Sterility Testing of Immonobiological Medicinal Products in Russia. Historical Background and Current Requirements

Abstract

Sterility is one of the key parameters of biological safety of immunobiological medicinal products. The article traces the history of the development of sterility test methods for immunobiological medicinal products from as far back as 1961 and up to the current requirements laid down in the State Pharmacopoeia of the Russian Federation, 13th edition. The article provides a detailed analysis of major approaches to the improvement of medicines quality evaluation based on this parameter, namely to the choice of: optimal growth media and methods of their evaluation, sensitive test strains, incubation conditions, the number of test samples (i.e., sample size) required for reliable demonstration of batch sterility; as well as approaches to the development of a test design that would accommodate specific aspects of production and use of immunobiological products. The article dwells upon the longstanding use of the sterility testing scheme developed in the national agency for control of immunobiological products — L.A. Tarasevich State Institute for Standardization and Control of Medicinal Immunobiological Products. The article analyses the current status of harmonisation of requirements for sterility testing of immunobiological products and other groups of medicines with those of the leading world pharmacopoeias, and prospects of using these requirements in the Eurasian Economic Union.

Keywords

• national control authority
• pharmacopoeia
• sterility
• medicinal immunobiological products
• microbiological safety
• membrane filtration
• direct inoculation
• contamination
• merthiolate
• quality evaluation