1.0 OBJECTIVE
To lay down the operating procedure for Multi mill.
2.0 SCOPE
This procedure is applicable for Operating of multi mill 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 Before assembling, Production person shall ensure the cleanliness of Multi Mill, sieves and gasket & “Cleaned” Label on it.
4.2 Before starting 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.
4.3 Assembly of multimill Processing chamber
4.3.1 Fix knives in rotor as per requirement of sizing i.e., “Impact edges” or “Knife Edge” forward. Ensure that blades fixed in the rotor are in 4,3,4,3 sequence and none of the blades are missing. Fix the key to the central shaft.
4.3.2 Fix the rotor with blades to the central rod of multimill with the rotor fixing screw.
4.3.3 Fix the required intact screen base plate on multimill properly tightening two sides nuts.
4.3.4 Check that knives of the rotor are not touching the screen by turning the belt by hand. Close and lock the milling chamber guards. Fix the feeding hopper and cover it with lid.
4.4 Operation of Multimill
4.4.1 Check the screen integrity before and after completion of operation.
4.4.2 Set the multi mill in required direction (Knife forward / Impact forward) by moving the lever / knob). Then adjust the required by changing the position of the V- knob.
4.4.3 Tie the poly bag to the discharge chute of multi mill and keep the poly bag in SS or other suitable container and then place container below the discharge chute.
4.4.4 Put “ON” the mains and load the material, adjust the feed chute plate so that material will feed slowly.
4.4.5 The material fed in the hopper enters into the processing chamber where SS beaters having knife and impact edges rotate within a selected screen in a spiral motion and mill the material which is finally passes through screen.
4.4.6 Control the flow with stopper plate and ensure that the hopper is not charged heavily otherwise the multi mill can get blocked.
4.4.7 Put off the mains after completion of the operation
4.4.8 Place a “TO BE CLEANED” tag on it.
4.4.9 Enter Usage the details of mulitimill in the “Equipment Log” book.
5.0 ABBRIVIATIONS
5.1 SS-Stainless Steel
5.2 IPQA - In-process Quality Assurance
5.3 QA - Quality Assurance
6.0 ANNEXURE
Nil
--------------------------Cleaning SOP-----------------------------
1.0 OBJECTIVE
To lay down the cleaning procedure for Multi mill
2.0 SCOPE
This procedure is applicable to Cleaning of Multi mill 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 Remove the dust from the external surface of the body with wet / dry lint free cloth.
4.2 As soon as the milling process is completed, dismantle the following parts.
4.2.1 Beater assembly
4.2.2 Feed frame
4.2.3 Screen
4.2.4 Gasket
4.3 Remove all the dismantled parts and take it in to washing area.
4.4 Remove all the residual powder adhering to above mentioned articles with the help of a nylon brush and vacuum cleaner.
4.5 Clean each dismantled parts with potable water followed by spraying the warm 0.1% Teepol and scrub with sponge.
4.6 Rinse with Potable water until traces of the 0.1% Teepol is completely removed.
4.7 Then rinse with Purified water.
4.8 Check the Clarity of the purified water.
4.8.1 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.
4.9 Wipe out the water completely from the dismantled parts by dry lint free cloth.
4.10 After Completion of drying, Keep “CLEANED” status label on the equipment.
4.11 Enter the details in the cleaning Log sheet.
4.12 Re-cleaned, if not used within 72 hours.
5.0 ABBRIVIATIONS
5.1 IPQA - In-process Quality Assurance
5.2 QA - Quality Assurance
6.0 ANNEXURE
Nil
---------------------------Line clerance SOP----------------------------------
1.0 OBJECTIVE
To lay down the procedure for line clearance of multi Mill.
2.0 SCOPE
This procedure is applicable for line clearance for multi mill 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 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 milled should be affixed with details like Name of the Product, Batch No and batch Size etc.
4.5 Ensure that the outer surface of the multi mill is clean and dry.
4.6 Ensure that Feed chute is clean and dry and the discharge plate is open and close as and when required.
4.7 Make sure that the speed of the multi mill is correctly adjusted for the Drug product milling.
4.8 Ensure that the knives are in good condition and moving in clock wise direction.
4.9 Check the sieve integrity and should not have any scrapes and holes.
4.10 Ensure that the sieve is correctly fixed to the base plate and tightly the base plate of the multi mill.
4.11 Ensure that the discharge chute is clean and dry.
4.12 Make sure that the milled material collecting HDPE container should be clean and the fitted with two polythene bags such as inner and outer.
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 SOP- Standard operating procedure
5.2 HDPE- High Density Polyethylene
6.0 ANNEXURE
Nil
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