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MICRO BI
High quality rotary filling system

MICRO BI is a rotary filling system for RTU vials for clinical and early-stage pharma production. MICRO BI is a specialist for fill and finish advanced aseptic manufacturing for pharmaceutical and biologics injectables built to be used in an isolator.

The isolator is designed to grant aseptic conditions inside the machine process area and to protect operators from product toxicity.

A-MICRO BI - rotary filling system

The rotary filling system MICRO BI offers a winning combination of:

  • Unmatched Adaptability: MICRO BI caters to your specific requirements, handling both liquids and powders. Whether you require bulk or ready-to-use (RTU) vial formats, this system can handle it all.
  • Scalable Efficiency: Choose between filling speeds of 50 or 200 units per minute (upm) to perfectly match your production needs. No more struggling with underutilized equipment or bottlenecks in your production line.
  • Consistent Quality: Experience peace of mind knowing MICRO BI prioritizes batch consistency. Its intelligent servo-driven design ensures smooth operation and minimizes the risk of errors.
  • Compact Footprint: Even with its impressive capabilities, MICRO BI boasts a space-saving design. This allows you to optimize your production floor layout and maximize efficiency.

MICRO BI is an integrated solution between the ATS Scientific Products rotary filler and the Comecer aseptic isolator

In essence, this integrated filling and isolation system offers a comprehensive solution for sterile liquid production. It merges cutting-edge rotary filling system with a superior aseptic environment, paving the way for efficient, reliable, and contamination-free production cycles.

MICRO BI is the perfect solution for achieving a streamlined and adaptable fill-finish process that prioritizes quality and efficiency.

Filling line main features

This unit offers a minimized starwheel 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 SP internal core competencies include excellent glass handling/fluid dynamics skill sets and automation practice. The machinery is very friendly for cleanability and ISO 5 air flow practice. Easy changeovers and easy touch screen interface; Modern Documentation and validation support.

Base Unit Equipmen

  • 1 or 2 Filling Pumps fully integrated with IDT scale algorithm with auto feedback to peristaltic pumps. Piston pumps available upon request
  • One size part set for each type of closure with base machine (up to 2)
  • Central machine starwheel performs all functions – filling and closing and optional items.
  • Baseline Keba controls for motion control/AB or Siemens PLC optional, PC based touch panel screen.

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 the 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 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%

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