Pure Steam, Purpose:
Pure Steam, The purpose of this SOP is to define the Operation of Pure Steam Generation System manufactured by Watertown in order to ensure its smooth & trouble-free operation and generation of qualified pure steam.
Pure Steam, Scope:
This Standard Operating Procedure applies to the pure steam generation system manufactured by Watertown, which is located at the Utility area (roof top) of Sterile block of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]PS: Pure steam.
Responsibilities:
[][]The roles and responsibilities are as follows:
Engineering (Validation) Department
[][]Preparing the SOP and revise it when necessary.
Engineering (Maintenance) Department
[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.
Operators
[][]To operate the system according to the SOP.
[][]To fill up the logbook.
Head of Engineering
[][]To ensure that the operation of PW plant are done properly.
Head of Quality Assurance
[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.
Procedure:
Precautions:
[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]The tank walls are hot. The water in the tank is at 80°C when the unit is operating. Contact with 80°C water will cause burning.
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.
System Description:
[][]Pure steam is generated by heating the purified water. In this plant it is generated during the production of Water For Injection.
[][]So, the main control panel for WFI Generation system and PS is same. Purified water is converted to pure steam by exchanging the heat with the industrial steam in the heat exchanger.
[][]Then, the pure steam is supplied to the user point by opening the pneumatic valve PBV501. The capacity of steam generation is 250 Kg/hr.
Operating Procedure:
Starting of Pure steam generation:
[][]Switch on the main breaker to supply electrical power of the plant.
[][]Open the industrial steam inlet valve such that the pressure is within 3-4 bar.
[][]Ensure compressed air and other utilities to run the plant.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Then starting page will appear and press on HMI.
[][]Press Start on that screen
[][]Press User key. After that following screen will appear
[][]Press the “Parameter setting**” button to set the parameters. Following screen will appear:
[][]Give user ID and Password and press OK.
[][]Then the parameter setting screen will appear.
[][]Press on any reading (yellow marked) to change the value if required.
[][]Then press flow chart status on Figure V.
[][]Screen of WFI/PS generation flow chart will appear.
[][]Press the Auto On button to operate the plant automatically.
[][]Open the pneumatic valve PBV501 when the temperature of pure steam reaches the required temperature limit.
During operation:
[][]Check PS temperature.
[][]Check Pure Steam pressure.
[][]Check that there is no unusual noise or vibration. Stop and investigate if it is found.
[][]The Operational Log Sheet (Annexure – I) of PS generation will be filled up by the operator on hourly basis.
Stopping procedure:
[][]Close the PS valve (PBV501).
[][]Press the Auto Off to stop the plant.
[][]Then switch the power off by turning the circuit breaker to off position.
[][]Close the industrial steam inlet valve.
Annexure:
Annexure – I: Operational Log Sheet of pure steam generation system.