Qualification of Equipment's in detail.

1. Qualification of manufacturing
equipment
Prepared by: khushboo kunkulol
Guided by: Dr. Ganesh andhale sir.
Alard college of pharmacy, pune.

2. Equipment Qualification:
 Equipment is an collective analytical measurement assembled to perform a mechanical process.
 Without an equipment we cannot manufacture a product.
 So, EQ ( Equipment Qualification) is action of proving that an equipment works correctly and
accordingly so, as to give the accurate and reliable result.
 If equipment is validated we can ensure that our product is of best quality.
 So term validation and qualification are interlinked to each other.
QUALIFICATION:
Qualification is a process of proving and documenting that an equipment or its ancillary
system are installed properly, work accordingly, and lead to actual expected result.
So, term QUALIFICATION is categorised into four different parts as followed:
I. Design Qualification
II. Installed Qualification
III. Operational Qualification
IV. Performance Qualification.

3. WHY IT IS REQUIRED?
 To increased throughput
 For reduction in rejections and reworking
 For reduction in utility costs
 For avoidance of capital expenditures
 Fewer complaints about process-related failures
 Reduced testing in-process and in finished goods
 More rapid and reliable start-up of new equipment
 Easier scale-up from development work
 Easier maintenance of equipment
 Improved employee awareness of processes
 More rapid automation

4. Who should do Equipment Validation? :
 The vendor or the user has the ultimate responsibility for the accuracy of the analysis
results and also 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, 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 because it is very application specific, and the
vendor may not be familiar with these.
 As PQ should be done on a daily basis, this practically limits this task to the user.

5. Design Qualification (DQ):
 "Design qualification (DQ) defines the functional and operational specifications of the
instrument and details for the conscious decisions in the selection of the supplier".
 The steps that should be considered for inclusion in a design qualification. Description of the
analysis problem, Description of the intended use of the equipment, Description of the intended
environment, Preliminary selection of the functional and performance specifications,
Preliminary selection of the supplier, Final selection of the equipment, Final selection of the
supplier, Development and documentation of final functional and operational specifications,
Installation Qualification (IQ):
 “Installation qualification establishes that the instrument is received as designed and specified,
that it is properly installed in the selected environment, and that this environment is suitable for
the operation and use of the instrument.”
The qualification involves the coordinated efforts of:
 The vendor.
 The operating department.
 The project team (which provide input into the purchase, installation, operation and
maintenance of the equipment).

6. Operational Qualification (OQ):
 "Operational qualification (OQ) is the process of demonstrating that an instrument will function
according to its operational specification in the selected environment”.
 The proper operation of equipment is verified by performing the test functions specified in the
protocol.
 A conclusion is drawn regarding the operation of equipment after the test functions are checked
and all data has been analyzed.
Following are the contents of equipment operation qualification:
 1. Application S.O.P’s
 2. Utilization List
 3. Process Description
 4. Test Instrument Utilized To Conduct Test
 5. Test Instrument Calibration
 6. Critical Parameters
 7. Test Function (List)
 8. Test Function Summaries

7. Performance Qualification (PQ):
 "Performance Qualification (PQ) is the process of demonstrating that an instrument
consistently performs according to a specification appropriate for its routine use ".
 PQ should always be performed under conditions that are similar to routine sample
analysis.
 PQ should be performed on a daily basis or whenever the equipment is being used.
 In practice, PQ can mean system suitability testing, where critical key system
performance characteristics are measured and compared with documented.

8. LIST OF MANUFACTURING EQUIPMENT
USED MORE OFFENLY:
 Dry powder mixer
 FBD ( Fluidised Bed Dryer)
 Tablet Compression Machine
 Autoclave
 Capsule filing machine
 Homogenizer

9. Dry Powder Mixer:
 The mixing of dry ingredient that is excipient and API is critical step in
solid dosage form preparation that affect content uniformity at great extent.
Types of Powder Blender:
 V cone Blender
 Double Cone Blender
 Drum mixture
 Ribbon Blender
 Conical Screw Mixer
 Tumble Blender.

