PTB 500 NICE 5-in-1 Semi-Automated Tablet Testing System with Integrated Balance
SKU : #PD1611-PTB-
PTB 500 NICE
Semi-Automated Tablet Testing System with Integrated Balance
The semi-automated tablet testing system PTB 500 NICE is a dual test mode instrument to measure five different parameters of one sample. Hardness, diameter (or length), thickness, width and the weight of tablets can be determined here. The instrument features an integrated analytical balance and a sample carousel. The instrument is made in strict compliance with the EP <2.9.8> and USP <1217> Pharmacopoeia.
Features
Tablet hardness testing in full compliance to USP <1217> and EP <2.9.8> Pharmacopeia
5 results of the same sample: thickness, width, diameter (length), hardness and weight
Dual force mode instrument with linear speed increase and linear force increases modes
Statistical calculations of mean value, absolute and relative standard deviations, minimum and maximum result
Networking capabilities
Multiple point validation procedure built-in
Programmable print-out of force increase curve
Graphical user interface with clear operator instructions
Advantages
Select either linear force or linear speed increase (dual mode selection)
Stepless adjustment of the force or speed increasing rate
Sophisticated user management and method management
Result database and audit trail
Secure passwords with password rules
Time and date display and print-out
Test start functionality to start testing with minimal preparation
Directly connectable to LIMS or other network options
Serial data transfer via RS-232 interface
Validation and calibration program for the measurement stations
Dual point adjustment of the load cell for the hardness test station
Multiple point validation (calibration) up to 30 or 50kg
Programmable print-out of force increase curve
Test program for soft gelatin capsule testing by setting up a testing distance
Technical Specifications
| Parameter | Specification |
| Number of testing stations | 5 (Hardness, Thickness, Width, Diameter/Length, Weight |
| Hardness testing range | PTB 500 NICE-300: 2.0 – 300.0 N ± 10 N PTB 500 NICE-500: 5.0 – 500.0 N ± 50 N PTB 500 NICE-1000: 10.0 – 1,000.0 N ± 50 N |
| Hardness accuracy | Better than 1N |
| Hardness resolution | 0.1N |
| Thickness testing range | 2.00 – 20.00 mm |
| Thickness accuracy | Better than ±0.02 mm |
| Width & diameter testing range | 2.00 – 32.00 mm |
| Width & diameter accuracy | Better than ±0.02 mm |
| Thickness, width & diameter resolution | 0.01mm |
| Weight measurement | By internal Sartorius balance cell |
| Weight testing range | 0.0001g – 200.0000g |
| Weight accuracy | 0.1mg |
| Measuring units | Thickness, diameter and width selectable between millimeter (mm) and inches (IN); Hardness selectable between Newton (N), Kilopond (kp) and Strong Cobb (Sc) |
| Force mode | Selectable: linear force increases or linear speed increase |
| Force rate | 5 – 250 N/sec. (linear force increase); 5 – 250mm/Min. (linear speed increase) |
| Display | 7”, high resolution color LCD, backlit |
| Data entry | Touch screen, USB keyboard and/or mouse supported |
| Instrument firmware compliance | 21 CFR Part 11 compliant user management and result database, electronic signatures, integrated audit trail |
| Method storage | Integrated database |
| User management | Integrated database |
| Result storage | Integrated database |
| Interface | USB, LAN |
| Printer | Built-in thermal printer (optional), connect standard USB or LAN printers |
| Instrument Housing | Stainless steel (304) to meet GLP requirements |
| Power | 115/230 Volt AC, 50/60 Hz |
| Installation Requirements | Ambient Temperature 15-35 °C
Relative Humidity 15-80 %rH Desk with at least 50 kg working load. All around the instrument at least 10 cm free distance to walls or other equipment. Free access to the mains power plug and switch. |
| Instrument Dimensions | Approx. 500 x 500 x 400 mm (Length x Width x Height) |
| Packaging Dimensions | Approx. 650 x 660 x 440 mm (Length x Width x Height) |
| Net / Gross Weight | Approx. 25 kg / 30 kg (without optional accessories) |
| 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 PTB 500 NICE comes ready to use with the following standard scope of supply:
Broken sample collector
Comprehensive documentation folder including:
User manual
QC/DQ testing certificate
IQ documentation
OQ documentation
Conformity Declaration
CE/EMC Declaration
Instrument logbook
Data Sheet Download Click here
Options
In addition to the standard scope of supply Pharma Test offers a broad range of accessories and options including:
» 500N (PTB 500 NICE-500) and 1,000N (PTB 500 NICE-1000) extended force range
» Recommended spare part set
» Full range of certified validation tools available
» Different splints for tablet guidance in test station via exchangeable bottom plates