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. 

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

Peristaltic Pump

Fill volume range

0.5-50 mL

Fill accuracy

±0.5 (±1.0% below 1 mL)

In-process control (IPC) fill volume check

Programmable, up to 100% of units

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.

  • 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.

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

Fill out my online form.