为了确保生物工艺设备、软件和零部件有正常的和一致的功能,根据 Cytiva 公司内部质量管理体系 (QMS) 的要求,设计、验证、生产、测试和正式放行生物工艺设备、软件和零部件。Cytiva 公司已通过 ISO 9001 标准认证,并且在 Cytiva 全球质量管理体系下运营。

为了让我们的客户满足当前《药品生产质量管理规范》的要求,设计和制造在监管环境中使用的生物工艺设备。Cytiva的业务使用符合整个生物制药行业公认标准的程序和文件。所有接触工艺流体的部件和保压部件的质量均符合大多数生物技术和/或制药行业的法规和法律要求。

产品随附文档包括符合行业文件指南(即 美国机械工程师协会生物工艺设备的供应商文件要求)的文档,以及证明生物工艺设备符合法规和法律要求的文档。

USP <88>6 级,或ISO 10993-6、10 和 11

 

USP <88> 6 级

生物反应性测试旨在通过体内实验确定动物对直接或间接接触患者的弹性体、塑料及其他聚合物材料的生物反应。

ISO 10993

医疗器械的生物学评价;包含一系列评估医疗器械体内生物相容性的标准。

- ISO 10993-6

评价植入后局部效果的测试

- ISO 10993-10

刺激性和皮肤致敏性测试

- ISO 10993-11

全身毒性的测试

21 CFR 177 间接食品添加剂 - 聚合物

确定聚合物材料的单体、添加剂、加工助剂和聚合工艺是否符合定性和定量限制。

不含动物源成分

不含动物源成分的产品是指:不含动物源成分的聚合材料和保压材料;或符合 EMA 410/01 第 6.4 部分动物油脂衍生物要求。接触工艺流体的任何部件(包括非聚合物)的生产过程均不含动物源成分,或符合 EMA 410/01 第 6.4 部分动物油脂衍生物衍生物要求。

RoHS2 指令 2011/65/EU

RoHS 指令是一项源自欧洲的倡议,其中关键目标是消除电气和电子设备中的某些有害物质。 消除这些物质将有助于保护人类健康以及对废弃电气和电子设备进行无害环境的回收和处置。

RoHS 指令限制以下六种物质的使用:铅 (Pb)、汞 (Hg)、镉 (Cd)、六价铬 (Cr6+)、多溴联苯 (PBB) 和多溴联苯醚 (PBDE)。

WEEE 指令 2012/19/EU

废弃电气和电子设备 (WEEE) 倡议是一项源自欧盟的倡议,旨在防止不当的废物处理。 该指令旨在促进此类废物的再利用以减少其处置。 它致力于提高所有参与电气和电子设备处理的成员的生态绩效。

电池指令 2006/66/EC

欧盟关于废旧电池和蓄电池的指令 2006/66/EC 旨在尽量减少废旧电池和蓄电池对环境和人类健康的影响。

包装和包装废弃物指令 1994/62/EC 及其修订案

该欧盟指令涵盖欧盟市场上所有的家庭、商业和行业包装废物。限制包装中某些重金属(Hg、Pb、Cr6+、Cd)的存在,以保护环境免受有害物质和材料的侵害。 欧盟包装指令还包括注册、报告和回收要求。 该欧盟指令范围涵盖欧盟市场上的所有家庭、商业和工业包装废弃物。

危险品运输

联合国关于危险品运输 (TDG) 的建议涵盖了除散装油轮以外的所有危险品运输方式。该建议对各个国家/地区没有强制性或法律约束力,但已获得广泛的国际认可。该建议构成了若干国际协定和许多国家法律的基础。

  • Remove batteries and accumulators not enclosed in WEEE in a non-destructive manner if possible and put them in the battery collection
  • If they are built-in, put the entire product in the electrical waste
  • Remove any lamps that can be removed from the WEEE without destroying it.
  • Delete any data, if applicable

You can contribute to the re-use, recycling and other forms of recovery of WEEE by making use of the available collection and take-back systems. [WEEE from private households supplied by Cytiva can be returned free of charge on a one-to-one basis.] If you have any queries concerning the return of your EEE, please contact us at [email protected] directly.

