Ampoule filing and sealing machines for Annex 1

An Ampoule Filing and Sealing machine is the aseptic core of an ampoule production line. It fills liquid pharmaceuticals into glass ampoules and flame seals them under controlled conditions. Syntegon designs these machines for various different products, with gentle handling, accurate dosing and secure sealing as central design targets.

Syntegon ampoule filling machines process standard ampoule sizes and, in the combi version, also vials. The portfolio covers small liquid fills for ampoules as well as higher fill volumes up to 500 ml for selected vial formats, depending on the model. Engineers can select the right range based on product, container and campaign mix. 

Syntegon ampoule production lines are designed for Annex 1 focused aseptic concepts, with options for RABS or isolator integration that separate operators from the aseptic area. Layouts combine washing, depyrogenation, filling, closing and inspection so you can implement contamination control strategies and documentation that help you meet applicable GMP and Annex 1 expectations. 

Ampoules require gentle glass handling and reproducible flame sealing to avoid breakage, cosmetic defects and leakers. Syntegon uses proven transport concepts and controlled burner technology to keep movement stable and flame parameters consistent. This supports container quality and helps reduce scrap, interventions and rework in daily production. 

Cost per filled ampoule is a key KPI under price pressure in liquid pharma. Syntegon supports this with compact line layouts, optimized machine functionality and consistent flame control that stabilizes throughput and sealing quality. Fewer stops, reduced scrap and easier maintenance help keep unit cost predictable while you maintain GMP focused quality standards. 

Yes. Automatic ampoule filling and sealing machines from Syntegon integrate into complete lines with formulation, washing, depyrogenation, sterilization, inspection and secondary packaging. Interface design, buffer concepts and layout engineering ensure smooth product and data handover between units so you can upgrade the aseptic core without rebuilding every surrounding process step.  

Syntegon designs control systems so they can integrate into modern automation landscapes and support data collection for OEE and batch documentation. Depending on your site standards, machines can exchange signals with MES, SCADA or line monitoring tools. This reduces manual data handling and supports data integrity objectives for ampoule production lines. 

Ampoules are usually liquid finished products, while lyophilization mainly targets vial based products. Syntegon can design concepts where ampoule filling lines and vial filling and lyophilization lines share upstream or downstream infrastructure, for example formulation or inspection. This keeps facility use efficient while you run liquid ampoules and lyo vials in one coordinated setup. 

Syntegon offers lifecycle services from installation and qualification through preventive maintenance, spare parts and training to upgrades and modernization. Service concepts address long service lives, obsolescence risk and changing Annex 1 or GMP expectations. This helps you maintain availability, plan budgets and keep your ampoule production line aligned with future technical and regulatory needs.