URS OF A TABLET HARDNESS TESTER

Name of Equipment TABLET HARDNESS TESTER
Purpose ·    In-process products (Tablets)

·    Finished products (Tablets)

 

TECHNICAL SPECIFICATION

 

A. GENERAL SPECIFICATION
1.   Type Bench Top Type
2.  

Operating Temperature

And Humidity

 4 0C to 40 0C
0% to 80% RH (Non-condensing)

 

B. SPECIFICATION

1. MAIN UNIT
1.    

Capacity

 1- 99 samples per test, Pre-selectable, minimum 6 samples per minute
2.     Measuring Range/ Units 3 –500 N
3.    

Accuracy

  ± 1.0 N
4.    

Resolution

 0.08N
5.     Diameter/ Thickness Range 2.0 –35.0 mm
6.     Range 5 – 50 mm/minute or 5 – 50 N/sec.
7.     Test method Manual / Automatic
8.     Test Statistics High, low, mean values RSD, ASD
9.     Display LCD display showed errors, results and status
10.                 Interface RS232
11.                 Printer IBM –Compatible printer language
12.                 Supports GLP/GMP requirements.

 

3. VALIDATOIN/QUALIFICATION MATERIALS
1.      Reference Weights with certificate traceable to NIST or equivalent.
2.      Standard tablets: Magnetic tablet at 50 – 85 and 130 N

 

4. DOCUMENTS AND CERTIFICATIONS
1.      To be supplied certificate of compliance.
2.      To be supplied copy of IQ/OQ license holder from the manufacturer.
3.      To be supplied user list in Bangladesh.
4.      All operational and installation manuals IQ/OQ/PQ documents

 

5. Installation, testing, commissioning, validation, qualification & training

 

6. UTILITIES AVAILABLE AT SITE
1.      Electrical power supply: AC 220V±10% 50/60Hz

 

  1. AVAILABLE SIZE/AREA FOR THE EQUIPMENT

Sufficient area for the instrument is available in the IPQC of Iron Plant..

  1. SUPPLIER’S RESPONSIBILITIES
  • Supplier will ensure full warranty of the machine for one year.
  • Machine/ Equipment supplier shall have one year maintenance contract  after commissioning.
  • Installation, testing, commissioning, validation, qualification & training along with relevant documentation.
  • Supplier will responsible for successful trail run of first three tests of product.
  • Power fluctuation to be considered. Voltage stabilizer for PLC to be taken in consideration.
  1. COMMERCIAL CONDITIONS
  • Offer must be based on tender documents.
  • Payment terms as per tender document.
  • It will remain the supplier’s responsibility to adequately protect equipment under his supply whilst in transportation, off loading and final positioning up to and including installation and commissioning at site, if not mentioned otherwise in the tender document.
  • Part shipment is not allowed.
  1. DISCUSSIONS/REVIEW/COMMENTS

The user requirement specification is prepared for communicating the user expectation from the equipment manufacturer/supplier with respect to the equipment. The requirements specified are the basic requirements based on the available information for the process, operation and GMP requirements. The vendor is encouraged to suggest and/or quote for the latest developments to increase/improve the productivity, product quality, process control, safety etc.

 

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