COMECER S.p.A

HELIOS

HELIOS

High-Throughput Aseptic Isolator for Vials and Syringes Filling

HELIOS is a fully automatic system, able to provide an aseptic GMP dispensing process on vials and syringes. It is possible to have in the same batch, different vial format, different syringe format or even a hybrid batch of vials and syringes

Highlights

• Integrated fully automatic dispensing system in the main chamber
• No visible mechanical parts in the area
• Complete cleanability for aseptic area
• Easily removing of the vial holder
• Easy change of formats between vial size and syringes
• Large batch size
• Illuminate™ MI: IIoT manufacturing intelligence platform and factory-floor management

Features

• Material introduction chamber (pre-chamber) with air quality complying with Class B “At rest” (EEC-cGMP) and equipped with handling gloves
• 75 or 100 mm of lead shielding available
• Shielded side sliding door between material introduction chamber and dispensing chamber
• Optional waste compartment with air quality complying with Class B “At rest” (EEC-cGMP) equipped with front door for extraction
• Filtration system for main chamber and pre-chambers with HEPA H14 absolute filtering cartridge
• Air outlet filtration system made with active carbon filtering cartridge
• Operator panel to check and trace the critical parameters of the machine both in “at rest” or “in operation” mode
• Shielded entry for radioactive fluids
• Connection for DOP test (filter sealing test) for absolute filters
• Semi-automatic Bubble Point Test for the dispensing system
• Geiger-Muller probe to detect radioactivity inside the cell and door interlock management
• Set-up for connecting hydrogen peroxide generators (VHP) in the main chamber and in the pre-chamber
• Automatic leak test for main chamber and pre-chamber
• Set-up for a particle counter sensor in the main chamber and in the pre-chamber