On the event of Power Failure :
- Once the production is stopped due to power failure during manufacturing and Packing Process, switch off the equipment’s immediately after power failure which are having moving parts and directly connected to main supply.
- Record the stoppage time in the respective record wherever required. If power failure is less than one minute, interruption start and stop time can be same as time is being recorded in hour & minute format.
- Cover the material with polythene bag which is exposed in the machine and close all the product containers available in the room or cubicle or area.
- Restrict man movement and opening of doors in manufacturing and Packing area during the period of power failure.
- If power resumes after 20 minutes then raise deviation with proper Corrective action & preventive action and risk assessment study if required and continue with manufacturing and packing operation. The disposition of the lot or the batch which are affected due to power failure will be decided with the consultation with Quality assurance and ‘Production Head’ and ‘Technical Head’ etc.
- Power failure study shall be performed to decide the time.
After Resuming of the Power:
Once the power resumes, wait for 10 minutes, for condition to restore consistently, before restarting activities ensure that temperature and RH, Differential air pressure of area is achieved as per batch record and restart the procedure as outlined below. Follow all applicable individual SOP’s for operation and start-up of equipment’s.
Power stoppage can happen, at various stages of operation, Intention of the instruction below is to cover critical step, to assist a uniform, restart procedure, which takes in to the requirements.
During Sifting of Material:
Ensure that all the materials pass from the top hopper and the bottom hopper, if materials are present in the top and bottom hopper then pass materials after recovery of power supply then Check the vibration of the sifter and then start the process as per batch record instruction. In Multimill check the RPM of the blade and the direction of the blade after recovery of power supply & then start.
During Drying in Fluid Bed Dryer :
Ensure that the sealing gasket pressure before continuing the operation.
Ensure that set inlet and outlet temperature is as specified in BMR.
Rake the materials to break any lumps formation and draw sample for LOD checking.
Air dry the lot at intervals as mention in the batch record to ensure proper fluidization. Once fluidization is normal, resume drying as per instructions given in the batch record.
Rapid Mixer Granulator :
If the power failure occurred during the dry mixing and if RMG is running in “PLC”mode then select “MANUAL” mode run after power recovery and enter required parameters as per batch record and for remaining time depending upon the power failure time.
In the event, power failure occurred during the binder addition process then weight the remaining quantity of paste and record , then rake the wet mass thoroughly and ensure that no binder is sticking to chopper and the agitator, then Before starting the wet mixing, ensure that the binder solution is visually checked and is fit for use and then addition of remaining binder as per batch record instruction.
If the power failure occurs during the wet mixing but after addition of binder solution then Manually rake the wet mass thoroughly and free the chopper and agitator from any adhered mass and then Knead the wet mass for 30 seconds with the chopper off.
Roll Compactor :
Ensure that any adhered materials are not stick in the auger, and in the hopper of the Roll compactor then Check all the parameters of the Roll compactor like hydraulic pressure of the roller, roller RPM, auger position, etc… then after ensuring the above, restart compaction process.
Ensure that timer is showing remaining time of blending then switch ‘ON’ the blender to restart the operation for remaining time and If timer is not showing remaining time of blending, then check the start time of blending in HMI and calculate the remaining time of blending depending up on the power failure time. Run the blender only for remaining period e.g. Initial setting of blending time is 30 minutes: power failure occurred after blending for 25 minutes and run the blender only for remaining 5 minutes.
During Tablet Compression:
After resumption of power, challenge test for metal detector should be performed and recorded in batch record before start the compression activity then Switch “ON” the machine and Ensure that at least two round of the tablets are rejected. Ensure the group weight variation of tablets is as per limits specified in batch record. If group weight variation of tablets is not in the limits as specified in Batch record, then reset the machine and reject the tablets obtained.
During Tablet Coating:
Check for coating defects of tablets, action to be taken in case of defected tablet during coating’ if found raise deviation then Start coater and ensure that actual RPM of pan, inlet and product/exhaust temperature and atomization air pressure are as specified in HMI and start spraying then Stir the coating solution for 5 min before start of spraying if it’s no continuous stirring.
During Capsule Filling:
Ensure running of plate sorter, metal detector, empty capsule loader and vacuum pressure before continuing the operations after resumptions of power supply then perform Metal Detector challenge Test and capsule sorter challenge test after power resumption. Collect the one round of capsules and reject the same & ensure group weight variation of capsules is as per limits specified in batch record and If group weight variation of capsules is not in the limits then reset the machine and reject the capsules obtained.
During Blister Packing:
In case of blister packing activity, check sealing and forming temperature, compressed air pressure once the power is resumed then run the machine and ensure blisters below sealing plate should be rejected. Check coding quality of blisters. Non filled detection if available shall be challenge and Leak Test shall be performed after power resumption.
Bulk and Bottle Packing :
In case of bulk pack Reject the bottle under induction sealer, metal detector & screw capping heads. Wait until the sealing temperature is achieved before proceeding for sealing perform the challenge test. After sealing of pack, check the sealing quality. Perform metal detector challenge test after resumption of power failure and before start of the operation.
During dry Syrup Filling and Packing:
In case of dry syrup filling activity, all the bottles under the filling stations,Metal Detector, check weigher, screw capping & induction Sealing shall be rejected. After power resumption perform challenge test for metal detector, check weigher, screw capping & induction sealing (as applicable) and check net Fill content of individual bottles, sealing quality of cap and leak test of filled bottles.
Sticker Labelling machine:
In case of labelling, remove the bottles in coding section & conveyor belt Check the continuous 05 bottles/Packs once the power resumed and check visually printing matter of bottles/Packs prior to continuing the operation.
In case of cartooning, remove the cartons in front of coder, challenge test for code reader system (Pharmacode) and challenge test for Blister, Carton and leaflet shall be done after resumption of power failure and when all tests are Ok then continue the operation.
In case Checkweigher operation, remove the carton on checkweigher, balance & conveyor belt, challenge test for Checkweigher shall be performed after resumption of power and when all tests are Ok then continue the operation.