristics of these high-grade silicone products are their purity, biocompatibility, cleanliness and consistency. The goal is to ensure that the products have been tested and demonstrated to be safe for human beings in all applications and produce the expected results for life-enhancement and life-saving care.
Are medical grade silicones safe for human beings, in terms of the ingredients they contain?
Medical and pharmaceutical grade silicones made by Elkem Silicones are fully tested to comply with the strictest national and international regulatory standards to ensure they are safe and used strictly for the designated applications in accordance with ISO 10993-1 standards. For example, our SilbioneTM line of medical grade products are subjected to exaggerated extraction testing procedures, based on the ISO 10993-12 standard, in polar and non-polar solvents prior to biocompatibility testing. All our healthcare silicone products are made of synthetic materials and are free of any natural latex, TSE/BSEs, GMOs or BPAs and do not contain any animal-derived ingredients. Since medical grade silicones are in direct contact with human beings in a wide variety of life-enhancing and life-saving medical devices, they are produced in strictly controlled manufacturing processes (e.g. cleanrooms).
What are medical grade silicones used for in healthcare?
- Fluid management in medical devices, such as tubing, drains, catheters and valves are often made of silicones because of their inherent characteristics, such as biocompatibility, chemical inertness, purity, and stability.
- Adhesives for wound-care products to make skin-friendly, low-trauma, anti-allergenic bandages, dressings and surgical tapes. They are designed to alleviate pain when removing skin adhesives and avoid exacerbating existing wounds and ulcers or creating new ones.
- Transdermal patches which enable medicines and analgesic products to be gradually absorbed by patients, eliminating the need for invasive injections or oral ingestion, providing exactly the right doses needed over time.
- Other applications include medical implants, audiology devices, pacemakers and other devices used in cardiac resynchronization therapy (CRT), vaginal rings (IUD devices), audiology applications, etc.