A seminar on Validation of Dry Powder Mixers

advertisement

A seminar on

Validation of Dry Powder

Mixers

By

WWW.PARASSHAH.WEEBLY.COM

M.Pharm. (Sem - III)

Department of Quality Assurance

Maliba Pharmacy College.

1

Contents

Introduction variables

Powder mixers validation

Revalidation

Latest advancements in the blend analysis

References

2

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

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

3

Types of the powder blenders

V cone blenders

Double cone blenders

Drum mixer

Ribbon blenders

Conical screw mixer

Tumble blender

4

Variable and monitoring

Variable

RPM

Mixing time

Mixing load

Monitoring

Blend uniformity

5

Worst case

Evaluation of worst case: Worst case include, maximum and minimum load, maximum and minimum rpm, maximum and minimum time.

6

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

7

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

4.

5.

6.

7.

2.

3.

Sr no.

1.

Description

Equipment type

Specifications

Capacity (L)

Dimensions H

L

W

Surface finish

Driving motor

Gear box

Control panel & buttons

Made by

RPM

Voltage

Phase

Made by

Type

Method of evaluation

Check visually

Observation

Measure tape

Check visually

Check visually

Check visually

Check visually

9

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.

10

Sr no.

Description

1.

On/off switch

Specifications Method of evaluation Observation

2.

3.

RPM

Gross capacity

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

11

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.

12

Sampling

Drum mixer Double cone blender V cone blender

Top

Middle

Bottom

13

Content uniformity

Sampling location

Top

Middle

Bottom

In process parameter

Content uniformity

Sieve Analysis

Sieve analysis

Retained on

20#

Retained on the 40#

Retained on

60#

Passed through 60#

Top Middle

Result

Bottom

%RSD

%RSD

14

Density

Density

Bulk

Tapped

Top Middle Bottom %RSD

15

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.

16

Latest advancements in the Blend analysis

1.

2.

3.

NIR spectroscopy

Raman spectroscopy

Microscopic FTIR mapping

17

Online Monitoring with NIR probe

18

Online Monitoring with Raman probe

19

References

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

www.askaboutvalidation.com

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

H.Timmermans

20

Thank you

21

Download