Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

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This document was prepared by Technical Committee ISO/TC 276, Biotechnology.

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Introduction

Biobanks represent a central element of biological research and development. By providing biological materials and their associated data of defined quality, they enable meaningful and reproducible research results. Prerequisites for this are not only validated methods and qualified equipment, but also consumables that ensure a defined quality of the biological material. Most of the consumables used come into contact with the biological material only temporarily and can therefore influence the quality of the biological material only to a limited extent. However, primary containers for storage, particularly when storage is over a period of several years, can influence the properties of the biological material. This can occur, for example, through adsorption or absorption of components of the biological material on the surface of the container, contamination of the biological material through released contents of the container material, penetration of foreign substances, or loss of components of the biological material through leaks in the primary container. Furthermore, the material properties of the primary container can change during longer storage periods (ageing). The properties of these primary containers can have a crucial effect on the quality of the biological material.

This document specifies minimum requirements for primary containers that serve the purpose of storing biological materials in biobanks. The requirements described in this document form the basis for verification of the usability of primary containers for the storage of biological materials to ensure that there are no adverse effects on the intrinsic quality of the biological material. In addition, test criteria and test methods are specified to enable proof of conformity with the minimum requirements.

The requirements included are intended to enable biobanks to provide biological materials of suitable quality for research and development. The specification of requirements for primary containers and methods for verifying conformity with these requirements enables manufacturers of primary containers to demonstrate the suitability of their products for their intended purpose. The standardization of primary containers facilitates the exchange and gathering of biological materials from different biobanks for large-scale research projects and use in automated processes.

This document supports biobanks in achieving defined quality targets, collaborating with researchers, and in harmonizing the quality of biological materials for the benefit of research and development. This document is primarily aimed at manufacturers that produce primary containers for the storage of biological materials. Biobanks, submitters and users of biological material, and organizations that monitor or control the work of biobanks can also use this document.

The following verbal forms are used in this document:

“shall” indicates a requirement;
“should” indicates a recommendation;
“may” indicates a permission;
“can” indicates a possibility or a capability.

1 Scope

This document specifies requirements for primary containers intended for the storage of biological materials in biobanks. In addition to general requirements, this document also specifies special requirements depending on the storage conditions, the biological material and the intended use, as well as requirements for documentation and quality control. These requirements establish the framework for ensuring that primary containers meet the necessary quality criteria.

This document specifies test criteria and test methods that enable proof of conformity with the requirements.

This document is primarily aimed at manufacturers that produce primary containers for the storage of biological materials. Biobanks, submitters and users of biological material, and organizations that monitor or control the work of biobanks can also use this document.

NOTE For primary containers intended for biological material for therapeutic use, other requirements can apply.

2 Normative references

3 Terms and definitions

4 Requirements

4.1 Requirements for the manufacturer

4.2 Requirements for the primary container

5 Test methods

5.1 General

5.2 Performance of tests and scope of testing

5.3 Testing stability under storage conditions

5.4 Testing leak-resistance

5.5 Testing for the release of substances from the primary container material

5.6 Testing for adsorption or absorption of components of the biological material by the material of the primary container

5.7 Testing for changes in the shape and mechanical properties of the primary container

5.8 Test report

6 Labelling

6.1 Identifiability and traceability

6.2 Testing the labelling

Bibliography