Pharma and medical technology specialist Gerresheimer has established small series production at its Technical Competence Center at Peachtree City, Georgia. This kind of small series is regularly needed for clinical samples or stability batches during the development and approval of pharmaceutical products and medical devices. Small quantities of products can now be manufactured under series conditions and in ISO class 8 cleanroom.
Before the 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 example, 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 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 mold making and automation can be harnessed to design series molds and equipment.
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The setup of small series production began at the Technical Competence Center at the Peachtree City location in 2020 with converting an existing building and setting up an ISO Class 8 cleanroom according to DIN EN ISO 14644 1 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,” explains Manfred Baumann, global executive vice president of Sales and Marketing, Administration and TCC, Gerresheimer Regensburg.
Based on these projects, the equipment in small series production currently includes an injection molding machine with a clamping force of 120 tons that connects with handling systems and parts conveyors. Project-specific assembly and packaging units such as granulation, fill and seal plants, and manual assembly stations, including ultrasonic welding systems, are also available. 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 for quality assurance.
