The document discusses the qualification requirements for a tapped density tester and disintegration tester used in pharmaceutical validation. It outlines the user requirements, design qualification, installation qualification, operational qualification, and performance qualification that must be completed to ensure the equipment is properly installed and operating as intended according to specifications. Key steps include verifying the equipment dimensions and operating conditions, testing that the tapped density tester can accurately measure density and the disintegration tester can oscillate tablets at the appropriate speed and temperature.

1. PRESENTED BY,
USHA
KHANAL
SUBJECT: PHARMACEUTICAL
VALIDATION
M1(Pharmaceutical Analysis & Quality
Assurance)
QUALIFICATION OF TAP
DENSITY TESTER &
DISINTEGRATION TESTER

2. 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.

3. Tap Density Tester

4. 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 2different modes.
 USP mode
 User Mode
Minimizes any possible separation of mass during
tapping down.

5. 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.

6. 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

7. 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.

8. 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.

9. 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.

10. 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.

11. Disintegration Test
For a drug to be readily available to the body , it
must be in solution.
 For most tablets, the first important step toward
solution is break down of the tablet into smaller
particles or granules, a process called
disintegration.

12. URS Of Disintegration Test
Apparatus
Operating criteria must be adequate.
Easy maintenance.
Equipment should not disseminate dust.
Low cost.
Spares should be available
Non reactive surface.
Audio visual indicators for system status.
Printer attachment facility.

14. 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.

15.   .

Disintegration Apparatus Model 901
System Digital Tablet Disintegration Apparatus
Up and Down Speed 30 rpm ± 2 rpm
Accuracy 2%
Resolution 1 sec
Operating Temp. Range 0 - 100°C
Power 230V ± 10%, 50Hz.AC
Dimensions 450 mm (H) X 300 mm (W) X 320 mm (L)
(Approx.)
Weight 8 ltrs. (Approx.)

16. Performance Qualification
Verifies that the equipment performs according to
design specifications and user defined
requirements in a reliable & reproducible manner
under normal production conditions.
Ensure the apparatus is properly connected to
the power supply .
When the power is switched on the timer and
temp. shows digital value.

17. Fill the beaker of disintegration apparatus
with Purified water and adjust the temperature
between 37 ± 2 C.
 Fix the beaker in its position and adjust the level of
water.
Start the basket – rack assembly and
timer simultaneously.
 Place the standardized calibrated thermometer to
record the actual temperature against the
temperature displayed.
Note the temperature of water in the beaker and
oscillation per minute of the basket-rack assembly.
 Switch off the apparatus and record the
observations in the calibration record.

18. Acceptance Criteria
The temperature shall be between 37 ± 2 C.
 The frequency of basket rack shall be between
29 to 32 cycles per min.
Frequency Of Calibration
Once in a month and after each maintenance.

19. References
ManoharAPotdar.cGMP.Pharmaceutical
validation.2009:444-446.
www.pharmatips.in
http://www.electronicsindia.co.in