Small batch production

Development samples, clinical samples up to small batch production of drug delivery systems at any project stage

Prior to series production, drug delivery devices and pharmaceutical packaging 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 Center (TCC) offers you its 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

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.

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.

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.

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.

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 pharmaceutical and medical technology products.

Contact us!

Krisztian Hetey
Sales Europe
Phone: +49 9431 639 6246
E-Mail: Krisztian Hetey

Aron Haber
Sales North America

Phone: +1 770 688 5000
E-Mail: Aron Haber

Mike Nie
Sales Asia

Phone: +86 769 8851 7100 317
E-Mail: Mike Nie