Filling and closing machines for syringes, vials, and cartridges in nest.
Compact machine / Dosing of syringes, vials, and cartridges in nest / Output up to 22,600 uph. / Conforms with cGMP - US FDA.
Ready-to-use disposable syringes provide security, hygiene and dosing accuracy for medical injections.
The machine we present is a combination of filling and closing equipment for processing disposable syringes, vials, and cartridges in nests. The syringes, vials, and cartridges are supplied ready-to-use (RTU), 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 operations to be carried out on the machine are:
- Manual or automatic positioning of the nest, depending on the model of the machine.
- Dosing through valveless rotary piston pumps or peristaltic pumps.
- Automatic infeed and positioning of plungers or stoppers.
Production speed: up to 22,600 units per hour.
The filling station can be equipped with peristaltic pumps, model SpeedFill®, for liquid products, valveless rotary pistons for semisolids, or powder doser.
When using CIP / SIP cons-truction elements, it is not necessary to remove the product contact parts for cleaning or sterilizing.
All production parameters can be saved in the PLC through different recipes. The parameters are:
- Dosing volume.
- Kinematics of the filling process.
- Insertion depth of plungers / stoppers.
- Adjustment of the component feeders.
These parameters are automatically regulated and associated to each format of the syringe, vial, or cartridge. The recipes can be loaded from the HMI, re-establishing automatically the parameters for a selected format.
New recipes can be easily created and edited.
The changeover to a different format is carried out quickly, easily and without tools, by exchanging complete sets of format parts.
Feeding of stoppers and plungers is automatically done through AISI-316L vibrating feeders with electromechanical toolless fixation for easy change of format.
In order to work in sterile or clean room conditions, DARA Pharma provide different solutions, such as LAF, RABs, or isolators.
Using an isolator or RABs system improves the sterily conditions and offers a better protection of the product and for the user, according to pharmaceutical standards.
- Automatic debagging and de-lidding.
- Automatic loading and unloading of the nest.
- Vacuum-assisted filling to prevent air trapped in the luer channel.
- Dosing control of 100% 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.
- Laminar flow / RABs / Isolator.
- IQ / OQ validation package.