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Gravimetric Filler

Gravimetric Filler

The Gravimetric Filler, part of 3P's Pharma Equipment Discover Range, benefits from Fill2Weight - the world's fastest gravimetric powder micro-dosing technology.

This Gravimetric Filler has been designed with pharmaceutical and biotechnology filling applications in mind to response to the rise in the development of personalized medicines requiring low-volume cGMP manufacture, and high degree flexibility. It also enables handling of ultra-low-dose and high-potency APIs, alongside the increasing need for high-accuracy, precision powder filling in in clean-room and sterile environments for inhalation, parenteral and oral solid dose (OSD) applications.

Designed for use in existing isolators and containment solutions, the system is a part of the Discover Ecosystem with 3P's Liquid Fill-finish platform and Rotary Crimper, which accentuates the benefits of integrated quality and control system.

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. It 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

  • Fill2Weight powder filling technology:  100% weight verification and faster cycle times with high-precision dosing
  • Scalable:  Identical systems used in our fully-automated, higher-speed machines.
  • Handles and fills the most challenging powders (including delicate biologics, spray-dried and freeze-dried, blends, micro-spheres and engineered particles)
  • Reduces drug development lead-times by enabling formulators to bypass the need for excipients with the associated benefit of avoiding the need for excipient compatibility tests.
  • Fills syringes, vials, cartridges, capsules and custom containers
  • Isolator ready:  Aseptic, GMP design
  • Entry-level system:  Cost-effective, with short lead-times.
  • Suitable for spray dried and lyophilised powders
  • Autoclavable dispensing head
  •  Tool-less disassembly for cleaning and sterilisation
  •  Suitable for VHP environments
  • Ultra-compact and portable:  Use inside existing isolators, RABS, LAF’s and down-flow booths.**

** Subject to size of enclosure

Added value

  • Reducing drug development lead times

This Gravimetric Filler helps customers significantly reduce drug development lead times: The system 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 a faster return on investment and ability to develop more products with the freed-up capacity.

  • Smaller Doses

The Gravimetric Filler can dose very small quantities of powder. The need for smaller doses is driven by the 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 the Gravimetric Filler'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. The Filler 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

The fillers gravimetric system means that every dose is verified and any doses outside limits are rejected. Precision weighing enables tighter tolerances, meaning smaller doses can be dispensed. This is essential for high-potency drugs, were inaccurate dosing poses risks to patient safety.

  • Enables filling of biologics and engineered particles

The Gravimetric Filler 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

 

Get in touch with us today here or by calling us on 01926 408933.

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