SOP Title: Operation and Cleaning of Empty Capsule Sorter

SOP Title: Operation and Cleaning of  Empty Capsule Sorter

 

1. Objective:

To define a procedure for Operation, Cleaning and Preventive Maintenance of Empty Capsule Sorter.

2. Scope:

This SOP is applicable to Empty Capsule Sorter used for sorting (separating) empty unfilled capsules from the filled capsules by means of air blower located in capsule department.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation cleaning and preventive maintenance of Empty Capsule Sorter.
   • Engineering Department: To perform the preventive maintenance and calibration of Empty Capsule Sorter.
   • Quality Control Department: To analyse and report the swab/rinse samples.
   • Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the Preventive Maintenance and Calibration reports. To review and approve the SOP and Annexure.
4. Accountability:

Head Production Department, Head, Engineering Department and Head Quality Assurance

5. Procedure:
   • Definition:
     • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
       • Remove the previous batch residue.
       • During end of the shift.
       • Before starting the next batch of the same product.
       • Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
     • Type B Cleaning: Wet cleaning by using soap solution in the following cases.
       • Removal of traces of the previous product, and is ensured by testing rinse /swab sample of the cleaned equipment.
       • Change in product.
       • Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
       • After continuous five batches of the same product.
       • After seven days of cleaning before use, if equipment is not in use.
       • After replacement or repair of any product contact part.
     • Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
     • Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
     • Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
   • Procedure

	Precautions
5.2.1	Switch ‘OFF’ the main supply during machine setting, cleaning and product change over activity.
5.2.2	During operation of the machine do not touch the moving parts /do not put hand in the running machine.
5.2.3	Visually ensure that, all parts are connected properly.
5.2.4	Use proper personal protective equipment like Nose Masks, Gloves during operation of Empty Capsule Sorter.
5.3	Operation
5.3.1	Before starting the activity ensure that the line clearance is taken and recorded in the BMR Record the activity in the equipment log book as per Annexure.
5.3.2	Before starting the operation ensure the temperature and relative humidity of the area is within the limit specified in the BMR.
5.3.3	Fix the empty capsule rejection hopper over the main frame of the equipment. Fix the empty capsule collection container to the side of the hopper by the screw provided.
5.3.4	Fix the main hopper over the empty capsule rejection hopper and tighten it with then screw provided.
5.3.5	Place the equipment exactly below the outlet of the Capsule polishing machine or Metal detector such the filled capsules flows into the hopper for sorting.
5.3.6	Place a clean container with double polybag under the sorted filled capsules ejection port of the machine before start of the operation.
5.3.7	Switch ‘ON’ the main electric supply then turn the toggle switch to “ON” position.
5.3.8	Set the blower voltage as per requirement or as mentioned in the BMR
5.3.9	The Filled capsule ejecting out of the Polishing machine or Metal detector will be passed through the Empty Capsule Sorter.
5.3.10	Due to air stream generated by the Empty Capsule Sorter, empty capsules if any will be separated from the filled capsules.
5.3.11	All rejected empty capsules will be collected in the empty capsule collection box.
5.3.12	All Filled capsules will be collected in a clean container with double polybag placed under the sorted filled capsules ejection port.
5.3.13	If required the empty capsules collected in rejection box can be again passed through the empty capsule sorter to separate any filled capsules.
5.3.14	Upon completion of activity, switch “OFF” the machine as well as main supply.
5.3.15	Label the rejected capsules as ‘Non Recoverable Rejects’.
5.3.16	Weigh the Filled capsules and rejected empty capsules for yield reconciliation. Record the respective weight in the BMR.
5.3.17	After completion activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”.
5.3.18	Record the activity in equipment log book.
5.4	Type A Cleaning.
5.4.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.4.2	Switch OFF the equipment and dismantle the Empty capsule collection box, Main hopper and Empty capsule rejection hopper.
5.4.3	Clean the outer surface of the equipment and the dismantled parts with the help of dry clean duster or vacuum cleaner.
5.4.4	Ensure the cleanliness, by checking visually for the presence of any granules or particles, then affix “Type A Cleaned” label.
5.4.5	Record the activity in equipment log book as per Annexure.
5.5	Type B Cleaning.
5.5.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.5.2	Switch “OFF” the equipment and dismantle the Empty capsule collection box, Main hopper and Empty capsule rejection hopper.
5.5.3	Clean the outer surface of the equipment and the dismantled parts with the help of dry clean duster or vacuum cleaner.
5.5.4	Cover the dismantled parts with poly bag and transfer to the wash area with “To Be cleaned” label.
5.5.5	Clean the dismantled parts with 0.1% soap (teepol) solution.
5.5.6	Then wash these parts with potable water to remove the soap solution.
5.5.7	Finally rinse above cleaned parts with sufficient quantity of purified water.
5.5.8	Dry the cleaned parts with dry clean duster/ tray dryer.
5.5.9	Fill the Swab / Rinse Sample Intimation Slip and submit to QA department for collection of samples.
5.5.10	Record the activity in equipment log book.
5.5.11	Collect the Swab/Rinse sample result from Quality Assurance department. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.5.3 to 5.5.9.
5.5.12	After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.
5.6	Breakdown
5.6.1	If breakdown occurs during operation, hold the sorting activity. Inform to the Head Production.
5.6.2	Fill the “Complaint Note” and submit to Engineering Department.
5.6.3	Fill the “Incident Report” and submit to Quality Assurance Department.
5.6.4	If breakdown occurs prior to start of operation, follow step 5.6.2
5.6.5	After completion of repairs, the operations can be resumed. Perform Type A or Type B cleaning if the tablet has been unloaded from the machine.
5.6.6	Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.
5.6.7	Record the repair completion activity in Equipment Log Book.
5.6.8	Describe the breakdown activity in the respective product BMR.
5.7	Preventive Maintenance
5.7.1	Perform the preventive maintenance as per Annexure.
5.7.2	If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.
5.7.3	Attach the preventive maintenance label on the equipment.

 

6. Abbreviation:

Abbreviation	Expansion
SOP	Standard Operating Procedure
PDD	Production Department
o C	Degree Centigrade
%	Percent
±	Plus or Minus
ml	Milliliter
v/v	Volume By Volume

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.