The pilot production will further help in the development of clinical samples for small series production in every project phase for the company’s American customers
The small series production setup with injection moulding machine. (Credit: Gerresheimer AG)
German pharma and medical technology company Gerresheimer has started a small series production at its Technical Competence Centre at its Peachtree City location in Georgia, US.
The pilot production will help make small quantities of products under series conditions and in ISO class 8 cleanroom with the help of an injection moulding machine equipped with a clamping force of 120 tonnes that connects handling systems and parts conveyors.
Gerresheimer said that the small series are needed repeatedly for clinical samples or stability batches during the development and approval of products and devices.
The setup also features project-specific assembly and packaging units such as granulation, fill & seal plants as well as manual assembly stations, including ultrasonic welding systems.
For quality check, the plant has its own fully equipped measurement laboratory with product-specific testing equipment with optical and tactile measuring machines and other testing equipment.
The latest addition of small series production for American customers will join the list of already existing Gerresheimer’s own small series production at its Technical Competence Centre in Wackersdorf, Germany which was established in 2013.
In the pilot phase, the firm can use the established set-up to develop and streamline the processes, while optimising the production process. The experience of mould making and automation can be used in designing series moulds and series equipment.
The plan for small series production began with renovating the existing building along with an ISO class 8 cleanroom in accordance with DIN EN ISO 14644-1 at Technical Competence Centre at the Peachtree City location in 2020.
Gerresheimer Regensburg administration & TCC global executive vice president sales & marketing Manfred Baumann said: “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.”
In December last year, Jassen selected Gerresheimer for its new OJESH Pro Regeneration skincare series.