1.0 OBJECTIVE:
1.1 To define the procedure for operating of Multimill machine.
2.0 SCOPE:
2.1 This Sop applies to the operating procedure for Multimill machine in the company.
3.0 RESPONSIBILITY:
3.1 Production Operators:
3.1.1 Responsible for operating the Multimill strictly as per this SOP.
3.1.2 To report any abnormal observations immediately.
3.2 Designee Production:
3.2.1 Responsible for ensuring that operators are trained and that the procedure is followed during every batch.
3.3 Designee Quality Assurance (QA):
3.3.1 Shall ensure line clearance.
3.3.2 To verify compliance.
3.3.3 To review batch-related documentation.
3.4 Engineering Dept:
3.4.1 Shall ensure equipment readiness.
3.4.2 To attend breakdowns.
3.4.3 To maintain the equipment.
4.0 DEFINATION:
4.1 Multimill :A Multimill is a versatile, high-speed machine for particle size reduction (granulating, pulverizing, mixing, shredding, chopping) of wet/dry materials, using interchangeable blades (knife/impact) and screens for controlled output, crucial for uniform drug mixing and improved dissolution in formulations.
5.0 PROCEDURE:
5.1 Safety precautions:
5.1.1 Before operating the equipment, ensure that all machine guards, safety interlocks, and emergency stop buttons are fully functional.
5.1.2 Operator shall never attempt to open the lid during equipment operation, and the Beater must not be run when the discharge valve is open unless specified for the process.
5.1.3 Operator shall ensure screen is not damaged, check mesh before and after every batch process.
5.1.4 Ensure that the rotating Beater (blade) does not rub with the frame and the screen.
5.2 Prestart check and operation:
5.2.1 Operator and Designee production shall ensure the cleanliness of equipment and area.
5.2.2 After line clearance from Designee QA, Operator / designee production shall put “EQUIPMENT STATUS” label duly filled and signed on the machine as per SOP.
5.2.3 Operator and designee production shall enter the start time of the batch in equipment usage log as per SOP.
5.2.4 Operator and designee shall check the integrity of S.S. screen used for milling process.
5.2.5 Place the required size S.S. screen holding plate and amount the holding plate and mount the holding plate on the two studs.
5.2.6 Lock by rotating clamp with the S.S. screen and mount the hopper.
5.2.7 Before start the machine, shall be set the required speed (Low, Medium and High) as per the requirement in the BMR by shifting the position of belt attached to motor and rotor.
5.2.8 Operator shall check and set the rotation of the blade (Impact forward or Knives Forward) by operating the knob.
5.2.9 Tightly tie a clean polybag open at both end at discharge port of multimill and keep clean container having polybag at down side of discharge port.
5.2.10 Switch ‘ON’ the main switch of Multimill.
5.2.11 Load the material to be milled scoop by scoop with steady speed.
5.2.12 Continue the operation till batch material is over.
5.2.13 After completing the operation, switch off the equipment, open the polybag and remove the cover.
5.2.14 Remove any adhering material outside the screen with gloved hand and collect it into the polybag.
5.2.15 Remove the container in which milled material is collected and label it properly.
5.2.16 After batch completion, shall remove “EQUIPMENT STATUS” label and affix “TO BE CLEANED” label to the sifter.
5.2.17 Enter the batch completion time in equipment usage log as per SOP
6.0 REFERENCES:
6.1 Machine operating manual
6.2 Equipment Cleaning SOP
7.0 RECORDS:
Sr No. Title Document No.
NA NA NA
8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01