Shanghai Daoqin Plastics Co., Ltd.

• USA 药典USP＜661.1＞ will formed is product packaging materials necessary 规定
• MEVOPUR and REMAFIN-EP plastics color and additives masterbatch tool meet/satisfy new standards testing 声明
• meanwhile also 支持元素杂质ICH-Q3D风险 assessment

specialty chemical product manufacturing Clariant already formed MEVOPUR and REMAFIN-EP series product formed separation testing, ensure its combined USA 药典USP<661.1> requirements.

this suitable for product packaging and material type medical devices standards will 于2020 year 5 month positive 式生效, it will effect/influence USA market upper has already and future will need production material.

Clariant positive in formed product testing, 以帮助客户 in new 规生效之 front inner launch “ future anti 护” packaging, is in for material 元素杂质进行风险 assessment ICH-Q3D guide provide data 支持.

“凭借我们 MEVOPUR  and REMAFIN-EP color masterbatch and modified material, Clariant 始终秉承 let formed separation ‘受控, and combined 规’ 宗旨. is 此, in 2017 year necessary USP661.1, ICH-Q3D元素杂质 and Europe testing, in year year formed testing. ” Clariant color masterbatch business mono medical polymer solutions full 球总监Steve Duckworth说道, “ for/regarding will product export to USA or Europe China made company 而言, has combined future requirements packaging materials has 助于节省 time and a large amount of cost. ”

in 渡期间, USA food product tube/pipe 理局（ FDA ） will made company in new 药申请备案 in use through 旧 <661> or new <661.1> standards testing packaging materials.
但至2020 year, has new material / packaging combined need based on new standards testing meet/satisfy new 标. Duckworth understanding 释道, through front formed related testing, Clariant can 帮助客户走 in this tube/pipe front 面, 以避免 in 2020 year day 期临近时出现 can can method through <661.1> standards testing 情况.

他补充道, <661.1> combined is heavy large 变化, not only and new requirements, but also also and to testing methods 现代化改进. this 一变化 main/primary effect/influence in 于, to 2020 year, long 期以 支持 in product packaging in use more material “ food contact 声明” will by is “不足以”支持 this material future use. rear, type product, is solid 体口服 agent, also is more high water packaging materials, must to for metal solvent material USP<661.1> standards and for fine property USP<87> standards in 规定 体 outer testing data 支持. for/regarding high type 别, also need through USP＜88＞生 material versus property and other outer testing.

凭借 its 10 more year made 定 监 tube/pipe testing plan, Clariant utilizing its Knowledge and can, can development formed separation testing combined 国际规定 various plastics color and function property additives.

although has manufacturing must its formed product product packaging and material type medical devices combined new standards, 但Duckworth table/sheet 示, plastics packaging or to equipment manufacturing will MEVOPOR and REMAE-EP product as is its color 源, can development and testing product, is Clariant product has 支持欧美 di heavy standards 声明.

该声明指出: “ if testing already table/sheet packaging and product between generate function very small, that 么客户就 can 进行额 outer testing, ratio necessary can property and use lifespan stability property testing, ensure packaging can through more add 严格 规定. ”

Duckworth指出, from long 远 看, Clariant combined ISO:13485 standards medical manufacturing using/adopting GMP production control has ensure MEVOPUR and REMAFIN-EP material and formed separation 不会发生变化, from ensure full scope/range inner combined 规.