To view country information of WEEE waste procedures, click here.

Country Country information
Professional proceeds the data submission to the Authorities on behalf of Cytiva.
Netherlands

According to the Dutch Regulation on WEEE, producers, distributors, and importers of EEE are obligated to register with the national WEEE register and to either join a WEEE compliance scheme or individually meet their obligations. Therefore, Cytiva Europe GmbH, Branch Netherlands is registered with “OPEN”. For further information, please see E-waste solved - Stichting Open (stichting-open.org)

Cytiva Europe GmbH, Branch Netherlands places non-household EEE (B2B) onto the Dutch market. Thus, Cytiva Europe GmbH, Branch Netherlands is registered with the national producer register for B2B WEEE. No official EEE producer registration number exists in the Netherlands.

Norway

Distributors are obligated to accept B2B WEEE from r customers who purchase similar products from them, free of charge. WEEE shall be stored safely and safeguarded against theft. Electronic memory devices shall be locked in a container. Consumers may also deliver WEEE to recycling stations.

Producers of EEE are obligated to register with an authorised collection and recovery scheme company. Authorised companies are listed in https://produsentansvar.miljodirektoratet.no/returselskap. For further information, see Norwegian Regulations relating to the recycling of waste (Waste Regulations) § 1-10. Cytiva Europe GmbH, filial Norge is a member of the producer compliance scheme Norsirk in association with ‘Elretur AS’. For further information, see .www.norsirk.no

Poland

Global Life Sciences Solutions Poland Sp. z o.o. has met national regulatory requirements and complies with national WEEE regulations.

Global Life Sciences Solutions Poland Sp. z o.o. satisfies its obligations through a specialized recovery organisation (Biosystem) with the following registration number: 516614.

The compliance scheme takes on a producer’s legal duties and ensues the data compliance to the relevant authorities. Additionally, the compliance scheme systematizes the collection of WEEE and guarantees recycling at an approved treatment facility. To fund the collection and recycling, producers need to pay compliance charges calculated on the volumes of EEE placed by the producer onto the market.

Portugal

According to the WEEE Act, producers, packagers and suppliers of service packaging of EEE must submit their waste management obligations to to an individual or integrated system (and if the latter to pay an annual contribution). They must register on the central register SIRER/SILIAmb.

Cytiva Europe GmbH, sucursal em Portugal has joined the WEEE Take-Back System Electrao. For further information, please see Electrão | Confiar para reciclar (electrao.pt). Cytiva Europe GmbH, sucursal em Portugal is registered in the Portuguese Environment Agency SILIAmb platform under the registration number 516614.

Spain Cytiva Europe GmbH, Sucursal en España is registered with the number RII AE 5655 in the Registro de Productores de MINCOTUR. Cytiva Europe GmbH, Sucursal en España is a member of the Ecotic foundation, which is part of the Extended Producer Responsibility System (EPRS). For more information, please visit https://www.ecotic.es/. Ecotic is responsible for managing the WEEE compliance obligations of Cytiva Europe GmbH, Sucursal en España.
Sweden

Producers of EEE are obliged to register with the Swedish EPA's e-services for producer responsibility (EUPA-System). Cytiva Europe GmbH Tyskland Filial Sverige has registered with the EUPA-System for EEE. The official registration number is 5564620374. Additionally, Cytiva Europe GmbH Tyskland Filial Sverige is member of producer compliance scheme “El-Kretsen”. For further information, please see https://www.el-kretsen.se/english/.

The compliance scheme El-Kretsen takes on a producer’s legal obligations and proceeds the data submission to the authorities. Furthermore, El-Kretsen organizes in collaboration with the municipality’s the collection of WEEE and guarantees recycling by an approved treatment facility. In order to finance the collection and recycling, producers have to pay compliance fees calculated on the volumes of EEE they place onto the market.

