01-Feb-17
Clariant通过在两个重要的贸易展览会上为硅胶弹性体产品提供产品，继续全球推出其MEVOPUR®-LQ家族和添加剂液体主机，即在加利福尼亚州阿纳海姆市举行的Parmicapack Europts：Pharmapack Europe 2017和MD＆M West 2017
可用于医疗应用，多种不透明和半透明的颜色，包括标准颜色。Mevopur液体浓缩物结合了Mevopur“受控，一致和合规”配方和制造方法的好处，以及Clariant的Hi前®液体车辆技术，非常适合与硅酮弹性体一起使用。这些塑料树脂也称为液体有机硅橡胶或LSR，通常通过将两个液体成分结合和交联处理。因此，可以方便地在混合站引入液体形式的颜色和功能添加剂。现有的剂量设备可以使用或Clariant可以提供定制的剂量和处理系统，该系统与现有处理设备接口。
Silicones 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.
Mevopur-LQ产品线中的主体类似于已经以实体形式可用的主体。特定的载体系统是由HI前液体主体团队开发的，可与硅树脂高兼容。与Mevopur范围内的其他产品一样，根据医疗设备调节测试协议USP <87>，<88>（VI类设备）和ISO10093-1评估了用于制定浓缩物的成分。该数据以及基于ISO13485的制造质量流程，完整的更改控制程序以及诸如设备主文件之类的文档，有助于支持医疗设备生产者的风险管理过程。
Mevopur-LQ家族还包括适用于通常用于药品包装的聚对苯二甲酸酯（PET和PETG）材料的透明琥珀色浓缩液。琥珀色以及黄色和红色，是透明包装中经常使用的颜色，可通过过滤特定波长的光线来保护药物免受降解。现有的Mevopur系列中的固体浓缩物可以使用，但是液体技术在PET等透明或半透明的聚合物中具有一些优势。高度浓缩的液体很容易被掺入聚合物基质中，即使在低至0.5％的给药水平下，也可以确保出色的颜色一致性，并满足USP <671>光传输标准的需求（在290和290和290波长下少于10％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 others made with 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 <671> 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 <661.1> <87>, <88> and the relevant European Pharmacopeia 3.1 monograph (e.g. 3.1.15 for polyester packaging).
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