SOP for Magnetic Stirrer in Pharmaceutical

1.0 Purpose: To describe the procedure for cleaning, sterilization, and operation of a Magnetic Stirrer.
2.0 Aim: This Standard Operating Procedure is applicable for cleaning, sterilization, and operation of the Magnetic Stirrer.
3.0 Responsibility:
3.1 The line coordinator shall be responsible to carry out the procedure as per SOP.
3.2 In-Charge/ Officer shall be responsible for checking and compliance with instructions and activities as mentioned in this SOP.
3.3 Head Production shall be responsible for overall compliance with this SOP.
3.4 Head- QA shall be the authorizing authority of this SOP.
4.0 Safety considerations:
4.1 Wear safety equipment (goggles, gloves, and nose mask) while handling the hot WFI.

5.0 Procedure for Magnetic Stirrer:
5.1 Pre-checks before starting the system:-
5.1.1 Compress air supply should be available at 6 bar pressure.
5.1.2 Pure steam should be available at the required pressure and temperature.

5.2 Cleaning:
5.2.1 Take the vessel to the wash area.
5.2.2 Fill the vessel completely up to the top with 1N NaOH solution and keep it as such for 30 minutes and then drain the solution completely from the vessel.
5.2.3 Fill the vessel completely up to the top with hot WFI and drain it after 15 to 20 minutes.
5.2.4 Remove the head plate of ruttens vessel and clean the head plate with hot WFI and place it again as such.
5.2.5 Continuously add WFI with pressure from the side of the neck in a circular motion and drain the WFI when it is filled completely.
5.2.6 Fill again WFI with pressure into the vessel and drain completely.
5.2.7 Send rinse sample of the vessel to QC for testing of pH, conductivity, TOC, endotoxin, and previous product residues along with the Test Request Form.
5.2.8 Drain water completely from the vessel by applying filtered compressed air into the vessel.
5.2.9 Apply 0.5 kg pressure to the vessel and put it on hold for 60 minutes if the pressure withstands for the time period then it is ok the acceptance limit for the leakage is 0.1 bar.
5.2.10 If the vessel is not sterilized within 48 hours of the cleaning follow the washing procedure again with hot WFI.

5.3 Sterilization:
5.3.1 After completion of cleaning load the ruttens vessel into the autoclave chamber.
5.3.2 Start the sterilization cycle as per “dry heat sterilization” SOP.
5.3.3 After completion of the cycle unload the sterilized vessel in the buffer zone.
5.3.4 Keep the sterilized vessel under LAF.
5.3.5 Connection for SIP of the compress air filter on the SIP unit and sampling port of the vessel, SIP of the compress air filter of the SIP unit, and SIP of sampling port of a vessel.
5.3.6 Open the manual valve of the sampling port of the vessel.
5.3.7 Press the ‘START’ button on the SIP unit to start the SIP of the sampling port of the vessel.
5.3.8 After sterilization holds complete, cooling starts.
5.3.9 When the cooling temperature reaches nearly 40 °C then place the vessel under LAF disconnect the hose pipe and connect a sterilized vent filter with the help of a nozzle aseptically and close the manual valve of the sampling port of the vessel simultaneously.
5.3.10 Press the ‘STOP’ button to stop the process of SIP on the SIP unit.

Related: SOP for operation and calibration of autoclave

5.4 Operation for Magnetic Stirrer:
5.4.1 Assembly of magnetic agitator:
5.4.1.1 Components Rutten Magnetic Agitator :

1. Double magnetic stir-bar.
2. Outer bearing (SiC)
3. Inner bearing (SiC)
4. Disk plate
5. Stirrer cap
6. Elastic pin
7. PTFE buffer

5.4.1.2 Check the integrity of all parts to be mounted and the harvesting tube.
5.4.1.3 Assemble together the double magnetic stir-bar (1), the PTFE buffer (7), the outer bearing SiC (2), the inner bearing SiC (3), and the disk plate (4).
5.4.1.4 Take care when sliding the outer bearing SiC (2) over the inner bearing SiC (3). It must slide easily without stress avoiding damaging the SiC parts.
5.4.1.5 Pull over the stirrer cap (5).
5.4.1.6 Slide the above-mentioned assembly onto the harvesting tube and push it in the direction of the cover plate until the hole for the split pin (6) has been surpassed.
5.4.1.7 Introduce the split pin (5) in its hole being sure that it is properly blocked.
5.4.1.8 Turn the magnetic stir-bar until the ribbing on the disk plate (4) fits together with the slot on the lower face of the inner bearing SiC (3).
5.4.1.9 Fit the head plate with the mounted Rutten magnetic agitator on the rutten vessel and tighten it.
5.4.1.10 To avoid damage to the SiC bearings and scratches, do not touch during this operation the vessel with the rutten magnetic agitator.
5.4.2 Operation:-
5.4.2.1 Never run the Rutten magnetic agitator dry to avoid total damage to the SiC bearings. A small amount of liquid is sufficient to lubricate the bearings.
5.4.2.2 The head plate is properly fixed with a torque wrench. A wiggling harvesting tube can block the rutten magnetic agitator and allow vapor out of Rutten’s vessel.
5.4.2.3 Center the Rutten vessel exactly on the rutten magnetic drive HD-033 to provide maximum magnetic transmission.
5.4.2.4 Stop the rutten magnetic drive HD-033 when the magnetic stirrer is blocked, a noise can be heard.

