SOP Title: Operation and Cleaning of Vibratory Sifter

SOP Title: Operation and Cleaning of Vibratory Sifter

1. Objective:

To lay down procedure for Operation, Cleaning, Preventive  Maintenance of Vibratory Sifter and Sieve Integrity.

2. Scope:

This SOP is applicable to vibratory sifter used for sifting of granules/raw material located at granulation section of the production department.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the Operation, Cleaning and to support the Preventive Maintenance.
   • Quality Control Department: To analyse and report the swab/rinse samples.
   • Engineering Department: To perform the Preventive Maintenance.
   • Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To review and approve the SOP and Annexure.
4. Accountability:

Head, Production.

Head, Engineering.

Head, Quality Assurance.

5. Procedure:
   • Definition:
     • Production Associate: Executive or Operator of Production department trained to perform duties as per this SOP.
     • QA Associate: Personnel of QA department trained to perform duties as per this SOP.
     • QC Associate: Personnel of QC department trained to perform duties as per this SOP.
     • Engineering Associate: Personnel or operator of engineering department trained to perform duties as per this SOP.
     • 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, same strength and colour.
       • 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 or change in 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.
       • Monthly, if it is not 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.
   • Procedure:

	Precautions
5.2.1	Switch “OFF” the electrical mains during cleaning, setting and dismantling of Sifter.
5.2.2	Before starting operation ensure that the clamps of the sifter is fitted properly.
5.2.3	Do not over load the sifter by adding more materials to the sieve.
5.2.4	Use proper personal protective equipment as per respective product.
5.2.5	Before starting sifter, connect static discharge clip to the sieve as well as to the sifter body to discharge the static charge if developed during sifting operation.
5.3	Operation of Sifter
5.3.1	Check cleanliness of vibratory Sifter and sieves before start of the operation.
5.3.2	Before starting the sifting process make sure that the line clearance is taken and recorded in the respective BMR. Record the activity in the equipment log book as per Annexure.
5.3.3	Before starting the operation ensure that the temperature and relative humidity of the area is within the limit specified in the BMR.
5.3.4	Check and get the sieve issued as per respective product BMR from the production department. Record the issuance and integrity details in ‘Usage and Cleaning Record of Sieves” as per Annexure.
5.3.5	Place the respective sieve over the vibratory sifter.
5.3.6	Place the lid of the vibratory sifter over the sieve. Place the silicon gasket and fix it tightly by means of the clamps provided.
5.3.7	Tie a clean double polybag to the discharge port of the vibratory sifter to collect the sifted materials and also tie a clean double polybag to the discharge port provided at the lid of the vibratory sifter to collect any oversized or excess materials.
5.3.8	Place a SS container below the polybag tied to the discharge port of the vibratory sifter to avoid any spillage or damage to the poly bag.
5.3.9	Switch ‘ON’ the main electric switch, and then push the green button to start the Sifter.
5.3.10	Load the material to be sifted by clean SS scoop over the sieve.
5.3.11	Material will be sifted by vibratory movement and are collected through the discharge port. Label the polybag and the container for ‘In Process Label’.
5.3.12	If required mill the oversized or retained material if any collected in the poly bag fitted in the lid of the vibratory sifter and can be added back for further sifting. (Milling procedure to be performed as per respective product BMR).
5.3.13	Continue the sifting process until all the materials are sifted.
5.3.14	After completion of sifting process push the red colour button to stop the sifter followed by the main electric supply.
5.3.15	Unclamp, remove gasket from the sifter, remove the top lid and take out the sieve. Remove any sifted granules/material remained in the bottom of the lid and to the discharge port.
5.3.16	Record the activity in equipment log book as per Annexure No 01 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	Ensure that the electrical utilities to the vibratory sifter are switched ‘off’ during the cleaning process.
5.4.3	Clean the outer surface of the vibratory sifter with dry, clean lint free cloth.
5.4.4	Remove adhered previous batch granules/powder present inside the Sifter with vacuum cleaner or dry clean duster.
5.4.5	Dismantle the Sieve locking clamps, top lid. Remove the sieve and bottom lid.
5.4.6	Dry clean the above dismantled parts with the help of clean dry duster / Vacuum cleaner.
5.4.7	Ensure the cleanliness by checking visually for the presence of any granules or material on the sifter, then affix “Type A Cleaned” label.
5.4.8	Record the activity in equipment log book as per Annexure.
5.5	TYPE B Cleaning (Product to Product Cleaning)
5.5.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.5.2	Ensure that the electrical utilities to the vibratory sifter are switched ‘off’ during the cleaning process.
5.5.3	Clean the outer surface of the vibratory sifter with dry, clean lint free cloth.
5.5.4	Remove adhered previous batch granules/powder present inside the Sifter with vacuum cleaner or dry clean duster.
5.5.5	Dismantle the Sieve locking clamps, top lid. Remove the sieve and bottom lid.
5.5.6	Dry clean the above dismantled parts with the help of clean dry duster / Vacuum cleaner.
5.5.7	Cover the dismantled parts with clean poly bag and transfer to the wash area with “To Be Type B Cleaned” label.
5.5.8	Clean the outer surface of the sifter body and motor cover with vacuum cleaner followed by moist clean duster then with dry clean duster.
5.5.9	Wash the dismantled parts with 15-20 litres of potable water and clean with nylon scrubber dipped in 0.1% soap (teepol) solution.
5.5.10	Wash again with 25-30 litres of potable water to remove the traces of soap solution.
5.5.11	Finally rinse with 20-25 litres purified water.
5.5.12	Dry the cleaned parts with clean, dry duster/tray dryer.
5.5.13	Do not use any, metal of hard brush to clean the sieves.
5.5.14	Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the samples.
5.5.15	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 5.5.7 and 5.5.8.
5.5.16	After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.
5.5.17	Record the cleaning activities of Sifter in “Equipment Log Book” refer Annexure.
5.6	Sieve Integrity
5.6.1	Sieve integrity to be checked before start and after the completion of sifting activity.
5.6.2	Sieves should be checked visually for the following, a)      Adhered particles, b)      Cut or damage to the surface of the sieve, c)      Intactness of the sieve.
5.6.3	Record the observation in the Annexure.
5.6.4	Record the inventory of the sieve as per Annexure. Update the inventory details monthly.
5.7	Breakdown
5.7.1	If breakdown occurs during operation, hold the material in closed condition. Inform to the Head Production.
5.7.2	Fill the “Complaint Note” and submit to Engineering Department.
5.7.3	Fill the “Incident Report” and submit to Quality Assurance Department.
5.7.4	Unload the material/granules only, if required for breakdown rectification.
5.7.5	Store the unloaded material/granules separately in closed container with proper status label.
5.7.6	If breakdown occurs prior to start of operation, follow step 5.7.2.
5.7.7	Record the breakdown activity in Equipment Log Book
5.7.8	After completion of repairs, the operations can be resumed. Perform “Type A” or “Type B’ cleaning if the material have been unloaded from the Sifter.
5.7.9	Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.
5.7.10	Describe the breakdown activity in the respective product BMR.
5.8.	Preventive Maintenance
5.8.1	Perform the preventive maintenance as per attached Annexure.
5.8.2	If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.
5.8.3	Attach the preventive maintenance label on the equipment.

 

6. Abbreviation:

Abbreviation	Expansion
SS	Stainless Steel
BMR	Batch Manufacturing Record
QA	Quality Assurance
QC	Quality Control
ml	Milliliter
%	Percent
v/v	Volume by Volume

 

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