validation of colloidal mill
DESCRIPTION
validation of colloidal millTRANSCRIPT
VALIDATION OF PULVERISATION MACHINESM.SRINIVASM.PHARM. II SEM.VAAGESWARI COLLEGE OF PHARMACY
CONTENTS
•DEFINITION•PRINCIPLE•CONSTRUCTION •WORKING•APPLICATIONS•VALIDATION•CONCLUSION
PULVERISATION:
pulverization is process to make a fine particle (powder)form of any solid substance by hammering ,attrition or any other
compression methods
VALIDATION:
Validation is defined as a documentary evidence which provides a high degree of assurance that a
specific process /equipment will consistently produce a product meeting its predetermined
specifications and quality attributes.
WHY TO VALIDATE?
To ensure that the products intended for human administration are manufactured under state
of control.
Principle:The size reduction is effected due to shears when the material is placed between the narrow gap of milling surfaces of rotor & stator.
construction:colloidal mill consists of a rotor & a stator, the rotor rotates at a speed of 3000 to 20,000rpm.The stator have conical milling surface between which there is an adjustable clearance between 0.002 to 0.3 .
working:The material Eg:- emulsion & suspension is placed into the hopper of the mill. It is then passed through the narrow gap between the rotor & stator & thus reduced to fine particle size.
APPLICATIONS:
colloid mill is used for preparing suspensions, emulsions and ointments.
capable of producing pharmaceutical products with reduced particle size <1 μ.
Colloidal mill can be sterilized so it can be used in the production of sterile products
COLLOIDAL MILL
VALIDATION
VALIDATION
DESIGN QUALIFICATION
INSTALLATION QUALIFICATION
OPERATIONAL QUALIFICATION
PERFORMANCE QUALIFICATIO
N
1)DESIGN QUALIFICATION:
There is no legal requirement to perform a design qualification and to check the design documents of a technical system to ensure that they fulfill the user requirements.
2)INSTALLATION QUALIFICATION:
An IQ evaluation establishes confidence that the equipment is
properly installed .
The installation must meet the manufacturers specified
guidelines along with design changes at installation, also the
supporting electrical utilities must meet all electrical codes.
EQUIPMENT QUALIFICAT
ION
REQUIRED
DOCUMENTS
UTILITIES
MAJOR COMPONENT
S
COMPONENT MATERIAL
LUBRICANTS
EQUIPMENT SAFETY FEATURES
MANNUAL DRAWINGS
SOPS
VOLTS(460)
AMPS(20)
DRIVE&
AUGERMOTORS
IQ ELEMENTS OF A COLLOID MILL
EQUIPMENT IDENTIFICATION:Record the equipment identification numbers along with the following order
REQUIRED INFORMATION:
Purchase order 009235 Model number DAS60Serial number 78801Equipment number 6492Location Room 270(this equipment is portable)
• REQUIRED DOCUMMENTS:• Record the equipment manufacturers operation
and maintenance manual and maintenance manual and draw a table.
• Record the SOPs that cover the setup operation cleaning of the mill.
• EQUIPMENT UTILITY REQUIREMENTS:
utility specified
Measured result
acceptable
Volts Drive motor
460±10%
A-B455;A-C457
Yes
amperes Drive motorAuger motor
11
1.17
B-C456
20 circuit rotations
yes
MAJOR COMPONENTS:The component specifications of the protocol verifies that the mill components purchased were delivered and installed.Record the major components:
MAJOR COMPONENTS
AS FOUND CONDITIONS
Drive motor Manufacturer
Model number-A51QA
Volts-460
Ampers-11
Rpm-3000 to 20,000
Material-stainless steel
Type-conical
Size-2-7/8 in diameter
Phases-3
Clearance between 0.002
To 0.03 inches
COMPONENT MATERIAL:mainly high strength, low corrosion materials are used for construction of colloid mill
Component material
Mill chambers 316 stainless steel
Rotor 316 stainless steel
Auger feed Stainless steel
stator 316 stainless steel
EQUIPMENT OPERATION:The objective of the rotation direction test is to verify that the rotor blades and the auger feed rotate in the proper direction.The following tests will be performed with the colloidal mill empty.Record the results in the table.
