1.0 Objective: To establish a procedure for handling products during power failures in the production area.
2.0 Scope: This procedure applies to the handling of products during power failures in the production area.
3.0 Responsibility: Officers and Executives in the Production Department are responsible for this procedure. The Production Department Manager also has a role.
4.0 Definitions: NA
5.0 Procedure:
5.1 Granulation Area:
- Cover in-process material with lids or polybags.
- Do not move any material or machines during a power failure.
- After power resumes, check the temperature, humidity, and air differential pressure of the area.
- Ensure parameters are within limits.
- Switch on the machine mains.
- Check elapsed and required time for drying, mixing, and blending.
- Allow balances to stabilize before weighing.
- If the power doesn’t resume within 30 minutes, unload material from the RMG/FBD/vibratory sifter and affix the status label.
5.2 Compression Area:
- Discard tablets in the de-dusting machine.
- Cover granule containers, hoppers, and tablets with polybags.
- After power resumes, check the temperature, humidity, air differential pressure, and rotation direction of the machine in ‘inch’ mode.
- Allow analytical balance to stabilize.
- Ensure in-process parameters are within limits before continuous compression.
- QA certification is required after parameter alignment.
- If the power doesn’t resume within 30 minutes, unload granules from the hopper and affix the status label.
5.3 Coating Area:
- Remove the gun assembly from the coating pan.
- Turn off the machine’s ‘main’.
- After power resumes, check temperature, humidity, and air differential pressure.
- Ensure parameters are within limits.
- Switch on the machine’s ‘main’.
- Start spraying when the tablet bed reaches a specified temperature.
- QA certification is required after parameter alignment.
- If the power doesn’t resume within 30 minutes, unload tablets from the coating pan and affix the status label.
Related: SOP on Making entries in equipment usage and cleaning log sheet
5.4 Inspection Area:
- Turn off the machine’s ‘main’.
- If power doesn’t resume within 30 minutes, unload tablets from the hopper and affix the status labels.
- Remove tablets from the inspection belt.
- After power resumes, check temperature, humidity, and air differential pressure.
- Ensure parameters are within limits.
- Switch on the machine’s ‘main’.
- Discard leftover tablets between belts and place them in the hopper.
5.5 Packing Area:
- Turn off the machine’s ‘main’ for strip/blister packing.
- Cover product containers and hoppers with polybags.
- If the power doesn’t resume within 30 minutes, unload products from a hopper, feeding box, feeding channel, and guide track.
- After power resumes, check temperature, humidity, and air differential pressure.
- Switch on the machine’s ‘main’.
- Discard strips/blisters/sachets under sealing and forming rollers if the machine stops for more than 2 minutes.
- Check sealing and forming roller temperatures and set parameters before continuous operation.
- Perform a leak test before running the machine.
- Allow check weighing balances to stabilize before weighing.
6.0 Abbreviations:
PLC: Programmable Logical Controller
RMG: Rapid Mixer Granulator
FBD: Fluidized Bed Drier
BMR: Batch Manufacturing Record
SS: Stainless Steel
SOP: Standard Operating Procedure
QA: Quality Assurance
7.0 References:
NA
8.0 Annexures:
None available.