PTB 500 NICE 5-in-1 Semi-Automated Tablet Testing System with Integrated Balance
PTB 500 NICE 5-in-1 Semi-Automated Tablet Testing System with Integrated Balance PTB 500 NICE 5-in-1 Semi-Automated Tablet Testing System with Integrated Balance

PTB 500 NICE 5-in-1 Semi-Automated Tablet Testing System with Integrated Balance

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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

ParameterSpecification
Number of testing stations5 (Hardness, Thickness, Width, Diameter/Length, Weight
Hardness testing rangePTB 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 accuracyBetter than 1N
Hardness resolution0.1N
Thickness testing range2.00 – 20.00 mm
Thickness accuracyBetter than ±0.02 mm
Width & diameter testing range2.00 – 32.00 mm
Width & diameter accuracyBetter than ±0.02 mm
Thickness, width & diameter resolution0.01mm
Weight measurementBy internal Sartorius balance cell
Weight testing range0.0001g – 200.0000g
Weight accuracy0.1mg
Measuring unitsThickness, diameter and width selectable between millimeter (mm) and inches (IN); Hardness selectable between Newton (N), Kilopond (kp) and Strong Cobb (Sc)
Force modeSelectable: linear force increases or linear speed increase
Force rate5 – 250 N/sec. (linear force increase);
5 – 250mm/Min. (linear speed increase)
Display7”, high resolution color LCD, backlit
Data entryTouch screen, USB keyboard and/or mouse supported
Instrument firmware compliance21 CFR Part 11 compliant user management and result database, electronic signatures, integrated audit trail
Method storageIntegrated database
User managementIntegrated database
Result storageIntegrated database
InterfaceUSB, LAN
PrinterBuilt-in thermal printer (optional), connect standard USB or LAN printers
Instrument HousingStainless steel (304) to meet GLP requirements
Power115/230 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 DimensionsApprox. 500 x 500 x 400 mm (Length x Width x Height)
Packaging DimensionsApprox. 650 x 660 x 440 mm (Length x Width x Height)
Net / Gross WeightApprox. 25 kg / 30 kg (without optional accessories)
CertificationAll components certified to USP / EP requirements
CE / EMC CertificationAll CE / EMC Certification provided
ValidationAll 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