CLEANING PROCEDURE FOR MASS MIXER

1.  Objective:

To provide a standard cleaning procedure of  mass mixer  and its accessories.

2.  Scope:

2.1      This procedure covers dismantling and cleaning of mass mixer  and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours

3.  Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯  Q.A. Manager

4.  Procedure:

4.1      Switch off the main and close the material discharge hole .

4.2      Open the lid of themass mixer. Dismantle the propeller blade .

4.3      Wash the dismantled accessories with 0.5% (v/v) Teepol solution, 0.1 % Sodium Lauryl Sulphate by using nylon brush and finally rinse with DM water.

4.4      Fill raw water upto ¼ of the MM and wash with nylon brushes to remove powder of previous product.

4.5      Drain the washed water through discharge hole, wash with 0.5% (v/v) Teepol solution and 0.1 % Sodium Lauryl Sulphate and finally rinse with DM water.

4.6      Wipe all machine parts with wet cloth and then with dry cloth.

4.7      Collect the washed water and send it to Quality Assurance to check the presence of any residual moiety.

4.8      Assemble the dismantled parts in it, after the approval of Quality Assurance.

4.9      Ensure that the discharge hole & panel board have been washed thoroughly.

4.10   Put the status label as “Cleaned” with date & time and allow for drying.

CLEANING PROCEDURE FOR FLUIDISED BED DRIER

1.    Objective:

To provide standard cleaning procedure of  Fluidized bed drier and its accessories.

2.    Scope:

2.1      This procedure covers dismantling and cleaning of Fluidized bed drier and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯  Q.A. Manager.

4.   Procedure:

4.1      Switch off the main supply.

4.2      Dismantle the product chamber, Retard chamber, prefilter and finger bag strap.

4.3      Wash the fixed chamber & dismantled accessories with 0.5% (v/v) Teepol solution and product chamber should be washed with 0.1% Sodium Lauryl Sulphate by using nylon brush. Finally rinse with DM water.

4.4      Wipe whole machine with wet cloth and then with dry cloth.

4.5      Collect the washed water and send it to Quality Assurance to check the presence of any residual moiety.

4.6      Assemble the dismantled parts in it, after the approval of Quality Assurance.

4.7      Put the status label as “Cleaned” with date & time and allow for drying.

CLEANING PROCEDURE FOR DRY SYRUP FILLING AND SEALING MACHINE

1.    Objective:

To provide standard cleaning procedure of Dry Syrup Filling & Sealing Machine & its accessories.

2.    Scope:

2.1      This procedure covers dismantling cleaning and assembling of Dry Syrup Filling & Sealing Machine and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯  Q.A.Manager.

4.    Procedure:

4.1      Wash all parts of the Dry Syrup Filling & Sealing machine with 0.5%v/v Teepol solution and rinse with DM water.

4.2      After that clean  the machine with dry cloth.

4.3      Collect the washed water and send it to Quality Assurance to check the presence of any residual moiety.

4.4      After the approval of Quality Assurance, Put the status label as “Cleaned” and allow for drying.

CLEANING PROCEDURE FOR DE FOILLING MACHINE

1.    Objective:

To provide standard cleaning procedure of De Foilling Machine & its accessories.

2.    Scope:

2.1      This procedure covers dismantling cleaning and assembling of De Foilling Machine and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯  Q.A.Manager.

4.    Procedure:

4.1      Remove all the previous products ( tablets,capsules,empty strips) from the De Foilling machine.

4.2      Clean the machine and it parts by clean musclin cloth.

4.3      Then clean the machine by IPA.

4.4      Then dry it properly and then switch on the De Foilling machine.

4.5      After that start   the machine.

CLEANING PROCEDURE FOR DE DUSTER

1. OBJECTIVE:


To provide standard cleaning procedure of De Duster & its accessories.

2. SCOPE:

2.1 This procedure covers dismantling cleaning and assembling of De Duster and its accessories.

2.2 Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3. RESPONSIBILITY:

 Operator.

 Chemist.

 Production Manager.

 Q.A.Manager.

4. PROCEDURE:

The vibratory tablet de-duster is primarily used to de-dust the core tablets, to exclude any loose powder adhering to the surface, otherwise the coated tablets produced are with uneven coating whereby they do not pass through the feed chute on strip sealing machine. Improper cleaning of this de-duster may also contribute addition of particles of the tablets already dedusted on this equipment. Therefore, it is necessary to clean this equipment as per standard operating procedure given below



4.1 As soon as dedusting operation of a particular batch of tablets is over, dismantle the entire sifting chamber by removing the 4 bolts on the sides.



