A Seminar On

Equipment Qualification

By,

B.Rakesh M.Pharm Pharmaceutics

Priyadarshini College Of Pharmacy

CONTENTS : 1) Equipment Qualification 2) Types 3) Validation Of Cone Blender 4) Validation Of Fluidized Bed Dryer 5) References

Equipment Qualification (EQ)

Equipment Qualification is a formal process that provides documented evidence that an instrument is fit for it intended purpose and kept in safe of maintenance and calibration consistent with its use. EQ is mainly divided into four types; 1) Design Qualification 2) Installation Qualification 3) Operation Qualification 4) Performance Qualification

Equipment

Validation

Design

Qualification (DQ)

Installation Qualificatio

n (IQ)

Operational

Qualification (OQ)

Performance

Qualification (PQ)

Stages of qualification

Design qualification

Installation qualification

Operational qualification

Performance qualification Change control

Typical process flow of

solid dosage form Addition of raw material -active excipients

Preble bending -high speed mixer granulator

Granulating

- high speed mixer granulator

Drying -fluid bed dryer -tray dryer

Tableting -high speed

rotary

Blending -v-blender

Addition of raw material -lubricant -disintegrants

Sizing -mill/sieve

Validation For Conical Blender

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.

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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