UK Producers of EEE are obliged to register with the national WEEE producers register. Global Life Sciences Solutions Operations UK Limited is registered with the number is WEE/MM0093AA. Additionally, Global Life Sciences Solutions Operations UK Limited is member of the WEEE producer compliance scheme ERP UK. For further information, please visit: www.erp-recycling.org/uk

Battery Directive 2006/66/EC

The EU Directive 2006/66/EC on waste batteries and accumulators is intended to minimize the impact of waste batteries and accumulators on the environment and on human health.

Used batteries may still contain hazardous substances which could harm the environment and health of people. Therefore, used batteries should never be disposed of in household waste and Cytiva’s batteries are clearly marked with the symbol of the crossed-out wheelie bin. Close to this symbol, you will find the following chemical symbols where the battery contains the requisite amounts of cadmium, lead and mercury:
  • Cd - the battery contains more than 0.002% cadmium by mass
  • Pb - the battery contains more than 0.004% lead by mass
  • Hg - the battery contains more than 0.0005% mercury by mass

Used portable batteries supplied by Cytiva can be handed in free of charge at collection points, which will include stores that sell portable batteries and accumulators. These collection points will typically have labelled battery collection boxes.

If you have any queries concerning the return of batteries, please contact us at [email protected] directly.

To view country information of WEEE battery procedures, click here

Country Country information
Austria

Cytiva Europe GmbH Vienna International Branch has discharged its waste batteries obligation by contracting with ERP Austria.
It is registered as a manufacturer according to the Battery Ordinance under the GLN number 9008390581346 in the manufacturer register of the Austrian Federal Ministry for Climate Action, Environment, Energy, Mobility, Innovation and Technology (EDM-Portal).

For more information about ERP Austria, please visit: https://erp-recycling.org/

Belgium

Cytiva Europe GmbH, Branch Belgium is member of the battery producer compliance scheme Bebat with the membership number 291505. For further information, please see www.bebat.be/

For further information on battery collection points in Belgium, please visit: https://www.bebat.be/en/find-a-collection-point

Denmark

Cytiva, Filial Af Cytiva Europe GmbH, Tyskland is a member of the battery producer compliance scheme elretur. For further information, please see www.elretur.dk

Finland

Cytiva Europe GmbH Suomen sivuliike (filial Finland) has fulfilled its producer responsibility obligations by joining the producer responsibility organisation Recser Oy. Cytiva Europe GmbH Suomen sivuliike (filial Finland) is registered in the producer database maintained by the Centre for Economic Development, Transport and the Environment (ELY Centre) of Pirkanmaa.

For further information, please see www.paristokierratys.fi

France

Cytiva Europe GmbH, succursale France is registered with the National Register of Battery and Accumulator Producers under number FR000696_06GA3X.

Cytiva Europe GmbH, succursale France offers portable batteries on the market. Cytiva Europe GmbH, succursale France fulfills its obligations as a producer of portable batteries and accumulators through its membership of Corepile, an eco-organisation approved by the public authorities to which it pays an eco-contribution. Corepile is responsible for consumer communication and all logistical and recycling operations (collection and treatment). For more information, please visit page https://www.corepile.fr/

Germany Producers who place batteries on the German market are obliged register with Stiftung elektro-altgeräte register (Stiftung ear), indicating battery type and brand.
Italy

Producers of batteries and accumulators must register with the national battery producer register. The official battery producer registration number of Cytiva is IT08020000000392.

To fulfil their producer obligations, Cytiva, has joined the battery producer compliance scheme Erion Energy. For further information, please visit their webpage https://erionenergy.it/en/. To finance the collection and recycling, Cytiva pays environmental fees calculated on the volumes of batteries they place onto the Italian market. Thanks to Erion Energy, Cytiva declares also data to the corresponding Italian Authorities.

Luxembourg

Cytiva Europe GmbH, Branch Belgium has met national regulatory requirements and complies with national battery and accumulator regulations.

