General precautions to be taken during power failure are as follows:
i. Inform to Engineering department for immediate action.
ii. Avoid unnecessary movement from current location to prevent an accident.
iii. Do not carry out any operations during power failure.
iv. Do not touch any of the moveable machine parts that may lead to an accident.
v. Do not open any door except in case of emergency.
vi. Do not touch any article / object.
vii. Do not use pass box.
viii. Emergency lamps, which are operated by UPS, will remain “ON”.
ix. As soon as the power goes off, stop the men or material movement.
Precautions to be taken during power failure for equipment and process are as follows:
Sifting (For excipients):
i. Stop the operation.
ii. Close all exposed material.
iii. Close the hopper of the sifter with lid / polythene cover.
iv. Cover the discharge chute with poly bag.
v. Inform to engineering department.
vi. Note down the power failure time in equipment log book.
vii. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it. Restart the activity.
Sifting (For API):
i. Stop the operation. Close the buck valve of in process charging bins. Tie the poly bag with a cable tie containing remaining API.
ii. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it.
iii. Switch ON the isolator, allow to stabilize differential pressures of isolator as per validated limits. Continue the sifting activity.
Granulation (RMG):
i. Note down the power failure time in equipment logbook. (if granulation is in operation).
ii. Inform to engineering department.
iii. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it. Restart the activity.
Drying (FBD):
i. Note down the power failure time in equipment logbook. (if drying is in process).
ii. Inform to engineering department.
iii. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it. Restart the activity.
Blending:
i. Note down the power failure time in equipment logbook. (if blending is in process).
ii. Inform to engineering department.
iii. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it. Restart the activity.
Dry milling:
i. Note down the power failure time in equipment logbook. (if milling is in process).
ii. Inform to engineering department.
iii. Close the split butterfly valves of both (In process charging bins and discharge collection bins) in process charging bins.
iv. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature/ humidity/differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it. Restart the activity.
Compression:
i. Stop granules flow and close the buck valve.
ii. Note down power failure time in equipment logbook (If compression is in process).
iii. Cover the tablet section chute with poly bag.
iv. Come out from the area.
v. Inform to engineering department.
vi. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it.
vii. Remove and destroy the first two rounds of tablets from compression machine. Confirm all the physical parameters before restart the activity.
Coating:
i. Close the outlet valve of solution vessel.
ii. Remove the spray gun bar from the coating pan immediately. Put sampling poly bag to the mouth of spray gun.
iii. Close the pan mouth.
iv. Note down the power failure time in equipment logbook.
v. Inform to engineering department.
vi. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it.
Capsule filling:
i. Note down the power failure time in equipment logbook.
ii. Inform to engineering department.
iii. Close the capsule hopper and empty capsule container properly.
iv. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it.
v. Remove and destroy the first two rounds of capsules from capsule filling machine.
vi. Confirm all the parameters before restart the activity.
Tablets Inspection:
i. Stop the inspection activity.
ii. Note down the power failure time in inspection logbook.
iii. Inform to engineering department.
iv. As the power will resume, ensure that the differential pressures of Isolator are OK.
v. Ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it. Restart the activity.
Bottle Packing:
i. Cover the hopper with poly bag / lid.
ii. Inform to engineering department. Note down the power failure time in equipment logbook.
iii. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it.
iv. Check the sealing and labeling of bottles. Restart the activity.
Blister Packing:
i. Remove all the tablets / capsules from guide track and close them with a poly bag. Inform to engineering department. Note down the power failure time in equipment logbook.
ii. As the power will resume, ensure that the AHU of area is started and allow all environmental conditions temperature / humidity / differential pressures to reset as per its validated limit. Wait for another 5 minutes to stabilize it.
iii. Check the sealing integrity of blisters. Restart the activity.
Filtration:
i. Stop the activity and inform to Engineering department.
ii. Immediately close all the gas line valves, which are using for the activity.
iii. Whenever AHU operation is resumed of filtration isolator then confirm the environmental conditions of temperature / humidity / differential pressures of area and confirm differential pressures of isolator are within limit.
iv. Inform to QA head and production Head for further action.
v. Continue the activity as per the instructions of production head, QA head.
Filling:
i. Stop the activity and inform to production head, QA, Engineering department.
ii. Avoid unnecessary movement from current location to prevent an accident.
iii. Do not touch any of the moveable machine parts, which may lead to an accident
iv. Ensure that HVAC of filling & sealing machine isolator is working, by visually observing magnehelic pressure gauges on isolator. (HVAC unit is provided with UPS backup).
v. Note down the time of power failure in BMR and log book, indicating “power failure” in remark column of the logbook.
vi. Do not start activity immediately after the power resumption and start of AHU. Check whether temperature, humidity and differential pressure are within specified limits by visually observing on MLS display provided in the room.
vii. Discard filled but un-stoppered vials / syringes from filling star wheel, which were open during power failure.
viii. Ensure that all utilities are available. Start the machine 10 min after starting of AHUs as per SOP.
Lyophilization:
Note: Freeze dryer control panel and computer is provided with UPS hence there is no impact of power failure and parameter monitoring and recording will continue.
i. Avoid unnecessary movement from current location to prevent accidents.
ii. Do not touch any of the moving machine parts which may lead to an accident.
iii. If power failure occurs in auto cycle (i.e. condenser de-frost, CIP, SIP, VLT, auto freeze drying cycle) the freeze drying control system will pause the respective step time wherever applicable.
iv. After power resumption, check and ensure the required utilities like compressed air, nitrogen, pure steam, potable water, chilled water are within limit.
v. After power failure happens the Lyophilizer gets “OFF”, but connected computer are remain “ON” due to UPS system and shows alarm.
a. Red indicator alarm will glow and hooter gets “ON”.
b. Operator shall wait till power gets resume back.
c. After power resumes, the alarm indicator will disappear automatically.
d. Acknowledge the alarm on computer system.
e. Ensure that all the utilities like compressed air, chilled water and nitrogen are “OK”.
f. Lyophilizer starts automatically and continues operation from step, at which power was failed.
g. If power failure is more than validated time, Inform to QA, Production head and Engineering department for further action.
Procedure for warehouse:
i. Stop the activity. Once power resumes, ensure that area AHU is “ON”, confirm that environmental conditions temperature / humidity / differential pressures are within specified limits, and switch on the isolator / RLAF. Confirm the differential pressures of isolator / RLAF/ceiling suspended LAF are within specified limits.
ii. If the power failure is more than validated time, clean the area as per respective SOP.
iii. If sampling / dispensing activity in going on and power failed in between, during this stage any excipient / API weighing is going on, then once power resumed freshly weigh the same excipient / API.