Dry Powder Mixer Types of Dry Powder Mixer Qualification of Dry Powder Mixer Variable & Monitoring Design Qualification Installation Qualification Operational Qualification Performance Qualification Qualification of Dry Powder Mixer References

1. Topic:- Qualification of Dry Powder Mixer
Subject Name :- Pharmaceutical Validation
Subject Code:- MQA204T
Department of Pharmaceutical Quality Assurance
Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–vapi
Presented by:-
Machhi Dhruvi A.
2nd sem M.Pharm.

2. CONTENTS
 Dry Powder Mixer
 Types of Dry Powder Mixer
 Qualification of Dry Powder Mixer
 Variable & Monitoring
 Design Qualification
 Installation Qualification
 Operational Qualification
 Performance Qualification
 Qualification of Dry Powder Mixer
 References
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3. Dry Powder Mixer
 Powder mixing may be regarded as an operation in which two or more than two
solid substances in particulate form intermingled in mixer by continuous
movement of particles.
 It is an example of neutral mixture & is one the most common operation
employed during preparation of different formulation like powder, tablets,
capsules etc.
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4. Types of Dry Powder Mixer
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5. Qualification of Dry Powder Mixer
 It is defined as the action of proving & documenting that the Dry powder mixer is
properly installed, work correctly & leads to expected result.
 Need of Qualification of Dry Powder Mixer:
 Mixing of API & excipients is the critical step in the solid dosage form
preparation that affects the content uniformity at great extent.
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6. Variable & Monitoring
 Monitoring:
 Blend uniformity
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Variable
RPM
Mixing
Time
Mixing
Load

7. Design Qualification
 Design Qualification of Dry powder mixer includes:
 Equipment name, made by & model number shall be noted down
 Location for the installation of equipment shall be checked
 Utilities required shall be listed down
 Required capacity of the mixer, type of materials to be mixed & mixing time also
should be taken into consideration
 Any deviation observed while following above procedure shall be informed for
corrective action.
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8. Installation Qualification
 The IQ process is intended to demonstrate that the Dry Powder Mixer
 Meet all specification
 Installed properly &
 Supporting program like SOP, Maintenance sheet are in place
 After checking all the specifications as mentioned in the selection criteria, service
engineer shall commission the equipment.
 Authorized validation team shall carry out installation checks as per the
specification criteria.
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9.  IQ checks :
 Manufacturer name & address shall be checked
 Equipment name & model no. shall be noted down
 Check Gear Box, Control Panel, Buttons & Driving Motor
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Installation Qualification

10. Operational Qualification
 After completion of IQ, initiate the actual operation, to ensure that machine is
operating within the specification.
 Check the operation qualification parameters against their specifications.
 It includes following checks :
 On/ off Switch
 Gross Capacity
 RPM
 After that, document the deviation details.
 The quality head & the department head shall decide whether the deviation is
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11. Performance Qualification
Load the material into the mixer
Start the mixer & rotate it for the time as mentioned in the BMR
After completion of mixing switch off the mixer & separate out material
Collect the sample as per sampling procedure
Send the samples to QC department for content uniformity, bulk density & site analysis
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12. References
1. http://www.slideshare.net/AditiRoy29/validation-of-
drypowdermixer?from_m_app=android
2. http://www.slideshare.net/JadhavAnkushJadhav/qualification-of-
manufacturing-equipments?from_m_app=android
3. http://www.slideshare.net/RIPERAutonomus/qualification-of-dry-powder-
mixture?from_m_app=android
4. 7. Subrahmanyam CVS, Setty JT, Sarasija S & Devi VK in “ Pharmaceutical
Engineering- Principles & Practices”, Vallabh Prakashan, New Delhi, 2001,
390-391, 397-399.
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Dhruvi Machhi Smt.BNB.SPC, Salvav-Vapi

13. THANK YOU
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