Small Batch Production of diagnostic and medical devices
Development samples, clinical samples up to small batch production at any project stage
Prior to series production, diagnostic products and medical products 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. Our Technical Competence Centers (TCC) in Wackersdorf (Germany) and Peachtree City (USA) offers you their own production systems for this task, on which the quick and uncomplicated production of development samples, clinical samples or small series is possible at any point in the project.
Your PLUS with Gerresheimer
Broad spectrum of services including micro-injection molding
The production area of our small batch production for glass and plastics is approximately 1,800 sqm (19,5 thousand sqft). A clean room class 7 and 8 in accordance with DIN EN ISO 14644-1 with about 1,100 sqm (12 thousand sqft) for injection molding and assembly of plastic parts and a clean room GMP class C and D for pharmaceutical glass products with about 370 sqm (4 thousand sqft) are available as well. The equipment includes injection molding machines with a clamping force of 65 – 420 tons, glass forming lines, RTF and cannula assembly lines as well as a line for baked-on siliconization. Project-specific assembly units and specific measuring technologies complete the equipment.
Product-specific assembly and refinement
In addition to the injection molding machines, small series production is equipped with project-specific assembly systems like automatic joining systems, gluing apparatus or systems for ultrasound and laser welding. We offer our customers both manual and semi-automatic assembly.
Measuring technology
Small series production is equipped with an own measurement laboratory with product-specific test equipment for the optical and tactile valuation of plastic parts and assembly units.
Production in series quality
In small series production we already produce in series quality; the know-how acquired can later be used directly for large series production at a freely selectable location. Weaknesses are detected through small series production at an early point in the project and can be optimized in the development context.
Control according to series standard
The control of the entire production process, including order management, production planning, mold service, injection mold, assembly, quality management, and logistics for small series production takes place according to series standard. A Management Execution System (MES) thereby ensures efficient, fast and economical production. Automated quality tests coupled with the production process and completely documented traceability of individual modules or batches ensures that all products correspond to the required quality standard for diagnostic products and medical products.
