FDA competences for special applications
Unitechnologies frequently moves from the role of an automated equipment supplier to an automation partner for several reasons, such as:
- Automation projects in the medical industry often go together with the development procedure of a new product or the enhancement of an existing product. Consequently, Unitechnologies is usually involved from the very start of the project to coach the customer, which is a typical sysmelec® “co-engineering ” scenario.
- The nature of the applications and the very strict safety requirements associated with the medical industry lead to a very strong need to check well in advance mission-critical processes in automated environment; this need is as significant for customers wishing to check the feasibility of their processes in automation situation as it is for Unitechnologies.
- In addition, the relationship with the customer is reinforced by the compliance to the design rules, the realization principles and the structure of the required documentation for a possible FDA validation procedure (application of the GAMP rules).
If necessary, sysmelec® equipment can also be designed and realized to comply with a clean room environment meeting requirements from class ISO 4 to ISO 8.
In the medical field, the laser surface processing applications require a significant qualification effort. In addition to the requirements for material stability (stainless steels, titanium alloys, high performance polymers) and for component shapes, experience plans are prepared to describe the performance limits and the laser process robustness (for example in the welding case). Furthermore, a close working relationship with the suppliers of sources and optics are required for stability and traceability purposes.