PTG-S5

Automated Powder Flow Analyzer

PTG-S5

Automated Powder Flow Analyzer

The PTG-S5 automated powder flow analyzer is used to measure the flow behavior of granules and powders in compliance with the EP <2.9.36>, EP <2.9.16>, USP <1174> Pharmacopoeia and ISO 4324 standards. This instrument determines the powder flow time, the powder cone angle of the collected powder mound, the weight, the density and the volume of the powder cone. Furthermore, the EP “flowability” result is calculated by measuring the flow time of 100g of sample through a specified pouring nozzle.

The PTG-S5 is equipped with a clear view dust hood, made from anti-static material, to protect the user from most of the dust during the powder analysis. This hood can easily be opened or removed completely for cleaning. The instrument is operated using a large color touch screen.

The PTG-S5 is equipped with a clear view dust hood, made from anti-static material, to protect the user from most of the dust during the powder analysis. This hood can easily be opened or removed completely for cleaning. The instrument is operated using a large color touch screen.

Why Measure the Flow Properties of Powders?

It has been estimated that over 50% of the materials used in all industrial applications were at some stage in a powder form. These powders need to be transported, injected, propelled and be able to pass through various process stages before they achieve their final form. This final form may be a tablet, a suspension or indeed a powder formulation. The need to be able to measure, control or test for reproducible powder flow has been well established in many industrial applications. Powder flow characteristics are important for:

  • Reduction in cost of raw process materials: reject bad batches before processing
  • Maintenance of the optimum formulation for the process concerned
  • Reduction in process costs
  • Maintaining the quality and consistency of the final product
  • Maintaining process efficiency and costs by optimization of product storage, packing, handling and transportation
  • Maintaining powder quality from different suppliers or from the same supplier over a long time period
  • Development of new processes where powders are required to be formulated into end products
  • Checking moisture effects: use of powders in open systems in different climates
  • Investigating and maintaining the quality of dry mixes

In processes, which rely on powder and / or powder, mix integrity, the need to have the correct powder flow characteristics is paramount. These powder mixes have to be formulated, mixed and certainly transported. Transportation, even over small distances an easily lead to classification of sorts such that “fines” may drop out and alter the particle size distribution and hence the flow characteristics.

For example, we can look at formulated mixtures, which are fed into tableting machines: these powders need to flow in exactly the same way from batch to batch. Generally, the active ingredients are materials that have no natural flow properties. They are sticky (cohesive) and prone to agglomeration. Additionally, the requirement of active material in ever decreasing dosages means that the active must be able to be dispersed in a non-active medium (normally made up of wellestablished and mainly natural products) in a reproducible way in the mixers prior to the introduction of the formulation into the tablet press.

The fact that the non-active materials such as MCC (Micro Crystalline Cellulose), starch and lactose are natural products means that these materials are prone to variations in particle size, agglomeration, surface area, and so on, depending on the product source. Then we have to consider the effect of the introduction of materials such as silica (e.g., Aerosil 300), which aid the flow of these normally quite stubborn powders. The need to control each of the components as well as the final mix now becomes clear. Control of this type can save a lot of time, wasted money and resources if checks are made at the right time on these component powders.

Areas Where Powder Flow Characterisation is Commonly Used

Area Use for Powder Flow Characterization
Pharmaceuticals Granulation, micronizing, tablets and other solid dosage forms
Abrasives Ceramics, metallic powders and grinding pastes
Catalysts Powders for extrudates, catalyst rings, and finely divided metals
Chemicals Bulk chemicals, fine chemicals
Printing Pigments, toners and binders
Washing Powders Powdered surfactants, bulking agents and granulates
Fertilizers Extrudates, granulates, powdered pesticides

Operating Principle of the PTG-S5

The PTG-S5 is widely used to compare batches of powders perhaps supplied by the same manufacturer over a period of time or for similar materials provides by different suppliers. The flow characteristics can be easily and quickly determined as a QC tool for inter- batch reproducibility, as this may have a distinct bearing on the ease of production especially if powders are capable of agglomeration and cohesion over time.

Design

The design is compliant to the ISO 4324 (12/83) standard, EP <2.9.36>, and USP <1174>. A conical funnel, which can be equipped with different pouring nozzles, takes the sample to be tested. A built-in analytical Sartorius balance cell takes the product collecting dish. The PTG-ER electrical stirrer may be used for powders, which do not flow well. Most pharmaceutical material contains such a high amount of fine particles that it will not start to flow without assistance.

The Test Procedure

Then start the test. Depending on the powder, the PTG-ER stirrer may be used. When the test is started, the funnel is opened and two IR sensors detect the powder flow, this will start the timer to measure the flow time and to record the flow chart. The product itself is collected on a 100mm diameter dish and forms a cone. Once the powder flow stops, the funnel is closed and the movable measuring arm, which holds the two infrared sensors, starts to measure the height of the cone up to the tip. Since the surface of the collecting dish is completely filled, the cone angle can be calculated and displayed.

