Medical device manufacturers; Before placing a new medical device on the market, it must ensure that appropriate controls are in place in its manufacturing processes to produce safe products that meet regulatory and related standard requirements. This requires medical device manufacturers to verify, through post-production inspection and/or testing, that their products meet specified design specifications.

It is not practical for the manufacturer to test every product it produces, to test every product;

• Product losses for testing, if the predetermined requirements of the product can only be met by destructive testing,
• It does not represent all variations with the tests performed according to the sampling instruction,
• time wasted etc. not applicable for reasons such as

In this case, the most effective approach is process validation.

Validation processes; It is defined in regulatory requirements such as FDA and 2017/745 MDR. In addition, it is explained in detail in the ISO 13485 standard, which is frequently applied by medical device manufacturers.

ISO 13485:2016 Article 7.5.6,

"The organization should validate all processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement."

FDA (Food And Drug Administration) section 820.75,

“Where the results of a process cannot be fully verified by subsequent inspection and testing, the process should be validated with a high degree of assurance and validated according to established procedures. Validation activities and results should be documented, including the date and signature of the person(s) approving the validation and, where appropriate, the main equipment being validated.”

2017/745 MDR Annex II, Chapter 6

“Product validation and validation

Documentation; It includes the results and critical analysis of all verifications and validation tests and/or studies carried out to demonstrate the conformity of the device with the requirements of this Code, and in particular the applicable general safety and performance requirements.”

As can be seen clearly, process validation processes are frequently encountered in legal requirements and related standards.

Process validation activities; corrective and preventive actions, statistical techniques for design control and sampling methodologies, etc. It is essential that it is fully integrated into the processes.

Examples of processes that need to be validated are:

• Sterilization
• Clean room ambient conditions
• Aseptic filling
• Sterile packaging and sealing
• heat treatment
• Covering
• plastic injection molding
• extrusion
• Source
• Test methods
• air systems
• To mix up
• Plastic or material bonding
• wave/hand soldering
• Formulations
• Software controlled processes
• water systems

To perform process validation; Critical product features that need to be defined, monitored and controlled, as well as critical process parameters and critical raw material parameters that will adversely affect product safety, efficiency and quality should be determined.

The validation process consists of three qualification steps:

1.Installation Qualification (IQ)
Important installation qualification considerations include:

• Equipment design features (e.g. machine capabilities, capacity, etc.)
• Installation conditions (cabling, utilities, functionality, etc.)
• calibration,
• preventive maintenance,
• cleaning programs,
• security features,
• supplier documents,
• drawings and guides,
• software documentation,
• Environmental conditions (clean room requirements, temperature, humidity, etc.)

2.Operational Qualification (OQ)

Important operational competence considerations include;

• Process control limits (time, temperature, pressure, line speed, installation conditions, etc.)
• Software parameters
• Raw material specifications
• Process operating procedures
• Material handling requirements
• Process change control
• Education
• Short-term stability and capability of the process (latitude studies or control charts)
• Potential failure modes, action levels and worst case conditions (Fault mode and impact analysis, fault tree analysis)

3.Performance Qualification (PQ)
Important operational competence considerations include;

• Actual product and process parameters and procedures established at OQ
• Acceptability of the product
• Assurance of process capacity as estimated at OQ
• Process repeatability, long-term process stability
• A final report should be prepared at the end of the validation activities. This report should summarize and reference all protocols and results. It should draw conclusions about the validation status of the process. The final report should be reviewed and approved by the verification team and competent persons.

Infigen Consultancy, which has assisted countless clients in Process Validation and other quality management steps, will be happy to assist your efforts.