· Enhancing Gamma & E-beam resistance for radiation sterilization
· Stabilization for autoclave steam sterilization
· Low dosage and high cost-efficiency
· Compliance with EU 10/2011, Pharmacopoeia 3.1.3 & 3.1.13 and FDA 21 CFR 173
· Application in PP, TPE, PE, PS, PA, ABS, PETG, PC, TPU, FEP, POM and PVC
Limax Chemical Pte Ltd specializes in developing high-performance stabilizers for protecting medical grade plastics against severe damage induced by radiation sterilization or steam sterilization. Use of these stabilizers is instrumental in creating Gamma-sterilizable and autoclave-compatible plastics. Our customers include both compounders and processors of medical, food and hygiene grade plastics.
Why is a radiation stabilizer needed for medical plastics?
Sterilization by radiation, either Gamma radiation or E-beam, has been widely applied for various medical plastics whereas the traditional ETO (ethylene oxide) sterilization is increasingly under scrutiny. The ETO method is likely to pose damage to either users, or production workers, or the environment if no precautionary measures are properly taken. On the other hand, the plastics sterilized by radiation might suffer adverse affects such as discoloration, deterioration in mechanic properties, and creation of unhygienic extractables. To counter all these, a specialized stabilizing additive needs to be added into medical plastics to boost radiation resistance.
Limax Chemical is proud to offer our RS-01 to meet the market’s demand for a high-quality anti-rad for sterilizable medical plastics. Moreover, as for the commercial radiation-compatible medical compounds or end-products already existing in the market, RS-01 can promise to further enhance Gamma or E-beam stability so as to meet more stringent or specific requirements accordingly.
What merits does RS-01 have as a stabilizer for sterilization?
- RS-01 can be either mixed with medical plastics resin and other additives to produce medical grade compound pellets, or directly added into the medical grade compound pellets purchased from a commercial supplier to make end-products such as film, tubing, packaging and device components by extrusion, injection molding, compression and so on.
- RS-01 can also be added into the commercial-grade compounds & end-products already claiming radiation sterilizability so as to further boost Gamma and steam stability.
- RS-01 is highly efficient in stabilizing medical plastics for radiation sterilization by Gamma ray or electron beam.
- RS-01 is also capable of stabilizing medical plastics for autoclave steam sterilization.
- RS-01 complies with EU Pharmacopoeia 3.1.3 & 3.1.13, EU Regulation 10/2011, and FDA Title 21 CFR Part 173.
- RS-01 applies to a variety of medical plastics including PP, TPE, PE, PS, PA, ABS, PETG, PC, TPU, FEP, POM, and PVC.
Examples for Gamma-ray & E-beam resistant formulations
- Medical consumable & appliance materials: medical grade plastics compound ― 99.9~99.5%; RS-01 ― 0.1~0.5%
- Medical film-grade PP compound: PP resin ― 98.5%; *antioxidant ― 0.2%; CS ― 1.0%; RS-01 ― 0.4%
- PC compound for dialyzers: PC resin ― 98.9%; *anti-oxidant ― 0.3%r; RS-01 ― 0.4%; others ― 0.5%
- ABS compound for medical appliances: ABS ― 98.6%; *anti-oxidant ― 0.2%; RS-01 ― 0.4%; others ― 0.8%
- FEP compound for medical appliances: FEP ― 99.3%; *anti-oxidant ― 0.2%; RS-01 ― 0.5%
- POM compound for medical devices: POM ― 74.2%; PTFE ― 10%; glass fiber ― 15%; anti-oxidant ― 0.3%; RS-01 ― 0.5%
*Antioxidant: phenolic antioxidant or/and hindered amine
Radiation stabilizers for PVC
PVC is used in a wide range of sterilizable medical consumables & devices. Sterile flexible PVC medical applications include blister packs, solution containers, fluid transport tubes, diaphrgms, pull rings, drip chambers, oxygen face masks, secondary packaging and gloves. On the other hand luer connectors and Y-sites are examples of rigid PVC and usually need sterilizing before use.
Strong PVC heat stabilizers, such as organotin stabilizers and high-performance Ca/Zn stabilizers, can boost radiation resistance in addition to heat stability, especially for rigid or semi-rigid PVC. However, even those very strong heat stabilizers alone still can not ensure sufficient protection for Gamma or E-beam exposure in radiation sterilization in terms of color appearance and mechanic strength. Therefore, specialized radiation stabilizers are needed on top of PVC heat stabilizers in order to overcome the problems like yellowish discoloration and loss of tensile strength after sterilization exposure at relatively high radiation dose, say, more than 2.5 Mrad for Gamma ray.
As such, Limax Chemical offers RS-06 and RS-08, both of which are radiation stabilizers specially designed for medical grade PVC. They are highly efficient stabilizers for either Gamma or E-beam sterilization. RS-06, which is in powder form, is recommended for rigid PVC thanks to its particularly strong stabilizing power, whereas RS-08, a transparent pale-yellow liquid, works well for flexible PVC due to its ease of dispersion in all kinds of liquid plasticizers. Both RS-06 and RS-08 can be used in semi-rigid PVC, depending on the specific amount of the liquid plasticizer.