Qualification in Precision Plastics Production

Fast Competent Support for Healthcare Product Solutions

Flex Precision Plastics Solutions (Switzerland) AG is a company of Flex Ltd., one of the Global 500 and 2021 Fortune World's Most Admired Company. With more than 400 employees at its Hägglingen and Küssnacht am Rigi locations, Flex Switzerland is a renowned specialist in plastics solutions for the medical field. This includes medical devices components, laboratory consumables, medical  disposables, pharmaceutical packaging and delivery devices. 

gempex supports Flex Precision Plastics Solutions.

During the commissioning of two production lines, resource bottlenecks occurred. Short-term support required expertise in the qualification of systems in GMP-regulated production as well as extensive knowledge of the requirements of 21 CFR 820 and ISO13485. 

First, master plans for qualification and validation of the manufacturing lines had to be developed. Event-related or periodic requalifications were also defined. Internal and external qualification activities were coordinated with a view to efficiency and then carried out in a target-oriented manner. The moderation of risk analyses (FMEA) was also part of the services. The task was completed by the final knowledge transfer to the customer's quality unit.

Support was provided both remotely and directly on site at the Hägglingen and Küssnacht am Rigi sites. The support was integrated into the customer's team in a routinely and flexible manner. Close, competent cooperation with internal and external parties was characteristic. 

The resource provided at short notice enabled the production lines to be put into operation compliantly and on schedule. The initial quick deployment developed into longer-term support. 

For questions on this topic, please contact Ralf Gengenbach, Managing Director gempex GmbH, at contact@gempex.com