A seminar on

Validation of Dry Powder Mixers

By

WWW.PARASSHAH.WEEBLY.COMM.Pharm. (Sem - III)

Department of Quality Assurance Maliba Pharmacy College.

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Contents Introduction variables Powder mixers validation Revalidation Latest advancements in the blend analysis References

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Introduction 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 mixing of the API and excipients is the critical step in the solid dosage form preparations that affect the content uniformity at great extent

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Types of the powder blenders V cone blenders Double cone blenders Drum mixer Ribbon blenders Conical screw mixer Tumble blender

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Variable and monitoring Variable RPM Mixing time Mixing load

Monitoring Blend uniformity

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Worst case Evaluation of worst case: Worst case

include, maximum and minimum load, maximum and minimum rpm, maximum and minimum time.

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URS for the powder mixers Operating criteria must be adequate Spares should be available Easy maintenance Equipment should not disseminate dust Low cost Non reactive surface Capacity Mixing speed

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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 checks. 8

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Operational qualification 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.

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Performance qualification 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.

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Sampling

Drum mixer Double cone blender V cone blender

TopMiddleBottom 13

Sampling location

In process parameter

Result %RSD

TopContent

uniformity Middle

Bottom

Content uniformity

Sieve analysis

Top Middle Bottom %RSD

Retained on 20#

Retained on the 40#

Retained on 60#

Passed through 60#

Sieve Analysis

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Density

Density Top Middle Bottom %RSD

Bulk

Tapped

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Revalidation Criteria 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.

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Latest advancements in the Blend analysis

1. NIR spectroscopy2. Raman spectroscopy 3. Microscopic FTIR mapping

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Online Monitoring with NIR probe

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