1.0 Purpose
1.1 To define a standard operation and cleaning procedure of Vibro Sifter.
2.0 Scope
2.1 This procedure is applicable for Vibro Sifter of Solid Manufacturing area at “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1. Only concern operator is responsible for normal operation. He/ She inform the supervisor about any deviation from normal operation. He also maintains logbook.
3.2. Sr. Officer- Production/Officer- Production is responsible for monitoring day to day activity.
3.3 Production and Quality Assurance Officer shall ensure that the procedure is implemented properly.
4.0 Abbreviations and Definitions
4.1 BMR : Batch Manufacturing Record
5.0 Materials and Equipment
5.1 Polybag
5.2 Tap water
5.3 Hot water (60⁰ c)
5.4 Purified water
5.5 Hand brush / Nylon brush
5.6 Clean lint free cloth
5.7 Detergent Solution / Cleaning agent : 0.4% (w/v) Sodium Lauryl Sulphate solution ; 4 gm Sodium lauryl Sulphate is dissolved in 1.0 liter of portable / tap water to prepare detergent solution.
5.8 70 % Isopropyl Alcohol.
6.0 Precaution / Health and Safety Considerations
6.1 Use mask, hand gloves and goggle’s during operation.
6.2 Check the electric connection before operation.
6.3 Never clean or work in a running machine or any moving parts.
7.0 Procedure
7.1 Operation
7.1.1 Production person shall ensure the cleanliness of the machine.
7.1.2
Check the cleanliness
of the gasket intermediate ring feet at between two gasket clipart Copper and
other contact parts of the machine.
7.1.3 Before starting the
operation production person get the line clearance from QA person and affix the
status label with Product Name, batch
details to equipment.
7.1.4
Set the lower gasket no
hopper.
7.1.5
Fit the intermediate
ring with lower gasket.
7.1.6
Set the upper gasket on
intermediate ring.
7.1.7
Set the desire mesh (as
per mentioned in the Batch Manufacturing Record) on the upper gasket.
7.1.8
Fit the mesh with
barrier ring.
7.1.9
Tighten the above
setting with clipper.
7.1.10
Plugged the switch into the socket to start
operation.
7.1.11
Place a drum with double lined polybag before
discharge chute opening to keep powder, granules.
7.1.12
Transfer powder or
granules on the mesh and rub the powder or granules by hand.
7.1.13
Collect the powder or
granules into the drum.
7.1.14
After completion of
operation affixed “To Be Cleaned” Label and record in Machine Logbook.
(Annexure-I)
7.2
Cleaning
7.2.1
Disconnect the power by
pulling out the industrial socket.
7.2.2
Dismantle gaskets,
intermediate ring fitted between two gaskets, clippers, hopper mesh and barrier
ring.
7.2.3
Remove residual powder
from the gaskets, hopper, mesh and barrier ring by vacuum suction device.
7.2.4
Wet rest of the powder
adhered with the gaskets, rings, clippers hopper, and mesh by the wet lint free
duster soaked in portable water.
7.2.5
Keep the gaskets,
rings, clippers mesh in a polybag and cover the motor of the Sifter by the
polybag and take it in washing room.
7.2.6
Wash the gaskets, rings
and clippers with portable water thoroughly. Clean mesh as per cleaning SOP of
mesh.
7.2.7
Spray hot water on
rings, clippers and hopper in such a way that no residue of previous product
remains.
7.2.8
Rub the surface of the rings, gaskets,
clippers and hopper with nylon brush soaked in 0.4 % sodium lauryl sulphate solution.
7.2.9
Wash the gaskets, rings
and clippers with potable water that no residue of sodium Lauryl Sulphate
solution remains. Finally rinse with purified water.
7.2.10
Wipe the surface of the
rings, clippers and gaskets with dry cleaned lint free duster to remove the
water and then 70% IPA (Isopropyl Alcohol) solution to remove surface water.
7.2.11
Rub the wheel, main frame and other parts with
clean cotton duster soaked in potable water.
7.2.12
Rub the wheel mainframe
and other parts with clean cotton duster soaked in 0.4% sodium Lauryl Sulphate
solution that no residue of a previous product remains.
7.2.13
Wipe off all the parts
with 70 % v/v solution of Isopropyl Alcohol (IPA) and allow drying.
7.2.14
Machine operator /
worker will request Production Officer and QA Officer for checking visual
inspection.
7.2.15
At first Production
Officer will check the machine and its surroundings, then QA Officer will check
the machine and its surroundings. If it found satisfactory result, then he /
she will issue “Cleaned” label.
7.2.16
Record in Machine
logbook and affix the label of “Cleaned” in the machine.
7.2.17
Keep the gaskets, mesh,
clippers and rings in a polybag and take those in clean equipment room with a
“CLEANED” label mentioning a previous product Name, batch number, cleaned by
and checked by.
7.2.18
After cleaning the
machine if it remains without operation for next 72 hour, will undergo
Re-cleaning operation.
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 Annexure-
I : Format of Machine Logbook
10.0 Revision History
|
Revision
No. |
Brief reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
|
02 |
|
|
|
11.0 Training
11.1 Head
of Production or his nominee give the training of Production Officer operator and
worker.
