Sterilisation process validation

Sterility is a mandatory requirement for medical procedures. Medical products must be decontaminated for both surgical procedures and sample collection for analysis. Safety is guaranteed by a procedure for assessing production in terms of reliability, or sterilisation validation, which manufacturers undergo in order for their products to enter the medical goods market.

What is sterilisation validation?

The control and certification of medical device decontamination processes is called validation. This is documented confirmation of the receipt, registration and interpretation of medical device sterilisation results, ensuring the reproducibility of the production cycle, sterility for each unit of production and compliance with technical requirements.

It is carried out for the entire production line, since checking individual product samples is meaningless — the sterility of a single sample does not guarantee the safety of others. Each link in the serial production chain is subject to verification according to parameters that allow the technological process to be evaluated in terms of obtaining safe products.

Why validation is needed

The manufacture of medical products requires the manufacturer to strictly comply with all regulatory requirements. The validation procedure is necessary to verify that the products comply with the established parameters and quality criteria. The control assessment allows manufacturers to:

• register sterile medical devices with Roszdravnadzor;
• certify the quality of the disinfection process according to ISO 13485;
• demonstrate to regulatory authorities that the sterilisation process guarantees the reproduction of a sterile product.

Thus, validation will allow you to go through the state registration procedure with Roszdravnadzor and obtain registration certificates for medical devices and products.

Sterilisation methods

Product sterility can be achieved in various ways. The method is selected based on the nature and parameters of the product, its aggregate state and other factors. The following methods are most commonly used:

• radiation – decontamination is achieved using sources of ionising radiation;
• plasma - sterilisation with hydrogen peroxide plasma;
• chemical - treatment with a disinfecting gas mixture or chemical solutions, known as sterilisants;
• membrane - sterilisation using filters with particularly small pores that trap microorganisms that compromise the sterility of the product;
• thermal - decontamination with warm or dry hot air.

After disinfection, the product is placed in aseptic packaging. Sometimes this option can impair the properties of the product. In such cases, disinfection is carried out together with packaging.

Sterilisation validation requirements

The validation of the sterilisation process is regulated by the national standard GOST R ISO 14937-2012, which is consistent with the international standard ISO 14937:2009. The main regulatory requirements are as follows:

• documentation of the procedure, including equipment and product specifications. Each stage must be carried out in accordance with the approved algorithm;
• justification of the selected method, taking into account the characteristics of the production process;
• verification of the consistency of data examined using the selected tools and control of the error detection system;
• documentation of equipment installation and maintenance processes, verification of its operability;
• certification of equipment at the installation and operation stages;
• verification of information on the procedure for compliance with the criteria of each stage.

The requirements for the implementation methodology are reflected in the interstate or national standard GOST R.

Regulatory documents

The validation of the sterilisation process is based on key legislative and regulatory acts, including:

• Federal Law No. 323-FZ of 21 November 2011 ‘On the Fundamentals of Health Protection of Citizens in the Russian Federation’ - this establishes the general principle of mandatory safety and effectiveness of medical devices introduced into circulation;
• Order of the Ministry of Health of the Russian Federation No. 11n of 19 January 2017 - establishes a list of mandatory documents for the registration of devices, including confirmation of validation for sterile goods;
• Decree of the Government of the Russian Federation No. 1416 of 27 December 2012 - on the regulation of state registration of medical devices, including the procedure for confirming sterility;
• GOST R 56431-2015 (GNTF/SG3/N99-10:2004) ‘Quality management system. Medical devices. Guidance on process validation.’

The procedure for validating sterilisation by a specific method is set out in the relevant regulatory document. For example, the rules for validating sterilisation using moist heat are set out in the national standard GOST R ISO 17665-1-2016, and for sterilisation using ethylene oxide - in the interstate standard GOST ISO 11135-2017.

What happens when validation is performed incorrectly

Sterilisation validation is a mandatory procedure. Manufacturers must ensure that they produce products that meet strict quality, safety and efficacy requirements. Incorrectly performed validation leads to critical risks – the appearance of pathogenic flora when using medical devices. The appearance of non-sterile medical devices in hospitals is becoming a problem, as the appearance of infection contributes to nosocomial infections.

Validation errors (superficial procedures, testing violations, incorrect load configuration, etc.) lead to the refusal to register medical devices with Roszdravnadzor, which means a ban on the sale of products.