原材料

Resins Used

國(guó)產(chǎn)醫(yī)用

Domestic

進(jìn)口醫(yī)用

Imported

進(jìn)口醫(yī)用

Imported

進(jìn)口醫(yī)用

Imported

質(zhì)量指標(biāo)Specification

外觀Appearance

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尺寸Size

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容積Capability

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密封性Leakproof

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跌落性能Drop resistant

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微生物限度

Microbiological Purity

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無菌Sterility

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無熱源（內(nèi)毒素）Endotoxin

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無人類DNA

Free human-DNA

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無DNase/RNase

Free DNase/RNase

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原材料

Resins Used

國(guó)產(chǎn)醫(yī)用

Domestic

進(jìn)口醫(yī)用

Imported

進(jìn)口醫(yī)用

Imported

進(jìn)口醫(yī)用

Imported

食品接觸塑料制品法規(guī)Regulation on Food Contact for Plastics and Articles

歐盟：10/2011/EC (PIM)及修訂版

European Union: 10/2011/EC (PIM)

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美國(guó)：FDA 21 CFR 177.1520

United States: FDA 21 CFR 177.1520

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中國(guó)：GB4806.7-2016

China: GB4806.7-2016

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藥典符合性Pharmacopeia Complies 

USP 39  塑料容器

USP 39  Containers

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EP 9.0章節(jié)3.1.3聚乙烯類產(chǎn)品

EP 9.0 Chapter 3.1.3Polyolefins

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EP 9.0章節(jié)3.1.5注射用和滴眼用聚乙烯類產(chǎn)品EP 9.0< 3.1.5>Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations

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生物相容性Biocompatibility

ISO 10993-5細(xì)胞毒性

ISO 10993-5 Cytotoxicity

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ISO 10993-10皮刺和致敏試驗(yàn)

ISO 10993-10 Irritation and Sensitization tests

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ISO 10993-11系統(tǒng)毒性試驗(yàn)

ISO 10993-11 Acute Systemic Toxicity Test

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USP 內(nèi)毒素測(cè)試

USP Bacterial Endotoxins-LAL test

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USP 體外生物反應(yīng)測(cè)試

USP Biological reactivity testing, in vitro

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USP 體內(nèi)生物反應(yīng)測(cè)試

USP Biological reactivity testing, in vivo, class VI

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原材料

Resins Used

國(guó)產(chǎn)醫(yī)用

Domestic

進(jìn)口醫(yī)用

Imported

進(jìn)口醫(yī)用

Imported

進(jìn)口醫(yī)用

Imported

動(dòng)物來源Animal Origin

TSE/BSE申明

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過敏源

Allergen

無過敏源申明

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雜質(zhì)Elemental Impurity

ICH Q3D

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環(huán)境影響Environment Impact

ROSH

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REACH

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密封完整性Leakproof

產(chǎn)品經(jīng)確認(rèn)，密封性能完整。

Leakproof as validation

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顆粒 Particulates

USP 和EP 2.9.19

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溶出物 Extractables

USP 塑料制容器

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滅菌 Sterilization

產(chǎn)品經(jīng)輻照，滿足無菌要求（SAL=10-6）。

Meet the sterility level(SAL=10-6) after irritation.

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