SOP Title: Operation And Cleaning Of Colloidal Mill

SOP Title: Operation And Cleaning Of Colloidal Mill

 

1. Objective:

To define procedure for Operation, Cleaning and Preventive Maintenance of Colloidal Mill

2. Scope:

This SOP is applicable to Colloidal Mill used for milling of coating material during coating process in production 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 colloidal Mill.
   • Engineering Department: To perform the preventive maintenance of Colloidal Mill.
   • Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the Preventive Maintenance reports. To review and approve the SOP and Annexure.
   • Quality Control Department: To analyse and report the swab samples.
4. Accountability:

Head Production Department, Head Engineering Department and Head Quality Assurance

5. Procedure:
   • Definition:
     • Production Associate: Executive or Operator of Production department or any personnel trained to perform duties as per this SOP.
     • Quality Assurance Associate: Executive of Quality Assurance department or any personnel trained to perform duties as per this SOP.
     • Quality Control Associate: Executive of Quality Control department or any personnel trained to perform duties as per this SOP.
     • Engineering Associate: Executive or operator of engineering department trained to perform duties as per this SOP.
     • Type A Cleaning: Dry cleaning with clean lint free cloth from outer surface and circulating the water in the milling chamber in the following cases,
       • Remove the previous batch residue.
       • During end of the shift.
       • Before starting the next batch 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 if there is change in coating material.
       • 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

	5.2.1		Precautions
	5.2.1.1		Use safety goggles, nose mask and hand gloves during milling activity.
	5.2.1.3		Keep the container below the out let of the colloidal mill.
	5.3		Operation
	5.3.1		Ensure that the colloidal mill is cleaned and line clearance is obtained from QA department on BMR.
	5.3.2		Start and check the rotation of rotor and free movement.
	5.3.3		Switch ‘ON’ the Colloidal Mill and slowly add the material to be milled in to the hopper of the mill as mentioned in product BMR.
	5.3.4		Mill the material in circulation mode by operating the valve for about 15 minutes or as mentioned on the BMR.
	5.3.5		Visually check the milled material for fineness and absence of black particles.
	5.3.6		After completion of milling, collect the milled solution in separate containers.
	5.3.7		Rinse the colloid mill with circulating the solvent or water used for the preparation of solution.
	5.3.8		After completion of the milling switch “OFF” the colloidal mill switch, then main supply.
	5.3.9		Label the colloidal mill as “ To be Type A cleaned” or “To be Type B Cleaned”.
	5.3.10		Record the activity in equipment log book.
5.4		Cleaning:
5.4.1		Type A Cleaning ( Batch to Batch Cleaning)
	5.4.1.1		Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
	5.4.1.2		Clean the external surface of the Colloidal Mill with moist clean duster.
	5.4.1.3		Switch “ON” the colloid mill and Pour approximately 2-4 litres of purified water into the Colloidal Mill hopper and circulate for about 5 minutes.
	5.4.1.4		Drain and collect the used turbid water from opening of the circulating pipe in to the container.
	5.4.1.5		Switch “OFF” the colloid mill and affix “Type A Cleaned” label to the colloid mill.
5.4.2		For Type B Cleaning (Product to Product):
	5.4.2.1		Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
	5.4.2.2		Clean the external surface of the Colloidal Mill with moist duster.
	5.4.2.3		Pour approximately 2-4 litres of purified water into the Colloidal Mill and put ’ON’ for about 5 minutes  in circulation and  drain the  turbid water from the out let pipe. Repeat the above step for 2-3 times for colour product till the clear water obtained from the colloid mill.
	5.4.2.4		Dismantle the hopper and wash the hopper with approx.10 litres of potable water. Apply 0.1% soap (teepol) solution and then wash with 10 litres of potable water to remove the traces of the soap solution.
	5.4.2.5		Finally rinse with 10 litres of purified water.
	5.4.2.6		Wash the Colloidal mill outlet pipe with 5-7 litres of potable water then clean with 0.1% soap solution (teepol).
	5.4.2.7		Again clean with 5-7 litres of potable water to remove traces of the soap solution. Finally rinse the Colloidal Mill outlet pipe with5-7 litres of Purified water.
	5.4.2.8		Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the samples.
	5.4.2.9		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 5.4.2.3 to 5.4.2.8.
	5.4.2.10		Wipe the outer body with moist clean duster.
	5.4.2.11		Dry the outside of Colloidal Mill by using dry and clean duster.
	5.4.2.12		After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.
	5.4.2.13		Cover the Colloidal mill with clean poly bag.
	5.4.2.14		Record the activity in equipment log book as per Annexure.
			Frequency: Clean the colloidal mill 1. During product changeover 2. Whenever major maintenance done to the colloidal mill 3. After continuous five batches of the same product. 4. Same product with change in coating colour. 5. Monthly, if it is not used for production activity.
5.5		Breakdown
	5.5.1		If breakdown occurs during operation, hold the milling activity. Inform to the Head Production.
	5.5.2		Fill the “Complaint Note” and submit to Engineering Department.
	5.5.3		Fill the “Incident Report” and submit to Quality Assurance Department.
	5.5.4		If the breakdown is major, unload the material from the colloid mill only, if required for breakdown rectification.
	5.5.5		Store the solution in a closed container with proper status label.
	5.5.6		If breakdown occurs prior to start of operation, follow step 5.5.2
	5.5.7		After completion of repairs, the operations can be resumed. Perform Type A or Type B cleaning if the solution has been unloaded from the colloidal mill.
	5.5.8		Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.
	5.5.9		Record the repair completion activity in Equipment Log Book.
	5.5.10		Describe the breakdown activity in the respective product BMR.
5.6		Preventive Maintenance
	5.6.1		Perform the preventive maintenance as per Annexure.
	5.6.2		If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure and external party certificate to be attached.

 

6. Abbreviation :

Abbreviation	Expansion
SOP	Standard Operating Procedure
%	Percentage
BMR	Batch Manufacturing Record

 

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