In 2004, The Food and Drug Administration (FDA) called for improvement and innovation in the pharmaceutical manufacturing process.
The FDA was concerned about product consistency.
“Product testing alone is not sufficient to assure that a process consistently produces a product with predetermined specifications. Adequate process design; knowledge and control of factors that produce process variability: and successful process validation studies, in conjunction with product testing, provide assurance that the process will produce a product with the required quality characteristics.” – FDA
In fact, it went further:
The FDA categorized the pharmaceutical industry’s hesitancy to embrace innovation as “undesirable from a public health perspective.”
Lenterra Steps Up
In 2012, Lenterra introduced its breakthrough sensor instrumentation solution – the first in-line, real-time PAT that allows users to monitor accurate process information – without having to interrupt the process flow.
The Lenterra measurement system allows for in situ monitoring of a rheologically complex fluid flow (e.g., particulate and multiphase fluids) by measuring a force exerted by the flow on a sensitive member of the probe or sensor.
Lenterra’s Drag Force Flow (DFF) probe sends a continuous, real-time stream of data via optical fiber cable to an optical interrogator or controller which allows the user to make manufacturing process decisions – without the need to stop and restart the process that current technology requires.
The benefits to all stakeholders involved in pharmaceutical manufacturing are enormous and are congruent with the FDA’s vision:
- Reduce/eliminate deviations
- Improve customer service (product availability)
- Reduce cycle times (operational efficiency)
- Reduce inventory levels
- Reduce costs (reworks, resample, retesting, etc)
- Improve capacity utilization
- Improve compliance (reduce deviation reports)
- Improve assurance of quality
A Revolutionary PAT With Expanded Capabilities
Its proprietary DFF flow force cylindrical probe sensor offers extensive capabilities:
- the ability to measure force by wet mass in a high shear granulator at a high data acquisition rate
- the capability to provide a signal that explains wet mass consistency and granule densification, distinct from granule PSD
- Lenterra’s DFF sensor is readily capable of differentiating batches with different formulation composition (HPC% w/w content)
- determine the process parameters (% w/w water used for granulation)
- identify different stages of processing
- the DFF sensor time-to-peak response identifies a stage after the end of water addition when granulation processes
- reach maximum wet mass consistency
- DFF sensor can be used as a tool to identify the end point of a WG process with respect to granule densification or wet mass consistency – a parameter to enable robust formulation and process design
- efficient scale-up of WG processes
For additional information about Lenterra’s PAT system, please refer to our Patent Application.