The compliance scheme is responsible for the producer’s legal responsibilities and ensures that relevant data is submitted to the competent authorities. Moreover, the compliance scheme arranges the collection of batteries and accumulators and ensures recycling by a permitted treatment facility. To finance the collection and recycling, Cytiva pays environmental fees calculated on the volumes of batteries they place onto the market.

Cytiva Europe GmbH, Branch Belgium is a member of the battery producer compliance scheme “Ecobatterien” and is registered under certificate number B10/00385. For further information, please see https://www.ecobatterien.lu/en/

Netherlands

Producers, distributors and importers of batteries and accumulators are obligated to register as portable batteries producers and provide the take-back and recycling of waste portable batteries. No authorised batteries producer registration number issued by the government exists in the Netherlands.

For that reason, Cytiva Europe GmbH, Branch Netherlands has joined the battery producer compliance scheme Stichting Batterijen (STIBAT) and is registered with participants number 40129. For further information, please see www.stibat.nl.

Generally, portable batteries can be disposed of freely in public recycling centres or battery collection points. For further information, please see https://www.legebatterijen.nl/inleveren/waar-inleveren/

Norway Producers of batteries are obligated to register with an authorised collection and recovery scheme company. For further information, see Waste Regulations §§ 3-7 and 3-7a. Authorised companies are listed in https://produsentansvar.miljodirektoratet.no/returselskap. Cytiva Europe GmbH, filial Norge is a member of the producer compliance scheme Norsirk in association with Elretur AS.

For further information, see www.norsirk.no

Poland

Global Life Sciences Solutions Poland Sp. z o.o. is a member of the battery producer compliance scheme Biosystem (a specialised recovery scheme).

The compliance scheme is responsible for the producer’s legal responsibilities and ensures the data is submitted to the relevant authorities. Moreover, the compliance scheme arranges the collection of batteries and accumulators and ensures recycling by a permitted treatment facility. To finance the collection and recycling, producers need to pay compliance fees calculated on the volumes of batteries they place onto the market.

For further information, please see https://www.biosystem.pl/.

Portugal

According to the Battery Act, producers, packagers and suppliers of service packaging of batteries/accumulators must submit its waste management obligations to a battery take-back scheme and register on the central register SIRER/SILIAmbe.

Cytiva Europe GmbH, sucursal em Portugal has therefore joined the Batteries Take-Back System Electrao. Further information can be found at Electrão | Confiar para reciclar (electrao.pt)

Cytiva Europe GmbH, sucursal em Portugal is registered with the central manufacturer register (SILIAmb) under number PT001288.

Spain Cytiva Europe GmbH, Sucursal en España is registered under the number RII-PYA 593 in MINCOTUR's Register of Producers, and is a member of ERP España, an Extended Producer Responsibility Collective Scheme (EPRCS). For more information, please visit https://erp-recycling.org/en-es/batteries/. ERP España is responsible for managing the compliance of Cytiva Europe GmbH, Sucursal en España's waste batteries and accumulators obligations.
Sweden

Producers of batteries and accumulators are obliged to register with the Swedish EPA's e-services for producer responsibility (EUPA-System). Cytiva Europe GmbH Tyskland Filial Sverige has registered with the EUPA-System for Batteries. The official registration number is 5564620374.

Additionally, Cytiva Europe GmbH Tyskland Filial Sverige is member of the producer compliance scheme ‘El-Kretsen’. For further information, please see https://www.el-kretsen.se/english/
The compliance scheme ‘El-Kretsen’ takes on a producer’s legal obligations and proceeds the data submission to the authorities. Furthermore, ‘El-Kretsen’ organizes in collaboration with the municipality’s collection of batteries and guarantees recycling by an approved treatment facility. In order to finance the collection and recycling, producers have to pay compliance fees calculated on the volumes of batteries they place onto the market.

UK

Producers of batteries and accumulators are obliged to register with the national battery producer register. Global Life Sciences Solutions Operations UK Limited has registered directly with the Environment Agency.

Packaging and Packaging Waste Directive 1994/62/EC and Amendments

Restricts the presence of certain heavy metals in packaging (Hg, Pb, Cr6+, Cd) with the goal of protecting the environment from hazardous substances and materials. The EU Packaging Directive also includes requirements for registration, reporting, and recycling. This EU directive scope covers all household, commercial, and industrial packaging waste in the European Union market.

