Assembly of medical devices Mikron helps its clients get their systems qualified

An assembly system used to manufacture medical equipment not only needs to meet customer requirements, but must also comply with certain criteria to ensure that it is safe to use. These criteria have been developed by the pharmaceutical industry, in compliance with regulations issued by the USA's Food & Drug Administration (FDA).

It is easy to understand that a device used to administer medicine by inhalation, aspiration, or injection, must be completely safe, accurate, and reliable in its operation; both for the user as well as for the dose of medicine it contains. This requirement influences not only the design of the device, but also that of the assembly system (which often must operate in a clean room environment from class 100,000 to class 10,000). In this environment, the number of particles is carefully monitored and the premises are equipped with laminar flow hoods. The machine used therefore needs to be adequately protected in the area the product passes through. Such special guarding requires that a restricted work area be set up to reduce the risk of contamination from dust and the like. In addition the machine will need to be cleaned frequently in order to prevent the possible accumulation of particles which may, in turn, contaminate the device being assembled. Materials resistant to aggressive cleaning agents, such as stainless steel, need to be selected.

Leading pharmaceutical companies have come up with document known as the "Good Manufacturing Practices" (GMP) guide, to be used by suppliers of automatic equipment and assembly systems. This tool establishes a standard in the industry, and outlines the requirements for the engineering, manufacture and documentation of automated systems which should be followed to achieve FDA validation for medicinal products.

To obtain FDA approval, an equipment manufacturer must be able to prove that the assembly system in question operates in accordance with industry specifications and to the required quality standards, and that these standards can also be maintained. The manufacturer is required to provide detailed documentation showing the outcome of the testing procedures followed. Approval procedures follow a four-stage qualification process as follows:

1. Design Qualification – DQ Engineering and development of the assembly system, in accordance with GMP requirements.

2. Installation Qualification – IQ This stage verifies that the system has been constructed and installed in compliance with the relevant requirements, and that the calibration systems are accurate.

3. Operational Qualification – OQ This stage verifies that the assembly system operates properly and complies with all requirements. These tests, which may be carried out on Mikron's premises, are conducted in idle mode, or by using a "placebo". Upon completion, a protocol on the preliminary testing results is signed.

4. Performance Qualification – PQ Once the machine has been installed on the client's premises, this stage verifies that the system, in operational mode and containing the product, operates properly and complies with all necessary requirements. Upon completion of this phase, a protocol on the final testing of the system is signed. Of course, it would be possible for the customer to do without Mikron's "Qualification Service" and to seek FDA approval via the usual qualification process. However, this would require a significant investment of time for preparing all the necessary documentation.

Relieving the client of this cumbersome task is in fact the very reason Mikron introduced its "Qualification Service", which monitors the entire process (except for generating the application destined for the FDA). By entrusting this task to Mikron, one of the benefits enjoyed by the client is that, when the final stage of qualification (Performance Qualification) gets underway, he is already in possession of the essential documentation to be provided to the FDA. This documentation will have already been prepared by Mikron based on the outcome of the various stages of the qualification process. Another benefit is the time the client saves between delivery of the machine to his premises and the point at which the application is submitted to the FDA for approval. This results in a considerable reduction in lead-times.

It goes without saying that an additional investment is required for Mikron's Qualification Service. However, the cost involved has only a minor impact on the project as a whole, since it generally amounts to less than 1% of the value of the assembly system.