Pharma test PTG-S5 NIR Automated Powder Flow Composition Analysis System
By combining the Pharma Test PTG-S5 with a NIR (Near-Infrared Spectroscopy) module, simple "physical flowability testing" can be upgraded to a "physicochemical integrated real-time analysis system" that conforms to the PAT (Process Analysis Technology) and QbD (Quality by Design) framework. As the powder flows out of the funnel, the system can simultaneously collect spectral and physical data, providing in-depth analysis of the relationship between powder flow behavior and chemical composition/moisture content.
I. Implement the PAT and QbD modern pharmaceutical R&D framework to integrate powder flow physical properties with NIR spectral analysis in real time, and directly establish a dynamic relationship between key process parameters (CPP) and key quality attributes (CQA).
II. Non-destructive real-time monitoring of dynamic flow processes: real-time capture of spectral signals during powder discharge, and simultaneous analysis of principal component uniformity, admixture distribution, and dynamic moisture content.
III. Automated measurement of multiple physical flow parameters, integrating high-precision sensors and electronic balances, automatically completing the measurement of flow time, flow rate, angle of repose, and powder pile morphology.
IV. Equipped with advanced chemometric analysis software, providing real-time spectral prediction models and complete data statistical reports, the software architecture fully complies with 21 CFR Part 11, GMP and ALCOA+ data integrity specifications.
Equipment Introduction
Simultaneous Physical & Chemical Parameter Analysis
Chemical Profiling
A single test can simultaneously obtain physical properties (flow rate, angle of repose, density) and chemical properties (moisture content, principal component API concentration, excipient distribution), directly establishing a model of the influence of chemical components on flowability.
Real-time online moisture content monitoring
Moisture is a key factor affecting the adsorption, bridging, and agglomeration of fine powders. NIR can measure moisture content in real time during powder flow, and quickly assess the dynamic impact of dryness or ambient humidity on flowability.
Evaluation of Powder Feeding Segregation and Homogeneity (Segregation & Homogeneity Analysis)
During the feeding process, powders often undergo "particle size segregation" due to differences in particle size or density. NIR can perform continuous spectral scanning during the feeding process to monitor the minute changes in API concentration over time and determine whether the mixing uniformity has deteriorated.
Non-destructive, immediate, and requires no sample pretreatment (Non-Destructive & In-Line Measurement)
Using a fiber optic reflective probe or a sapphire measurement window, data collection is completed as the powder passes through naturally, without damaging the sample or consuming reagents. The analyzed sample can be recycled or used for subsequent tablet testing.
Accelerate formulation development and scale-up optimization.
It provides R&D personnel with more comprehensive powder fingerprint maps, accurately predicting die filling stability and capsule filling weight differences, reducing pilot run trial and error costs.
J&M High Sensitivity NIR Diode Array Spectroscopy
Equipped with a J&M high-resolution NIR diode array spectrometer, it features extremely high spectral acquisition speed and excellent signal-to-noise ratio; the beam passes through the powder cone for continuous diffuse reflection measurement, ensuring that the optical data has extremely high reproducibility and accuracy.
Rotatable Under-Plate Fiber Optic Probe
The fiber optic probe is rotated and installed below the PTG-S5 transparent glass powder disk. Light passes through the probe window and penetrates the glass disk to directly irradiate the powder cone formed by the falling material, achieving non-contact, non-destructive, and sample-free real-time spectral scanning.
Real-Time Moisture Content Analysis
The moisture content is accurately measured in real time during the powder discharge process to thoroughly evaluate the physical effects of dynamic moisture on fine powder surface adsorption, particle bridging, and flow resistance.
Active ingredient (API) concentration and spatial distribution profiling.
It can analyze the concentration distribution of active pharmaceutical ingredients (APIs) in real time during powder flow and cone formation, and monitor whether particle size segregation occurs when the material flows and falls.
Qualitative Powder Chemical Fingerprinting (QF) of Raw Materials and Powders
By establishing near-infrared spectral fingerprints of each component of the powder, the chemical consistency and purity of different batches of raw materials, premixes, and various inactive excipients can be quickly identified.
