1.0 OBJECTIVE
To lay down the procedure for Operation of rapid mixer granulator.
 |
2.0 SCOPE
This procedure is applicable to Operation of rapid mixer granulator present XXX Company.
3.0 RESPONSIBILITY
3.1 Executive-Production
3.2 Head-Production
3.3 Executive-IPQA
3.4 Head-QA
4.0 PROCEDURE
4.1 Before starting of the operation, Production person get the line clearance from IPQA person and affix the status label with Product Name, Batch Details to equipment and area.
4.2 Open the bowl lid by disengaging the toggle clamps.
4.3 Fix the impeller blade and chopper blade.
4.4 Close the discharge assembly.
4.5 Open the compressed air valve to supply the air to impeller & chopper, maintain adequate air pressure. Ensure that air is coming out through the vent port provided on lid.
4.6 Switch “ON” the mains electrical supply.
4.7 Charge the material to be granulated and close the lid and switch “ON”
4.8 Set the Timer for dry mixing by impeller blade selector provided in the panel.
4.9 Start the dry mixing by impeller blade at slow or fast speed ( as required) as per batch manufacturing record.
4.10 After completion of the dry mixing, reset the timer as per batch manufacturing record and add paste / binder for biding through charging port.
4.11 Similarly set the timer for chopper as required and operate the chopper at slow or fast given the BMR.
4.12 Start the impeller blade by setting the time in the panel.
4.13 After completion of granulation, keep the bowl discharging port point & start the mixing motor at slow speed (Chopper motor should be “OFF”) open the discharge valve and collect the material.
4.14 Scrap the leftover material from inner surfaces of mixer and chopper and add into bowl and transferred for further process.
4.15 Put “OFF” the mains after completion of the operation.
4.16 Affix “TO BE CLEANED” Label and fill the “Equipment Log Book.
5.0 ABBRIVIATIONS
5.1 RMG-Rapid Mixer granulator
5.2 IPQA-In process Quality Assurance
5.3 BMR-Batch Manufacturing Record
5.4 QA-Quality Assurance
6.0 ANNEXURE
Nil
-------------------Cleaning SOP-------------------------------------------
1.0 OBJECTIVE
To lay down the procedure for cleaning of rapid mixer granulator.
2.0 SCOPE
This procedure is applicable to cleaning of rapid mixer granulator present at XXX company.
3.0 RESPONSIBILITY
3.1 Executive-Production
3.2 Head-Production
3.3 Executive-IPQA
3.4 Head-QA
4.0 PROCEDURE
4.1 Wipe of the all residual powder from external surface of Rapid Mixer Granulator (RMG) with dry lint free cloth followed by wet cloth.
4.2 Clean the External surface of the RMG with about 50 litres of potable water followed by 0.1% teepol solution and again rinse with 50 Litres of potable water.
4.3 Close the discharge valve by start purging the air.
4.4 Fill the RMG Bowl with sufficient quantity of potable water and make sure that the copper and impeller blades should be dip into the potable water.
4.5 Start the impeller and chopper at slow speed for 5 minutes followed by impelled and chopper for 2 minutes.
4.6 Stop the impeller and chopper.
4.7 Open the discharge port and run impeller at slow speed to drain the water to the designated drainage system. Stop the impeller and after completion of the drain.
4.8 Open the lid and wipe with lint free cloth.
4.9 Dismantle the chopper and impeller.
4.10 Clean the parts with potable water followed by 0.1% teepol solution.
4.11 Clean the parts with potable water until trances of detergent are completely removed.
4.12 Assemble the chopper and impeller
4.13 Start purging air, close the discharge lid.
4.14 Collect the about 100 liters of hot water and repeat the 4.6 to 4.8.
4.15 Start purging air, close discharge port, open lid and collect about 200 Ltrs of purified water and repeat the step 4.6 to 4.8.
4.16 Check the Clarity of the purified water.
4.17 Send a sample of 100 ml finally rinsed water (those are collected from the outlet of tank) for Rinse water analysis to Quality Control department. The sample shall be collected by IPQA Person.
4.18 Wipe out the water completely from the dismantled parts with clean dry lint free cloth.
4.19 After Completion of drying, Keep “CLEANED” status label on the equipment.
4.2 Enter the details in the cleaning Log sheet.
4.21 Re-cleaned, if not used within 72 hours.
5.0 ABBRIVIATIONS
5.1 RMG-Rapid Mixer granulator
5.2 IPQA- In-process Quality Assurance
6.0 ANNEXURE
Nil
----------------------------------------LINE CLERANCE---------------------
1.0 OBJECTIVE
To lay down the procedure for line clearance for Rapid mixer granulator.
2.0 SCOPE
This procedure is applicable for line clearance for Rapid mixer granulator at XXX company.
3.0 RESPONSIBILITY
3.1 Executive-Production
3.2 Head-Production
3.3 Executive-IPQA
3.4 Head-QA
4.0 PROCEDURE
4.1 Make sure that the equipment is cleaned as per SOP and the equipment is affixed with “CLEANED” status.
4.2 Ensure that all the accessories of previous product/batch are removed.
4.3 Check the Temperature and Relative Humidity of the cubicle and enter the same in the BMR Record.
4.4 Ensure the status label for next product to be Granulated or mixed should be affixed with details like Name of the Product, Batch No and Batch Size etc.
4.5 Ensure that the rapid mixer granulator bowl inner surface is clean and free from visible particles.
4.6 Ensure that the main impeller blade present in the rapid mixer granulator is clean and dry.
4.7 Ensure that the Granulator present on one side of the body in the rapid mixer granulator is clean and dry.
4.8 Ensure that the pneumatically opening and closing discharge port is working properly or not.
4.9 Ensure that the outer surface of the rapid mixer granulator (RMG) is clean and dry.
4.10 Ensure that the SS cover with suitable ring gasket seal is intact.
4.11 Ensure that the clamps for main lid and feeder lids are working properly.
4.12 Ensure that the feeder for slurry or solution, air vent is clean and the clamps are tightly closed.
4.13 Line clearance is given by Production Executive to start the next batch, after checking the above mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
4.14 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance (IPQA) Executive.
5.0 ABBRIVIATIONS
5.1 QA-Quality assurance
5.2 SOP- Standard Operating Procedure
6.0 ANNEXURE
Nil
.JPG)
![Difference between Stability[Shelf life] Specification and Release Specification](https://4.bp.blogspot.com/-O3EpVMWcoKw/WxY6-6I4--I/AAAAAAAAB2s/KzC0FqUQtkMdw7VzT6oOR_8vbZO6EJc-ACK4BGAYYCw/w680/nth.png)
0 Comments