1.0 Purpose
1.1 To describe the procedure for operation and cleaning of Tablet De-duster
2.0 Scope
1.2 This procedure is applicable for Tablet De-duster of production 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 None
5.0 Materials and Equipment
5.1 Tap water
5.2 Purified Water
5.3 Clean lint free cloth
5.4 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.
5.5 70 % Isopropyl Alcohol.
6.0 Precaution / Health and Safety Considerations
6.1 Don’t touch the moving parts of the machine during operation.
6.2 Wear hand gloves and mask during the operation.
7.0 Procedure
7.1 Operation
7.1.1
Before starting
operation, the operators and the personnel with this operation must ensure that
the
Room is properly
cleaned and all materials of previous product are removed.
7.1.2
Production person get
the line clearance from QA person and affix the status label with Product Name, batch details to
equipment.
7.1.3
Put a container with
polybag at the discharge point of the de-duster.
7.1.4
Switch “On” the main
power supply of the de-duster and then of the compression machine.
7.1.5
Continue the de-dusting
operation till the compression machine is “On”.
7.1.6
After completion of the
compression process, switch “Off” the main power supply of de-duster and ensure
there are no tablets inside it.
7.1.7
Affix ‘To be cleaned’
label on the equipment and record the activity in logbook.
7.2
Cleaning
7.2.1 Cleaning for Batch Change
7.2.1.1 Open perforated plate by uncovering the top cover.
7.2.1.2 Clean the perforated plate, hopper bowl and external surface of the de-duster to the maximum possible extent, using the designated vacuum cleaner.
7.2.2 Cleaning for Product Change
7.2.2.1 Switch “Off” the main power supply.
7.2.2.2 Open perforated plate by uncovering the top cover.
7.2.2.3 Put all the parts like perforated plate, top cover and chute in to the polybag and affix “To Be Cleaned” label on it.
7.2.2.4 Transfer it to the washing area.
7.2.2.5 Clean the perforated plate, hopper bowl and chute with Detergent Solution / Cleaning agent [0.4% (w/v) Sodium Lauryl Sulphate solution] with nylon brush.
7.2.2.6 Then wash with potable water till there is no residue of previous product and cleaning agent.
7.2.2.7 Finally rinse with purified water and dry it with lint free cloth.
7.2.2.8 Wipe the removal parts with cotton cloth dampened with 70% IPA (Isopropyl Alcohol).
7.2.2.9 Clean the outer surface of the de-duster with clean dry lint free cloth.
7.2.3
Machine operator / worker will request
Production Officer and QA Officer for checking visual inspection.
7.2.4
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.
7.2.5
Record in Machine Logbook
(Annexure-I) and affix the label of “Cleaned” in the machine.
7.2.6
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 |
|
|
11.0 Training
11.1 Head
of Production or his nominee give the training of production operator and
worker.