Blend & Content Uniformity Assessment
It supports online analysis of the blend uniformity of multiple active and inactive compound ingredients, and can further develop econometric prediction models to provide key process indicators for the content uniformity (CU) of subsequent tablets or fillings.
Product Features
Providing accurate measurements ensures consistent drug quality.
The equipment can perform stability, solubility, and release tests. Suitable for various types of pharmaceuticals.
Intuitive user interface; researchers quickly got started.
Application Examples
Mixtures of inactive materials can also be analyzed. The system can also reveal the distribution of active pharmaceutical ingredients in powder mixtures. Methods can be developed to provide indicators of content uniformity.
The figure below shows the near-infrared spectra of lactose powder with moisture contents of 5.0% and 3.8%. These results clearly demonstrate that the TIDAS L NIR sensor can detect changes in powder moisture content. For powders with higher moisture content, the light absorption measured at 1925 nm is significantly increased.
Studies show that the flow rate measured by the PTG-S5 powder flow analyzer is a reliable indicator of humidity: the flow rate values of lactose at different humidity levels can also be analyzed in mixtures of inactive materials. The system can also reveal the distribution of APIs in powder mixtures. Methods can be developed to provide indicators of content uniformity. The figure below shows the near-infrared spectra of lactose powder at 5.0% and 3.8% humidity. These results clearly demonstrate that the TIDAS L near-infrared sensor can detect changes in powder humidity. For powders with higher humidity, the light absorption measured at 1925 nm increases significantly.
Overall Specifications
Product Model : PTG-NIR (PTG-S5 paired with J&M TIDAS L NIR)
Manufacturer : Pharma Test Group, Germany
Version Specification : Version 2.0
Product positioning and operating principles :
A multifunctional analytical system combining a fully automated powder flow property analyzer and a high-order near-infrared diode array spectrometer.
Designed specifically for simultaneous testing of the physical flowability and chemical properties of powders, granules, and solids.
Non-destructive optical spectral scanning is performed directly through a dedicated fiber optic probe located beneath the transparent glass sample tray, penetrating the deposited powder cone.
Simultaneously acquire physical flow behavior, morphological information, chemical composition, moisture content, and principal component uniformity in one step.
Compliance with International Pharmacopoeia and Regulatory Standards :
Fully compliant with the powder flowability testing standards and specifications of the European Pharmacopoeia and the United States Pharmacopoeia.
Compliant with International Organization for Standardization (ISO) standards 4324 and DIN EN 12047.
Built-in database, multi-level access control, and electronic audit tracking system compliant with Section 21, Paragraph 11 of the Federal Regulations of the United States.
The entire fuselage structure and contact materials fully comply with the requirements of Good Laboratory Practice and Good Pharmaceutical Manufacturing Standards.
Applications of analysis and detection :
Measurement of physical flow properties:
Powder flow time determination
Measurement of Angle of Repose and Powder Taper
Measurement of the volume and weight of the stacked cone
Plotting dynamic graphs of bulk density versus flow rate
Standard powder flow index determination (collection time per 100 mg)
Chemical and spectral characterization:
Rapid quantitative determination of material moisture content
Concentration analysis of active pharmaceutical ingredients
Rapid qualitative fingerprint identification of raw and auxiliary materials
Batch uniformity assessment and bioequivalence monitoring of mixed materials
PTG-S5 Powder Physical Analysis Unit Technical Specifications :
Display: High contrast LCD monitor
Data Input: Full-function keys for English and Math, and dedicated function keys
Sample identification: Supports inputting 12-digit product codes and 12-digit batch numbers.
Stainless steel funnel capacity: approximately 450 ml
Angle of repose measurement range: 1.0° to 45.0°
Flowability test range: 0.1 to 999 seconds (standard sample weight 100 grams)
Flow time measurement range: 0.1 to 999 seconds
The bulk density of cones ranges from 0.000 to 6.0 g/mL.