4.2 W Remove the dust-collecting cup from the sifting chamber. Collect and weigh the dust. Record this weight in the relevant document.



4.3 R Clean the dismantled sifting chamber along with the bolts and empty dust-collecting cup with the help of nylon brush to remove any residual powder



4.4 Wash the parts mentioned in step 4.3 with running hot water.

CLEANING PROCEDURE FOR COMPRESSION MACHINE

1.    Objective:

To provide standard cleaning procedure of Compression Machine & its accessories.

2.    Scope:

2.1      This procedure covers dismantling cleaning and assembling of Compression Machine & its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯  Q.A.Manager.

4.    Procedure:

4.1      Dismantle the hopper, feed frame, upper & lower punches and dies.

4.2      Wash the hopper, feed frame & body cover with raw water followed by 0.5%v/v Teepol solution and finally rinse with DM water.

4.3      Wipe all the parts with wet cloth and then with dry cloth.

4.4      Clean the turret, weight adjustment screw, lower & upper punches with kerosene.

4.5      Wipe the tarret with wet absorbance cotton and squeeze the water .Send it to Quality Assurance for checking the presence of any residual moiety.

4.6      Assemble the dismantled accessories after the approval of QA.

4.7      Put the status label as “Cleaned” with Date and Time.

CLEANING PROCEDURE FOR COLLIDAL MILL

1.    Objective:

To provide standard cleaning procedure of Collidal Mill & its accessories.

2.    Scope:

2.1      This procedure covers dismantling cleaning and assembling of Collidal Mill and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯  Q.A.Manager.

4.    Procedure:

4.1      Switch off the mains.

4.2      Dismantle the hopper, hopper blade and SS hose.

4.3      Transfer all dismantled accessories into the steam kettle. Fill the steam kettle with cold water and heat it by means of steam.

4.4      Wash the accessories with 0.5%v/v Teepol solution. Now add preservatives into it and assemble the washed accessories.

4.5      Wipe all the parts with wet cloth and then with dry cloth.

4.6      Finally rinse with DM water by milling for 2 to 3 times. Collect the rinsed water and send it to Quality Assurance to check for the presence of the any residual moiety of previous product.

4.7      Put the status label as “Cleaned” with date and time after the approval from Quality Assurance.

CLEANING PROCEDURE FOR AF 40 CAPSULE AUTO FILLING MACHINE

1.    Objective:

To provide a standard cleaning procedure of  AF 40 Capsule filling machine and its accessories.

2.    Scope:

2.1      This procedure covers dismantling, cleaning and assembling of AF 40 capsule filling machine and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯   Q.A. Manager.

4.    Procedure:

4.1      Switch off the mains and close the air valve. Dismantle the hopper, augers, rotating table top, needle plates.

4.2      Wash the hopper with raw water followed by 0.1% sodium lauryl sulphate.

4.3      Wash the auger, rotating table top, needle plates with 0.5%v/v Teepol solution.

4.4      Rinse with DM water.

4.5      Clean the entire machine with wet cloth and then by dry cloth.

4.6      Put the status label as “Cleaned” with date and time.

CLEANING PROCEDURE FOR BLISTER PACKING MACHINE

1.    Objective:

To provide a standard cleaning procedure of  Blister packing machine and its accessories.

2.    Scope:

2.1      This procedure covers dismantling, cleaning of Blister packing machine and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

?  Operator.

?  Chemist.

?   Production Manager.

?  Q.A. Manager.

4.    Procedure:

4.1      Switch off the mains, close the air valve.

4.2      Dismantle the hopper, feeding channel, guide track, vibrator bowls, sealing & forming heater, sealing and forming roller, cutting tools main gear. Dismantle the printing gear, printing stereo’s/embossing letters from the cutting tools or BCP (Batch Code Printing) unit.

4.3      Wipe the printing roller and photosensitive unit with IPA. Wash the forming and sealing roller by raw water with high pressure.

4.4      Wipe the forming & sealing heater with liquid paraffin.

4.5      Wipe the all machinery parts with clean white wet cloth and then with dry cloth, which is free from fiber. Assemble the dismantled accessories.

CLEANING PROCEDURE FOR BALANCE USED IN PRODUCTION AREA

1.    Objective:

To provide standard cleaning procedure of Balance Used in Capsule Filling.

2.    Scope:

2.1      This procedure covers dismantling cleaning and assembling of Balance Used in Capsule Filling and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯  Q.A. Manager.

4.    Procedure:

4.1      Remove all the previous products from the base of the balance.

4.2      Clean the balance and its  parts by clean musclin cloth.

4.3      Then clean the balance by IPA.

4.4      Then dry it properly and then switch on the balance.

4.5      After that start  weighing the product.