Transcript
A Seminar On
Equipment Qualification
By,
B.Rakesh M.Pharm Pharmaceutics
Priyadarshini College Of Pharmacy
CONTENTS :
1)Equipment Qualification2)Types3)Validation Of Cone Blender4)Validation Of Fluidized Bed Dryer5)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 Qualification2) Installation Qualification3) Operation Qualification4) Performance Qualification
Equipment
Validation
Design Qualification
(DQ)
Installation Qualification
(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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Installation qualification(IQ) Details of the Equipment:
• Equipment name, made by & model No. shall be noted down.
• Location for the 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 commission the equipment.
• Authorized validation team shall carry out installation checks.
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Sr no.
Description Specifications Method of evaluation
Observation
1. Equipment type Check visually
2. Capacity (L)
3. Dimensions HLW
Measure tape
4. Surface finish Check visually
5. Driving motor Made byRPMVoltagePhase
Check visually
6. Gear box Made byType
Check visually
7. Control panel & buttons
Check visually
Operational qualification(OQ)
• 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.
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Sr no. Description Specifications Method of evaluation Observation
1. On/off switch
Lift the switch to ON position & ensure that power supply gets ON & drum/cone starts rotating.
Lower the switch to OFF position & ensure that power supply gets OFF
2. RPMMeasure the actual RPM using stop-watch
3. Gross capacity
Fill the drum/cone with potable water using measuring cylinder & record
Performance qualification(PQ)
• Load the materials to be mixed in the mixer
• Start the mixer and rotate it for the time as mentioned.
• 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
Sampling
Drum mixer Double cone blender V cone blender
TopMiddleBottom
Revalidation Criteria
• Location of the equipment is changed.
• There is change of spare/ parts that have a direct effect on the performance of the equipment
• At normal revalidation schedule.
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Validation of
Fluidized BedDryer
Fixed Variable(monitor)
Response (Test)
Bowl changePorosity of filter bagsBowl sieve
Inlet/exhaust air temperatureProduct temperatureDrying timeAir volumeHumidity of incoming air Humidity of exhaust air
Particle size distributionDensitiesLoss on dryingAssay
FBD control parameters
Installation Qualification(IQ)Installation Procedure: Authorized validation team shall carry out installation.
Department Head of production, QA & engineering shall evaluate installation report
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 orderThe manufacturer/supplier shall provide complete equipment manual along with the equipment
Revalidation Criteria:The equipment shall be revalidated if;
Location of the equipment is changed.
There is change of spare/parts, major maintenance or breakdown.
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
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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 panelRecord the observation Perform and attach report of heat distribution study as per ` Heat distribution study procedure’
Acceptance criteria: All operating inputs provided on the
equipment when tested shall-successfully comply
-meet tolerance limitThe equipment should successfully
perform when operated as per SOP Critical gauges provided on the
equipment---calibrated The equipment when operated shall not - produce abnormal sound - show any discrepancy in its smooth operation.
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 ± 5°C for two hour after achieving the temperature on the controlling sensors to ensure proper heat distribution.
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Procedure for Drying Efficiency: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 and will be reported
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
Acceptance criteria:The reduction in moisture content after
drying should be as per the specification.
% RSD of LOD should not be more than 6 %
The equipment should produce intended outputs with respect to quality & quantity consistently
References :
1)http://www.hachlange.pt/countrysites/action_q/download%3Bdocument/DOK_ID/14788116/type/pdf/lkz/PT/spkz/pt/TOKEN/Hd-dpwCWfH3lq-8TDM8aiE315Z8/M/CliuUg
2) http://www.validationonline.net/Mixer.html
3) Berry I.R., and Nash R.A., ”Pharmaceutical Process validation” second edition, revised and expanded; Marcel Dekker series; 83-110.
4) www.usvalidationservices.com
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