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Powder Filling

Lab Fill2Weight

The world’s fastest, gravimetric powder micro-dosing technology has been designed to meet the increasing need for high-accuracy, precision powder filling in clean-room and sterile environments for inhalation, parenteral and oral solid dose (OSD) applications.

Fill2Weight is a scalable system that supports manufacture from clinical supply through to commercial production. The system is highly innovative as it combines several different technologies in one solution to get challenging powders to flow and dispense accurately.

Fill2Weight does not compact the powder unlike alternative filling technologies, which in turn increases the proportion of a drug that is able to have an active effect in inhalation applications. In addition, the very localised application of low-frequency vibration at the dispense point ensures that powder blends are not segregated or damaged.

Benefits summary:

  •  High-speed, high-accuracy gravi-metric filling
  •  For use in Aseptic environments
  •  Suitable for spray dried and lyophilised powders
  •  Slim-line design for unidirectional down flow applications
  •  FDA approved materials
  •  Autoclavable dispensing head
  •  Tool-less disassembly for cleaning and sterilisation
  •  Suitable for VHP environments

How Fill2Weight adds value:

  • Reducing drug development lead times

Fill2Weight helps customers significantly reduce drug development leadtimes: Fill2Weight handles very challenging powders, avoiding need for costly and time-consuming 'formulation development' which takes weeks and is traditionally needed to enable filling of powders with poor flow properties. Customers achieve 'first-in-human' (FIH) milestones typically 2-3 months faster, knowing sooner if their new drug will work or not. The end result is
launching sooner, with faster return on investment and ability to develop more products with the freed-up capacity.

  • Smaller Doses

Fill2Weight can dose very small quantities of powder. The need for smaller doses is driven by development of high-potency drugs and desire to administer drugs in pure API form.

  • Scalable for total life-cycle support

A key challenge in a new drug programme is ensuring early-stage manufacturing processes are applicable to commercial production. Fill2Weight’s narrow design means multiple modules can be installed side-by-side to create a multi-lane solution, however the core process remains the same, thereby avoiding the need to develop and validate costly new technologies which add delay and risk.

  • Minimal drug product required and zero waste

In early stages of a new development, very low quantities of API are available as manufacture is carried out with lab-scale methods. Fill2Weight works with very small quantities of powder; Just 2-3 grams is sufficient to enable doses to be created for administration to patients or for other development tests. Unused powder can be recovered, meaning zero waste.

  • Improved product quality and patient safety

Fill2Weight is a gravimetric system, where every dose is verified. Any doses outside limits are rejected. Precision weighing enables tighter tolerances, meaning smaller doses can be dispensed. This is essential for high-potency drugs, where inaccurate dosing poses risks to patient safety.

  • Enables filling of biologics and engineered particles

Fill2Weight enables dosing of new drugs in a form previously not possible. Delicate, ‘long-chain’ biologics and ‘engineered’ particles made with technologies such as spray-drying are typically unsuitable for volumetric dosing, but can be dosed successfully with Fill2Weight.

                                                                TECHNICAL DETAILS
Configurable dose: 2.5mg to 500mg
Tare weight up to 40g
Weighing resolution: 10μg
Dosing accuracy <3% RSD (programmable)
Dosing cycle time per feed: 2 secs
Records 100% of sample data: 21CFR11 option
Hopper capacity 7000mg + bulk feeding options
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