5.4.3 Disassembling of magnetic agitator for cleaning:
5.4.3.1 Release overpressure in the vessel first and check by reading the installed pressure gauge.
5.4.3.2 Remove the head plate with the harvesting tube and installed rutten magnetic agitator carefully to avoid damaging SiC slide bearings.
5.4.3.3 Remove the split pin (5) from its hole.
5.4.3.4 Remove the disk plate (4).
5.4.3.5 Slides off together the double-magnetic stir-bar (1), the PTFE buffer (7), the outer bearing SiC (2), and the inner bearing SiC (3) from the harvesting tube.
5.4.3.6 Remove the double-magnetic stir bar (1) and the PTFE buffer (7) carefully.
5.4.3.7 Disassemble the outer bearing SiC (2) by simultaneously sliding and rotating the Inner bearing SiC (3) very carefully.
5.4.3.8 Take care when sliding off the Outer bearing Sic (2) from the Inner bearing SiC (3). It must slide easily without stress avoiding damaging the SiC parts.
5.4.4 Operation of Magnetic Drive
5.4.4.1 Magnetic Drive HD 033 –
The magnetic drive HD 033 is specially designed for stirring fluids in sterile vessels. The housing is made from stainless steel 1.4301 (AISI 304) and has ingress protection (lP55) against contaminants from any direction.
5.4.4.2 Rear Panel of Magnetic drive –
5.4.4.2.1 Located on the drive’s rear panel are the power supply cable, main power switch, fuse, and several supplementary connectors.
5.4.4.2.2 The ON and OFF positions of the main power switch are vertical and horizontal, respectively.
5.4.4.2.3 The TERMINAL connector on the right side connects to the operation terminal to control the drive.
5.4.4.2.4 The I/O connector allows operation by an external process control system or supervision by a line recorder via the 4- 2OmA output.
5.4.4.2.5 The CAN connection is a serial bus system to control several CAN units via a computer or process-control system.
5.4.4.3 Operating Terminal –
The terminal is used to configure the operating parameters, switch the drive ON and OFF, set the RPM, and control the drive with a timer. The graphic display indicates the actual RPM and the current parameter settings.
5.4.4.4 Terminal Controls –
5.4.4.4.1 Manual Operation of Magnetic Drive –
5.4.4.4.2 Press the RUN/STOP key to start the drive. RUNT/STOP will increase to the indicated set RPM.
5.4.4.4.3 The ramp-up and ramp-down values (RPM/Second) are set in the SETUP- menu.
5.4.4.4.4 The set RPM (nominal RPM) is adjusted by pressing A V-keys.
5.4.4.4.5 The RUN-LED when the drive is running. When pressing RUN/STOP again, the system decreases the RPM to zero.
5.4.4.4.6 During ramp-down, the RUN-LED flashes to indicate that the drive is still running and decreasing RPM.
5.4.4.4.7 The RUN-LED turns off upon reaching zero RPM.
5.4.4.6 Timer Operation –
5.4.4.6.1 To operate the drive in the timer mode, press the TIMER key and then the A V-keys to set the appropriate time. The time will increase in 15-minute increments. If the timer is set to more than 4 hours, the time will increase in 1-hour increments. The maximum time value is 99 hours.
5.4.4.6.2 To exit the timer input, press the TIMER key again.
5.4.4.6.3 The timer is only running when the drive is running.
5.4.4.6.4 When the timer shows a time higher than zero and the drive has been stopped, the TIMER-LED is flashing to indicate that also the timer has been stopped.
5.4.4.6.5 when starting the drive, the TIMER-LED illuminates to indicate that the timer is running.
5.4.4.6.6 The time will be stored every 15 minutes in the local EEPROM memory. In case of a power loss, the timer will continue from the last stored time.
5.4.4.6.7 To switch off a running timer, press the TIMER key and decrease the time to zero. Exit by pressing the TIMER key.
5.4.5 pH Calibration
5.4.6 Jumo data downloading

6.0 Abbreviations:
HOD: Head of the department
ID No. : Identification Number
QA: Quality assurance
Rev.: Revision
SOP: Standard operating procedure
WFI: Water for injection
PTFE: Polytetrafluoroethylene

Annexure-1: Magnetic Stirrer