Cleaning & Assembling of Membrane Filter Assembly and Accessories
1. Purpose:-
1.1. This
procedure is developed to clean & install Membrane Filter Assembly.
2. Scope:-
2.1.
This procedure is applicable for the cleaning and assembling
of Membrane Filter Assembly & other accessories in sterile section.
3. HSE Statement:-
3.1.
Follow the following instructions to perform subjected
job in safe manners.
§
Personal protective equipment necessary for safe
use of the equipment,
§
Only trained and knowledgeable persons perform subjected
job.
§
All work is performed in accordance with
applicable regulatory requirements.
§
Report any job related injuries or illnesses,
questions on health and safety, or any unsafe or unhealthy working conditions
to supervisor.
4. Responsibilities:- |
Ø
Lab
Attendant is responsible to conduct assigned tasks in safe manners and report
to supervisor in case of any problem.
5. Materials:- |
i.
Membrane Filter Assembly
6. Definition:- |
6.1. Cleaning
§
Cleaning is the process which is use to free the
object from marks, pollutants and any remaining residues of previous batch.
6.2. Assembling
§
To fit the parts or pieces of machine together
for a common purpose.
6.3. Membrane Filter Assembly:
§ Equipment which is used for filtration of liquids by membrane filter
is known as Membrane Filter Assembly.
1.2. Accessory:
§ A thing which can be added to something else in order to make
it more useful and versatile.
7. Flow Chart:- |
|
Chapter
No.
|
Process
Flow Chart
|
Description
|
Responsibilities
|
|
8.1
8.2
|
Perform Cleaning of
Membrane Filter Assembly
Perform Assembling
of Membrane Filter Assembly for Sterilization
|
§
Cleaning Procedure:
§
Assembling for Sterilization
§
Precautions:-
|
§ Lab Assistant
|
8. Description:-
8.1. Cleaning Procedure:
8.1.1.
Disassemble the Membrane filter holder immediately
after use.
8.1.2.
Dismantle all the components i.e. Top Plate, Base
Plate, Gasket, Support Screen, Nozzles, Air bleed valve and its holder and wash
with hot Water For Injection three
times.
8.1.3.
While cleaning the inlet and outlet Nozzles, Gasket
recesses Orifices, Membrane Support Screen and Air Bleed Valve, use a clean
Sponge or lint free duster for Scrubbing and for cleaning the inside of nozzles
use lint free duster.
8.1.4. Check all the parts carefully for cleanliness and
finally rinse all parts with hot water for injection.
8.1.5.
Dry all the components with filtered compressed air.
8.2. Assembling for Sterilization
8.2.1.
Check that the unit parts are completely dry before
assembling.
8.2.2.
Press the Teflon / Neoprene Gasket firmly into place in
the top plate groove and underside of the filter support screen.
8.2.3.
Wrap the exposed nozzle of the inlet hose adopter and
outlet connector with Aluminum Foil paper.
8.2.4.
Install the
adopter and tighten carefully.
8.2.5.
Wrap the bottom nozzle of the vent valve with Aluminum
Foil.
8.2.6.
Position the under drain screen and filter support
screen in the recess of the bottom plate.
8.2.7.
Place the top plate into position and tighten the
locking wheels uniformly.
8.2.8.
Wrap the inlet and outlet nozzles of the filter holder
by using Aluminum Foil or butter paper.
8.3. Precautions:-
8.3.1.
Do not install membrane filter in membrane filter
assembly during sterilization in PVS.
8.3.2.
Every time, use new membrane filter for filtration.
9. Reference:-
9.1.
NA
10.
Distribution:-
|
Sr. #
|
Distributed
to
|
Received
(Current)
|
Returned
(Obsolete)
|
|
01
|
Quality Control Department
|
|
|
|
02
|
Quality Assurance Department
|
|
|
|
03
|
Quality Management Department
|
|
|
11.
Revision
History:-
Date Changes
N/A