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 authorities such as USA’s Food & Drug Administration (FDA) the European Medicine Agency (EMEA) and some other organisations as Good Automated Manufacturing Practice (GAMP).

A device used to administer medicine by inhalation or injection or an aspiration-device, must be completely safe, accurate, and reliable in its operation; both for the user and for the pharmaceutical product or device-application.

This requirement influences not only the design of the device, but also the design of the assembly system (which often needs to operate in a controlled production area or in a clean room – eg according to FDA from class100000 to class100 or according to EMEA from classD to classA).

In this environment a lot of parameters are monitored (eg, number of particles, microbiological cleanliness, etc) and the premises may need laminar flow hoods (depending of class and operation).

The machine used therefore needs to be adequately protected in the area the product passes through. Such special guarding requires a restricted work area to be set up to reduce the risk of contamination from dust and other materials. In addition the machine will need to be cleaned frequently to prevent contamination. Materials that are easy to clean and are resistant to aggressive cleaning agents, such as stainless steel, need to be selected.

The authorities also require healthcare companies to ensure the performance of the computerised management system meets the required standard.

The Good Automated Manufacturing Practices (GAMP) guidance aims to ensure that validated and compliant automated systems meet all current healthcare regulatory expectations, by building upon existing industry good practice in an efficient and effective manner.

To obtain approval from the related agencies, an equipment manufacturer must be able to prove that the assembly system in question operates in compliance with industry and quality standards, and that these standards can be maintained. The manufacturer is required to provide detailed documentation showing the system runs as specified.

Approval procedures involve the following specification and test phase-steps:

• Design. The process of defining the architecture, components, interfaces, and other characteristics of a system or component (IEEE). Set of processes that transform requirements into specified characteristics or into the specification of a product, process or system (ISO).
• Design Qualification. The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose (EMEA)
• Installation Qualification (IQ). Documented verification that a system is installed according to written and pre-approved specifications. (PDA).
• Operational Qualification (OQ). Documented verification that a system operates according to written and pre-approved specifications throughout all specified operating ranges (PDA).
• Performance Qualification (PQ). Documented verification that a system is capable of performing or controlling the activities of the process it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment.(PDA)

Mikron can support customers through all these steps and related activities (eg approval of documents). Most of the test phase related steps are fulfiled during the Factory Acceptance Test (on Mikron’s site) and where necessary during the Site Acceptance Test (on the customer’s site). It is, of course, possible for the customer to proceed without Mikron’s Medical Validation Support and to seek the approval of the authorities via the usual qualification/validation process. However, considerable resources and experience are required to satisfactorily complete the necessary steps.

Relieving the client of this cumbersome task is the reason Mikron introduced its Medical Validation Support, which monitors the entire process (except for generating the application destined for the authorities).

Jean-François Bauer is with Mikron Assembly Technology, Boudry, Switzerland. www.mikron.com