validation of dry powder mixer

8/10/2019 Validation of Dry Powder Mixer

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A seminar on

Validation of Dry PowderMixers

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 whichprovide the high degree of the assurance thatPowder Mixer equipment actually leads to thedesired mixing or blending.

Why it is essential

The mixing of the API and excipients isthe critical step in the solid dosage formpreparations that affect the content uniformity atgreat 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 caseinclude, 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 noteddown.

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 theselection criteria, service engineer shall commission theequipment.

Authorized validation team shall carry out installationchecks.

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Srno.

Description Specifications Method ofevaluation

Observation

1. Equipment type Checkvisually

2. Capacity (L)

3. Dimensions HLW

Measuretape

4. Surface finish Checkvisually

5. Driving motor Made byRPMVoltagePhase

Checkvisually

6. Gear box Made byType

Checkvisually

7. Control panel &buttons

Checkvisually

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Operational qualification

After completions of successful installationqualification initiate the actual operation of toensure that machine is operating withinspecification.

Check the operation qualification parametersagainst their specifications.

Document the deviation details

The Quality head and the department head shalldecide whether deviation is acceptable or not.

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Sr no. Description Specifications Method of evaluation Observation

1. On/off switch

Lift the switch to ONposition & ensure thatpower supply gets ON &drum/cone startsrotating.

Lower the switch to OFFposition & ensure that

power supply gets OFF

2. RPMMeasure the actual RPMusing stop-watch

3. Gross capacity Fill the drum/cone withpotable water usingmeasuring cylinder &record

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Performance qualification

Load the materials to be mixed in the mixer

Start the mixer and rotate it for the time asmentioned in the BMR.

After completion of mixing switch OFF the mixerand separate out the drum.

Collect the sample as per sampling procedure.

Send the samples to Quality control dept. for

content uniformity, bulk density and sieveanalysis.

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Sampling

Drum mixer Double cone blender V cone blender

TopMiddle

Bottom 13


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Samplinglocation

In processparameter

Result %RSD

TopContent

uniformityMiddle

Bottom

Content uniformity

Sieveanalysis

Top Middle Bottom %RSD

Retained on20#

Retained onthe 40#

Retained on60#

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 havea direct effect on the performance of the

equipment At normal revalidation schedule.

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Latest advancements in the Blend analysis

1. NIR spectroscopy

2. Raman spectroscopy

3. Microscopic FTIR mapping

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Online Monitoring with NIR probe

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Online Monitoring with Raman probe

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References

http://www.validationonline.net/Mixer.html

www.askaboutvalidation.com

Pharmaceutical Master Validation Plan by Sayed

Imtiyaz Haider published by st. Luice press pageno 125.

A Report of the Product Quality ResearchInstitute Workshop on Blend Uniformity by JozefH.Timmermans

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Thank you

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validation of dry powder mixer

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