QUALIFICATION AND VALIDATION OF FLUID BED EQUIPMENT

WITH BOTTOM SPRAY TECHNOLOGY

MASTER OF PHARMACY DISSERTATION PROTOCOL

SUBMITTED TO THE

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE,

KARNATAKA
BY
MANEESH MADHUKAR NARKAR
Under The Guidance of
Mr. KRISHNANANDA KAMATH K., M.PHARM.

P.G. DEPARTMENT OF QUALITY ASSURANCE,

SRINIVAS COLLEGE OF PHARMACY, MANGALORE 574143
2012 2013
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA

ANNEXURE
REGISTRATION OF SUBJECT FOR DISSERTATION
1.0

NAME OF THE CANDIDATE

MANEESH MADHUKAR NARKAR.

ADDRESS

DEPT. OF QUALITY ASSURANCE,

SRINIVAS COLLEGE OF PHARMACY,
VALACHIL, POST FARENGIPETE,
MANGALORE - 574143

2.0

NAME OF THE INSTITUTION

SRINIVAS COLLEGE OF PHARMACY,

VALACHIL, MANGALORE.

3.0

COURSE OF STUDY &

MASTER OF PHARMACY

SUBJECT

(QUALITY ASSURANCE)

4.0

DATE OF ADMISSION

26/05/2012

5.0

TITLE OF THE TOPIC:

QUALIFICATION AND VALIDATION OF FLUID BED EQUIPMENT
WITH BOTTOM SPRAY TECHNOLOGY

6.0
BRIEF RESUME OF THE INTENDED WORK :

6.1

NEED FOR THE STUDY:

Equipment qualifications are always performed to confirm functionality of the equipment as
per defined specifications, both prior to and after installation. However, documented records of
equipment qualification and validation have sometimes not been given sufficient consideration.
As a consequence, companies have not always been able to provide documented evidence to
inspectors reflecting the time and effort spent in carrying out these activities.
Quality Assurance function have critical role in overseeing and coordinating
qualification and validation activities. The qualification and validation approach has been
discussed due to its real importance within a productive process in relation to the products quality
attributes, like purity, safety and effectiveness. Process validation is establishing documented
evidence which provides a high degree of assurance that a specific process will consistently
produce a product meeting its predetermined specifications and quality characteristics. So, the
validation consists of a series of qualifications that involves tests, systems verifications and also
critical process parameters that are its regulating keys, and can vary within an acceptance limit.
The process for equipment qualification follows the 4Qs model for the specification,
installation check, and monitoring of ongoing equipment performance.
Design Qualification (DQ): Define the functional and operational specifications of the
equipment, any associated software and ancillary system for the intended purpose. To be
performed before purchase of a new equipment.
Installation Qualification (IQ): Establish that equipment is delivered as designed and specified
and that it is properly installed in the selected environment.
Operational Qualification (OQ): Document that the equipment will function according to its
operational specification in the selected environment.
Performance Qualification (PQ): Document that the equipment consistently performs according
to specification and intended use.

6.2

EQUIPMENT DESCRIPTION:
The Fluidised Bed Equipment, FBE is used for:Rapid and efficient drying of wet
granulation mass, granulation of powders andCoating of Pellets.
The material to be processed is loaded into the bowl of the FBE.
The bowl has a fine SS mesh at the bottom. The air used for drying/fluidizing is successively
filtered through Pre (EU 4- filter grade, 10 micron rating, 95% efficiency), Fine (EU 7 grade, 3
micron rating, 99% efficiency) and finally through HEPA filters (EU 13 grade, 0.3 micron rating,
99.997% efficiency).
Hot, filtered air up to 90oCel. is passed at high velocity from the bottom of the FBE bowl through
the process material. Because of the high velocity of the air the process material is fluidised.
The fluidising air results into a very efficient heat and mass transfers (heating, cooling, drying,
granulating, coating).
The machine can be divided in following sub sections:

Inlet Air Handling Unit

Machine Tower (Lower Plenum, Product Container, Expansion Chamber & Product Filter
Housing)

Spraying System

Exhaust Air Handling Unit

Wet Scrubber

Control Panel

7.0
7.1

BRIEF PATHWAY OF THE INTENDED WORK :

OBJECTIVE OF STUDY : The objective of this work is to qualify Fluid Bed Equipment,
according to the specified requisites and validate the Process.

