SOP Title: Operation and Calibration of Double Cone Blender

SOP Title: Operation and Calibration of Double Cone Blender

 

1. Objective:

To define a procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Double Cone Blender.

2. Scope:

This SOP is applicable to Double Cone Blender, used for the mixing of granules/raw material and is installed at the Capsule Section of the Production area.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support the Preventive Maintenance and Calibration of Double Cone Blender.
   • 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.
   • Engineering Department: To perform the Preventive Maintenance and Calibration of Double Cone Blender, wherever applicable.
   • Quality Control Department: To analyse and report the swab/rinse samples.

 

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.
       • 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 and colour
       • 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 or change in colour.
       • Monthly, if it is not in used after cleaning.
     • 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.
     • Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These tests are performed half yearly, yearly and also after repair or replacement of parts coming in direct contact with product.
   • Procedure

	Precautions
5.2.1	Switch off the mains of the double cone blender during loading, unloading and manual cleaning.
5.2.2	Always rest the Blender vertically, such a way that the butterfly valve is at the bottom.
5.2.3	Always engage the safety guard before starting the blending operation.
5.2.4	Wear proper Personal protective equipment (as per product requirement) during loading and unloading of materials.
5.3	Operation of Double Cone Blender
5.3.1	Before starting the blending process make sure that the line clearance is taken and recorded in the respective BMR. Record the activity in the equipment log book.
5.3.2	Before starting the operation ensure that the temperature and relative humidity of the area is within the limit specified in the BMR.
5.3.3	Remove “Cleaned” status label and affix “In-process” label.
5.3.4	Close the butterfly valve before loading the materials into the blender.
5.3.5	Open the loading lid of the blender by loosening the screws of the lid. Keep the blender in inclined position for loading of material by rotating the blender manually.
5.3.6	Manually load the materials to be blended into the blender by means of Polybag / Clean SS Scoops.
5.3.7	Close the lid of the blender by tightening the screws provided.
5.3.8	Visually check the lid and the butterfly valve for tightness and no spillage should occur during the blending process.
5.3.9	Engage the safety guard and switch ON the mains of the machine.
5.3.10	Set the required time as per the respective product BMR. The timer is to be set in minutes Eg. If the time required for blending is 10 minutes then ‘010’ is to be set in the timer.
5.3.11	Now push the forward button to start the blending process.
5.3.12	The elapsed time will be displayed in the digital display in minutes.
5.3.13	The machine will stop automatically upon the completion of set time.
5.3.14	Before proceeding for unload, switch OFF the mains and remove the safety guard.
5.3.15	If required Rotate the blender manually to place the blender in an inclined position such that the butterfly valve is at the bottom.
5.3.16	Hold a clean polybag to the mouth of the butterfly valve and check the integrity. Place a clean container beneath the poly bag to prevent any damage to the poly bag
5.3.17	Open the butterfly valve slowly such that the blended material will be unloaded into the polybag.
5.3.18	Control the flow of the materials by butterfly valve such that the blended materials are unloaded completely without any spillage.
5.3.19	Upon completion of unloading, close the butterfly valve and remove the polybag.
5.3.20	Tie, label properly and secure the poly bag.
5.3.21	Record the usage time in equipment log book as per attached Annexure.
5.3.22	After completion of blending activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”.
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	Remove all previous batch documents, containers and labels from the area.
5.4.3	Dry clean the blender with vacuum cleaner /dry clean duster.
5.4.4	Ensure the cleanliness and affix “Type A CLEANED” label as per SOP.
5.4.5	Record the cleaning time in equipment log book.
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	Remove all previous batch documents, containers and labels from the area.
5.5.3	Dry clean the blender with vacuum cleaner /dry clean duster.
5.5.4	Wash the blender inner and outer surface with potable water to remove any traces of powder.
5.5.5	Wash the inner and outer surface with 0.1%Teepol solution and then wash with potable water to remove any traces of soap solution.
5.5.6	Wash the lid of the blender with potable water followed by 0.1%Teepol solution.
5.5.7	Finally rinse the blender and lid with purified water.
5.5.8	Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the Swab / Rinse samples.
5.5.9	Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.5.1 to 5.5.5
5.5.10	Record the activity in equipment log book.
5.5.11	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, switch “OFF” the main supply and inform to Head Production and QA Associate.
5.6.2	Record the blending time in the product BMR.
5.6.3	Fill the “Complaint note” and submit to engineering department.
5.6.4	Fill the “Incident report “and submit to Quality Assurance Department.
5.6.5	Unload the product / material only if required and keep the product/ material in closed condition as per requirement.
5.6.6	If breakdown occurs prior to start of operation, follow step 5.6.3.
5.6.7	Record breakdown activity in Equipment log book .
5.6.8	After completion of repairs, the operations can be resumed. If break down is major perform Type A or Type B cleaning as per the requirement.
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.
5.8	Calibration:
5.8.1	Calibrate the Timer and RPM once in a year as per Annexure.
5.8.2	If calibration activity is outsourced, the values are to be transcribed in the Annexure and external party certificate to be attached.

 

6. Abbreviation:

Abbreviation	Expansion
TAB	Tablet.
BMR	Batch Manufacturing Record.
%	Percent.
v/v	Volume by Volume.
ml	Milliliter.
RPM	Rotation per Minute

 

CALIBRATION OF DIGITAL TIMER

OBSERVATIONS

Sr. No.	Reading on the UUC MIN	Reading on Standard instruments HRS:MIN:SEC:MSEC.	Deviation ± 2 min	Remarks
1
2
3
4
5
UUC : Unit Under Calibration

 

CALIBRATION OF RPM

Sr.No.	Standard RPM	Observed RPM	Acceptance Criteria	Deviation
1			± 1 RPM
2
3

 

Remark :

Calibration of Blender is performed successfully and readings are within limit / not within limit and Can be Used / Do Not Use for regular activity.

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