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Medtech OEMs typically need small quantities of devices during the product development and regulatory approval processes.

March 20, 2022

2 Min Read
small series production facility
Image courtesy of Gerresheimer

A contract manufacturer serving medical device and pharmaceutical OEMs, Gerresheimer offers small series production capabilities at its Technical Competence Center in Peachtree City, GA. Small quantities of products can be manufactured under series conditions and in an ISO Class 8 cleanroom. Small series production is typically needed for clinical samples or stability batches during the product development stage and regulatory approval processes.

The service is modeled after a small series production center that Gerresheimer set up in 2013 at its headquarters in Wackersdorf, Germany. It proved to be popular with customers, which prompted Gerresheimer to duplicate the service at its US plant.

Setup of the small series production began at the Peachtree City Technical Competence Center in 2020, with the conversion of an existing building as well as the installation of an ISO Class 8 cleanroom in accordance with DIN EN ISO 14644-1. Small series production began in earnest in 2021.

Gerresheimer small series production testing lab

A range of small series production and testing equipment at Gerresheimer's Peachtree City facility is available to support specific projects.

In addition to enabling small series production, the center allows optimization of the production process during the pilot phase. The expertise required for series production can be honed, while processes are developed and streamlined. The experience gained during mold making and automation at this stage improves efficiency in final mold and equipment design.

“The equipment in small series production adapts to the project,” said Manfred Baumann, Global Executive VP Sales & Marketing. “We are currently producing an innovative product for ophthalmology, a point-of-care test system, and a combination product.”

Currently the center is equipped with a 120-ton injection molding machine and auxiliary handling systems and conveyors. Project-specific assembly and packaging units as well as manual assembly stations, including ultrasonic welding systems, are also available. For quality assurance, a fully equipped measurement laboratory with product-specific testing equipment is on site.

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