试剂瓶系列-方形PETG产品


发布时间:

2023-08-15

试剂瓶系列-方形PETG产品

PET化学名:聚对苯二甲酸乙二醇酯;PETG化学名:聚对苯二甲酸乙二醇酯共聚物;PETG是在PET基础上进步化学合成-PETG是PET的一种共聚物,在生产过程中添加了一种叫做环己二甲醇(CHDM)的成分。这种改性使得PETG具有不同的性能特点。

物理性质方面:由于化学结构的不同,因此表现出来的物理性质也不同,相比PET材质,PETG透明度更高、韧性更好-更具抗冲击性和耐化学性。 耐低温方面也比PET更低。因此PETG方瓶可以在低至-70度以下反复冻融后,仍然不影响性能。

气体阻隔性方面:PETG在气体阻隔性方面表现出优异的性能,尤其是对氮气、氧气和二氧化碳的阻隔性特别强,数据见下表(1),高阻隔性使得对氧气和二氧化碳敏感的化学试剂和生物试剂的储存和运输有着极其的重要性,可以防止试剂的变质和失效。

表1:(常见材料的物性表)

作为储存生物试剂尤其是细胞培养基、血清和活性酶的容器,材料和产品还必须符合相关的法律法规要求,常见的法规要求如下:

Substances of Animal Origin (BSE/TSE)-Regulation 999/2001;
Food Contact-Commission Regulation EU 10/2011 (and amendments) &US FDA 21 CFR
Applicable Regulations:
-Coalition of Northeastern Governors (CONEG) 
-California Proposition 65&Regulation EC No. 1005/2009 on Substances that deplete the Ozone layer
-40 CFR Part 82 Subpart E, ODS
-40 CFR 63 Subpart 112(b)(1), HAP
-Directive 2011/65/EU (Restrictions of Hazardous Substances - RoHS), as amended by Commission Delegated Directive (EU) 2015/863 (RoHS 3)
-REACH EC/1907/2006 and Substances of Very High Concern (SVHC), Annexes XIV and XVII
-Directive 2006/122/EC (Relating to Restrictions on the Marketing and Use of Certain Dangerous Substances and Preparations (perfluorooctane Sulfonates), as amended
-Regulation 2005/1895/EC (Epoxy Derivatives), as amended
-Directive 2012/19/EU (to replace Directive 2002/96/EC) - Waste Electrical and Electronic Equipment (WEEE), as amended
-Health Canada – Inventory
Residual Solvents(残留溶剂要求):
-USP General Chapter <467> Residual Solvents, ICH Guideline Q3C – Solvents (ICH Class 1,2,3 solvents), EMEA Guideline on the Specification Limits for residues of metal catalysts
-ICH Guideline Q3D on Elemental Impurities
-Directive 94/62/EC, Packaging and Packaging Waste (amended by 2004/12/EC, 2005/20/EC, and Regulation (EC) No 219/2009)
-Directive 2003/53/EC (Restricting Nonylphenol and Nonylphenol Ethoxylates), as amended
-EU Regulation 208/2005 on Polycyclic Aromatic Hydrocarbons (PAHs), as amended
Pharmacopoeia(药典要求):
-US Pharmacopeia – Class VI
-US Pharmacopeia – USP Monograph
其中药典的要求尤其重要,在我们产品的检测中都必须体现出来;
US Pharmacopeia – Class VI详细的要求如下:
Samples made from this product were sterilized (Gamma at 50 kGy dosage and ETO at 130 degrees F), and these samples passed the following FDA-Modified ISO 10993 tests with human tissue contact time of 30 days or less: cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute), implantation, hemocompatibility, physicochemical (USP)
-US Pharmacopeia – USP Monograph
USP General Chapter < 661 > is “Plastic Packaging Systems And Their Materials Of Construction”. Section 661.1 is titled “Plastic Materials Of Construction.” It provides test methods and specifications for plastic materials of construction used in packaging systems. The following is stated: A plastic material of construction is deemed to be well-characterized for its intended use if the following characteristics have been adequately established: its identity, biocompatibility (biological reactivity), general physicochemical properties, and composition (i.e., additives and extractable metals likely to be present). A representative sample of this product met the requirements for the following physicochemical tests: heavy metals, nonvolatile residue, residue on ignition, and buffering capacity from water extracts. These tests are not routinely conducted on the product.
在考察PETG瓶的指标中,还经常考虑到以下几个质量特征;
-产品外观;
-尺寸;
-容量刻度;
-旋盖扭力;
-抗跌性;
-压力密封性;
-降温速率;
-低温反复冻融性能(-70度)‘
-辐照后性能(极端测试46-50 kGy)

 
PETG作为包装容器,需要长时间的储存,对试剂和产品本身都有严格规范的要求,因此选择合适的产品和厂家非常重要;常州申百特生化科技有限公司有着多年的生物医药包装研发和生产经验,对材料、工艺和产品都有非常深入的研究;目前我们推出了30-1000ML系列的符合药典标准的PETG血清、培养基瓶。
详细产品介绍如下:
         方型PETG 血清瓶/培养基瓶系列产品
 

产品特点:

l认证的十万/万级净化车间内生产;

l由耐用、防碎的聚对苯二甲酸乙二醇酯共聚物改性乙二醇 (PETG) 材质制成;

l先进的一步法工艺,日本进口ASB机器生产;

l符合USP Class VI 进口医用级PETG原料、透明,降低CO2 和 O2的渗透性,无动物源、无细胞毒性;

l辐照灭菌,γ 辐射等级 10-6无菌保证水平(SAL),无菌、无酶、无热源(内毒素);

l瓶体带刻度,瓶身和瓶盖材料不含动物源性组分 (ADCF);

l极佳的气体阻隔性和出色的耐低温性能(-70度);

l防漏设计,低温和负压环境密封完好;

l四层包装:热缩+塑封+外套+五层纸箱;

用途:

 可用于血清、培养基、酶、缓冲液和pH敏感型液体等产品的储存。

产品规格和货号

订购热线: 13815085372  邮箱:sales@sbt-biotech.com  网址:www.sbt-biotech.com