Disposable sterile medical device products mainly include syringes, infusion sets, blood transfusion sets, injection needles, infusion needles, blood collection sets, etc. In their production process, especially the production of disposable needles and disposable syringes, it is necessary to use silicone oil to coat their surfaces for silicification, silicification of needle tips and silicification of inner walls, which can increase lubricity and reduce friction. At present, the domestic disposable medical device industry in the production and processing of injection needles, infusion needles, syringes and other disposable medical device products need to use cleaning agents to clean the products, while in the injection needles, infusion needles, blood collection needles, syringes and other products need to be silicified after assembly, after silicification treatment, on the one hand, can reduce the piston and the inner wall friction resistance, improve the lubricity of the product, on the other hand, can make the needle On the other hand, it allows the needle to form a smooth outer surface, minimising frictional resistance during puncture and improving the sharpness of the needle tip.
The principle of siliconising needles is to form a thin layer of silicone oil on the surface of the needle. However, due to the high viscosity of conventional silicone oil, it is necessary to dilute the silicone oil with a thinner before using it in the siliconising process. The usual practice is to dissolve the silicone oil in a volatile silicone oil diluent to form a dilute solution of silicone oil, then soak the needle in this solution for a period of time, allowing the needle to be coated with a layer of the solution, dry for a period of time, and then leave a thin layer of silicone oil on the surface of the needle once the volatile silicone oil diluent in the solution has evaporated, creating an extremely smooth surface. The diluent has two main uses, one is used as a silicone oil diluent for the siliconization of needle tips and syringes, and the other is used as a cleaning agent for the cleaning of needles and needle-making jigs.
At present, the domestic disposable medical device industry use of silicone oil diluent are mainly: HCFC-141b, HCFC-225, in addition to hydrocarbon products, etc.. Among them, HCFC-141b and HCFC-225 are ozone-depleting substances of HCFCs, with ODP value and high GWP value, and will complete the complete phase-out of HCFCs in the disposable medical device industry by 2020; hydrocarbon products have flash point, flammable and slow volatility, so the use of hydrocarbon products need to be equipped with fire and explosion-proof fire fighting facilities.
In response to the current situation of silicone oil diluent products in the disposable medical device industry, we have launched InnoFluo-003 silicone oil diluent (IF-003 silicone oil diluent for short), a replacement for HCFC-141b and HCFC-225 products. IF-003 Silicone Diluent is a safe and environmentally friendly product with an ODP of 0, a low GWP, a non-flash point and a non-combustible nature, which meets the current and future requirements of the disposable medical device industry for silylation and cleaning, while ensuring excellent solvency of silicone oils, as well as excellent chemical and thermal stability.
Table 1. IF Series Semiconductor Solvent Cleaner Product Characteristics
|Ø Ozone Depletion Potential (ODP) of 0
|Ø Low GWP
|ØLow surface tension
Ø No residues
|Ø High dissolution capacity
Ø Fast drying
|Ø No flash point
|Ø Excellent chemical stability
Ø Stable composition during use
|Ø Excellent thermal stability
|Ø Moderate boiling point
Ø Low equipment requirements
|Ø Low volatility and low consumption
Ø Distillable and recyclable
IF-003 silicone oil diluent has passed the biocompatibility and drug compatibility tests of authoritative institutions, and has been tested and passed in a number of disposable medical device manufacturers and has started to be used in the disposable medical device industry.IF-003 silicone oil diluent is suitable for the silicification and cleaning process of the disposable medical device industry, and its supporting process and equipment are the same as the original silicone oil diluent containing HCFC-141b. Basically no need to change the existing process and equipment.
(1) Silicification of puncture needles. IF-003 silicone oil diluent is used to dilute different manufacturers and grades of silicone oil, and the puncture force of the piercing needle after silicification meets the requirements of national standards.
(2) Syringe silicification. Using IF-003 silicone oil diluent to dilute different manufacturers and grades of silicone oil, syringes after silicification sliding performance in line with the national standard requirements.
(3) Cleaning of the silicone suit. Directly use IF-003 silicone oil diluent to replace the original HCFC-141b containing silicone oil diluent can be, the two cleaning effect is equivalent.