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



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)
Quality Control Department

Quality Assurance Department 

Quality Management Department

11.            Revision History:-

Date                                        Changes