BioProcess equipment, software, and spare parts have been designed, verified, manufactured, tested, and formally released for delivery according to the Cytiva’s business internal quality management system (QMS) to ensure their proper and consistent function. Cytiva’s business is certified according to the ISO 9001 standard and operates under Cytiva global QMS.
BioProcess equipment is designed and built to be used within a regulated environment to enable our customer to fulfil current good manufacturing practice (cGMP). Cytiva’s business uses procedures and documentation that comply with standards accepted throughout the biopharmaceutical industry. All parts in contact with the process flow and pressure holding parts are qualified to fulfil most biotechnology and/or pharmaceutical industry regulatory and legal requirements.
Product documentation delivered with the product includes documentation following industrial guidelines for documentation, that is, ASME BPE vendor documentation requirement, as well as documents that show the compliance to regulatory and legal demands for BioProcess equipment.
USP <88> Class VI or ISO 10993-6, -10 and -11 together
USP <88> Class VI
Biological reactivity tests designed to determine the biological response of animals to elastomeric, plastics, and other polymeric materials in vivo, with direct or indirect patient contact.
Biological evaluation of medical devices; contains a series of standards for evaluating the biocompatibility of medical devices, in vivo.
- ISO 10993-6
Tests for evaluation of local effects after implantation
- ISO 10993-10
Tests for irritation and skin sensitization
- ISO 10993-11
Tests for systemic toxicity
21 CFR 177 Indirect Food Additives - Polymers
Determine compliance to qualitative and quantitative limits for monomers, additives, processing aids, and the polymerization process for a polymeric material.
An animal origin-free product is defined as: polymeric materials and pressure holding materials free from animal-derived ingredients; or compliant with EMA 410/01 part 6.4 Tallow derivatives. The manufacturing process of whatever part (including non-polymeric), in contact with process stream are free from animal-derived ingredients, or compliant with EMA 410/01 part 6.4 Tallow derivatives.
RoHS2 Directive 2011/65/EU
The RoHS directive is a European-derived initiative in which the elimination of certain hazardous substances in electrical and electronic equipment is the key objective. The elimination of these substances will contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment.
The RoHS directive restricts the use of the following six substances: lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (Cr6+), polybrominated biphenyls (PBB), and polybrominated diphenyl ether (PBDE).
WEEE Directive 2012/19/EU
The Waste Electrical and Electronic Equipment (WEEE) initiative is a European Union-derived initiative for the prevention improper waste disposal. The directive seeks to promote the reuse of such waste to reduce its disposal. It strives to improve the ecological performance of all members involved in the handling of electrical and electronic equipment.
Producers of electric and electronic equipment (EEE) are required to register with national producer registers for producers of waste EEE (WEEE) and to finance the collection, recovery, treatment and environmentally sound disposal of WEEE.
Recycling of WEEE
EEE may contain hazardous substances that are harmful to human health and the environment. Therefore, Cytiva’s EEE is marked with the following symbol, which indicates that these products must not be disposed of as unsorted municipal waste (i.e. with household waste) and should instead be collected separately. Before you dispose of your end-of-life EEE, please:
- 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.
|Professional proceeds the data submission to the Authorities on behalf of Cytiva.|
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.
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
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.
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.|
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
Cytiva Europe GmbH Vienna International Branch has discharged its waste batteries obligation by contracting with ERP Austria.
For more information about ERP Austria, please visit: https://erp-recycling.org/
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
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
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
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.|
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.
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/
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/
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
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/.
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.|
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/
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.
International Organization for Standardization (ISO)
ISO International Standards ensure that products and services are safe, reliable, and of good quality. ISO Standards are documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose.
International Electrotechnical Commission (IEC)
IEC is a non-profit, non-governmental international standard organization that prepares and publishes international standards for all electrical, electronic, and related technologies This standards collection addresses product development, performance, compatibility, and related topics in order to ensure product compatibility and environmental safety.
European and US directives
Relevant legislations for EU and US are shown on this page. Similar legislations, standards and methods etc. for environmental and safety, have been developed in many countries but are not shown.
Machinery Directive (MD) 2006/42/EC
The MD is used for safety of instrument or equipment defined as machines.
The MD provides the regulatory basis for the harmonization of the essential health and safety requirements applicable to machinery for Europe and EEA. Before placing a machine on the EU market, the manufacturers have to ensure that their product complies with this directive as well as show compliance to all other applicable EU directives. After the CE marking, the product can be placed on the market. An EU declaration of conformity document is included with all Cytiva's BioProcess systems defined as machinery.
Pressure Equipment Directive (PED) 2014/68/EU
The PED concerns pressure equipment used in the process industry such as vessels, pressurized storage containers, heat exchangers, steam generators, boilers, industrial piping, safety devices, and pressure accessories. Pressure equipment and assemblies must meet essential safety requirements covering design, manufacture, and testing.
Low Voltage Directive (LVD) 2014/35/EU
The LVD ensures that electrical equipment within certain voltage limits both provides a high level of safety and protection to the operators. The LVD covers electrical equipment with a voltage between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current (electrical input or output). For most electrical equipment, the health aspects of emissions of electromagnetic fields are also under the domain of the LVD.
Equipment for explosive atmospheres (ATEX) 2014/34/EU
The ATEX directive controlling explosive atmospheres; describing what equipment and work environment is allowed in a potentially explosive atmosphere.