Cone weight measurement range: 1 mg to 325 g
Cone volume measurement range: 0.1 to 275 ml
Built-in balance unit: Integrates Sartorius high-precision analytical balance module
Optical detection mechanism: Dual infrared sensor movable measurement cantilever, automatically tracking powder height to the top sharp corner.
Auxiliary mixing mechanism: Standard configuration includes an electric motor-driven mixer to assist in the stable feeding of fine powders with poor flowability.
Discharge nozzle specifications: Equipped with 6, 8, 10, 15, and 25 mm replaceable standard stainless steel discharge nozzles.
Output interface: RS-232 serial communication interface
Built-in printer: Features a built-in thermal printing printer for real-time output of data reports and flow rate dynamic charts.
TIDAS L NIR Near-Infrared Spectroscopy Analysis Unit Technical Specifications :
Spectrometer architecture: Full-spectrum diode array dispersive technology, with no moving mechanical components or grating wear.
Detector type: Hamamatsu extended thermoelectric cooled 256-pixel indium gallium arsenide sensor
Built-in light source: 7.5 watt high-stability tungsten halogen lamp (standard lifespan 2000 hours)
Dark current and reference correction: Built-in automatic shutter and external high-reflectivity standard white board
Wavelength measurement range: 1100 to 2100 nanometers
Wavelength accuracy: better than 1 nanometer
Wavelength reproducibility: better than 0.1 nanometers.
Pixel dispersion: approximately 3.9 nanometers
Optical spectral resolution: approximately 12 nanometers full width at half maximum (FWHM).
Integration time setting range: 3 milliseconds to 10 seconds
Fiber optic interface: SMA-905 standard optical interface
Computer communication interface: High-speed TCP/IP Ethernet port (10/100/1000 megabits per second)
Power requirements: 90 to 265 volts, 47 to 63 Hz, 80 watts AC.
Operating temperature: +5 to +40 °C
Control software and data integrity :
Dedicated control software: Equipped with the manufacturer's professional spectral acquisition and analysis software (with built-in automated scripts for powder analysis)
Single Integrated Report: Automatically integrates physical flow data, stacking charts, and near-infrared spectroscopy into a single standard inspection report, and automatically generates a portable file format.
Econometrics Extension: Supports seamless integration with advanced chemometrics and multivariate statistical analysis software suites.
Compliance: Fully compliant with U.S. federal regulations, Section 21, Paragraph 11, with built-in multi-level user access control, password protection, and complete electronic audit tracking logs.
Safety protection and fuselage structure :
The testing area is equipped with a transparent antistatic dustproof cover to maintain a stable testing environment and prevent dust from escaping.
The fuselage casing is made of high-quality, laboratory-grade, corrosion-resistant stainless steel.
Standard Scope of Supply :
Fully automatic powder flow property analyzer main unit
Near-infrared diode array spectrometer main unit
Spectrum control and data acquisition computer software suite
Dedicated high-transmission optical fiber conductors and customized powder measurement probes
High-precision standard whiteboard calibration block
Standard discharge nozzle assembly (orifice diameters 6, 8, 10, 15, 25 mm)
Dedicated transparent sample collection beaker (600 ml)
30° Standard Angle Correction Cone
A complete set of validated documents, including operating manuals, design and quality conformity certificates, installation validation documents, operation validation documents, declaration of conformity, electromagnetic compatibility statement, and instrument history logbook.
Airframe specifications and space requirements :
Instrument dimensions: Approximately 480 × 240 × 260 mm (length × width × height, excluding external computer and printer)
Packaging and shipping dimensions: Approximately 900 × 670 × 950 mm (Length × Width × Height)
Total instrument weight: Approximately 50 kg net weight, approximately 70 kg gross weight.
Validation and Certification :
All critical contact components of the system fully comply with the requirements of the United States Pharmacopeia and the European Pharmacopeia.
Possesses complete safety standards and electromagnetic compatibility certifications
Standard configuration includes complete original factory installation and operation confirmation documents.