MEDICAL | TECHNOLOGY
Process validation and dynamic controls
Engel has worked to integrate its adaptive iQ weight control for medical manufacturing compliance Injection moulding machines with assistance systems
open up new possibilities for even higher process accuracy and product quality, particularly for medical moulding. Such intelligent software solutions adjust the process parameters cycle by cycle based on current conditions. One example is iQ weight control by Engel, which automatically compensates for external influences, such as fluctuations in the raw material. However, the challenge for medical technology is to integrate this dynamic process control into the validation process. Different approaches have been examined and a procedure designed which makes it possible to validate processes with iQ weight control in compliance with both EN-ISO and FDA. Engel adds that for medical products, the
regulating groups of the EU and the USA require detailed documentation during the entire product development, process planning and manufacturing process. The requirements can be found in the European standard EN ISO 13485:2016 – Quality management systems for medical devices and in the US FDA regulation 21 CFR Part 820 – Quality Systems Regulations. Both regulations stipulate that a company must validate critical production processes of results that cannot be verified by subsequent monitoring or measurement. This includes injection moulding processes in mass production, where 100% inline inspection is usually not logical. However, the implementation of the validation is not specified either in the US regula- tion or in the European standard. Only the tasks to be performed by the manufacturer are recorded in various directives and guidelines. According to Engel, it is common practice to
validate injection moulding processes on the basis of machine parameters. However, changing ambient conditions that influence the viscosity of the melt can lead to rejects that are not taken into account. It says many processors are asking how the new dynamic process control can be integrated
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into a validation strategy for the manufacture of medical technology products in compliance with current laws and standards. The key lies in the definition of process windows and the validation of these process areas. Engel says that iQ weight control offers the possibility of limiting the scope of readjustment. Based on experience or test results, limit values are determined for the adjustable parameters switch- over point, injection profile and holding pressure, respectively, and are stored in the control system. This ensures that the process parameters do not fall outside of the validated range despite dynamic process control, and that the process complies with the regulatory requirements. The validation strategy must be adapted to the
product. First, product requirements must be defined by measurable acceptance criteria. This is usually done based on the risk analysis and is described in a validation master plan (VMP). The VMP contains the validation strategy of a company and should clearly define the key elements of the qualification and validation program. To this end, the VMP must describe specifically which validation principles are implemented in the company and how, and who assumes the responsibility at which level and in what form. This task should be per-
September 2020 | INJECTION WORLD 39
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