Transport of hazardous goods

The United Nations recommendations on the transport of dangerous goods (TDG) cover the transport of dangerous goods by all modes of transport except by bulk tanker. They are not obligatory or legally binding on individual countries, but have gained a wide degree of international acceptance. They form the basis of several international agreements and many national laws.

国际标准化组织 (ISO)

ISO 国际标准旨在确保产品与服务的安全性、可靠性和优质性。ISO 标准为要求、规范、指南或特征性文件,此类文件旨在确保材料、产品、工艺和服务始终与目的相符。

国际电工委员会 (IEC)

IEC 是一个非盈利、非政府的国际标准组织,为所有电气、电子和相关技术制定和发布国际标准。该标准集涉及产品开发、性能、兼容性及相关主题,以确保产品兼容性和环境安全性。

欧洲和美国法规指令

本页面列出了欧盟和美国的相关法规。许多国家均已编制了类似的环境和安全法规、标准和方法等,但未在此列出。

机器指令 (MD) 2006/42/EC

MD 用于评价机械类仪器或设备的安全性。

MD 为欧洲和 EEA(欧洲经济区)适用机器的基本健康和安全要求提供了统一的监管基础。机器在投放欧盟市场之前,制造商必须确保他们的产品符合该指令且符合所有其他适用的欧盟指令。获得CE 标志后,产品可以投放市场。所有定义为机械的Cytiva生物工艺系统均包含欧盟一致性声明文件。

压力设备指令 (PED) 2014/68/EU

PED 涉及加工行业中使用的压力设备,例如容器、加压储存容器、热交换器、蒸汽发生器、锅炉、工业管道、安全装置和压力附件。压力设备和组件的设计、生产和测试必须达到相关的基本安全要求。

低电压指令 (LVD) 2014/35/EU

LVD确保在特定电压限制范围内的电气设备为操作员提供高水平的安全和保护。LVD涵盖交流电压在50至1000 V之间,直流电压在75至1500 V之间(电气输入或输出)的电气设备。对于大多数电气设备,电磁场辐射的健康方面也属于LVD的范畴。

防爆设备 (ATEX) 2014/34/EU

控制易爆环境的 ATEX 指令;规定在有爆炸危险的环境中允许使用的设备和工作环境。

电磁兼容性 (EMC) 2014/30/EU

EMC 指令与大多数其他指令的不同之处在于其主要要求是保护电磁频谱。

该指令要求产品必须: 不发射不必要的电磁污染(干扰)并且不受正常水平的干扰。 符合这些要求通常通过测试统一标准来证明。

UL508A

UL标准508A规定了采用600伏或更低电压下运行的工业控制面板的构造。根据美国国家电气规范(NEC)或美国消防协会(NFPA)70的规定,这类设备拟安装在普通位置。NEC标准为面板制造商提供了关于各种问题的指南,包括正确的组件选择、接线方法和短路电流额定值的计算。

ASME 锅炉和压力容器规范 (BPVC)

BPVC 是美国机械工程师协会 (ASME) 的标准,规定了锅炉和压力容器的设计、生产和检查的相关标准。Cytiva 按照此标准设计部分层析柱以生产它们。

Cytiva产品生命周期由持续产品改进的标准化要求和质量程序控制。以实现持续的产品改进。变更控制通知 (CCN) 服务是产品生命周期的重要组成部分。注册 CCN 服务后,生物工艺仪器、层析柱备件和附件的变更信息将向所有订阅者发布。

停产后,Cytiva 承诺将继续为生物工艺主要硬件产品提供服务支持。

标准和可配置的硬件产品:Cytiva 承诺在产品重新设计或停产后的十年内,继续为客户提供标准和可配置生物工艺主要硬件产品的备件和服务。生命周期中的变更通知将以电子邮件通知客户。主要设备停产时,会在产品停止订购前发出通知。在支持终止生效日的前一年发出第二次通知,提醒服务支持即将终止。所有通知由 Cytiva 变更控制通知 (CCN) 服务发送*。

