Pharmaceutical Vial Filling Machine With Isolator

Jul 03, 2023

Rotary filler for clinical and early stage pharma production specialist for fill finish advanced aseptic manufacturing for pharmaceutical and biologics injectables. Designed to be used in an isolator.

This unit offers a minimized star wheel in tandem with dialed in servo control and flexibility. Trayed vials and/ or nested vials/syringes/cartridges are introduced for fill finish. Vials are weighed/filled and closed (stoppers and optional caps.) 2 up filling alternatives give the user a range of outputs and flexibility. The pre-designed units can be set up both “isolator ready” and open RABS configurations. Full servo design incorporates filling precision and repeatability, product conservation and closing systems with great process windows. The ATS Life Sciences Hull i-Dositecno internal core competencies include excellent glass handling/fluid dynamics skill sets and automation expertise. The machine is very friendly to cleanability and ISO 5 air flow practice. Easy changeovers and easy touch screen interface. GAMP documentation and validation support.

Isolator main features:

Filtration grade with H14 filters IN / OUT • Exhaust fans positioned in the technical area • Automatic shutter gates, for IN / OUT for differential pressure & containment control • LED lighting, positioned on the outside of the aseptic process area • Doors with 12 mm thick tempered glass with inflatable gaskets • Glove ports with independent safety barrier • Integrated Glove Integrity Tester with Speedy Glove • Return ducts for optimal uniformity of air flow • Bag-In Bag-Out filtration upon request

Isolator walls made of 3 mm thick stainless steel AISI 316L with internal finish Mirror Brite < 0.3μm and round corners of 20 mm radius • Spray balls and spray guns guns for facilitating the cleaning of the unit at the end of the production • Integrated Comecer VPHP generator for automatic decontamination of the equipment • Isolator & filling machine together will satisfy the containment level Class 3, ISO 10648-02. Leak rate < 1%