1.0 OBJECTIVE: To lay down a procedure for handling products during a power failure in the production area.
2.0 SCOPE: This procedure is applicable to the handling of products during a power failure in the production area.
3.0 RESPONSIBILITY:
Officer, Executive – Production Department, Quality Assurance
Manager – Production Department, Quality Assurance
4.0 DEFINITION(S):
NA
5.0 PROCEDURE:
5.1 Action to be taken in granulation area during power failure:
5.1.1 Switch off the ‘’main’’ of the machine.
5.1.2 Cover the in-process material with lid/polybag.
5.1.3 After the resumption of power, the following checks are to be done:
5.1.3.1 Check the temperature and humidity of the area.
5.1.3.2 Check the air differential pressure of the area.
5.1.4 Ensure that the parameters are within the limit.
5.1.5 Switch on the mains of the machines.
5.1.6 Check the time elapsed and required time of FBD for drying, RMG for mixing, and bin blender for blending.
5.1.7 Check and record the environmental conditions in the respective formats.
5.2 Action to be taken in compression area during power failure:
5.2.2 Switch off the ‘’main’’ of the machine.
5.2.3 Unload the in-process granules from the hopper.
5.2.4 Tie the poly bags of in-process granules and compressed tablets container.
5.2.5 After the resumption of power, the following checks are to be done:
5.2.5.1 Check the temperature and humidity of the area.
5.2.5.2 Check the air differential pressure of the area.
5.2.6 Remove the upper punches
5.2.7 Switch ‘on’ the main of the machine.
5.2.9 Check the direction of rotation of the machine in ‘inch’ mode.
5.2.10 Ensure that the parameters are within the limit.
5.2.11 Record the environmental conditions.
5.2.12 Replace the upper punches and discard the initial two rotation tablets.
5.2.13 Check all the in-process parameters as per BMR.
5.2.14 Record the downtime in the equipment usage and cleaning log sheet.
5.3 Action to be taken in coating area during power failure:
5.3.1 Take out the gun assembly from the coating pan.
5.3.2 Switch off the ‘’main’’ of the machine.
5.3.3 Unload the tablets/granules from the coating pan in the double-lined polybag with a proper status label.
5.3.4 After the resumption of power, the following checks are to be done:
5.3.4.1 Check the temperature and humidity of the area.
5.3.4.2 Check the air differential pressure of the area.
5.3.5 Ensure that the parameters are within the limit.
5.3.6 Switch ‘on’ the main of the machine.
5.3.7 After getting all the parameters within the limit, get it certified by QA.
5.3.8 Record the environmental conditions in the respective formats.
5.3.9 Load the tablets into the coating pan and start coating operation as per BMR.
5.4 Action to be taken in Inspection area during power failure:
5.4.1 Switch off the ‘’main’’ of the machine.
5.4.2 Unload the tablets from the hopper in the double-lined polybag with a proper status label.
5.4.3 Remove the tablet from the inspection belt.
5.4.4 After the resumption of power, the following checks are to be done:
5.4.4.1 Check the temperature and humidity of the area.
5.4.4.2 Check the air differential pressure of the area.
5.4.5 Ensure that the parameters are within the limit.
5.4.6 Switch ‘on’ the main of the machine.
5.4.7 Discard the leftover tablet between two belts.
5.4.8 Ensure that the metal detector conforms to the challenge test.
5.4.9 Check and record the environmental conditions in the respective formats.
5.4.9 Load the tablets into the hopper and start as per BMR.
5.5 Action to be taken in Packing area during power failure:
5.5.1 Switch off the ‘’main’’ of the machine (strip/blister packing).
5.5.2 Unload the tablets/granules from the hopper in the double-lined polybag with a proper status label.
5.5.3 Remove the tablets/granules from the feeding box, feeding channel guide track.
5.5.4 After the resumption of power, the following checks are to be done:
5.5.4.1 Check the temperature and humidity of the area.
5.5.4.2 Check the air differential pressure of the area.
5.5.5 Switch ‘on’ the main of the machine.
5.5.6 Discard the strips/blisters/sachets under the sealing roller, forming the roller of the machine if the machine is stopped for more than 2 minutes.
5.5.7 Check the temperature of sealing, and forming sealing roller for blister machine and side sealing for sachet machine with the help of calibrated thermometer.
5.5.8 After getting the set parameter within the limit, start the operation as per BMR.
5.6 Note: Record all power failures activity in respective BMR / BPR.
Related SOPs: In Process Quality check during Manufacturing
6.0 ABBREVIATION(S):
BMR: Batch Manufacturing Record
BPR: Batch Packing Record
RMG : Rapid Mixer Granulator
FBD: Fluidized Bed Drier
QA: Quality Assurance
Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has experience in Pharma manufacturing and has worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don’t hesitate to reach out via email at [email protected].