1.0 Purpose
1.1 To ensure a standard procedure for operation, proper cleaning and appropriate use of Paste Preparation Vessel.
2.0 Scope
1.2 This procedure is applicable for Paste Preparation Vessel 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
BMR :
Batch Manufacturing Record
5.0 Materials and Equipment
5.1 Tap water
5.2 Purified Water
5.3 Nylon
scrubber
5.4 Clean lint free cloth
5.5 Isopropyl Alcohol.
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.
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
Take purified water in
the vessel as mentioned in the BMR.
7.1.4
Prepare starch slurry
using purified water as per BMR in another container.
7.1.5
Main power switch “On”,
then main switch “On” from the Panel Board.
7.1.6
Put `ON’ the Heater and
set the temperature as per BMR and put `On’ the stirrer motor.
7.1.7
Take the hot water in
SS bucket to dissolve the binding materials (except starch slurry) as per BMR.
7.1.8
As soon as water starts
boiling add the prepared starch slurry then dissolved binding solution in it,
so as to make translucent paste.
7.1.9
After completed the
paste preparation, put `OFF’ the stirrer motor.
7.1.10
Bring the stirrer in
parallel plane with the vessel.
7.1.11
Rotate the side rotary
knob in clockwise direction to tilt the vessel so as to unload the paste in the
container placed below the discharge outlet.
7.1.12
Remove any remaining
material from the vessel using SS spatula.
7.1.13
Rotate the side rotary
knob in anticlockwise direction so as to bring the vessel in normal position.
7.1.14
Affix ‘To be cleaned’
label on the equipment after completion of the operation.
7.2
Cleaning
7.2.1
After completion the
operation, Switch OFF the machine and main switch.
7.2.2
Open the lid cover and
remove all adhered material from the vessel with the help of spatula.
7.2.3
Pour potable water into
the Vessel (1/3 of its volume) and closed the lid cover.
7.2.4
Turn on power switch
and run for 5 minutes. Then turn off the power switch.
7.2.5
Collect the waste water
into the tub.
7.2.6 Rub the inner part,
inner and outer surface of Paste Preparation Vessel with Sodium Lauryl Sulphate
0.4% solution using nylon scrubber.
7.2.7
Wash the Paste
Preparation Vessel and lid cover with portable / tap water to remove cleaning
agent.
7.2.8
Finally rinse with
purified water.
7.2.9 Wipe the surface of the
Paste Preparation Vessel and lid cover with dry clean lint free cloth to remove
the water.
7.2.10
Wipe the Paste
Preparation Vessel and lid cover with lint free cloth soaked in 70% IPA
(Isopropyl Alcohol).
7.2.11
Machine operator /
worker will request Production Officer and QA Officer for checking visual
inspection.
7.2.12
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.
7.2.13
Record in Machine Logbook
(Annexure-I) and affix the label of “Cleaned” in the machine.
7.2.14 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.
