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.

ISO 10993

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.

Animal origin-free

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.

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.

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.

UL508A

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.

Standard and configurable hardware products: Cytiva is committed to continuing to supply spare parts for standard and configurable BioProcess hardware products for a period of 10 years after product discontinuation. Customer will be notified* of the discontinuation of the end-of product sales support 1 year before the sales support period ends.

Custom hardware products: Cytiva is committed to continuing to supply spare parts for custom BioProcess hardware products for a period of 10 years after product delivery, unless otherwise defined in the custom project. The end-of-product sales support period will be included in the documentation package delivered with the product. No further notification of the discontinuation of the end-of product sales support will be sent out.

Cytiva reserves the right to discontinue end-of-product sales support within a shorter time period if and when regulatory, legal, or other reasons prevent the provision of such support.

*Notifications will be sent for BioProcess hardware products that are available for subscription to change control notification at www.gelifesciences.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.

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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.