Operation and Cleaning of Coating Machine

1.0           Purpose

1.1            To define the operation and cleaning procedure of Tablet Coating Machine to maintain the machine in proper use and in efficient working order.

 

2.0           Scope

2.1         This Sop is applicable for operation and cleaning of Tablet Coating Machine of tablet        manufacturing area at "NAME" Pharmaceuticals Ltd.

 

3.0           Responsibility

3.1            Only concern operator is responsible for normal operation. He/ She inform the supervisor about any deviation from normal operation. He also maintains log book.

3.2            Sr. Officer- Production/Officer- Production is responsible for monitoring day to day activity.

3.3            Production Officer and Quality Assurance Officer should ensure that the procedure is implemented properly.

 

4.0           Abbreviations and Definitions

4.1            BMR     :Batch Manufacturing Record

4.2            Machine Major parts and it’s functions:

Sl. No.	Name of Machine Part	Function
01	Coating Pan	To load the tablets for coating
02	Baffles	To provide the movement to the tablets during coating
03	Spray guns assembly	To spray the coating solution on the tablets
04	Control Panel	To control the various function of the machine

 

5.0           Materials and Equipment

5.1            Clean lint free cloth

5.2            Hose pipe

5.3            Hand brush

5.4            Tap water / portable water

5.5            Purified water

5.6            Detergent Solution / Cleaning agent : 0.4% (w/v) Sodium Lauryl Sulphate solution ;  4 gm Sodium lauryl Sulphate  is  dissolved in 1.0 liter of portable / tap water to prepare detergent solution.

5.7            70 % Isopropyl Alcohol.

6.0           Precaution / Health and Safety Considerations

6.1            Before Operation

6.1.1        Check the connecting condition of ducts and junction parts.

6.1.2        Check the pressure gauge of compressed air (4-6 bar)

6.1.3        Do not operate as soon as turning on the operation power.

6.1.4        Check the cleanliness of the coating pan and filter bag ( dust collector) before operation.

6.1.5        Ensure the drain line is “Off”.

6.1.6        Ensure the coating pan has been dried properly.

6.2            During Operation

6.2.1        Close the door to protect heat loss during the machine operation.

6.2.2        Check the spray status & nozzle performance.

6.3            After Operation

6.3.1        Check the main electric power has switched off.

6.3.2        Disassembling the coating objects & the coating solution liquid contacting part & clean.

6.4            During Cleaning

6.4.1        Check the drain line & Water line to “ON”.

6.4.2        Wear gloves during cleaning.

 

7.0           Procedure

7.1           Operation

7.1.1       Production person shall ensure the cleanliness of the machine and room.

7.1.2       Before starting the operation production person get the line clearance from QA person and affix the status   label with Product Name, batch details to equipment.

7.1.3       Switch on the main power supply, then Stabilizer switch on.

7.1.4       Switch on the power supply of the machine.

7.1.5       Transfer the uncoated tablets to the coating room .

7.1.6       Switch on the mains of Coating pan motor, Exhaust system and Hot air blowers.

Ø Ensure the work and effectiveness of exhaust system and hot air blowers.

Ø Arrange the position of hot air blowers and exhaust pipes.

7.1.7       Open the acrylic window and load weighted quantity of uncoated tablets in the coating pan.

7.1.8       Set the coating parameter such as inlet temperature, outlet temperature, pan speed, air pressure and spray rate as specified in product BMR.

7.1.9       Pre-warm the tablets at set temperature as mentioned in BMR.

7.1.10     Take the 20 tablets after pre-warming and record the weight in BMR.

7.1.11     Insert the spray guns assembly in to the pan and start atomizing air by turning the knob then start the peristaltic pump.

7.1.12      Adjust the spray rate of coating solution as mentioned in BMR / as required.

7.1.13     Carry out coating operation as per standard procedure laid down in the product BMR.

Following parameters must be strictly adhered to:

a.     Required temperature of the bed.

b.     Compressed air pressure.

c.     Rate of atomizing air pressure

d.     Exhaust system

e.     Spray pattern

7.1.14     After completion of the solution or process dry the tablets for at least 5 to 10 minutes or as per BMR.

7.1.15     After completion of coating, check physical parameter of coated tablets as per product BMR.

7.1.16     Unload the coated tablet in the double polyline HDPE containers with appropriate label affixed on them.

7.1.17      Affix “To Be Cleaned” label on the machine and fill the “Machine Logbook”. (Annexure-I)

7.2            Cleaning

7.2.1      Product to product cleaning (Type-A cleaning)

7.2.1.1     Dismantle the spray gins, silicon tubes from the gun stand and send it to washing area.

7.2.1.2     Rotate the pan for about 5 minute and spray sufficient potable water on coating pan by hose pipe.

7.2.1.3     Remove this turbid water and transfer it into container.

7.2.1.4     Clean adhered dust and sticky materials from coating pan, baffles with clean lint free cloth.

7.2.1.5     Rub the inner surface of coating pan and baffles with hand brush soaked in 0.4% Sodium Lauryl Sulphate solution (4 gm/liter).

7.2.1.6     Wash the coating pan, baffles with portable water until no residue of previous product remain.

7.2.1.7     Finally rinse with purified water.

7.2.1.8     Wipe the surface coating pan, baffles and machine cover with dry clean lint free cloth to remove the water.

7.2.1.9      Wipe the inner surface coating pan, baffles again with lint free cloth dampened with 70% IPA       (Isopropyl Alcohol).

7.2.1.10  Clean the electric parts of the machine with dry clean cloth.

7.2.1.11  Wash the spray gun, assembly and silicon tubes with purified water and dry it with lint free cloth.

  

7.2.2      Batch to Batch Cleaning (Type-B Cleaning)

7.2.2.1   Ensure the power supply to the machine is disconnected.

7.2.2.2   Clean the machine with clean lint free cloth.

7.2.2.3   Affixed the Cleaning Certificate label on it.

 

7.2.3      Machine operator / worker will request Production Officer and QA Officer for checking visual inspection.    

7.2.4      At first Production Officer will check the machine and its surroundings, then QA Officer will check the machine and its surroundings. If it found satisfactory result, then he / she will issue “Cleaned” label.

7.2.5      Record in Machine Logbook (Annexure-I) and affix the label of “Cleaned” in the machine.

7.2.6      After cleaning the machine if it remains without operation for next 72 hour, will undergo Re-cleaning operation.

8.0           Reference Document

8.1         In-house

 

9.0           Annexure

9.1         Annexure-I         : Format of ‘Machine Logbook’

  

 

10.0         Revision History

 

 

Revision No.	Brief reason for the revision	Effective Date	Remarks
01	New

 

11.0        Training

11.1       Head of Production or his nominee give the training of production operator and worker.