The document discusses the qualification process of dry powder mixers within pharmaceutical validation, outlining the types of mixers, and the qualifications required: design, installation, operational, and performance. It emphasizes the importance of proper mixing in achieving content uniformity in solid dosage forms, detailing monitoring variables like blend uniformity, RPM, and mixing time. References for further reading are provided to support the discussed concepts.

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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