High speed filling and closing machines for combined processing of vials and single-use syringes.
100% weight control / Liquid filling from 0.1 ÷ 250 ml. / Powder filling from 2 ÷ 1,500 mg. / Output up to 24,000 uph. / Conforms with cGMP - US FDA.
The equipment we present is a high speed compact filling and closing machine for the combined automatic processing of vials and single-use syringes, for all kinds of liquids, semi-liquids or powder, in sterile conditions.
The single-use syringes have quickly become the preferred format of pharmaceutical application among doctors and medical personnel as they provide security, hygiene and dosing accuracy for medical injections.
The syringes are supplied ready-to-use (RTU), in trays called Nest & Tub, already sterile and ready for filling. Thus, neither washing nor sterilization is necessary. The vials may be also supplied ready-to-use (RTU) or in Bulk. If provided in bulk, they are previously processed through a washing unit and a sterilizing and depyrogenation tunnel.
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.
Output up to 24,000 uph.
Dosing and weight control:
The filling station can be equipped with valveless rotary piston pumps, made of stainless steel or ceramic, or with SpeedFill® peristaltic pumps for liquid products, and with vacuum-pressure fill guns for powders.
When using CIP / SIP construction elements, it is not necessary to remove the product contact parts for their cleaning or sterilization.
The 100% weight control of vials and syringes is performed without reducing the speed of the equipment, using electronic weighing scales. The scales structure is integrated into the machine in such a way that the machine’s vibrations do not influence the precision of the weighing process.
Dosing volumes from 0.1 to 250 ml. for liquids, and from 2 to 1,500 mg. for powders.
Positioning and closing:
When processing vials, the pick & place station places the rubber stopper onto the vial fully or half, depending on the type of stopper (injection or lyophilized).
The closing station is equipped, depending on the required speed, with either 8 or 16 tangential rolling heads which work continuously and ensure reliable crimping and minimal particle generation during the closing process.
When processing syringes, the plunger insertion is done mechanically or through vacuum.
All closures currently used can be easily handled, such as:
- Injection or lyophilized rubber stoppers.
- Plungers for single-use syringes.
- Aluminium caps.
- Flip-off caps.
Feeding of different types of closures is done automatically through vibrating bowls, made of AISI-316L stainless steel.
Containment and asepsis:
In order to work in sterile applications, DARA Pharma provide tailored solutions, such as LAF or RABs (Restricted Access Barrier Systems). The generated vertical flow of sterile air ensures a permanent and reliable expulsion of particles and microorganisms from the working area.
By using an isolator, the sterile area is reduced to the smallest possible area, allowing the equipment to operate in a clean room class D, ensuring the safety of the product and people during the filling process.
- Washing unit and sterilization tunnel for vials supplied in bulk.
- De-nesting unit for ready-to-use (RTU) syringes or vials.
- 100% weight control using electronic weighing scales.
- Dosing system for CIP / SIP conditions.
- Vacuum-assisted filling to prevent air trapped in the luer channel.
- Gas flushing before, during or after the filling process.
- Monitoring and particle counting.
- Vacuum-assisted insertion of coated or rigid plungers.
- Automatic rejection of defective vials and syringes.
- Software complying with GAMP.
- Process data acquisition software in accordance with FDA 21CFR Part 11.
- Vial output through a double tray.
- Laminar flow unit / RABs / Isolator unit.
- IQ / OQ validation package.