SOP for Procedure to Cleaning and Operation Of Coating Pan 1

1.0 OBJECTIVE of Cleaning and Operation Of Coating Pan

1.1 This SOP for procedure to cleaning and operation of Coating pan.

2.0 SCOPE:

2.1 To prevent cross contamination between different products. To ensure error free operation of the machine. Cleaning and Operation Of Coating Pan.

3.0 RESPONSIBILITY:-

3.1 Production Executive

4.0 ACCOUNTABILITY:

4.1 Production Head

5.0 Procedure: Cleaning and Operation Of Coating Pan

5.1 CLEANING OF COATING PAN (FOR FILM COATING):

5.1.1 Pour approx. 20 liter of Tap water into the pan and allow rotating for 10 minutes.
5.1.2 Remove this water using a plastic tub and drain into the washing area.
5.1.3 Cleaning the inner surface of the pan with nylon softed brush.
5.1.4 Pour approx. 20 litres of D.M. Water/purified water into the pan and allow rotating for 10 min.
5.1.5 Remove this water using a plastic tub and drain into the washing area.
5.1.6 Allow the pan to dry. Mope with clean dry lint free cloth
5.1.7 Affix a “CLEANED” tag/label on the machine.& Record the details.

5.2 CLEANING OF SPRAY GUN (FOR FILM COATING) & SILICON TUBE

5.2.1 Clean using tap water with soft nylon brush.
5.2.2 Clean Silicon tube using tap water.
5.2.3 Wash it again using tap water to remove adhered mass if any.
5.2.4 Finally rinse it with DM water, dry clean it and set it.
5.2.5 Affix a “CLEANED” tag on it.

5.3 CLEANING OF COATING PAN (FOR ENTRIC COATING)

5.3.1 Pour approx 5 liter of DM Water into the pan and allow rotating for 10 minutes.
5.3.2 Remove this Solution using a plastic tub and drain into the washing area.
5.3.3 Clean the inner surface of the pan with nylon soft brush
5.3.4 Pour approx 20liter of DM Water into the pan and allow to rotate for 10 minutes.
5.3.5 Remove this water using a plastic tub and drain into the washing area.
5.3.6 Allow the pan to dry. Mope with clean dry lint free cloth.
5.3.7 Affix a “CLEANED” tag on the machine. & Record the details.

5.4 CLEANING OF SPRAY GUN (FOR ENTRIC COATING)

5.4.1 Cleaning using Methylene Chloride with soft nylon brush.
5.4.2 Clean silicon tube using Methylene Chloride.
5.4.3 Wash it again using Methylene Chloride to remove adhered mass if any.
5.4.4 Finally rinse it with DM water, dry clean it and set it.
5.4.5 Affix a “CLEANED” tag on it.
5.4.6 Record the details.

5.5 FREQUENCY: Cleaning and Operation Of Coating Pan

5.5.1 The frequency is Product to product changes over.
5.5.2 Procedure is given below for batch to batch cleaning record.

5.6 Procedure for Operation:

5.6.1 Ensure the cleanliness of coating pan, Minicota, spray gun and surrounding area.
5.6.2 Fix the exhaust and hot air blower attachment, switch on A.C. and dehumidifier and record the temperature and RH in BPR.
5.6.3 Take Line clearance from Q.A. department. Affix a ‘Stage label’ on to the machine.
5.6.4 Load the weighed quantity degusted tablet of uncoated tablets from the container into the coating pan.
5.6.5 Switch on the mains of hot air blower and exhaust system
5.6.6 Allowed the tablets to get warmed initial bed temp. requirement to start coating.(Rotate the tablets while heating by itching the pan frequently to get the loaded tablets heated uniformly.)
5.6.7 Assemble the cleaned parts of Minicota and spray gun and adjust pipes and locate it on the stand Fix the position of spray gun over the tablet bed at required distance. Set on time of Minicota as per requirement & set required air press.
5.6.8 Switch on the mains of coating pan and start the Minicota adjust the width of spray and rate of application in such a way that required tablet bed temperature should remained maintained throughout the coating process. During coating set the off time of Minicota for drying of Tablet.
5.6.9 Check the tablet. After Sufficient drying again start the Minicota & complete the coating in production.
5.6.10 Record the parameters in Batch Production Record(BPR).
5.6.11 When the coating solution is completely utilized, stop the coating pan & Minicota and get the tablet fully dried and then switch off the blower and take out the spray gun.

6.0 ABBREVIATIONS of Cleaning and Operation Of Coating Pan

6.1 EFF. : Effective
6.2 Mfg. : Manufacturing