Validation of fluid bed and tray dryer

1
Validation of
fluid bed and
tray dryer

• A
• Seminar
• on

2
Content

• Why to validate?
• Parts of Equipment Validation
• Who should do Equipment Validation?
• Equipment qualification
• Typical process flow of solid dosage form
• Validation of fluid bed dryer
• Validation of Tray dryer

3
Why to validate?

• Equipment validation is Vital for
• Safety
• Fewer interruptions of work
• Lower repair costs
• Elimination of premature replacement
• Less standby equipment
• Identification of high maintenance cost
• Reduction of variation in results
• Greater confidence in the reliability of
  results

4
Parts of Equipment Validation
Design Qualification (DQ)

• Equipment
• Validation

Installation Qualification (IQ)
Performance Qualification (PQ)
Operational Qualification (OQ) 
5
Who should do Equipment Validation?
The vendor or the user?

• The user has the ultimate responsibility for
  equipment qualification.
• DQ should always be done by the user.
• While IQ for a small and low cost instrument is
  usually done by the user, and
• IQ for large, complex and high cost
  instruments should be done by the vendor.
• OQ can be done by either the user or the vendor.
• PQ should always be done by the user

6
Equipment qualification

• Equipment qualification / validation includes
  following things
• Design qualification (DQ)
• Installation qualification (IQ)
• Operational qualification (OQ)
• Performance qualification (PQ)

7
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
Blending -v-blender
Addition of raw material -lubricant -disintegrants
Sizing -mill/sieve
Tableting -high speed rotary
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Typical variable of drying process
9
Validation of
fluid bed dryer
10
fluid bed dryer
11
FBD control parameters
12
Installation Qualification(IQ)

• Installation Procedure
• After checking all the specifications as
  mentioned in the selection criteria, service
  engineer of the manufacturer shall be called for
  commissioning, if necessary.
• Authorized validation team shall carry out
  installation.
• Department Head of production, QA engineering
  shall evaluate installation report
•  

13
Conti

• Acceptance Criteria For Installation
  Qualification
• The equipment shall fulfill the selection
  criteria its purpose of Application.
• Name of the manufacturer supplier shall be as
  mentioned in the Purchase order
• The manufacturer/supplier shall provide complete
  equipment manual along with the equipment
• All recommended utilities of recommended
  capacities are to be provided near the place of
  installation

14
Conti

• Revalidation Criteria
• The equipment shall be revalidated if
• Location of the equipment is changed.
• There is change of spare/parts,major maintenance
  or breakdown that have a direct effect on the
  performance of the equipment

15
Conti

• Conclusion
• The equipment shall be considered qualified for
  installation provided it meets all the parameters
  mentioned in the acceptance criteria.
• After receiving installation report, it shall be
  evaluated released for operational
  qualification, provided installation report is
  evaluated the equipment is found meeting all
  parameters of acceptance criteria

16
Operational Qualification (OQ)

• Training record
• Before initiating OQ ensure that SOP for Cleaning
  and operation of FBD is available.
• Purpose To train the qualification team for
  performing OQ
•  

17
Conti

• Procedure
• Initiate the actual operation of the FBD to
  ensure that machine is operating within
  specification.
• Check the OQ parameters against their
  specifications.
• Observe the functioning of all controls available
  on control panel
• Record the observation
• Perform and attach report of heat distribution
  study as per Heat distribution study
  procedure 

18
Conti

• Acceptance criteria (Heat Distribution Study)
• Temperature difference between all thermocouples
  and set temperature should not differ by more
  than 5 C.
• All operating inputs provided on the equipment
  when tested shall-successfully comply
• -meet tolerance
  limit
• The equipment should successfully perform when
  operated as per SOP

19
Conti

• Critical gauges/indicators provided on the
  equipment---calibrated
• The equipment when operated shall not
• - produce abnormal sound
• - show any discrepancy in its smooth
  operation.

20
Conti

• Revalidation Criteria
• The equipment shall be revalidated if
• Location of the equipment is changed.
• There is change of spare/ parts, major
  maintenance or breakdown that have a direct
  effect on the performance of the equipment
• Critical gauges shall be replaced or corrected
• At normal revalidation schedule.

21
Performance Qualification(PQ)

• To check Heat Distribution by placing 10
  thermocouples in geometric pattern with the FBD
  Shell and empty Product Container without any
  load to ensure heat distribution in the drying
  chamber
• Heat distribution study will be performed at 65
  5C for two hour after achieving the temperature
  on the controlling sensors to ensure proper heat
  distribution.

