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Research, Developments & Pilot Scale Freeze Dryers/Lyophilizers

Production Scale Freeze Dryers/Lyophilizers

Lyo PAT Tools

Freeze Dryer Loading-Unloading System

Vial Washers

Depyrogenation Tunnels

Filling/Stoppering/Capping

Fill-Finish Ready-To-Use Modules

External Vial Washers

Tray Loader

SP i-Dositecno Micro-Line Vial Filling Lines

Need a fill-finish solution that adapts to your needs and guarantees batch consistency? With a compact design, the capability to fill liquid or powder in bulk or ready-to-use (RTU) vials, and filling options of 50 or 200 units per minute (upm), you can be sure the SP i-Dositecno BI or MI Micro-Line is right for you.

  • Cleanroom ready
  • Fully compliant with manufacturing regulations – 21 CFR Part 11 integrated software and IQ/OQ validation packages available
  • Versatile – filling volumes ranging from 100µL to 500 mL
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Overview

When it comes to biopharmaceutical manufacturing, fill-finish can be a challenging process with any errors potentially leading to safety issues, production failures and loss of product. At SP, we understand that sterility, accuracy, speed and compliancy are key. That’s why we offer high-quality, dependable fill-finish solutions that are easily integrated and meet the expectations of cGMP, Annex 1, and regulatory agencies such as the FDA.

Our fill-finish systems offer complete versatility, including filling liquid or powder in bulk or ready-to-use (RTU) vials and covering multiple container closure types for different product dosage forms. Our customers benefit from superior accuracy and repeatability throughout the entire batch, either with statistical sampling or 100%, non-destructive In-Process Weight Control (IPC), with minimal reduction in processing speeds.
The SP i-Dositecno BI or MI Micro-Line™ have got you covered.
SP i-Dositecno BI Micro-Line™ – Rotary filling, stoppering and capping equipment with a simple mechanical driven design that can fill up to 50 upm.
SP i-Dositecno MI Micro-Line™ – Rotary fill-finish with intelligent servo-driven motion-controlled design for the smoothest operation. Capable of processing at speeds up to 200 upm.
All SP i-Dositecno BI or MI Micro-Line™ systems are designed to meet your needs.
  • Built to cGMP and compliant to GAMP5
  • Easily process multiple vial formats thanks to high-quality Polyoxymethylene Copolymer (POMc) change parts for quick changeover
  • Aseptic liquid dosing system by peristaltic pump or ceramic / SS rotary piston, micro-dose and solid powder filling by micro-auger for exceptional accuracy and precision
  • Servo-driven star wheel transport of containers and filling nozzles
  • Available with one or two filling nozzles and up to 2-channel pick and place for stoppers, tips and caps
  • Feeding system prepared for tanks or bag holder inside the machine

All SP i-Dositecno BI or MI Micro-Line Vial Filling Lines come complete with Siemens or Allen Bradley PLC-controlled servo motors that allow you to automatically set the output rate, height and water/air flow for each vessel size. With help from our subject matter experts and dedicated engineers, you can configure the SP i-Dositecno BI or MI Micro-Line Vial Filling Lines to meet your exact needs.

Features & Benefits

  • Easily integrated for a full line solution – compatible with our vial washers, sterilization and depyrogenation tunnels, semi or automatic freeze dryer loading & unloading systems, lyophilizers, capping machines, and external vial washers
  • No disruption – the SP i-Dositecno BI or MI Micro-Line modules slot easily into common isolators, and with identical dimensions they are fully interchangeable
  • Versatile – many optional features available including 100% IPC, PEEK change part materials, nitrogen flush, idle wheel crimping with vertical force monitoring, CIP/SIP

Application Examples

  • Human Injectables Products
  • Ophthalmic Eye Care Solutions
  • Veterinary Health Products
  • Diagnostic & Test Kits
  • Oral Solutions
  • Powder Fill