B-605
Vibratory Filler
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1.0 Purpose This procedure defines the process of setup, operation, and cleaning of the vibratory filler. 2.0 Scope This procedure applies to the vibratory fillers in operation at Ion Labs, Inc. 3.0 Responsibility 3.1 ‘It is the responsibility of Production (Packaging) personnel to follow this procedure. 3.2 It is the responsibility of the Department Supervisor/Manager to implement this procedure and to ensure that the procedure is being followed. Buck It is the responsibility of Production and/or Maintenance & Engineering to keep this procedure aligned with current practices. 4.0 Definitions N/A 5.0 References 5.1 B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment 5.2 B-105, SOP, Preparation of Cleaning and Sanitizing Chemicals for Production [SOP Standard Operating Procedure SOP No | Rev Vibratory Filler B-605 0 Page 2 of 4 6.0 Procedure 6.1 Setup 6.1.1 Ensure that the machine is clean and cleared of all previously used materials. 6.1.2 Select and install the correct Discharge Nozzle, making sure the Nozzle is directly above the bottle. 6.1.3 Install the hopper. 6.1.4 Adjust the hopper opening to 1.5x the product size. 6.1.5 Install all of the vibrator trays. 6.1.6 Install the Counter Headbox Block. 6.1.7 Edit the count to the count required in each bottle. 6.2 Startup 6.2.1 Start the Vibratory Filler 6.2.2 Allow trays to fill with product to achieve the proper count 6.2.3 Stop machine after 3 “batches of bottles are filled. 6.2.3.1 Ensure all product is correctly entering the bottle. 6.2.3.1.1 Make adjustments to the index method as needed. 6.2.3.1.2 Make adjustments to discharge as needed. 6.2.3.2 Count the product in the bottles to ensure correct count is being made. 6.2.3.2.1 Make adjustments to vibratory filler as needed to ensure good count. [SOP Standard Operating Procedure SOP No | Rev Vibratory Filler B-605 0 | Page3of4 6.2.4 Repeat the startup process until a good count is made. 6.3 Operation 6.3.1 Start the vibratory filler 6.3.2 The vibratory filler should be monitored throughout the entire production run to confirm good counts. 6.3.3 Keep hopper full of product at all times 6.3.4 Monitor trays to confirm good product separation 6.3.5 Monitor the bottles as they are coming out of the index pins and confirm they are stable 6.3.6 Monitor the bottles as they exit the conveyor and crossing over to the next conveyor without any difficulties 6.37 Monitor the indexing rate that it is not too fast or too slow for the next machine on the line 6.3.8 Monitor the bottles entering the filler that they do not entire harshly 6.3.9 Monitor the vibratory filler that the counter properly stops prior to indexing. 6.4 Cleaning 6.4.1 Prepare cleaning agents as outlined in SOP B-105 Preparation of Cleaning and Sanitizing Chemicals for Production. 6.4.2 Follow SOP B-111 Cleaning of Manufacturing/Production Areas and Equipment to ensure proper cleaning and sanitization are performed for this type of equipment and that these activities are properly documented. 6.4.3 The following disassembly steps are required prior to cleaning: [SOP Standard Operating Procedure SOP No | Rev Vibratory Filler B-605 0 Page 4 of 4 6.4.3.1 Remove the Discharge Nozzle. 6.4.3.2 Remove the hopper. 6.4.3.3 Remove all of the vibrator trays. 6.4.3.4 Remove the Counter Headbox Block. 6.4.3.5 Remove filler guard doors. 6.4.4 Inspect the equipment to ensure that no tablets or capsules are remaining prior to reassembling the equipment. 7.0 Revision History | Rev | Date | Description of Changes | CCR # | By | |-----|----------|------------------------|-------|----| | 0 | 05/15/23 | New procedure. N/A M. Busse | - | - |