M.Pharm. (Sem - III)
Department of Quality Assurance
Maliba Pharmacy College.
Powder mixers validation
Latest advancements in the blend analysis
Validation of Dry Powder Mixers
It is defined as documented act which provide the high degree of the assurance that
Powder Mixer equipment actually leads to the desired mixing or blending.
Why it is essential the
The mixing of the API and excipients is critical step in the solid dosage form preparations that affect the content uniformity at great extent
V cone blenders
Double cone blenders
Conical screw mixer
Evaluation of worst case: Worst case include, maximum and minimum load, maximum and minimum rpm, maximum and minimum time.
Operating criteria must be adequate
Spares should be available
Equipment should not disseminate dust
Non reactive surface
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.
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.
Control panel & buttons
Method of evaluation
After completions of successful installation qualification initiate the actual operation of 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.
Specifications Method of evaluation Observation
Lift the switch to ON position & ensure that power supply gets ON & drum/cone starts rotating.
Lower the switch to OFF position & ensure that power supply gets OFF
Measure the actual RPM using stop-watch
Fill the drum/cone with potable water using measuring cylinder & record
Load the materials to be mixed in the mixer
Start the mixer and rotate it for the time as mentioned in the BMR.
After completion of mixing switch OFF the mixer and separate out the drum.
Collect the sample as per sampling procedure.
Send the samples to Quality control dept. for content uniformity, bulk density and sieve analysis.
Drum mixer Double cone blender V cone blender
In process parameter
Retained on the 40#
Passed through 60#
Top Middle Bottom %RSD
Location of the equipment is changed.
There is change of spare/ parts that have a direct effect on the performance of the equipment
At normal revalidation schedule.
Microscopic FTIR mapping
Pharmaceutical Master Validation Plan by Sayed
Imtiyaz Haider published by st. Luice press page no 125.
A Report of the Product Quality Research
Institute Workshop on Blend Uniformity by Jozef