CHANGE CONTROL REPORT
AABBCC PHARMACEUTICALS
QUALITY ASSURANCE DEPARTMENT
INSTALLATION OF NEW FLUID BED DRYER (FBD)
1. SECTION-I : REQUEST FOR CHANGE
Change Control Number
CC/PROD/2026/FBD/001
Initiating Department
Production Department
Date
DD/MM/YYYY
Applicable To
- ☑ Manufacturing Equipment
- ☑ Granulation Process
- ☑ Facility and Utilities
- ☑ Equipment Qualification
- ☑ Process Documentation
- ☑ Quality Management System
- ☐ Product Formulation
- ☐ Packaging System
Details of Product / Item / Document / System / Facility / Equipment
The proposed change involves the installation of a new Fluid Bed Dryer (FBD) in the granulation area for drying wet granules used in the manufacture of tablet dosage forms. The new equipment will replace or supplement the existing drying capacity and is designed with improved automation, enhanced process control, GMP-compliant construction, and advanced safety features.
Equipment Information
- Equipment Name: Fluid Bed Dryer
- Existing Equipment ID: FBD-01 (where applicable)
- Proposed Equipment ID: FBD-02
- Location: Granulation Area
- Manufacturer: Approved Vendor
- Construction: SS316L product contact parts
- Control System: PLC with HMI interface
PRESENT / EXISTING PROCEDURE(S)
Wet granules produced in the Rapid Mixer Granulator are presently dried using the existing Fluid Bed Dryer according to approved manufacturing procedures.
Current operations include:
- Transfer of wet granules into FBD bowls.
- Drying under validated temperature and airflow conditions.
- In-process moisture monitoring.
- Sampling for Loss on Drying (LOD).
- Discharge of dried granules for milling and blending.
- Recording of process parameters in batch manufacturing records.
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CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
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CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
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Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
Find below pages for complete report
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
Find below pages for complete report
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
Find below pages for complete report
Click the link to download the word file copy of this document:
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
Find below pages for complete report
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
Find below pages for complete report
Key Parameter of the Below Page:
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
Find below pages for complete report
Click the link to download the word file copy of this document:
Click the link to download the word file copy of this document
