- Tablet Dissolution Testing Instruments
- Offline Automated Dissolution Systems
- Online Automated Dissolution Systems
- In-Situ Dissolution Testing (Coming Soon)
- Media Preparation
- UV/VIS Spectrometers
Tablet Disintegration Testing Instruments
Tablet disintegration testing instruments are widely used in the pharmaceutical industry to evaluate the disintegration characteristics of formulations and the quality control of different dosage forms.
Suppository Testing Instruments
This range of instruments to test the quality of suppositories, pessaries and creams includes disintegration and penetration testers.
Tablet Hardness Testing Instruments
Tablet hardness testing is used to test the breaking point and structural integrity of a tablet prior to storage, transportation, and handling before usage.
Ampoule Testing Instruments
Many liquid drugs are delivered in ampoules.We offer a fully DIN/ISO 9187 compliant solution to test the hardness of empty ampoules at line during production.
Tablet Friability Testing Instruments
Friability testing is used to test the durability of tablets during packing processes and transit. This involves repeatedly dropping a sample of tablets over a fixed time, using a rotating drum with a baffle.
Powder Testing Instruments
The Pharma Test powder testing product portfolio includes instruments to not only measure bulk density but also tap density and flowability.
Leak Testing Instruments
The leak test apparatus is used in the pharmaceutical industry to check the integrity of tablet strips, blister packs and small bottles.
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.
>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
| 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 |
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
PT-TD300
Tapped Density and Apparent Density Testing Instrument
The PT-TD300 is used to test the tapped (or “tamped”) density and apparent density of powders, granules, pigments and similar products in compliance with the current USP <616> methods 1 and methods 2 as well as with EP <2.9.34>, DIN EN ISO 787-11 and ASTM B527. The instrument automatically calculates the tapped density, Hausner flowability ratio and Carr compressibility index after each test and documents the results via the integrated protocol printer.
>Fully compliant to USP <616> methods 1 and methods 2 as well as with EP <2.9.34>, DIN EN ISO 787-11 and ASTM B527
>Determine tapped density and apparent density
>Connect a balance to determine the sample weight (optional, weight can be entered manually)
>Connect USB flash drive to copy methods, store test reports, install optional firmware updates and to restore factory settings
>Integrated protocol printer
>User management system
>Method management system
Advantages
>Use a single instrument to test tapped density and apparent density according to both method 1 and method 2 from USP <616>
>Automated detection of correct cylinder position according to selected method
>Integrated protocol printer reduces bench space requirements
>Detailed result report including calculation of Hausner flowability ratio and Carr compressibility index
>Evaluation of the results according to Hausner and Carr compressibility indices
>Determine the sample weight to automatically calculate apparent and tapped density
>Programmable qualification interval timer reminds the user to perform instrument calibration
>Dedicated calibration programs including reports for tap number, tap height, tap frequency, weight measurement and timer function
>Copy methods between instruments by using a common USB flash drive
>Export test reports as text files
>IQ/OQ documents included free of charge
| Parameter | Specifications |
|---|---|
| Supported Test Methods | USP <616> method 1 and method 2 (corresponds to requirements from EP <2.9.34> and DIN EN ISO 787-11:1995-10) |
| Number of Test Stations | One test station with two cylinder positions (one for each method), automated detection of correct position acc. to selected method |
| Stroke Height | Method 1: 14.0mm ±2.0mm; Method 2: 3.0mm ±0.1mm |
| Stroke Frequency | Method 1: 300 strokes/minute ±5 strokes/minute; Method 2: 250 strokes/minute ±5 strokes/minute |
| Number of Strokes | Programmable in three stages from 1 to 9999 each |
| Method Management | Up to 256 test descriptions (methods) can be stored on the instrument |
| User Management | Up to 32 users with selectable user right levels can be stored on the instrument |
| Result Data Storage | Store copies of result reports by connecting a USB flash drive |
| Display | LCD screen with color-changing backlight |
| Keyboard | Keypad with function keys and click wheel |
| Interfaces | USB type A host port to USB type B device port to connect flash drives, for PC communication and firmware updates; RS-232 balance port |
| Instrument Housing | Polished stainless steel housing with plastic frame |
| Power | 110/230 Volt, 50/60 Hz |
| Instrument Dimensions | Approx. 50cm x 50cm x 45cm (width x depth x height) |
| Packaging Dimensions | Approx. 60cm x 60cm x 50cm (width x depth x height) |
| Net / Gross Weight | Approx. 20 / 25 kg |
| Certification | All components certified to USP / EP requirements |
| CE / EMC Certification | All CE / EMC Certification provided |
| Validation | All IQ & OQ documents included |
Included in the Standard Scope of Supply
The PT-TD300 comes ready to use with the following standard scope of supply:
>250ml graduated glass cylinder and suitable adapter
>Comprehensive documentation folder including:
>>User Manual
>>DQ/QC instrument compliance test certificate
>>IQ documentation
>>OQ documentation
>>Instrument logbook
PTG-NIR
Powder Analysis System
The PTG-NIR automatic powder and granule analysis system combines the Pharma Test PTG-S5 powder flow testing instrument with an integrated J&M TIDAS L NIR diode array spectrometer. The system is controlled by the powerful TIDASDAQ3 software including a customized script for the PTG-NIR. The system is ideal to examine the flow characteristics of a powder or granule. This combination is ideal for simultaneous detection of chemical, physical and morphological information. This information is describing the flow behaviors of a powder or granule. Other forms of solids are possible to be tested too. All the results are presented in a single report generated by the included TIDASDAQ3 software.