10. URS for Powder Blender:
 Operating criteria must be adequate
 Spare should be available
 Easy maintenance
 Equipment should not disseminate dust
 Low cost
 Non reactive surfactant
 Capacity
 Mixing speed

11. Installation Qualification:
Detail of Equipment:
 Equipment name, made by and model no. shall be noted down.
 Location for 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 verify the equipment.
 Authorized validation team shall carry out installation checks.

12. Sr
no.
Description Specification Method of
Evaluation
Observation
1 Equipment type Visual inspection
2 Surface Finish Visual Inspection
3 Driving motor Visual Inspection
4 Gear box Visual Inspection
5 Control panel
and button
Visual Inspection
6 Dimension Measure tape

13. 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.
Sr
no
Description Specification Method of Evaluation Observation
1 On/off switch Lift the On switch and
ensure that power supply is
as required by proper
visualizing either
drum/cone started to rotate
or not.
2 RPM (Revolution
per minute)
Measure the actual RPM
using stop watch
3 Gross Capacity Fill the drum/cone with
potable water and record

14. 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

15. Fluid Bed Dryer:
 Fluid bed drying is most widely used technique for drying pharmaceutical powders and
granulation.
 The direct contact between particles and air/gas is possible in fluid bed system.
 Here any type of inert gas or air is used.
 They can be designed in either batch or continuous type fluid bed dryer
PRINCIPLE:
 In fluidized bed dryer, hot air is passed at high pressure through a perforated bottom of
the container containing granules to be dried.
 The granules are lifted from the bottom and suspended in the stream of air.
 This condition is called fluidized state.

16. FBD DESIGN QUALIFICATION:
 The goal is to perform something similar to a risk analysis and to check the design
documents of a technical system to ensure that then fulfils the user requirements.
In fluidized bed dryer the design of the instrument should be:
 Should occupy small place
 Based on our requirement we can go for horizontal or vertical.
 The bed which contain the material should be dried in conical shape or less some particles
may retain as such at the corners
 All technical considerations should be kept in mind while doing the design.

17. Installation Qualification (IQ):
Installation Qualification for fluidized bed dryer include the following steps:
 Verifying the approved purchase order.
 Check the manufacturer and supplier.
 Check for any physical damage.
 Verify that the utilities required are available.
 User manual
 Maintenance manual.
 List of charge parts.
 Electrical drawings.
Specially for FBD:
 Air temperature distribution.
 Inlet air installation
 Microbiological quality of the inlet air.
 Influence on weather on inlet air conditions.

18. Operational Qualification (OQ):
Documented verification that the system performs as intended throughout all anticipated operating
ranges, Some of them include:
 Verify alarm control.
 Verify that all switches and push button are functioning properly.
 Heat should distributed equally through out the system.
 Do the tests for uniform distribution of air.
 Establish training program for relevant stages.
 Operate all parts at their low, medium, and high level.
Run three batches of each product and analyze for:
 Speed of air (velocity of air).
 Active ingredients homogeneity.
 Moisture content.
 Particle size distribution.
 Percentage fines.
 Tap density.
 Based on this data we can fix drying end points for each process.

19. Performance Qualification (PQ):
PQ means to check what we want actually for that particular process from the equipment, what
processes are to be monitored.
 Inlet air speed.
 Quality of air.
 Uniform distribution of air.
 Mixing of air with temperature.
Run the trail batch during operation and there should not be any change in the
 Size
 Shape
 Surface characteristics.

20. Reference:
 https://www.slideshare.net/priyanka_odela/equipment-validation-of-
fbd#:~:text=Installation%20Qualification%20(IQ)Installation%20Qualification%2
0for%20fluidized%20bed%20dryer%20include,the%20utilities%20required%20ar
e%20available
 https://www.jgtps.com/admin/uploads/1fwM9K.pdf
 https://pharmapathway.com/basics-of-equipment-qualification/
 https://www.slideshare.net/JadhavAnkushJadhav/qualification-of-manufacturing-
equipments