1.0 Purpose
1.1 To define a standard cleaning and operation procedure of Octagonal Blender.
2.0 Scope
2.1 This procedure is applicable for Octagonal Blender of Tablet 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 Purified water
5.4 Hand brush / Nylon brush
5.5 Clean lint free cloth
5.6 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.
5.7 70 % Isopropyl Alcohol.
6.0 Precaution / Health and Safety Considerations
6.1 Check the electric connection before operation.
6.2 Cover the control panel, air control box and adjacent machine switch board with the poly bag.
6.3 Ensure the butterfly valve are close in position during operation.
7.0 Procedure
7.1
Cleaning
7.1.1
After completion the
operation, Switch OFF the machine and main switch.
7.1.2
Open the lid cover and
remove the dust/ powder of the previous product from the inner and outer
surface of the octagonal blender.
7.1.3
Pour potable water into
the blender (1/3 of its volume) and closed the lid cover.
7.1.4
Turn on power switch
and run the blender for 5 minutes.
7.1.5
Place a tub just below
the butterfly valve to collect washing water.
7.1.6
Open the butterfly valve
to collect water into the tub.
7.1.7
Rub the inner part,
inner and outer surface of octagonal blender with Sodium Lauryl Sulphate 0.4%
solution (if require).
7.1.8
Wash the Octagonal
blender and lid cover with Sodium Lauryl Sulphate 0.4% solution then wash with
portable / tap water to remove cleaning agent.
7.1.9
Finally rinse with
purified water.
7.1.10
Wipe the surface of the
octagonal blender with dry clean lint free cloth to remove the water.
7.1.11
Dry the octagonal
blender compressed air to remove water deposited on the different junction.
7.1.12
Wipe the octagonal
blender of the container and sieve with lint free cloth soaked in 70% IPA
(Isopropyl Alcohol) thus surface water evaporates quickly.
7.1.13
Machine operator /
worker will request Production Officer and QA Officer for checking visual
inspection.
7.1.14
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.
7.1.15
Record in Machine Logbook
(Annexure-I) and affix the label of “Cleaned” in the machine.
7.1.16
After cleaning the
machine if it remains without operation for next 72 hour, will undergo
Re-cleaning operation.
7.2
Operation
7.2.1
Production person shall
ensure the cleanliness of the machine.
7.2.2
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.
7.2.3
Check the butterfly
valve are close in position
7.2.4
Place the material into
octagonal blender and close the lid cover.
7.2.5
Close the safety guard.
7.2.6
At first “ON” the main
switch board.
7.2.7
Fix parameter according
to BMR.
7.2.8
Press start button.
7.2.9
After complete of
operation press stop button and discharge material.
7.2.10
Affix “To be Cleaned”
label & fill the “Machine Logbook”.
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 operator and worker.