Clariant Introduces New Liquid Colors, Additives for Medical Devices, Pharmaceutical Packaging
Muttenz, October 13, 2016 – Clariant, a world leader in specialty chemicals, is introducing MEVOPUR®-LQ, a family of color and additive solutions that combines the benefits of the MEVOPUR 'Controlled, Consistent and Compliant' formulation and manufacturing approach with Clariant's HiFormer® liquid-vehicle technology.
Initial product releases include a transparent amber color concentrate suitable for polyethylene terephthalate (PET and PETG) materials typically used in pharmaceutical packaging, and color and additive concentrates formulated for liquid silicone resin (LSR) The major benefit of these concentrates is that the ingredients used in the formulation of the concentrate, are evaluated according to USP, and ISO10993 and other relevant industry standards , thereby helping to reduce the risk of interaction with the body and/or the drug.
The new MEVOPUR-LQ liquid concentrates being launched in Asia at MEDTEC Shanghai 2016, where Clariant is exhibiting on stand H202. The new products result from investment in R&D and new capabilities at Clariant's ISO13485 cGMP certified site in Singapore.
"Clariant sees great potential for growth in this segment within Asia," comments Derrick Chan, Segment Head Asia Pacific of Clariant Healthcare Polymer Solutions. "The selection of our Singapore ISO13485 cGMP certified site as the pilot location for the development of MEVOPUR-LQ demonstrates again that we are constantly investing in this region and coming up with new innovative products to better fulfill local customers' needs."
MEVOPUR-LQ concentrates have been developed for silicone elastomers, which have become materials of choice for a wide range of healthcare applications in sealing, wound care, tubing, catheters and, more recently, in personal monitoring devices. They offer strength durability and flexibility and are among the most tested polymers for biocompatibility and hypo-allergenic properties. In the widely used LSR process, components are molded by combining and cross-linking two liquid components. Therefore, colors and functional additives in liquid form are needed so that they can be conveniently introduced at the mixing station. Existing dosing equipment can be used or Clariant can offer a customized HiFormer dosing and handling system that interfaces with existing processing equipment.
A wide range of opaque and translucent colors, including standard colors, are now available for LSR. In addition, Clariant plans to introduce a similar range of functional additives that is similar to those already in MEVOPUR range in the solid form. The specific carrier systems have been developed by the Hi Former liquid masterbatches team for high compatibility with silicone resins. As with other products in the MEVOPUR range, the ingredients used to formulate the concentrates, are evaluated for extractables according to the medical device regulatory test protocols USP , (Class VI devices) and ISO10093-1. This data, along with a ISO13485-based manufacturing-quality process, full change control procedures, and documentation such as Device Master File, help support the risk-management process of medical device producers.
The same risk-management support is also available to manufacturers of pharmaceutical packaging and Clariant is introducing MEVOPUR-LQ-Amber, a liquid color masterbatch developed for PET and PETG polyester based packaging.
Colors such as yellow, amber and red are often used in transparent packaging to protect pharmaceutical products from degradation by filtering light of specific wavelengths. Solid-based concentrates in the existing MEVOPUR range are often used, but liquid technology offers some advantages in transparent or translucent polymers like PET. The highly concentrated liquid is easily incorporated into the polymer matrix, ensuring excellent color consistency even at dosing levels as low as 0.5% and meeting the requirements of the USP standard for light transmission (less than 10% at any wavelength between 290 and 450 nm).
Risk of leaching and drug interaction are significantly reduced, as confirmed in laboratory extraction testing. Samples produced using the new MEVOPUR-LQ liquid amber masterbatch were compared to a PET liquid color marketed by a competitor. The dosing level for both concentrates was set based on the ability to pass the requirements of USP at the typical wall section of a PET bottle, since failure to block out light would mean failure of the packaging to protect the drug. Samples were subjected to extraction tests (based on ISO 10993 part 18) in various media, including polar, non-polar and mixed materials. In the polar media, (isopropanol) samples made with the competitive product surprisingly showed significant yellow extraction, whereas the MEVOPUR LQ showed no significant extraction, indicating a lower potential risk of drug interaction.
These new amber masterbatches, along with future products targeted at pharmaceutical packaging, offer regulatory declarations to US Pharmacopeia (USP) chapters , and the relevant European Pharmacopeia 3.1 monograph e.g. 3.1.15 for polyester-based packaging. As with all MEVOPUR products, the new liquid concentrates are manufactured under ISO 13485 cGMP protocols. Strict change-control procedures at the CAS Number and supplier level are followed along with batch inspection. Products are suitable for food contact according to EU/FDA norms.