7.2
REVIEW OF LITERATURE: A literature survey was carried out for the work done on
qualification of Fluid Bed Equipment. Few methods have been reported and the collections of
reference are reproduced below.

Dr.Mukesh Gohel and Dr. Rajesh Parikh 1 has elaborated history and chronological
developments in fluid bed systems. Various concepts of fluidization, parameters to be controlled
during fluidization, various classification of fluid bed system. They have elaborated various
advantages, disadvantages and applications of fluid bed system.
Lipsanen, T., 2 has described Process Analytical Technology Approach on fluid bed granulation
and drying Identifying Critical relationship and constructing the design space. The approach in
this thesis was to identify the source of variation that are mainly related to moisture. The aim was
to determine correlations and relationships, and utilize the PAT and design space concepts for
fluid bed granulation and drying. Physical in-line measurements (i.e. temperature , air flow
rate)and various particle size determinations were used to increase process understanding.
Samira El Mafadi, Murielle Hayert, Denis Poncelet3 in their scientific paper described about
fluidization control in wurster coating process. The particulate coating process in FBE involves
different sub process involves particle wetting, spreading also drying of coating applied. These
subprocesses are done simultaneously to particle fluidization. All parameters are known to affect
coating quality; due to this particle motion in Wurster needs to be observed carefully. These
observations have achieved to understand general phenomenon which takes place inside the bed
and allowed to develop easy methods for optimizing all parameters affecting this process.
Pam-Glatt FBE Manual 4 describes about safety precautions, technical description about AHU
,fan. Description about machine orientation, various components like machine tower, filter unit
,sealing unit of filter and product container, inlet AHU, exhaust air handling unit, spraying
system. It describes PLC unit and various interlocks , password protection facilities. It also covers
commissioning, maintenance data.

7.3

7.4

Source of Data:

References from library Srinivas college of pharmacy

www.pharmainfo.net

www.google.com

Journals and Publications

Methodology:Qualification and validation of fluid bed equipment with bottom spray technology
shall be carried out at Indoco Remedies Ltd., Goa. As part of validation requirements,
documentation and information file will be established. It will include a full description of the
equipment, specifying its acceptable criteria.

7.5

Fluid Bed Equipment : Make : Pam Glatt will be used for project work.
Does the study require any investigations or interventions to be conducted On
patients or other human or animals? If so please describe briefly:
-- Not applicable

7.6

Has the Ethical Clearance been obtained from your Institution in case of 7.3?

8.0

-- Not applicable
LIST OF REFERENCES:
1.

http://onlinelibrary.wiley.com/doi/10.1002/jps.3030480808/abstract
Journal of the American Pharmaceutical Association, Aug.1959

2.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2799576
Predicting Particle Size During Fluid Bed Granulation Using Processor

3.

Pharmaceutical process validation by Robrt A.Nash and Alfred H. Wachter.

4.

Fluid Bed Equipment manual supplied by Pam- Glatt.

9.0
10

SIGNATURE OF THE CANDIDATE

REMARKS OF THE GUIDE

Maneesh Madhukar Narkar.

Forwarded for Approval
Mr.Krishnananda Kamath K.,

10.1

NAME AND DESIGNATION OF GUIDE

Assistant Professor,
Dept of Quality Assurance

10.2

SIGNATURE
Dr. E.V.S. Subramanyam,

11

HEAD OF THE DEPARTMENT

Professor and Head,

Dept of Quality Assurance

11.1

12

12.1

SIGNATURE

REMARKS OF THE PRINCIPAL

SIGNATURE

Forwarded for approval

Dr. Ramakrishna Sharbaraya A.

Principal, Srinivas college of pharmacy,
Valachil, Mangalore.