HSL-VS
Vials + Syringes
High speed filling and closing machines for combined processing of vials and
single-use syringes.
HSL-VS
Vials + Syringes
• High speed filling and closing machines for combined processing
of vials and single-use syringes.
• Suitable for “Ready to Use” (RTU) materials supplied
in “Nest & Tub”, or materials supplied in bulk.
• 100% weight control using electronic weighing scales.
• For dosing volumes from 0.1 to 250 ml. for liquids, and from 2 to 1,500 mg. for
powders.
• In compliance with cGMP and US FDA, and in special accordance with the requirements of the
pharmaceutical and biotech industries.
Infeed of vials in bulk, connected to the washing unit and sterilization and depyrogenation tunnel.
Vial filling with gas flushing before and after the filling process.
The design has been made for use in sterile areas, in compliance with cGMP and US FDA regulations, and in special accordance with the require-ments 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.
HSL-VS
Vials + Syringes
High speed filling and closing machines for combined processing of vials and
single-use syringes.
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 appli-cation 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 pick & place station places the rubber stopper onto the vial fully or half, depending on the type of stopper (injection or lyophilized). Vials ready to be weighed. 100% weight control using electronic weighing scales.
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.
When using “CIP-SIP” construction elements, it is not necessary to remove the product contact parts for cleaning or sterilizing.
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 with 8 tangential rolling heads which work continuously and ensure reliable crimping and minimal particle generation during the closing process.
Feeding of single-use syringes "Ready to Use" (RTU) using a de-nesting unit.
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 micro-organisms 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.
Syringe filling with gas flushing before and after the filling process.
Pick & place station for rubber plungers. Plungers are transported inverted in order to avoid any contact with the liquid of the syringe, guaranteeing an ideal aseptic insertion.
Optional equipment:
• 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.
Pol. Ind. Coll de la Manya • Galileo Galilei, 5-19 08403 Granollers (BARCELONA) • ESPAÑA Tel. +34 938 718 784 • Fax +34 938 718 375 info@dara-pharma.com • www.dara-pharma.com P h a r m a c e u t i c a l P a c k a g i n g box. Electrical Vials infeed. Control panel. Droppers and plungers infeed. Caps infeed. Vials outfeed. Syringes infeed. 100% Syringes outfeed.
Pick & place for droppers and plungers. 900 ±50 mm. 1950 mm. 5400 mm. 1100 mm. 1600 mm. 3800 mm. 900 mm. Closing station. weight control. 100% weight control. Filling station. Dimensions: (*)
(*) The illustrations correspond to model HSL-VS/4. Other configurations are possible.
HSL-VS
HSL-VS/4
HSL-VS/6
HSL-VS/8
Max. Output / upm: 200 300 400
Type of closures:
Materials: AISI-304 stainless steel, anodised aluminium, POM and contact parts with product in AISI-316L stainless steel.
Container dimensions: Ø= 68 mm. max. h= 140 mm. max.
Rubber stopper + aluminium cap ø13/20 mm. / Plunger
Dosing range / accuracy: 0.1 ÷ 250 ml. ±0.5% (Liquid) / 2 ÷ 1,500 mg. ±0.5 ÷ 2% (Powder)
Electrical supply: 400 VAC – 50/60 Hz – 12 KW. max.
Max. Weight: 3,200 Kg.
Format range: (*)
(*) Processed in nest & tub / tray for RTU materials or individually processed for material in bulk.
Nest & Tub / Tray Vials Syringes