定制硬件产品:Cytiva 承诺在产品交付后的十年内继续为客户提供定制生物工艺硬件产品的备件和服务,除非定制项目中另有规定。服务支持期的结束将在产品随附的文档包中说明。将不再提供停止支持的通知。

如果出于(但不限于)监管、法律、设计变更或其他原因无法提供此类支持,Cytiva 保留短期停止备件和服务支持的权利。注意:对于使用年限超过十年的设备,我们会尽最大努力提供相关备件;但是,我们希望客户能够了解,随着设备使用年限的增加,可用性会有所降低。

*如上所述,所有通知通过法规支持门户的 Cytiva 变更控制通知 (CCN) 发送。如需接收通知,客户必须访问 www.cytiva.com/rsf注册此服务。

生物工艺硬件服务支持的终止政策

U为了适合在监管环境中使用,以使客户满足现行药品生产质量规范 (cGMP) 的要求设计与构造了UNICORN 控制软件和 FlexFactory 标准自动化控制软件。产品按照 GAMP™ 5 指南和相关药品生产质量规范进行开发。GAMP 指南以现行行业规范为基础,旨在确保计算机系统符合既定用途,同时满足现行监管要求。同样,此控制软件的功能符合 FDA 21 CFR Part 11(使用电子文件和签名)和 EU GMP 附件 11 的要求。该附件是欧洲关于以风险为基础处理以质量为重点的计算机化系统的法规。具有系统审计追踪、电子签名和电子记录等功能。

ISPE GAMP™ 5

按照可扩展的标准和检查 ISPE GAMP 5是一种基于风险的方法,适用于符合 GxP 的计算机化系统。 GAMP 5 是一项务实且实用的行业指南,以高效和有效的方式实现计算机系统的合规性,使其符合预期用途。

FDA 21 CFR Part 11—电子记录和电子签名

FDA 21 CFR第11部分涉及两个主要法规:电子记录和电子签名。这些法规规定了管理局认为根据电子记录执行的电子记录、电子签名和手写签名是可信的、可靠的,通常等同于纸质记录和手写签名的标准。

EudraLex 附件 11—计算机系统

EudraLex(欧盟药品管理规则,第 4 卷,当前人用和兽用药品生产质量规范)附件 11—计算机系统,该标准主要规定 cGMP 合规事项中的计算机系统合规事项。系统应用应通过验证,并且 IT 基础设施应合格 将计算机化系统作为 cGMP 监管活动的一部分进行监管。 应用程序应该经过验证,IT 基础设施应该是被确认的。

在计算机系统取代人工操作的情况下,应提供同等的产品质量、工艺控制或质量保证。工艺流程的整体风险不应增加。该过程的总体风险不应增加。

UNICORN 软件的验证支持文件 (VSF)

UNICORN VSF 提供有关 UNICORN 软件开发和文档的全面信息。 VSF 表明该软件已经以结构化的方式开发,并根据产品开发生命周期概念进行了验证。 在客户现场运行时,正确的开发、验证和文档对于 UNICORN 的功能和性能至关重要。 独立专家审计师对软件的每次重大更新进行了审计,并出具了审计报告。

订阅监管支持

FlexFactory 标准自动化验证支持文件 (VSF)

FlexFactory 标准自动化 验证支持文件提供有关 FlexFactory 标准自动化的开发和文档的全面信息。 文件表明 FlexFactory 标准自动化是以结构化的方式开发的,并根据产品开发生命周期概念进行了验证。 在客户现场运行时,正确的开发、验证和文档对于 FlexFactory 标准自动化的功能和性能至关重要。 已执行外部独立 GAMP™ 5 评估,独立专家已审核开发。

FlexFactory 标准自动化开发的所有项目文档都经过审核。 该文件可以在审计时出示。

基于 GAMP 5 指南的产品文档以产品文档活页夹/周转包的形式提供。