TAPPED DENSITY :
The tapped density is an increased bulk density attained after mechanically tapping a container (graduated measuring cylinder) containing the powder sample. The tap density of a material(powder) can be used to predict both flow properties and its compressibility.
Tap Density Tester URS for the tap density tester Operating criteria must be adequate. Easy maintenance. Equipment should not disseminate dust. Low cost. Non reactive surface. Capacity( 100ml,250ml) The test can be performed in two different modes.
- USP mode
- User Mode
Minimizes any possible separation of mass during tapping down.Design Qualification (D.Q) The DQ outline the key features of the system designed to address the user requirement, regulatory compliance and selection rationale of a particular supplier.The following are the key considerations for DQ: Physical dimensions of the equipment and accessories. Suitable operating environment of the instrument.Health and safety requirement.
Installation Qualification Details of the Equipment Equipment name, made by & model no. shall be noted down. Location for the installation equipment shall be checked. Utilities required shall be listed down. Any deviation observed while following above procedure should be informed for corrective action. Installation Procedure: After checking all the specifications as mentioned in the selection criteria, service engineer shall commission the equipment. Authorized validation team shall carry out installation
Operational Qualification After completions of successful installation qualification initiate the actual operation to ensure that machine is operating within specification. Check the operation qualification parameters against their specifications. Document the deviation details. The quality head and the department head shall decide whether deviation is acceptable or not.
Cont…… It should supports USP I (300 taps per min) and USP II (250 taps per min) and ASTM test methods.It should have simultaneous rotating and tapping motion assures an evenly packed surface. Calculation of test results like tapped density, compressibility index and Hausner ratio. It should have printer port for documenting test results as per GMP/GLP standards.The acoustic cabinet reduces the sound level to 71dB to meet laboratory standards.
Performance Qualification Verifies that the equipment performs according to design specifications and user defined requirements in a reliable & reproducible manner under normal production conditions. It is determined by placing a graduated cylinder containing known mass or volume of drug or formulation on a mechanical tapper apparatus, which is operated for a fixed numbers of taps until the powder bed volume has reached a minimum.
Cont….. Count and check rpm as per international standards.Measure and check the drop height according to international standards. Other procedures specified by relevant international standards. Such as in pharmaceutical test, weigh the tapping assembly including the cylinder and cylinder holder and check if weight is in the right range