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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.
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
21-05-2022
Dhruvi Anilkumar Machhi
2
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.
21-05-2022
Dhruvi Anilkumar Machhi
3
Types of Dry Powder Mixer
21-05-2022
Dhruvi Anilkumar Machhi
4
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.
21-05-2022
Dhruvi Anilkumar Machhi
5
Variable & Monitoring
 Monitoring:
 Blend uniformity
21-05-2022
Dhruvi Anilkumar Machhi
6
Variable
RPM
Mixing
Time
Mixing
Load
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.
21-05-2022
Dhruvi Anilkumar Machhi
7
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.
21-05-2022
Dhruvi Anilkumar Machhi
8
 IQ checks :
 Manufacturer name & address shall be checked
 Equipment name & model no. shall be noted down
 Check Gear Box, Control Panel, Buttons & Driving Motor
21-05-2022
Dhruvi Anilkumar Machhi
9
Installation Qualification
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
acceptable or not. 21-05-2022
Dhruvi Anilkumar Machhi
10
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
21-05-2022
Dhruvi Anilkumar Machhi
11
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.
21-05-2022
12
Dhruvi Machhi Smt.BNB.SPC, Salvav-Vapi
THANK YOU
13

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Qualification of Dry Powder Mixer.pptx

  • 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 21-05-2022 Dhruvi Anilkumar Machhi 2
  • 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. 21-05-2022 Dhruvi Anilkumar Machhi 3
  • 4. Types of Dry Powder Mixer 21-05-2022 Dhruvi Anilkumar Machhi 4
  • 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. 21-05-2022 Dhruvi Anilkumar Machhi 5
  • 6. Variable & Monitoring  Monitoring:  Blend uniformity 21-05-2022 Dhruvi Anilkumar Machhi 6 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. 21-05-2022 Dhruvi Anilkumar Machhi 7
  • 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. 21-05-2022 Dhruvi Anilkumar Machhi 8
  • 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 21-05-2022 Dhruvi Anilkumar Machhi 9 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 acceptable or not. 21-05-2022 Dhruvi Anilkumar Machhi 10
  • 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 21-05-2022 Dhruvi Anilkumar Machhi 11
  • 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. 21-05-2022 12 Dhruvi Machhi Smt.BNB.SPC, Salvav-Vapi

Editor's Notes

  1. Utilities = facilities required by the equipment like electricity, drainage Deviation = departing from standard Utilities – facilities required by the equipment ex.. electricity
  2. Comission – give instruction or command Control panel= part of instrument which is provided to monitor & control some of the parameters like temp., pressure, flow, etc