The Microcell Vial Filler is a vial filling machine used to manufacture personalized medicines and perform drug development.

Vial filling machine for personalized medicines and clinical trial supplies

Agile small-scale vial filling machine

The Microcell Vial Filler is a closed gloveless robotic isolator for filling vials. It is best suited for personalized medicines, clinical trial supplies and drug development (e.g. stability, toxicology, formulation).

The Microcell is a standard machine that can be installed and validated quickly (≤ 6 months). The closed isolator and removal of human intervention provides an optimal aseptic process, resulting in safer drug products for patients.

Customers are using the Microcell for the following applications:

  • Personalized medicines / advanced therapy medicinal products (ATMPs)
  • Drug development
  • Clinical trial supply manufacturing

Microcell Customers

Users of the Microcell Vial Filler include Roche / Genentech and Adaptive Phage Therapeutics.

Customer experience

Microcell Vial Filler

Speed to Market

The delivery lead time for the Microcell is 3 months, and customers have reached GMP production within 6 months following their purchase order. Compare this against manual filling or semi-automated filling in biosafety cabinets or glovebox isolators that may take a year or more to integrate, using significantly more labour. 

Flexibility

The Microcell can fill up to four different drug products in an 8-hour shift. Single-use consumables and a fast 15-minute decontamination cycle shorten time to fill and changeover times. 

Drug product quality

The Microcell is a fully integrated gloveless robotic isolator that removes the need for operator intervention through an optimized aseptic process. The Microcell is equipped with the Vanrx Dynamic Peristaltic Pump, which provides 10x less variability vs. conventional peristaltic pumps in low fill volume applications. 

Lower barrier to begin filling operations

The Microcell occupies the same area as a biosafety cabinet and is a standalone machine with simple utility requirements. The Microcell POD, offered in cooperation with a G-CON remanufactured clean room POD, is the first turnkey aseptic filling facility and is available pre-installed and qualified for shipping worldwide. 

Specifications

Throughput

Maximum of 300 units per load with 1,200 units producible in an 8-hour shift

Pump type

Vanrx Dynamic Peristaltic Pump

Fill volume range

0.1-50 mL

Pump accuracy

10x less variability than conventional pumps

In-process control (IPC) fill volume check

Programmable, up to 100% of units

Machine vision

Robotic guidance, container absence / presence

Product contact materials

Fill path assembly only (single-use)

Interior classification

Grade A

Exterior classification

Grade C or D (depending on regulator)

Dimensions

2.28 x 1.97 x 2.20m (7’5″ x 6’5″ x 7’2″) 

Required cleanroom space

13 m2 (140 sq. ft.)

Electrical

240 VAC, <60 A, single phase

Compressed air

6 Bar clean dry air, <10 CFM

Control system

21 CFR Part 11 compliant

Options

Drug product bag load cell

Automated clean-in-place (CIP)

Drug product quality

Safer injectables for patients
  • Optimal aseptic process

    Completely closed gloveless isolator that eliminates operator interventions.

  • Limited hazard pathway

    Drug product contact is limited to single-use flow path and inside of container.

  • The most accurate peristaltic pump

    Vanrx Dynamic Peristaltic Pump provides the best available accuracy and precision.

  • Reduces particle risk

    Uses press-fit closures with integrated stoppers, eliminating the particle risk and quality problems of crimp capping and stopper bowls.

  • Single-use consumables

    Single-use flow paths prevent cross-contamination.

The Microcell is a closed robotic isolator for injectables manufacturing.

Vanrx Pharmasystems introduces the Dynamic Peristaltic Pump

March 18, 2020 - Featured

Vanrx is introducing the Dynamic Peristaltic Pump, a new pump technology that helps biopharmaceutical companies bring advanced therapies to patients.

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Case studies

Learn about how Vanrx’s customers are using the Microcell

Container / closure options

Vanrx's partners in the Matrix Alliance provide nested vials and closures for use on the Microcell

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