Dara Pharma has presented its new high-speed equipment for injectable vials. It is, the company has reported, a combination of filler and / or sealer, to work cylindrical vials in glass, plastic or metal, for the automatic conditioning of all types of liquid, semi-liquid or powder products, in the area sterile.
Its design has been carried out in accordance with the cGMP and US FDA standards, in particular correspondence with the requirements of the pharmaceutical and biotechnology industry.
With the performance of up to 24,000 uph and for dosing volumes from 0.1 to 540 ml, the HSL-PP models are designed for both RTU (ready-to-use) vials and for bulk-fed vials.
The filling station is equipped with rotary piston pumps without valves, in stainless steel or ceramic, or SpeedFill peristaltic pumps. In addition, using CIP / SIP construction elements, it is not necessary to disassemble the product’s driving parts for cleaning and sterilization.
The equipment is provided with electronic scales for the control of dosed by weight for 100% of processed vials. The scales are integrated in the structure of the machine, but at the same time separated from it, allowing an exact weighing without the influence of the vibrations of the machine, or without reducing the performance of the machine.
The pick & place station places the shutters at their right height on the vial, depending on whether they are shutters for injectable vials or freeze-dried. The manipulation of the shutters is carried out by vacuum.
The closed station is equipped with an electronic head of a single tangential roller per vial, with which the minimum generation of particles is achieved during the closing process.
All commonly used closures can be treated without problems, such as rubber shutters for injectables or lyophilisates and smooth or flip-off aluminum capsules.
The feeding of the different types of closure is carried out automatically by vibrating feeders with electromechanical fixing, built in stainless steel AISI-316L.
To work in a sterile area, Dara Pharma has developed different laminar flow units or RABs (Restricted Access Barrier Systems) adapted to each machine size. The sterile air flow that is generated ensures a continuous and efficient extraction of particles and microorganisms outside the work area.
With the use of an insulator, the sterile zone is limited to the working area of ??the filling-closing machine, allowing work outside the sterile zone and respecting the standards of the pharmaceutical industry.
In addition, Dara Pharma has indicated that it offers optional equipment such as a washing machine and sterilization tunnel for vials that are supplied in bulk, weight-controlled control for 100% of processed vials, gassed before, during or after the filling process. , CIP / SIP cleaning and sterilization system, vacuum-assisted shutter placement, to reduce the percentage of oxygen inside the vial, ejection of vials with process defects, software for documentation of all relevant production data of FDA agreement 21CFR part 11, monitoring and counting of particles, exit of vials by double tray, laminar flow equipment / RABs / Isolator or IQ / OQ validation
Source : http://www.farmaindustrial.com/noticias/dara-pharma-presenta-equipos-de-alta-velocidad-para-viales-inyectables-MDaZC
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