During Pharmtech in Moscow, Dara Pharma will present a new filling and closing machine for processing disposable double-chamber syringes, vials, and cartridges in nests. The syringes, vials, and cartridges are supplied ready-to-use, already sterilized and ready to be processed, therefore no washing, sterilization, or special transportation is required.
The design has been made for use in sterile areas, in compliance with cGMP and US FDA regulations, and in special accordance with the requirements of the pharmaceutical and biotech industries.
The filling station can feature peristaltic pumps, model SpeedFill® or a powder doser to meet multiple dosing options for double-chamber formats, like:
- Liquid / liquid
- Powder / liquid
- Freeze-dried / liquid
Production speed: 4,800 uph. When processing single-chamber formats or vials, the speed is doubled as 2 nests are handled simultaneously.
To work in sterile or clean room conditions, DARA Pharma provide different solutions, such as LAF, RABs, or isolators.
- Automatic debagging and delidding.
- Automatic loading and unloading of the nest.
- Vacuum-assisted filling to prevent air trapped in the luer channel.
- Dosing control of processed syringes.
- Vacuum-assisted plunger insertion.
- Gas flushing during filling and/or positioning of plungers.
- Dosing system for CIP / SIP conditions.
- Data recording software to export the production data in compliance with FDA 21CFR part 11.