cGMP and Regulatory Updates

ASSEMBLING 1. Fix knives in rotor as per requirement of sizing i.e., “Impact edges” or “Knife Edge” forward. 2. 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. 3. Fix the rotor with blades to the central rod of multimill with the rotor fixing screw. 4. Fix the required intact screen base plate on multimill properly tightening two sides nuts. 5. Fix the belt on the appropriate wheel of the pulley, so as to get required speed fast, medium or slow. Give proper tension to the belt by moving movable pulley apart and lock it in position. 6. Check that knives of the rotor are not touching the screen by turning the belt by hand. 7. Close and lock the milling chamber guards. 8. Fix the feeding hopper and cover it with lid. OPERATION 1. Place a new polythene bag in a clean plastic container and tie to the bottom of the multi-mil...

CAUTION : 1. Check and certify that area and equipment are clean and suitable for starting the operation. 2. Ensure that main is in “OFF” position before dismantling FBD for loading. A. ASSEMBLING : 1. Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley. Take out trolley along with the retarding chamber. 2. Check and certify the suitability of the clean finger bag. 3. Fix the loops of the finger to the hooks of the shaker. 4. Place the bag in between the retarding chamber and fluidization chamber. 5. Clamp the retarding chamber on the body with fixing bolts. B. OPERATION LOADING 1. Load the bowl with material to be dried. 2. Rake the product uniformly in the bowl to avoid lumps. 3. Move the product bowl below the retarding chamber keeping the window in viewing position. 4. Position the bowl. 5. Lift the bottom of the FBD by moving the j...

Drying is required to remove moisture from wet granulation. Fluid bed drying offers saving of time and labour thus increasing efficiency. It is better described as air diffusion drying system. It is essential that the production supervisor confirm that the equipment is in clean condition before the same is used for any of the operations, in order to avoid cross contamination. Following cleaning and assembly procedure will be followed whenever there is a product change over or after the completion of 10 batches of the product even if the same product granulation is to be continued thereafter. A. Procedure for Product to Product Change Over. 1. Cleaning external surface and plenum – cleaning the body of the drier and plenum with a dry clean duster. Then wipe it with a duster soaked in 0.1% Teepol solution followed by a duster soaked in 5 micron filtered water. 2. Dismantling a. Detach finger bag from hook by opening perplex window in the retarding...

Operating Procedure Check the area is clear of previous product materials and documents. Remove the “Cleaned and Ready for Use” status label from the vessel. Start paste preparation after the steam jacketed vessel is cleaned as per SOP Make a slurry with specified amount of purified water and disperse the specified amount of starch by adding with spatula as per the product SOP. Load the specified amount of purified water into the SS steam jacked vessel open the steam valve till the water gets boiled. Dissolve the preservatives and other materials by stirring with SS spatula as per product SOP. Close the steam valve of the jacketed vessel unload the paste. Allow the paste to cool about 50°C Status label Display “To be Cleaned” status label once the operation is completed.

Objective It is absolutely essential to clean the steam jacked vessel thoroughly every day before and after activity to ensure the absence of traces of any product to prevent any cross contamination. Cleaning Materials Cleaning agents : 0.5% SLS, Purified Water Cleaning equipments : Nylon brush, dry cloth. Cleaning Procedure Remove the product label from steam jacked vessel Wash the vessel with potable water scrub the vessel (Inside & outside) with the help of nylon brush using 0.5% SLS in water. Wash the vessel with sufficient quantity of potable water so that all adhering material is completely removed and finally with purified water. Repeat the above steps if adhering of traces of any product material is found. Wipe the stand and steam pipe thoroughly using wet cloth. Rinse the vessel with purified water. If the vessel is not used immediately wipe with clean and dry cloth. Cleaning Schedule After every usage and also before...

1. Purpose : This procedure explains how to clean Planetory mixer. Cleaning is an important process which avoids cross contamination. 2. Scope : 2.1. Cleaning is an important process which avoids cross contamination. 2.2. This procedure needs to be performed whenever the manufacturing process is completed. 3. Responsibility : Operator Production Supervisor Production Executive 4. Materials & Equipments : Liquid Soap Solution Nylon brush Clean Lint free cloth Potable Water Purified Water Scrubber 5. Procedure : 5.1. Lift the beater assembly up. 5.2. Switch off the Mains and disconnect the power cord. 5.3. Ensure that the equipment is possessing ‘ TO BE CLEANED ‘status label. Remove the label and attach the same to the BMR. 5.4. Dismantle the beater from the main shaft. 5.5.Remove the bowl from the cradle. Wash the beater and bowl with water to remove t...

Instructions for the Officer 1. Collect the keys from the security gate. 2. Switch on the lights located at the entry of the department. 3. Check that the seal on the main door of the tablet department intact and only then open the department. 4. Switch on the main switches and switches of emergency light. 5. Switch on the air curtain and Fly-O-Cide. 6. Keep the main key on the department keyboard and collect other keys of different areas. 7. Open each section of the department. Switch on the lights. Switch on the dehumidifiers and air – conditioners. 8. After opening of each area, keep all the keys respectively on a department keyboard. 9. Switch on the air – blower and exhaust system of the granulation area. 10. Check the following points for cleanliness: a. Main Floor b. Floor of all areas c. Walls of the sifting area d. All ...