For medical devices released by the manufacturer in a sterile form, one of the main principles that assure quality, safety and efficiency is the use of a package that provides maintaining of the medical device characteristics in the process of transportation and storage within the declared service period. It does not seem possible to confirm compliance of the package with the abovementioned requirements during acceptance testing of medical devices. That’s why it is necessary to perform validation of the packing process (packaging) of medical devices delivered in a sterile form.
As influence of the medical device package to quality, safety and efficiency of medical devices is very important, para. 17 of section 4 of the Order of the Ministry of Healthcare of the Russian Federation dated the 19th of January, 2017, No. 11н «On establishment of the requirements to scope and contents of technical and operational documentation of the manufacturer (the vendor) of medical devices» sets the requirement that the manufacturer should provide the registration dossier for the medical device delivered in a sterile form to be registered that include documents on validation of the packing process.
The same requirement is set in para. 23 of Appendix No. 4 to the Rules of registration and expertise of safety, quality and efficiency of medical devices established by the Resolution of the Eurasian Economic Commission Council No. 46 dated the 12th of February, 2016. Thus, objective evidences of performed validation of the packing process (packaging) are required for undergoing the procedure of registration of the medical device both according to the national rules and within the frames of the EAEU rules.
We purposely give two variants of the term to describe the process – packing and packaging, as different regulations use different definitions:
As a rule, the document that confirms performing of validation of packing (packaging) process for medical devices is the summary report to which, when required, additional documents can be applied.
The corresponding standards do not establish strict requirements to the form of the summary report (or the documents that can replace it). However, some of them contain the requirements to the scope and the procedure of validation of the packaging process. These requirements are established by the following standards:
GOST ISO 11607-1-2018 determines main characteristics of the materials and components used for packing systems for terminal sterilization of medical devices supplied in a sterile form. It also contains a wide list of potential materials, medical devices, designs of packing systems and sterilization methods. The standard helps the manufacturers to consider the majority of the factors that influence the package ability to provide the quality of the sterile medical device. The main of these factors are the following:
GOST ISO 11607-2-2018 establishes the requirements to development and validation of the processes of packaging of the medical devices subjected to terminal sterilization. These processes include formation, sealing and assembling of the preliminarily prepared barrier systems for sterilization, the barrier systems for sterilization and packing systems. The standard contains examples of production processes associated with packing of the products that should be covered by validation. The following should belong to them:
The certain list of the processes depends on the chosen packing technology, the used equipment and the packing system. The standard requires the performance of attestation of packing equipment during mounting (IQ), functioning (OQ), use (PQ) and gives an approximate scope of each stage of attestation.
The manufacturer, according to the abovementioned standards, should do the following:
Each of these stages should be documented (the notes should be made as objective evidences of performance). Records on all the stages should be collected into a summary report on validation of packing (packaging) process.
This summary report (or any other document that can legally replace it) should be included into the scope of the registration dossier and submitted for state registration to an authorized body (in the Russian Federation – to the Federal Service for Surveillance in Healthcare)!
Implementation of the mentioned standards into the production process allows choosing of the packing system that corresponds best with the certain medical device and providing stability and repeatability of the packing process. This is the warranty of maintaining of quality, safety and efficiency of the medical device within the declared service period.
It is also should be noted that GOST ISO 11607-1-2018 and GOST ISO 11607-2-2018 require implementation within the frames of the quality management system applicable at the manufacturer’s and complying with the requirements of GOST R ISO 9001-2015 Quality management systems. Requirements (ISO 9001:2015 «Quality management systems – Requirements») and/or GOST ISO 13485-2017 Medical devices. Quality management systems. Requirements for regulation.
These requirement of the standards is explained by the fact that maintaining of stability of packing processes is strictly associated with other production processes, such as incoming inspection and operational quality control, designing and development, maintaining of the enterprise infrastructure. Without proper control over these processes, it is perfectly impossible to comply with the requirements of standards GOST ISO 11607-1-2018 and GOST ISO 11607-2-2018.
Performance of validation of packing (packaging) process for the medical devices delivered in a sterile form is a mandatory procedure that provides market release of high-quality, safe and effective medical devices. Mistakes made during this procedure can lead to negative consequences with various harmful effect grade for the patients and/or the medical personnel. For that reason, we strictly recommend to perform validation in a full scope prior to releasing the medical devices to the market and to consider all the risks associated with packing discovered during the process of risk management.
If you have any questions regarding validation of packing process, our experts can develop quickly the required documents in strict accordance to the applicable standards and the requirements of the Federal Service for Surveillance in Healthcare. Our company’s experts get practical experience at production of medical devices with different risk classes. Contact us in any applicable way or submit an application for a back call.
