A Rapid Mixer Granulator (RMG), also known as a High Shear Mixer Granulator, is a versatile piece of equipment widely used in the pharmaceutical industry.
TYPE “A” CLEANING:
Status label shall be updated as “TO BE CLEANED”.
RMG mains shall be switched off before cleaning.
Labels, materials and containers of previous batch shall be removed from the granulation area.
Material adhered to the inner surface of the RMG shall be scraped by using Teflon Scrapper.
Powder adhered to the outer surface of the RMG shall be removed by using vacuum cleaner.
The outer surface of the RMG shall be wiped using dry lint free cloth. Cleaning details shall be recorded in the equipment logbook. Update the status as “CLEANED”.
Frequency: After every batch of the same product.
TYPE “B” CLEANING:
Status label shall be updated as “TO BE CLEANED”.
Ensure that the mains are switched off before cleaning.Labels, materials and containers of previous batch shall be removed from the granulation area.
Remove any adhering material from the surface of the RMG with vacuum cleaner.
The outer surface of the RMG shall be wiped using dry lint free cloth.Ensure that the discharge valve shall be in open condition and place SS container below the discharge valve of the RMG.
Remove any adhering material from the inner surface of the RMG using Teflon scrapper.Ensure that the RMG top lid is in open condition.Remove any adherent material from the bowl with Teflon scrapper.
Remove the impeller by unlock the impeller tightening bolt manually and kept on pallet.Remove the chopper blades by unlock the chopper tightening bolt with help of an Allen key and keep on pallet.
Dismantle the co mill and co mill parts and keep the parts on pallet.Scrub the inner surface of the RMG 300ltrs shell with 100Ltrs of potable water and 100ltrs shell with 50ltrs of potable water by using nylon scrubber to remove all the adhering material.
Scrub the impeller and chopper blades with 50Ltrs of potable water by using nylon scrubber until all the adhering material will removes.Rinse the RMG shell, impeller and chopper blades with 25 Liters of potable water.
Dismantle the discharge port by unclamp the TC clamp.
Scrub the inner and outer surface of the discharge port with 25Ltrs of potable water to remove all adhering material.
Scrub the wet Co-mill parts with 25Ltrs of potable water to remove the adhering material.
Clean the outer surface of the RMG and platform with 25 liters of potable water.Finally rinse the 300Ltrs RMG shell, impeller, chopper and discharge port with 50Ltrs of purified water and 100Ltrs RMG shell with 30ltrs of purified water.Wipe the RMG body and control panel with lint free cloth dipped in purified water.
Clean the RMG gaskets, vent filters with 30 liters quantity of potable water and rinse with 20 liters purified water.Clean the binder addition port and silicon tubes with 30Ltrs of potable water followed by rinse with 20ltrs purified water.Drain out the water droplets from the silicon tubes by hanging the tubes to SS stand.
Wipe the peristaltic pump with lint free cloth dipped in purified water and wipe with dry lint free cloth.Wipe the inner and outer surface of the RMG shell, impeller, chopper and discharge port with dry lint free cloth.
Finally wipe the RMG body with dry lint free cloth.Walls, ceiling, doors and glass shall be wiped with lint free cloth dipped in potable water, wipe with dry lint free cloth.Area shall be moped with disinfectant solution.
Status label shall be updated as “CLEANED”.
Record the cleaning details in the equipment logbook.
Note for Type B Cleaning:
For Type B Cleaning first clean the equipment with lint free cloth then after clean with potable water. If needed the equipment surface can be rubbed with nylon brush or lint free cloth. If a product is not clean with water, then a cleaning agent can be added in potable water. Then after rinse with potable water and followed the rinsing of equipment with purified water. After rinsing equipment shall be dry with compressed air then wipe with lint free cloth. After drying the surface of equipment shall be wiped with 70% IPA.
Frequency:
After every batch of the same product from higher to lower strength and lower to higher strength.
For Product-to-Product changeovers.
Major breakdown of equipment.
As when required.
REFERENCES:
Not Applicable
ANNEXURES:
ANNEXURE NO
TITLE OF ANNEXURE
Annexure-I
Type B cleaning work sheet for Rapid Mixer Granulator (Tapasya -100ltrs, 300ltrs)
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Production
Master Copy : Quality Assurance Department
ABBREVIATIONS:
QA
:
Quality Assurance
SS
:
Stainless Steel
IPA
:
Isopropyl Alcohol
No.
:
Number
SOP
:
Standard Operating Procedure
REVISION HISTORY:
CHANGE HISTORY LOG
Revision No.
Details of Changes
Reason for Change
Effective Date
00
New SOP
Not Applicable
To be written manual
ANNEXURE-I TYPE B CLEANING WORK SHEET FOR RAPID MIXER GRANULATOR (TAPASYA -100LTRS, 300LTRS)
