SOP For Design Qualification of Colloid Mill
Pharma Editor
March 4, 2017
Validation & Qualification
2,600 Views
SOP For Design Qualification of Colloid Mill
- OBJECTIVE
- To design, engineer, and supply the Colloid Mill and to provide assurance that the machine is manufactured and it comply with the Scope of Supply.
- To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same at utmost transparency.
- The scope of this qualification document is limited to the Design Qualification of Colloid Mill. This qualification document is part of a validation activity for the Colloid Mill.
- SCOPE
- RESPONSIBILITIES
- CLIENT
- To Check and Approve the design qualification.
- MANUFACTURER
- To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
- Machine overview,
- General arrangement drawing,
- Equipment orientation with layout,
- Specifications of the sub-components/ bought out items, and their make, model & quantity, and backup records/ brochures,
- Details of Utilities,
- Material of construction of all components
- To confirm the safe delivery of the equipment to the user site.
- To ensure that no un-authorized and or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.
- To ensure the proper installation and commissioning of the equipment.
- MACHINE DESCRIPTION
- The design of colloid Mills is based on years of experience in wet communition, homogenization, emulsification, dispersion, fluidization mixing etc.
- The principle of Colloid Mill is based on the Stator /Rotor Principle. Stator is ring shaped with two different staggered special design tooth stages and conical shape tuning inside stator with special shape helical tooth system. Initial Rotor Stage is shaped impeller blades as preliminary drum, seizing the material, pre-breaking in and throwing it into the first station tooth stage. Product is fed to the operating area of a Rotor, having a speed of approximately 3000 R.P.M. by specially designed feed device. The product is processed by high shear, pressure and friction between the Stator and Rotor, besides the high shear, beating, collisions, bombarding and friction, the product is exposed to intense vibration which exert their force in it by means of pressing and realizing actions. At last stage of processing product is exposed to be basic oscillating frequency of 6000 Hz. The first upper oscillation of this stage lies with 18000 Hz utmost within the supersonic region, which explains high efficiency. The processed product continuously leaves the mill though the drain pope, if required, it can be recirculated.
- Due to the slightly deviating tapering of the milling surfaces of stator and rotor, the annular gap becomes narrower towards the discharge section. The special design facilitates adjustment of the griding gap be an exterior screw even during operation.
- Control / Electrical Panel
- Operating Control Panel
- The Non Flame proof control panel is made of MS covered with SS cover. It is located on the Machine.
- Control panel contains.
- TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS
Description |
Specification |
1.Equipment Description |
Name |
Colloid Mill |
Make |
|
Model |
CPM CM 3 WJ |
Hooper Capacity |
15 Liters |
Particle Size Reduction |
5-10 micron |
Overall dimensions |
1200 mm(H) X 410 mm(W) X 680 mm(L) |
2.Main Motor |
Type |
TEFC, FLP, 3 Phase induction motor |
Model |
Flange Mounted |
Make |
Crompton Greaves |
RPM |
2850 |
Power Rating |
3 HP / / 415 V / 50Hz / 2.2 KW |
3.Starter |
Type |
SDS – 31403 |
Model |
Flange Mounted |
Power Rating |
3 HP / 415 V |
Make |
PCG |
START / STOP Switch |
01 Nos. Each |
DESCRIPTION
|
SPECIFICATIONS
|
Electrical connection |
To be provided |
COMPONENT DESCRIPTION |
MOC
|
Hopper |
SS 316 |
Circulating pipe with Drain |
SS316 |
Lid(Hopper) |
SS316 |
Rotor |
SS316 |
Stator |
SS316 |
Sr. No. |
Description |
Drawing No. |
1 |
General arrangement drawing of Colloid Mill |
|
- CHANGE CONTROL PROCEDURE
- Change in the agreed design shall be addressed through the well-defined Change control procedure.
- DESIGN QUALIFICATION REPORT
cGMP |
current Good Manufacturing Practices |
GEP |
Good Engineering practices |
MS |
Mild steel |
NFLP |
Non Flame Proof |
SS |
Stainless Steel |
KW |
Kilo Watt |
DQ |
Design Qualification |
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