LUBRICANTS:Lubricants are used to increase the smoothness of the mill and to increase the life span of colloid mill.Mainly oil ,grease type of lubricants are used
Where to be used
type manufacturers
Product contact
Gear box Amolitb#2 oil No
Pillow block bearing and casters
Lubriplate 630-2 grease
No
Safety features test procedureTest function Expected results Acceptable
Safety interlock switch operations
When the mill and auger feed push buttons are pressed ,the miller and auger motors will not start with the throat removal
When the mill and auger feed push buttons are pressed , the mill and auger motors will not start with the safety guide removed
Yes
yes
EQUIPMENT CONTROL FUNCTIONS:The objective of testing equipment control functions in verify that the switches and push buttons on the mill operate as per the manufacturer specifications.
TEST FUNCTIONS EXPECTED RESULTS ACCEPTABLE
Mill start push button operation
The mill motor starts and the green light goes on
Yes
Mill stop push button operation
The mill motor stops and the green light goes off
Yes
Auger feed start push button operation
Auger feed motor starts and the green light goes on
Yes
Auger feed stop push button operation
Auger feed motor stops and the green light goes off
Yes
Auger feed control dial operation
Rotated from 0 to 6 & 6to0 ,the auger speed increases & decreases
Yes
Disconnect handle operation
Yes
O.Q elements in a colloidal mill
Colloid mill
Calibration requirements
Equipment control functions
Switches and push buttons
Equipment operations
Equipment rotation
directions
Motor directio
n
Auger feed
direction
Rotor blades1000 rpm.,2450 &4600
rpm
Motor fixed speed mill empty
Rotor blades
Auger feed21
rpm,208rpm
CALIBRATION REQUIREMENTS:Verify that all critical instruments on the equipment have been logged into the calibration system,record all information for the calibrated instruments used to control the mill in table
Calibrated and non calibrated instruments
Identification no.TypeManufacturerModel no.Serial no.RangeScale divisionLocationUseCalibration due dateCritical or non critical
AM-1463AMMETERAny gauge co.5449Not specified0-20AA0.5AMounted on the control panelMonitors the drive motorCalibration not required Not critical to be operation of the mill
There was no calibrated instruments on the blender non calibrated instruments as found conditions
Rotor and auger rotation test procedure
element Expected result
Result Acceptable
Rotor direction
The rotor should rotate in the same direction as the incoming product from the auger feed and the mill direction arrow
The rotor rotate in the same direction
Yes
Auger Feed direction
The auger feed should rotate in the same direction as the mill direction arrows
The auger feed rotating in the same direction
yes
Rotor blade test resultsSpecification(rpm±10%)
Rotor fly wheel pulley setting
Drive motor pulley settings
Measured speed(rpm)
Acceptable
100024504600
LargesmallSmall
SmallMediumlarge
102825804747
YesYesyes
Auger feed test resultsAuger feed speed control dial settings
Speed specialization (rpm±10%)
Measure speed(rpm)
acceptable
06
21208
21211
Yesyes
Instrument used
Test instrument Identification no. Calibration due date
Tachometer 64020
Colloidal mill operation
Motors fixed speed
Rotor blades(1000 rpm,2450 rpm,4600 rpm)
Auger feed(21 rpm,208 rpm)
Reduce granulation size
Milling medium sieve no
PQ ELEMENTS OF A COLLOIDAL MILL
Mill operation:The mill operation test is designed to document the performance of the colloidal mill using placebo granulation.The placebo is used for maximum loading conditions, this test is also design to verify the colloid mill can reduce the size of granules.The materials & instruments required for this test are a placebo , sieve , pan, scale & tachometer.Weigh the granulation in the sieve & pan before & after milling to verify the reduction in particle size.MILL PERFORMANCE TEST PROCEDURE:
Equipment
Granulating weight before milling
Granulation and weight after milling
Acceptable
Sieve 262g 0g Yes
pan 738g 1000g Yes
•Test materials & conditions:
item Specifications
Lactose hydrate 1kg
sieve 80 mesh size
Measure the speed of the rotor with a tachometer
Rotor speed specification=1000rpm±10%(±100)
Rotor speed specifications=2450±10%(±460)
Auger feed speed specifications =21rpm±10%(±2.1)
Auger feed speed specifications=208rpm±10%(±20.8)
Instruments usedTest instrument Identification
numberCalibration due date
1)Scale PE600
2)Stopwatch 54039
3)Tachometer 64020
conclusion
•Validation of equipments is done for the safety of the operators ,to minimize the errors in manufacturing products
•All this protocol of validation is to design by the quality control dept. in the industry
THANK YOU