Pharma and medical technology specialist Gerresheimer has established small series production in the Technical Competence Center at its Peachtree City, Georgia location, in the USA. Small quantities of products can now be manufactured under series conditions and in an ISO class 8 clean-room. During the development and approval of pharmaceutical products and medical devices, this kind of small series is regularly needed for clinical samples or stability batches.
Prior to series production, pharmaceutical products and medical devices run through an exhaustive approval process for which small numbers of units need to be produced repeatedly, for examples, as clinical samples, development samples or stability batches. In 2013, Gerresheimer opened its own small series production at its Technical Competence Center in Wackersdorf, Germany, to accomplish this task. The company is now continuing this success story, starting small series production at its Peachtree City production location to be able to offer American customers small series production locally.
Besides providing small volumes of product, small series production also enables Gerresheimer to optimize the production process in the pilot phase. All the expertise required for series production can be established, while processes can be developed and streamlined. The experience gained during mould making and automation can be harnessed to design series moulds and series equipment.
Setup of small series production began at the Technical Competence Center at the Peachtree City location in 2020 with the conversion of an existing building as well as setup of an ISO class 8 clean-room in accordance with DIN EN ISO 14644-1. Small series production then took up operation in 2021. “The equipment in small series production adapts to the project. We are currently producing an innovative product for ophthalmology, an innovative point-of-care test system and a combination product in accordance with the FDA definition,” said Manfred Baumann, Global Executive VP Sales & Marketing, Administration & TCC at Gerresheimer Regensburg GmbH.
For quality assurance, small series production has its own fully equipped measurement laboratory with product-specific testing equipment with optical and tactile measuring machines and other testing equipment.