HSL-LYO ASEPTIC FILLING

High speed filling and closing machines for injectable and lyophilized vials.Dosing control of 100% of vials / Filling from 0.1 ÷ 250 ml. / Output up to 24,000 uph. / Conforms with cGMP - US FDA.
The equipment we present is a compact filling and closing machine for automatic processing of cylindrical vials in glass, plastic, or metal, for liquid, semisolid, and powder products, in sterile areas or clean room.
Suitable for RTU vials (ready-to-use) as well as for vials supplied in bulk.
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.
Production speed: up to 24,000 units per hour.
The operations to be carried out on the machine are:
Automatic infeed of vials directly from sterilizing tunnel.Dosing through valveless rotary piston pumps or Speedfill® peristaltic pumps.Automatic infeed and positioning of injectable or lyophilized stoppers.Unloading of vials onto a tray at the exit of the machine.When using CIP / SIP construction elements, it is not necessary to remove the product contact parts for their cleaning or sterilization.
In order to work in sterile applications, DARA Pharma provide tailored solutions, such as LAF and 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 area of the filling and closing machine, that allows the equipment to operate in a clean room class D, complying with the regulations of the pharmaceutical industry.

Optional equipment:Dosing control of 100% of processed vials.Vacuum-assisted insertion of stoppers to reduce the presence of oxygen in headspace.Process data acquisition software in accordance with FDA 21CFR Part 11.Gas flushing before, during or after the filling process.Dosing system for CIP / SIP conditions.Automatic rejection of defective vials.Monitoring and particle counting.Vial output onto a double tray.Laminar flow / RABs / Isolator.IQ / OQ validation package.