The test should be repeated (in accordance to the ISO 4324 five times) and the deviation of results should not exceed 5%. The test results are displayed on the color touch screen display of the PTG-S5. A test report and powder flow-chart will be printed including descriptive information of the product. The report is printed either via the built-in thermal printer or using any Microsoft Windows compatible printer connected directly to the instrument by USB or through a network.

Measure

To measure the flowability as per EP <2.9.16> and USP <1174> the test is automatically stopped as soon as 100g of sample have been collected inside a plastic beaker. In addition to the flowability factor (100g/t) the powder flow chart can be printed. The standard instrument comes with all attachments to measure flow-time, cone angle and flowability in compliance to the current EP/USP. Different pouring nozzles from 4 – 10 mm can be used to test the product. A stirrer can be used to force nonflowing product through the selected pouring nozzle.

Additionally, a graph can be plotted on the built-in printer showing the flow behavior of the sample under test. Using the conical stainless steel funnel as described in the current EP/USP monograph and use the changeable nozzles of 10, 15 and 25mm, the cone angle can also be tested. If smaller diameter nozzles are to be used, an adapter ring, which allows the use of pouring nozzles from 4 to 10mm, is available.

Testing Smaller Volumes

For smaller volumes, a 10ml funnel and a smaller sample-collecting dish are available. This optional accessory can be used with pouring nozzles from 4 to 10mm diameter. A suitable stirring shaft completes the set.

The PTG-S5 Analysis

The PTG-S5 determines the following results:

  •  Powder flow time of a pre-defined mass
  •  Powder cone volume
  •  Powder cone density
  •  Cone angle (angle of repose according to EP <2.9.36>, USP <1174>)
  •  Flowability of 100g of product (according to EP/DAB <2.9.16>, USP <1174>)
  •  Amount of sample (mg in a preset time)
  •  Flow chart of sample (mg/time)

Printer

The data and results are displayed on the color touch screen, are stored in a database and can be documented as hard copy printouts using either the integrated protocol printer or an external printer connected by USB or LAN.

Features

  • Fully USP <1174>, EP <2.9.36>, EP <2.9.16 and ISO 4324 (12/83) compliant
  • Measure flow-time, cone angle, flowability, cone density and cone volume
  • PTG-ER stirrer included
  • Integrated analytical balance cell
  • Integrated dust protection bonnet
  • Built-in printer

Advantages

  • Reduce process costs
  • Improve product consistency from batch to batch
  • Keep tight control of component powders, especially if they are natural products
  • Compare sources of powdered products
  • Provides an easy method to achieve quality control on bulk incoming component products
  • Provides an easy method for the control of dry and wet mixing, tableting, granulating, and capsule filling
  • Predict powder transport through conveyors, air lifts and in silos
  • Predict powder suitability for capsule and bottle filling
  • Predict product settling during transport, so called classification
  • Predict powder influence on tablet hardness and solid dosage form stability
  • Predict powder influence on tablet disintegration and friability
  • Integrated clear view dust protection dust protection hood

Technical Specifications

Parameter Specification
Display 7”, high resolution color LCD, backlit
Data Entry Touch screen, USB keyboard optional
Instrument Firmware
Compliance
21 CFR Part 11 compliant user management and result database, integrated audit trail
Method Storage Integrated database
User Management Integrated database
Result Storage Integrated database
Cone Volume Approx. 450ml
Cone Material Stainless Steell
Range for Cone Angle Test 1.0° to 65.0°
Range for Flowability Test 0.1 sec. to 999 sec. – mass: 100g
Range for Flow Time Test 0.1 sec. to 999 sec.
Range for Cone Density 0.000g/ml-1 to 6.0g/ml-1
Range for Cone Weight 1mg to 325g
Range for Cone Volume 0.1ml to 275ml
Interfaces USB, LAN
Printer Built-in thermal printer, option to connect USB or LAN printers
Instrument Housing Stainless steel to meet GLP requirements
Instrument Dimensions Approx. 50cm x 55cm x 90cm (width x depth x height)
Packaging Dimensions Approx. 90cm x 67cm x 80cm (width x depth x height)
Net / Gross Weight Approx. 35 / 50 kg
Certification All components certified to USP / EP requirements
CE / EMC Certification All CE / EMC Certification provided
Validation All IQ & OQ documents included

We reserve the right to make technical changes without any prior notice.

Included in the Standard Scope of Supply

The PTG-S5 comes ready to use with the following standard scope of supply:

  • PTG-ER automatic stirrer
  • Integrated clear view dust protection hood
  • Integrated Sartorius balance cell
  • Poring nozzles size 6, 8, 10, 15, 25mm
  • 600ml beaker
  • 30° angle calibration cone (calibration certificate optional)
  • Comprehensive documentation folder including:
    • User manual
    • DQ/QC instrument compliance test certificate
    • IQ documentation
    • OQ documentation
    • Instrument logbook
    • Compliance certificates for vessels and stirring tools

 

Options

In addition to the standard scope of supply Pharma Test offers a broad range of accessories and
options including:

  • 10ml small volume test set, includes POM funnel, stirrer, sample collecting dish, validation cone
  • Hand scoop to fill in powder
  • Full range of certified validation tools available

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