An approach to the technological process validation of manufacturing medical devices using the example of injectable implants based on hyaluronic acid

Abstract

The aim. Technological process validation of manufacturing medical devices is a necessary condition for confirming the ability to continuously produce high-quality medical devices, reduce or eliminate the number of defects, improve the level of product quality, and is also one of the main requirements for product certification on the European Union market. Given the wide variety of medical device types (from patches to pre-filled syringes), unlike medicinal products, the validation procedure for medical devices does not have clear recommendations and guidelines.

Materials and methods. The subject of this article is the determination of the approach to the technological process validation of manufacturing medical devices using the example of injectable implants based on cross-linking hyaluronic acid, based on the experience of batch production of the specified type of products on an industrial scale and the regulatory requirements of Ukraine and the European Union.

Results. The article presents information about the nature of hyaluronic acid, its structure, sources and methods of production, and the scope of application.

Determination of critical points of the technological process was carried out by the method of risk assessment using the approach of forming the Ishikawa diagram, i.e. "analysis of cause-and-effect relationships ".

The main stages of the analysis of causal relationships are the following:

– determination of the process that is subject to analysis (obtaining high-quality finished products) and sub-processes that have an impact on the final result;

– determination of the main categories of impact on the process, displayed by blocks on the Ishikawa diagram.

The result of such an analysis is displayed in the form of the above-mentioned diagram Ishikawa ("fishbone").

Sub-processes that have the main influence on it were determined. These elements are the critical points that will be subject to validation. The impact of each of these elements, their key parameters and permissible operating ranges are described in the article.

Conclusions. The sub-processes that have the main impact on the technological process of manufacturing the medical device are identified. These elements are critical points that are subject to validation. The article describes the impact of each of these elements, their main parameters and permissible operating ranges, and also presents the validation process and confirmation of the validity of the corresponding technology