The high shear wet granulation (HSWG) process that is widely used in the pharmaceutical industry often involves a theologically complex fluid flow as part of the manufacturing process.

Effectively and efficiently managing that HSWG flow depends on the accurate and precise computation of certain particulate flow parameters.

Most of the current measurement systems available to pharmaceutical companies come with constraints and limitations that send the cost of drug manufacturing spiralling.

Why?

The main reason is that these systems are offline requiring the manufacturing process to be stopped and restarted each time a measurement is required resulting in unnecessary cost and delay.

Lenterra’s IN-LINE, real-time fluid flow sensor system is the first PAT that provides accurate measurement data – WITHOUT THE NEED TO INTERRUPT THE PROCESS.

PAT SYSTEM OVERVIEW

Technology

  • The probes (DFF – immersion, RealShear mounted flush with the wall)
  • Optical detection principle
  • Temperature compensation
  • 2-D measurements
  • Measurement system – Interrogator

Technology Advantages

  • Robust; No moving parts, rigid construction
  • Consistent measurements for indefinite periods without service (not achieved in other flow sensing technologies)
  • Operation with no (WSS) or minimal (DFF) intrusion
  • Chemically inert: only outer surface of the pillar is in contact with fluid – made of stainless steel
  • DFF sensor can be applied in ANY flow (powders, multi-phase, chemically aggressive)
  • Fully optical detection, electronics is far away from the probe: no ignition hazard
  • Wide range of sensitivities
  • DFF probe design parameters: pillar outer and inner diameter and length, material (stainless steel or light plastic, e.g. Teflon)
  • Combination of design parameters makes it possible to fabricate sensors capable of measuring forces as small as 0.05 mN (e.g. shear forces in protein solutions, bio-reactors) and as large as 50 N (forces in HME, HSWG) or more
  • Unprecedented sampling frequency – up to 500 Hz for long term mea-surements (hours, days) – up to 10 kHz for short term measurements (minutes)
  • Measuring not only a global parameter (e.g. viscosity), but the components (e.g. particle impacts)
  • Adds time as another dimension – for example, if we agree that the fluid does not change significantly in 10 seconds, we can accumulate 10000 measurements at 1 kHz sampling rate:
  • Statistically significant distribution – a number of statistical parameters as potential CPPs