OPTIMA complete aseptic vial filling and lyophilisation line

Description

This complete aseptic vial filling and lyophilisation line was built and commissioned by OPTIMA as a single line, with every module supplied by the same OEM. It is rated at 400 vials per minute, 24,000 vials per hour, and runs both bulk and ready-to-use vials. The filling and capping machines are specified for 2R, 6R and 10R formats, while the washer, depyrogenation tunnel and lyophiliser loading systems are also listed for 25R. Two separate filling systems are installed, time-pressure and peristaltic, so liquid, freeze-dried and suspension products can be run on the same line. Filling and stoppering take place under an active open-RABS barrier with integrated LAF control, a built-in particle counter and active air sampling in all zones.

The line is sold as one complete lot and comprises a rotary vial washer (OPTIMA WMR 2400, 24,000 vials/h), a depyrogenation tunnel (OPTIMA SHT 13, 24,000 vials/h), a filling and stoppering machine with open-RABS (OPTIMA VFVM 18000, 24,000 vials/h), two lyophiliser loading and unloading systems (OPTIMA RALUT), two freeze-dryers (OPTIMA FD D30), a capping machine (OPTIMA VVM 2428, 27,000 vials/h) and two Cooptech formulation systems. The smaller system has a maximum batch size of 80 litres and feeds the time-pressure filling system; the larger one has a maximum batch size of 500 litres, feeds both the time-pressure and the peristaltic system, and includes a colloid mill with dosing pumps and a sterile storage tank with recirculation loop for suspensions. Both formulation systems have integrated CIP/SIP, integrated TCU, Novaseptic bottom agitators and Simatic PCS7 process automation. The packaging materials handled are vials, rubber stoppers and flip-off caps.

The two freeze-dryers offer 30 m² effective shelf area each, with 13+1 shelves of 1520 × 1520 mm at 100 mm interdistance. Shelf temperature ranges from −60 °C to +50 °C with a distribution of ±1 °C across a single shelf, shelf cooling from +20 °C to −40 °C under full load takes under 40 minutes and heating runs at 1 °C/min. Condenser capacity is 400 kg with a coil temperature below −80 °C, the sublimation rate is 25 kg/h at 0.1 mbar and the minimum chamber pressure is 5 × 10-3 mbar. The chambers are designed for 2 barg and 133 °C. Loading capacity is approximately 126,000 vials in 2R and 66,000 vials in 6R format. Loading and unloading are fully automatic through the two RALUT systems, with Simatic Batch process automation, a TurnAround cycle and automatic WIT filter integrity testing.

Process control features include washing needle flow check on the vial washer, cooling zone sterilisation in the tunnel, quality control cameras on the filling line and the capper covering vial neck and bottom, stopper presence, cap colour and closing quality, a stopper height sensor on the capper and 100 per cent in-process weight check. The filling machine has a decontamination mode with H₂O₂ sensor. CIP/SIP is integrated for the filling line and the freeze-dryers, and all product and gas filters are integrity testable in line. The line runs with status control and recipe management.

The line was manufactured in 2016 and commissioned in 2018. It has been in commercial GMP production since 2020 and remains in operation until September 2026, so it can be inspected while running. The most recent OEM service was carried out in August 2026. Validation packages (IQ/OQ/PQ), maintenance and service records, CE declarations, size-part documentation and P&ID and layout drawings are available on site or on request. Photographs, a video walkthrough and the component list with serial numbers are released under a mutual non-disclosure agreement.

The line is located in Central Europe; the exact site is disclosed under NDA. Dismantling can begin in January 2027 and the equipment must be removed from the site during the first quarter of 2027. The line can be viewed by prior arrangement, and is sold ex works, in the condition inspected.