Total Pharmaceutical Solution

Operation and cleaning of sartorius water purification system

1.0 PURPOSE:

To lay down a procedure for Operation and cleaning of Sartorius Water Purification System.

2.0 SCOPE:

This procedure covers the operation and cleaning of Sartorius Water Purification System used in Quality Control department at (Company name).

3.0 DEFINITIONS:

Nil.

4.0 RESPONSIBILITY:

4.1 Analyst is responsible for operation and cleaning of Sartorius Water Purification System as per the SOP of the instrument.
4.2 Head-QC is responsible for ensuring compliance to SOP. 

5.0 PROCEDURE:

5.1 Precautions:
5.1.1 During holidays keep the system switched ON.
5.1.2 An unrestricted gravity fall of concentrate to the floor drain must be ensured.
5.1.3 General cleaning and maintenance.
5.1.4 De-dust the equipment daily externally with a clean dry cloth.
5.1.5 Drain the water from the tank once in a month and allow it to dry.
5.2 Operating Procedure:
5.2.1 Operation of Sartorius Stedim-Arium 61316 model (RO system):
5.2.1.1 Connect the equipment to main power supply and Switch ON the equipment.
5.2.1.2 Ensure that the potable water valve is in open position for the water to flow in to the system.
5.2.1.3 Ensure that there are no leaks at all connections.
5.2.1.4 Wait till initialization. Once the initialization is complete, water starts collecting to the tank.
5.2.1.5 If the quantity of water in the tank is less system automatically starts and tank will be filled.
5.2.1.6 System can be operated manually by pressing Operate Key system switch OFF after the tank is filled.
5.2.2 Operation of Sartorius Stedim-Arium PRO-VF:
5.2.2.1 Connect the equipment to main power supply and Switch ON the equipment.
5.2.2.2 Ensure that the potable water valve is in open position for the water to flow in to the system.
5.2.2.3 Ensure that there are no leaks at all connections.
5.2.2.4 Press start key to collect water the collection of water can be done either time based or volume based depending upon the need select.
5.3 Performance verification:
5.3.1.1 Collect the sample once in a week from the Stedim-Arium PRO-VF water system.
5.3.1.2 Analyze the samples for Description, pH, Conductivity and TOC.
5.3.1.3 Acceptance criteria:
pH: 5.0 to 7.0
Conductivity: Not more than 1.3 µS/cm.
TOC: Not more than 500 ppb

6.0 ABBREVIATIONS:

SOP : Standard Operating Procedure.
TOC : Total Organic Carbon
Ppb : parts per billion

7.0 REFERENCES:

Nil.

8.0 LIST OF ANNEXURES:

Nil.

Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top