B.Rakesh M.Pharm Pharmaceutics Priyadarshini College Of Pharmacy
CONTENTS : 1) Equipment Qualification 2) Types 3) Validation Of Cone Blender 4) Validation Of Fluidized Bed Dryer 5) 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 Qualification 2) Installation Qualification 3) Operation Qualification 4) Performance Qualification
Variable and monitoring Variable • RPM • Mixing time • Mixing load
Monitoring • Blend uniformity
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. 11
Method of evaluation
Made by RPM Voltage Phase
Made by Type
Control panel & buttons
H L W
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. 13
Method of evaluation
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
Measure the actual RPM using stop-watch 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
Top Middle Bottom
Double cone blender
V cone blender
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.
Fluidized Bed Dryer
FBD control parameters Fixed
Bowl change Porosity of filter bags Bowl sieve
Inlet/exhaust air temperature Product temperature Drying time Air volume Humidity of incoming air Humidity of exhaust air
Particle size distribution Densities Loss on drying Assay
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 order The 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 o 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
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’
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 provided on the equipment--calibrated The equipment when operated shall not - produce abnormal sound - show any discrepancy in its smooth
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. 26
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%3Bdocume nt/DOK_ID/14788116/type/pdf/lkz/PT/spkz/pt/TOKEN/HddpwCWfH3lq-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