When disposable medical equipment manufacturers design precision devices, friction between moving parts can be difficult to manage. Engineers typically use medical device lubricants, including oils, greases or dry surface coatings to smooth the delicate movements of parts.
Lubricants reduce the friction and sticking of parts that slide, shear, twist, rock or pivot. They resolve ‘stiction’ problems commonly found in single-use disposable medical devices such as cutting tools, staplers, staples, catheters, hypo tubes and other assemblies that utilize surface to surface movement during use.
Duraglide™ Dry Lubricant reduces the coefficient of friction on treated parts to as low as 0.06. This typically translates into a 25-30% reduction in actuation forces, greatly improving the finished assembly’s performance. Many of today’s complex medical devices would not be commercially viable without the aid of a lubricating coating like Duraglide Dry Lubricant.
In addition, Duraglide Dry Lubricant is also used on device-assembly equipment and fixtures to help speed the production of plastic and metal components. It is applied to chains and pulleys, metal extrusions, machine window guides and door tracks, part feed chutes and slides, conveyors and almost any other surface or assembly that benefits from a clean, durable, slick coating for optimum performance. Duraglide Dry Lubricant also helps release plastic parts from their injection mould die cavities without leaving an oily film. Here are other key benefits of Duraglide Dry Lubricant.
Hostile to biologic contamination:
Duraglide Dry Lubricant is a milky-white, medical-grade, dry lubricant using ultra-small PTFE particles to reduce friction. It is pre-mixed and packaged using factory-precise calibration during blending. A basic 2% concentration of solids dispersed in a solvent-based carrier fluid is often the ideal concentration. The Duraglide Dry Lubricant coating is certified as ISO 10993 tested and is hostile to bacterial growth and other bioburden issues. In addition to being inimical to pyrogens, it is compatible with all commercially used post assembly ETO (Ethylene Oxide), ultrasonic and radiation sterilisation processes.
Unlike most lubricant oils, Duraglide Dry Lubricant is non-migrating making it ideal for use in a cleanroom. This helps ensure a faster and easier validation for the coating process, its use on the treated device and for maintaining cleanroom protocols without added housekeeping requirements.
Duraglide Dry Lubricant has excellent materials compatibility. It is safe to use and effective on a variety of materials including metal, glass, plastic and ceramic parts commonly used on medical devices.
Good dispersion and low viscosity:
Duraglide Dry Lubricant is typically applied using dipping, spraying or wiping processes. The carrier fluid disperses the coating onto the treated surface then quickly evaporates, leaving a very thin, dry, uniform layer on the surface of the treated part. Duraglide Dry Lubricant also has a low viscosity to wet all surfaces and conform to the treated parts’ surface geometry. This ensures a highly-consistent surface coating in high volume production environments, even on complex geometries or assemblies. It is low odour and leaves no residue (other than the coating being deposited on the substrate).
Duraglide Dry Lubricant is easy to apply using simple in-house assembly processes. It comes packaged ready-to-use minimizing labour-wasting mixing or batching inconsistencies. It has an outstanding particle ‘hang-time’ with minimal bath agitation to consistently deliver smoother coatings. There’s no need to outsource your coating process. This saves both time and money in validating your assembly process since you always maintain custody of the parts during treatment.
Duraglide Dry Lubricant is nonflammable reducing shipping and storage costs while maintaining a safe work area when it is applied to devices. This is especially important for high-volume, high-speed production facilities. Many mechanical assembly operations are prone to static discharge, so nonflammability for safety during use is essential.
Durable and Attractive:
Duraglide Dry Lubricant coating quickly dries into a coating that is ideal for single-use/single procedure devices. It is often used as-applied, but the coating can be hardened using a simple post-application heating process called melt coating, giving the coating a longer service life. Melt coating imparts a more durable, uniform coating without any staining or unsightly clumps, drips or runs that might otherwise obscure required Unique Device Identification (UDI) markings.
Duraglide Dry Lubricant stays where it is applied. Unlike oil-based lubricants, it does not migrate or transfer to packaging or other untreated surfaces. Nonmigrating also minimizes production line housekeeping which is essential in holding costs down when the lubricant is applied in a cleanroom environment.
Meets EU Medical Device Regulations:
With the industry transitioning to the new EU Medical Device Regulations (EU MDR; ref., EU 2017/745) Duraglide Dry Lubricant offers many advantages in validation of the manufacturing process, as well as the validation of individual devices requiring lubrication. Post assembly audits are simplified because parts and assemblies can be coated in-house without loss of custody to outside vendors. Cleanroom sanitation validation is simplified because unlike water-based processes, Duraglide Dry Lubricant is shelf-life stable and hostile to bioburden. The physical properties of Duraglide Dry Lubricant actually provide a proactive approach to a measurable improvement in device function during use, ensuring positive user feedback on device function during post-market surveillance. It all adds up to a simplified manufacturing process that is relatively easy to validate and maintain for long-term process consistency.
Finally, MicroCare Medical also provides expert advice to help you simplify your medical device coating selection. This includes individualised consulting, in-lab testing, and the ability to provide both off-the-shelf and customised formulations to ensure the right dry lubricant for your specific device needs. Duraglide Dry Lubricant comes in concentrations ranging from 0.5% to 10%. Custom formulations also are available.
Contact microcare.com for more information and to discuss how Duraglide Dry Lubricant can boost your medical device manufacturing performance.