Electro Magnetic Compatibility (EMC) 2014/30/EU
The EMC Directive differs from most other directives in that its primary requirement is protection of the electromagnetic spectrum.
The directive requires that products must: not emit unwanted electromagnetic pollution (interference) and be immune to a normal level of interference. Compliance with these requirements is usually demonstrated by testing to harmonized standards.
The Underwriters Laboratories (UL) standard 508A addresses the construction of industrial control panels, operating from a voltage of 600 volts or less. This equipment is intended for installation in ordinary locations, in accordance with the National Electrical Code (NEC), or National Fire Protection Association (NFPA) 70. NEC standard gives guidelines to panel builders on various issues including proper component selection, wiring methods, and calculation of short circuit current ratings.
The ASME Boiler and Pressure Vessel Code (BPVC)
The BPVC is an American Society of Mechanical Engineers (ASME) standard that provides rules for the design, fabrication, and inspection of boilers and pressure vessels. Some columns designed for manufacturing from Cytiva follow this standard.
The Cytiva product lifecycle is governed by standardized requirements and quality procedures for continuous product improvement. The change control notification (CCN) service is an essential component in the product lifecycle. Changes of BioProcess instruments and columns spare parts and accessories are published to all subscribers after registered for the CCN service.
Post discontinuation, Cytiva is committed to continue providing service support for BioProcess hardware main products.
Standard and configurable hardware products: Cytiva is committed to continue supplying customers with spare parts and services, for standard and configurable BioProcess hardware main products, for a period of ten years after product redesigns or discontinuation. Notification of the changes during the lifecycle will electronically be communicated to customers. At discontinuation of main equipment, a notification will be sent out prior to the product stops to be orderable. A second notification reminding of end of service support will be communicated one year prior to the end of support takes effect. All communication takes place via Cytiva Change Control Notification (CCN) service*.
Custom hardware products: Cytiva is committed to continue supporting customers with spare parts and services for custom BioProcess hardware products for a period of ten years after product delivery, unless otherwise defined in the custom project. The end of service support period will be stated in the documentation package delivered with the product. No further notifications of the discontinuation of support will be provided.
Cytiva reserves the right to discontinue spare parts and service support within a shorter time period when factors such as (but not limited to) regulatory, legal, design changes or other reasons prevent the provision of such support. Note: Spare parts may be available on best effort bases for equipment older than ten years; however, we want to make customers aware that the likelihood of availability will decrease as the equipment age increases.
*As noted above, all communication takes place via Cytiva Change Control Notification (CCN) at Regulatory support portal. To receive notifications, customers must register for this service on www.cytiva.com/rsf.
UNICORN control software and FlexFactory Standard Automation control software are designed and built to be used within a regulated environment to enable customer to fulfil current good manufacturing practice (cGMP). Products are developed in accordance with GAMP™ 5 guidelines and related Good Practice Guides. GAMP guidance aims to achieve computerized systems that are fit for the intended use, and meet current regulatory requirements, by building upon existing industry good practice. Likewise the control software includes functionality that enables compliance with FDA 21 CFR Part 11 (use of electronic documents and signatures) and EU GMP Annex 11. This annex is a European regulation for risk-based handling of computerized systems with focus on quality. There are features such as system audit trail, electronic signatures, and electronic records.
ISPE GAMP™ 5
ISPE GAMP 5 is a risk-based approach to compliant GxP computerized systems based on scalable specification and verification. GAMP 5 is a guideline and provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner.
FDA 21 CFR Part 11—Electronic Records and Electronic Signatures
FDA 21 CFR Part 11 covers two main regulations, electronic record and electronic signature. These regulations set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures, executed to electronic records, to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
EudraLex Annex 11—Computerized Systems
EudraLex (the rules governing medicinal products in the European Union, volume 4, current good manufacturing practice, medicinal products for human and veterinary use) Annex 11—Computerized Systems regulates computerized systems as part of cGMP-regulated activities. Application should be validated and IT infrastructure should be qualified.
Where a computerized system replaces a manual operation, there should be an equivalent product quality, process control or quality assurance. There should be no increase in the overall risk of the process.
Validation support file (VSF) for UNICORN software
UNICORN VSF gives comprehensive information about the development and documentation of UNICORN software. The VSF demonstrates that the software has been developed in a structured manner and is verified in accordance with the product development life cycle concept. Proper development, verification, and documentation are vital to the functionality and performance of UNICORN when in operation at a customer site. An independent expert auditor has audited each major update of the software and audit reports have been issued.
Subscribe to Regulatory Support
FlexFactory Standard Automation validation support file (VSF)
FlexFactory Standard Automation VSF gives comprehensive information about the development and documentation of FlexFactory Standard Automation. The VSF demonstrates that the FlexFactory Standard Automation has been developed in a structured manner and is verified in accordance with the product development life cycle concept. Proper development, verification, and documentation are vital to the functionality and performance of FlexFactory Standard Automation when in operation at a customer site. An external independent GAMP™ 5 assessment has been performed and an independent expert has audited the development.
All project documentation for development of FlexFactory Standard Automation has been audited. This document can be shown at an audit.
The product documentation, based on the GAMP 5 guidelines, is delivered in the form of a product documentation binder/turn-over package.