22
Conti

• Procedure
• After completion of OQ initiate the PQ of FBD.
• The effectiveness of drying will be qualified by
  determining reduction of moisture content in
  drying process.
• 3 batches/ lots of any product will be taken for
  PQ of FBD.
• At least 2.0 gm of sample is sampled for MC
  check from the top, middle and bottom trays and
  will be reported

23
Conti

• In case of any deviation inform to department
  head for necessary action
• Document the deviation details
• Deviation is acceptable or not will be decided
• -if yes
• -if not

24
Conti

• Acceptance criteria
• The reduction in moisture content after drying
  should be as per the specification in the BMR
• RSD of LOD should not be more than 6
• The equipment should produce intended outputs
  with respect to quality quantity consistently

25
Conti

• Revalidation Criteria
• The equipment shall be revalidated if
• Location of the equipment is changed.
• There is change of spare/ parts, major
  maintenance or breakdown that have a direct
  effect on the performance of the equipment
• At normal revalidation schedule.

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Procedure for Drying Efficacy Study
in Fluidized bed Dryer

• Ensure the cleaning of machine
• Load the wet mass in the FBD product container
• Set the process time outlet temperature and run
  the FBD.
• After completion of drying take out FBD bowl and
  collect the sample
• At least 2.0 gm of sample is sampled for MC
  check from the top, middle and bottom trays and
  will be reported

27
Conti

• Sampling Procedure
• Ware nose mask, hand gloves before sampling.
• Label the sample bag with details as Product
  name, stage, date, time and sign
• Collect app. 2.0 gms of dried material composite
  sample in poly bag as per location shown
• Record the details of analysis.

28

• Validation of
  Tray dryer

29
Tray dryer
30
Tray Dryer control parameters
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Installation Qualification(IQ)

• Procedure
• Selection criteria shall be defined and based on
  specific function to be carried out by the
  machine its efficiency.
• Requirement of accessories shall be decided
  listed out.
• Supplier or manufacturer selection
•  

32
Conti

• Purchase Details
• The purchase order no. date shall be checked
• The accessories their spare parts if any shall
  be checked as per purchase order
• The delivery period shall be as per purchase
  order
• Supplier or manufacturer name address shall be
  checked
• Any deviation observed should be informed to the
  supplier or manufacturer

33
Conti

• Details of the Equipment
• Equipment name, make model no. shall be noted
  down
• In-house identification no. shall be allocated
• Location for installation shall be decided
• Utilities required shall be listed down

34
Conti

• Installation Procedure
• After checking all the specifications as
  mentioned in the selection criteria, service
  engineer of the manufacturer shall be called for
  commissioning, if necessary.
• Authorized validation team shall carry out
  installation
• Department Head of production, QA engineering
  shall evaluate installation report

35
Conti

• Acceptance Criteria For IQ
• Fulfill the selection criteria its purpose of
  Application
• The equipment shall be as per purchase order
• Accessories received shall be as per purchase
  order
• Should meet pre-selected design parameters
• Manufacturer/supplier shall provide complete
  equipment manual
• Material of construction shall be as per purchase
  order

36
Operational Qualification (OQ)

• Training record
• Before initiating OQ ensure that SOP for Cleaning
  and operation of Tray dryer is available.
• Purpose To train the qualification team for
  performing OQ

37
Conti

• Procedure
• Initiate the actual operation of the TD to ensure
  that machine is operating within specification.
• Check the OQ parameters against their
  specifications.
• Observe the functioning of all controls available
  on control panel
• Record the observation

38
Conti

• Acceptance criteria
• All operating inputs provided on the equipment
  when tested shall-successfully comply
• -meet tolerance limit
• The equipment should successfully perform when
  operated as per SOP
• Critical gauges/indicators provided on the
  equipment- --calibrated
• The equipment when operated shall not
• - produce abnormal sound
• - show any discrepancy in its smooth
  operation.

39
Performance Qualification(PQ)

• To check Heat Distribution by placing 10
  thermocouples in geometric pattern with the TD
  Shell and empty Product Container without any
  load to ensure heat distribution in the drying
  chamber
• Heat distribution study will be performed at 45
  C and 105C for one hour after achieving the
  temperature on the controlling sensors to ensure
  proper heat distribution.

40
Conti

• Procedure
• After completion of OQ initiate the PQ of TD
• The effectiveness of drying will be qualified by
  determining reduction of moisture content in
  drying process.
• 3 batches/ lots of any product will be taken for
  PQ of TD
• At least 2.0 gm of sample is sampled for MC
  check from the top, middle and bottom trays and
  will be reported

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42
Conti

• In case of any deviation inform to department
  head for necessary action
• Document the deviation details
• Deviation is acceptable or not will be decided
• -if yes
• -if not

43
Conti

• Acceptance criteria
• Temperature difference between all thermocouples
  and set temperature should not differ by more
  than ? 5 C.
• The reduction in moisture content after drying
  should be as per the specification in the BMR
• RSD of LOD should not be more than 6
• The equipment should produce intended outputs
  with respect to quality quantity consistently

44
references

• Berry I.R., and Nash R.A., Pharmaceutical
  Process validation second edition, revised and
  expanded Marcel Dekker series 83-110.

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Seminar open for discussion
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