Mass mixer operation, cleaning and Line clearance

Table of Contents

1.0 OBJECTIVE

To lay down the procedure for operation, cleaning and line clearance of Mass mixer (150Kg).

2.0 SCOPE

This procedure is applicable for operation, cleaning and line clearance of Mass mixer (150Kg) present at <Company Name>

3.0 RESPONSIBILITY

3.1 Executive-Production

3.2 Head-Production

3.3 Executive-IPQA

3.4 Head-QA

4.0 PROCEDURE

4.1 Operation:

4.1.1 Before Operation, Production person shall ensure the cleanliness of Mass Mixer & “Cleaned” Label on it.

4.1.2 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.

4.1.3 Open the lid of the mass mixer and load the materials as specified in the batch manufacturing record.

4.1.4 Close the lid with locking clamps.

4.1.5 Connect the power supply to mains, switch on the mains.

4.1.6 Mix the contents in specified time as given in the individual Batch Manufacturing Record.

4.1.7 Add the binder by opening the lid and close the lid after total addition of binder, and then run the mixer to the required time as per the BMR.

4.1.8 After the wet mixing, discharge the wet mass into the bowl by opening the discharge port at the bottom.

4.1.9 Collect the material from Mass Mixer into double layered polythene bag kept in SS or suitable container. Close the poly bags and label the container.

4.1.10 Close the mass mixer and place a “TO BE CLEANED” tag on it.

4.1.11 Enter Usage the details of the mass mixer in “Equipment Log” book.

5.1 Cleaning

5.1.1 Remove the dust from external surface of the Mass mixer with vacuum cleaner or dry lint free cloth.

5.1.2 Clean the inner surface of the mass mixer with plenty of warm potable water and soak for 15 minutes, if sticky material is present.

5.1.3 Then rotate the spiral Mass mixer 2 minutes and then discard the water.

5.1.4 Spray the warm 0.1% Teepol and scrub inner surface and baffle with sponge.

5.1.5 Rinse with Potable water until traces of the 0.1% Teepol is completely removed.

5.1.6 Then rinse with Purified water.

5.1.7 Check the Clarity of the purified water.

5.1.8 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.

5.1.9 Wipe out the water completely from the inner surface of the mass mixer by dry lint free cloth.

5.1.10 After Completion of drying, Keep “CLEANED” status label on the equipment.

5.1.11 Close the lid after drying.

5.1.12 Enter the details in the cleaning Log sheet.

5.1.13 Re-cleaned, if not used within 72 hours.

6.1 Line clearance

6.1.1 Make sure that the equipment is cleaned as per SOP and the equipment is affixed with “CLEANED” status.

6.1.2 Ensure that all the accessories of previous product/batch are removed.

6.1.3 Check the Temperature and Relative Humidity of the cubicle and enter the same in the BMR Record.

6.1.4 Ensure the status label for next product to be mixing should be affixed with details like Name of the Product, Batch No and Batch Size etc.

6.1.5 Ensure that the outer surface of the Mass mixer is clean and dry.

6.1.6 Make sure that the helical blades on the shaft present in the Mass mixer should be clean and dry.

6.1.7 Ensure the lid that covers the Mass mixer (Inner surface) should be clean and dry.

6.1.8 Ensure that the direction of Mass mixer movement (clock wise or anti clock wise) is appropriate for drug product.

6.1.9 Make sure that the inner surface of the Mass mixer is clean and dry.

6.1.10 The discharging port is cleaned or not.

6.1.11 Make sure that the mixed material collecting HDPE container should be clean and the fitted with two polythene bags such as inner and outer.

6.1.12 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).

6.1.13 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance (IPQA) Executive.