To lay down a procedure for cleaning, equipment line clearance & Operation of the double jacketed liquid manufacturing vessel.
It is applicable for cleaning, calibration, equipment line clearance & Operation of the double jacketed liquid manufacturing vessel.
Quality assurance officer
4. Cleaning Procedure
0.5% SLS, 0.1% Dettol, Potable Water, Purified Water, Hot Water,
cleaning equipment: Nylon brush, dry cloth.
For Product to Product Change Over and Batch to Batch Change Over
4.1 Remove the product label from double jacketed manufacturing vessel
4.2 Wash the vessel with potable water scrub the vessel (Inside & outside) with the help of a nylon brush using 0.5% SLS in water.
4.3 Wash the vessel with a sufficient quantity of potable water so that all adhering material is completely removed and finally with purified water.
4.4 Clean the inside surface with warm water from 40°C to 50°C followed by 0.1% Dettol solution. Then wash with plenty of water to remove the Dettol completely, and then rinse with purified water.
4.6 Wipe the stand and transfer pipe thoroughly using the wet cloth.
Rinse the vessel’s outer surface with purified water.
The equipment should be cleaned before and after every product to product and batch to batch change over. As per the above-given method.
Display the “Cleaned and Ready for Use” status label after cleaning the machine.
5. EQUIPMENT LINE CLEARANCE
5.1 Ensure that the area is cleaned as per SOP.
5.2 Ensure that the double jacketed manufacturing vessel is cleaned as an above-mentioned method.
5.3 Ensure that all containers, documents, and labels of previous product/batch are removed and the status board is updated.
5.4 Ensure that the nearby area is free from the previous products.
5.5 Ensure that all the gloves and accessories of the previous product/batch are removed.
5.6 Check the Temperature, Relative Humidity, and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
5.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all the above points and the BMR, Final Line Clearance should be given by the In-Process Quality Assurance Officer.
6.1. Check and make sure that the double jacketed Manufacturing Vessel has been cleaned as per SOP
6.2. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP
6.3 Load the materials from the containers/drums into the double jacketed vessel as per the sequence specified in the Individual product BMR.
6.4 Close the lid of the vessel.
6.5 After all the required materials are loaded into the vessel; it is allowed to run for the required time as per the Individual product BMR
6.6 Switch ON the equipment, open the steam valve& start the mixing of material as per the time specified in the BMR
6.7 Switch OFF the equipment, when mixing time is complete.
6.8 Close the steam valve of the jacketed vessel.
6.9 Allow the solution to cool about 50°C
7.1 Before starting the mixing ensure that the inner and outer surface of the double jacketed Manufacturing Vessel is cleaned as per the standard procedure.
7.2 During mixing attach the status label to the double jacketed Manufacturing Vessel specifying the name of the product, Batch no., Mfg Date., and Expiry Date along with the signature of the production manager.
7.3 The operator and other people involved in the manufacturing should wear clean hand gloves, a head cap, and a nose mask.