Cytiva

Cytiva

Marlborough, Massachusetts, United States

Microcell vial filler

Microcell vial filler

Microcell vial filler

The Microcell vial filler is a closed robotic isolator for pharmaceutical vial filling which enables small batch flexibility and standardized manufacturing. Whether its making personalized medicines or clinical trial supplies, the Microcell is built for agility and fast changeover.

Speed to market

Manual or semi-automated filling in biosafety cabinets or glove box isolators can take over a year to integrate. With a delivery time of just 3 months, and customers reaching GMP production within 6 months following their purchase order, the Microcell helps you get your essential therapies to those that need them faster.

Agility

The Microcell can fill up to 4 different drug products in an 8-hour shift. Single-use consumables and a fast 15-minute decontamination cycle reduce fill and changeover times, helping you make more drugs for more patients.

Drug product quality

The Microcell provides an optimal aseptic process in a completely closed gloveless isolator. Advanced automation removes the need for operator intervention and limits product contact to a single-use flow path. Particle risk is reduced with the use of press-fit closures with integrated stoppers, to overcome the quality problems of crimp capping and stopper bowls.

Microcell features

  • Fully automated, gloveless cGMP filling
  • Human-machine interface touch screen for intuitive access to input and initiate recipe sequences
  • Easy set-up with single-use flow paths and 15 minute vapor phase hydrogen peroxide decontamination

Specifications

  • Throughput: Up to 300 units per load; 1,200 units per 8-h shift
  • Pump type: Peristaltic pump
  • Fill volume range: 1.0–50 mL
  • In-process control: Programmable up to 100% of units
  • Product contact materials: Single-use flow path assembly
  • Interior classification: ISO 5 / Grade A
  • Cleanroom classification: ISO 7 / Grade C
  • Dimensions: 1.7 × 1.5 × 2.2 m (66 × 57 × 86 in.)
  • Required cleanroom space: 15 m² (160 sq. ft.)
  • Electrical: 208–240 VAC, single phase, 50–60 Hz, FLA 36
  • Air supply (from room): 250–700 m³/h
  • Compressed air: 120 L/min, >0.6 MPa (6 bar) (g)
  • Control system: 21 CFR Part 11 compliant

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