B-604

Slat Counter

Section B — Manufacturing Revision 0 5 pages

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1.0 Purpose

This procedure defines the process of setup, startup, operation, and cleaning of the slat counter.

2.0 Scope

This procedure applies to all slat counters 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.

3.3. ‘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

Sed B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment

5.2 B-105, SOP, Cleaning Product Preparation and Small Parts Cleaning

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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 Install the Slat Hopper.

6.1.3. Install the Rear brush.

6.1.4 Install the Top roll back brush.

6.1.5 Install the Dust collection nozzles.

6.1.6 Install the Filler guard doors.

6.1.7 Install the Return rails for the slats.

6.1.8 Turn on the Slat Counter.

6.1.9 Enable Slat Job Mode.

6.1.10 Select the product from this list of recipes for the product to be run.

6.1.11 Locate the slats for the slat counter which will be used for the product to be run
and the count required.

6.1.12 Load two slats at a time in proper sequences until all slat spaces are filled.

6.1.13 Adjust the brushes on the slat counter for the proper contact with the top of the

slat.

6.1.14 Set the conveyor points of adjustment for the particular bottle to be filled.

6.1.15 After a successful inspection checkout, load product into the hopper(s).

6.1.16 Adjust the hoppers for the product feed rate.

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6.1.17 Run the filler and inspect the slat fill, Verify that all bottles are removed from
the line as they are fed out until the slats show a complete fill.

6.1.18 Adjust the bottom and side shakers of the filler if necessary.

Note: These product parameters will require fine-tuning once production starts

to ensure a correct count.

6.2 Startup

6.2.1 Start the slat counter.

6.2.2 Allow slats to fill with product to achieve the proper count.

6.2.3 Visually confirm that each slat cavity is being filled with product.

6.2.4 Stop machine after 3 “batches” of bottles are filled.

6.2.4.1 Ensure all product is correctly entering the bottle.

6.2.4.1.1 Make adjustments to indexing method as needed.

6.2.4.1.2 Make adjustments to discharge as needed.

6.2.4.2 Count the product in the bottles to ensure correct count is being made.

6.2.4.2.1 Make adjustments to slat counter setup as needed to ensure

good count.

6.2.5 Repeat startup process until good count is made.

6.3 Operation

6.3.1 Start the slat counter.

6.3.2 The slat counter should be monitored throughout the entire production run to

confirm good counts.

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6.3.3 Keep hopper full of product at all times.

6.3.4 Monitor slat cavities to confirm they are being filled with product.

6.3.5 Monitor the bottles as they are coming out of the feed screw 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.

6.3.7 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 feed screw that they do not enter harshly.

6.3.9 Monitor the slat counter 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 Refer to SOP B-111 Cleaning of Manufacturing/Production Areas and
Equipment to follow the cleaning procedure applicable to this type of

equipment.

6.4.3 The following disassembly steps are required prior to cleaning:

6.4.3.1 Remove slat hopper.

6.4.3.2 Remove rear brush.

6.4.3.3. Remove top roll back brush.

6.4.3.4 Remove dust collection nozzles.

6.4.3.5 Remove filler guard doors.

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6.4.3.6 Remove return rails for the slats.

6.4.3.7. Remove slats.

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 | 03/27/23 | New procedure N/A M. Busse | - | - |