>Fully USP <1174>, EP <2.9.36> and ISO 4324 (12/83) compliant
>Measure flow-time, cone angle and flowability
>Gather chemical, physical and morphological information
>Included white standard for reference scan, integrated shutter for dark current measurement
>Includes TIDASDAQ3 software with customized script
>Integrated clear view dust protection hood for the powder test area
Advantages
>Measure the flow behavior of powders and granules to reduce process costs and maintain quality and consistency of the final product
>Gather chemical, physical and morphological information by using the integrated NIR spectrometer
>Fast diode array NIR spectrometer provides immediate full spectra and contains no moving parts
>Excellent S/N ratio to detect weak signals
>IQ/OQ documents included free of charge
| Parameter | Specifications |
|---|---|
| Display | High resolution color LCD, backlit |
| Data Entry | Touch screen, USB keyboard optional |
| Instrument Firmware Compliance | 21 CFR Part 11 |
| Firmware Features | User management, method management, result database, audit trail |
| Cone Volume | Approx. 450ml |
| Cone Material | Stainless Steel |
| Range for Cone Angle Test | 25.0° to more than 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, optional use of 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 |
Included in the Standard Scope of Supply
The PTG-NIR comes ready to use with the following system components and standard scope of supply:
>PTG-S4 powder flow analyzer
>TIDAS L NIR spectrometer
>TIDASDAQ3 PC software package
>Fiber optic cables and customized probe
>White reference standard
>Pouring nozzles size 6, 8, 10, 15, 25mm
>600ml beaker
>30° angle calibration cone
>Comprehensive documentation folder including:
>User manual
>QC/DQ testing certificate
>IQ documentation
>OQ documentation
>Conformity Declaration
>CE/EMC Declaration
>Instrument logbook
PT-SV100
Scott Volumeter
The PT-SV100 Scott Volumeter determines bulk density of powders according to the following standard Monographs: USP <616>, Method II bulk density and tapped density of powders, EP <2.9.34.1>, DIN ISO 3923-2 (metallic powders): determination of apparent density and optional ASTM B329 standard test method for apparent density of metal powders and compounds.
>Standard cup is fully compliant with: USP <616> Method 2, EP <2.9.34-2>, DIN ISO <3923-2> and GOST <19440-94>
>Additional optional cup for compliance with ASTM B329 available
>Applicable to powders including metal powders, compounds, pigments
>Instrument comes ready to use, only an analytical balance is needed in addition
Advantages
>Easy to use
>Solid design including vibration free baseplate
>Integrated spirit gauge to check levelness of the instrument
| Parameter | Specifications |
|---|---|
| Receiving Cup | 25 +/- 0.05ml, round, stainless steel |
| Funnel Mesh Size | 1.0mm (18 mesh) and 2.00mm (10 mesh) |
| Instrument Dimensions | Approx. 200 mm x 260 mm x 450 mm (width x depth x height) |
| Packaging Dimensions | Approx. 200 mm x 260 mm x 400 mm (width x depth x height) |
| Net / Gross Weight | Approx. 11 / 14 kg |
| Certification | All components certified to ISO, USP and EP requirements |
| CE Certification | All CE Certification provided |
| Validation | All IQ & OQ documents included |
