1.0 OBJECTIVE:
To
lay down the procedure for cleaning of Dissolution apparatus.
2.0 SCOPE:
This
shall be applicable to the Dissolution
apparatus of Quality Control Instrument Lab.
3.0 RESPONSIBILITY:
3.1
Technical
Assistant/ Helper.
3.2
Q.C Analyst.
4.0 ACCOUNTABILITY:
4.1
Manager-Quality
Control.
5.0 MATERIAL AND
EQUIPMENT:
5.1
Disintegration apparatus.
5.2
Detergent.
5.3
Lint free cloth.
5.4
Waste bucket.
5.5
Purified water.
6.0 PROCEDURE:
6.1
Lift the stirrer
unit by UP ( ) key.
6.2
Switch “OFF” the instrument.
6.3
Switch “OFF” the
main power supply.
6.4
For
cleaning of Dissolution apparatus:
6.4.1
Frequency:
After
completion of every dissolution test.
6.4.2
Remove the bowl
from its place and discard the medium of each bowl. Wash each bowl properly
with purified water then keep it inside the dissolution bath number wise.
6.4.3
Remove the basket/
paddle apparatus from the dissolution apparatus. Wash them with purified water
and dry with tissue paper and keep at proper place.
6.4.4
Keep the record in
the instrument log card.
6.5
For
cleaning of water bath of Dissolution apparatus:
6.5.1
Frequency:
Once
in a week, if necessary.
6.5.2
Remove all the
bowls from water bath.
6.5.3
Remove the
baskets/ paddle apparatus from the stirrer unit.
6.5.4
Remove the
circulating pipe which is provided at right rear side of water bath (inlet).
6.5.5
Start the
circulating pump from the option menu and drain the dirty water in wastage water
bucket.
6.5.6
Insert the
circulating pipe in its proper place.
6.5.7
Wash the bath with
purified water, detergent solution and purified water sequentially, until no
foam of detergent remains in the bath. After complete removal of the detergent,
wash the bath finally with purified water.
6.5.8
Fill the bath with
purified water up to level mark.
6.5.9
Record it as per
Annexure-1.
6.5.10
Affix the “CLEANED” label and fill the “Cleaning Equipment Log Book”.
6.6
Precautions:
6.6.1
Do not use
abrasive materials to clean the instrument.
6.6.2
Do not bend the
heater while cleaning the water bath.
7.0 REVISION LOG:
Revision No.
|
Effective Date
|
Reason
|
00
|
|
New
SOP
|
8.0 REFERENCES:
8.1 Not Applicable.
9.0 ANNEXURES:
Annexure 1: Cleaning
record for dissolution apparatus water bath (Cleaning Equipment Log Book).
Annexure:
1
(Cleaning
Equipment Log Book)
Cleaning
record for dissolution apparatus water bath.
Name
of the instrument: _________________________
Make:
__________________
Model
No.: ______________
Identification:
__________________
|
10.0
ABBREVIATIONS:
Abbreviation
|
Expanded Form
|
SOP
|
Standard operating
procedure
|
&
|
And
|
No.
|
Number
|
Ltd.
|
Limited
|
QCEC
|
Quality control equipment
cleaning
|
Q.C
|
Quality control
|
F
|
Format
|
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