B-621

Powder Fillers

Section B — Manufacturing Revision 16 6 pages

Original Document

Scanned document (image-only PDF)

Extracted Text

Searchable text extracted from PDF

1.0 Purpose

The purpose of this procedure is to define the process for the setup, operation, and cleaning of
powder fillers.

2.0 Scope

This procedure applies to any powder filler in operation at Ion Nutritional Labs.

3.0 Responsibility

3.1 It is the responsibility of Production (Packaging) personnel to follow this procedure.

3.2 ‘It is the responsibility of Production Management to implement this procedure and to

ensure that the procedure is being followed.

3.3 ‘It is the responsibility of Production Management and/or Maintenance & Engineering

personnel to keep this procedure aligned with current practices.

4.0 Definitions

4.1 QC — Quality Control

4.2 FF — Free Flow

4.3 Non-FF — Non-Free Flow

5.0 References

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

[SOP

Standard Operating Procedure SOP No Rev
B-621 Page 2 of 6
Powder Fillers
5.2 B-105, SOP, Preparation of Cleaning and Sanitizing Chemicals for Production

5.3. B-103, SOP, Small Parts Cleaning and General Sanitation

6.0 Procedure

6.1 Setup

ote: Refer to the machine manual for setup and operation.

Note: Ensure that the machine is clean, sanitized, and cleared of all previously used

materials.

6.1.1 Dual-head Filler

6.1.1.1 Ensure that the indexing pins are set up correctly so that the selected

bottle can be consistently spaced.

6.1.1.2 Determine the conveyor speed required and adjust guides as needed.

6.1.1.3 Determine and install the Hopper Assembly required, based on the
selected product powder:

6.1.1.3.1 Install Auger Shaft.

6.1.1.3.2 Install Agitation Blade.

6.1.1.3.3 Install High-Speed “D” Agitation Blade.

6.1.1.3.4 Install correct Auger (FF/non-FF, size).

6.1.1.3.5 Install Hopper(s).

6.1.1.3.6 Install correct Funnel (Straight, Lip, etc.).

6.1.1.3.7 (ONLY for FF Auger) Install Spinner Plate.

[SOP

Standard Operating Procedure SOP No Rev
B-621 Page 3 of 6
Powder Fillers
6.1.1.3.8 (ONLY for FF Auger) Install Collector Funnel.

6.1.1.3.9 Connect hopper to product dispense tube.

6.1.1.4 Power on the AMS Filler.

6.1.2 Rotary Filler

6.1.2.1 Install and adjust the timing screw for the product being run.

6.1.2.2 Determine the conveyor speed required and adjust guides as needed.

6.1.2.3. Determine and install the Hopper Assembly required, based on the
selected product powder:

6.1.2.3.1 Install Dust Shroud.

6.1.2.3.2 Install Shroud Vents.

6.1.2.3.3 Install Track Base.

6.1.2.3.4 Install Intake and Discharge Star Wheels.

6.1.2.3.5 Install Center Star Wheel.

6.1.2.3.6 Install Center Track pieces.

6.1.2.3.7 Install Rubber Flex Seals.

6.1.2.3.8 Install Auger Shaft.

6.1.2.3.9 Install Agitation Blade.

6.1.2.3.10 Install High-Speed “D” Agitation Blade.

6.1.2.3.11 Install correct Auger (FF/non-FF, size).

6.1.2.3.12 Install Hopper.

[SOP

Standard Operating Procedure SOP No Rev
B-621 Page 4 of 6
Powder Fillers
6.1.2.3.13 Install correct Funnel (Straight, Lip, etc.).

6.1.2.3.14 (ONLY for FF Auger) Install Spinner Plate.

6.1.2.3.15 Install Collector Funnel.

6.1.2.3.16 Install Yoke Connector.

6.1.2.3.17 Install Hopper Vent.

6.1.2.3.18 Install Air Vacuum.

6.1.2.4 Power on the AMS Filler.

6.2 Operation

6.2.1 Ready up the AMS Filler.

6.2.2 Fill the hopper with product.

6.2.3 Adjust the Machine Settings based on the product being run.

6.2.3.1 The Machine Settings must be observed during the entire packaging run

and adjusted based on the following metrics.

6.2.3.1.1 Number of bottles filled per minute

6.2.3.1.2 Fill amount required

6.2.3.1.3. Conveyor speed

6.2.3.1.4 Auger Revolution setting

6.2.3.1.5 Vibration setting

6.2.3.1.6 Agitation setting

[SOP

Standard Operating Procedure SOP No Rev
B-621 Page 5 of 6
Powder Fillers

6.2.3.2 The Machine Settings are performing as required when the following
occurs:

6.2.3.2.1 The bottle is consistently filled with the amount of product
required.

6.2.4 Monitor and adjust the following systems as needed:

6.2.4.1 Indexing Assembly/Timing Screw

6.2.4.2 Conveyor Setup

6.2.4.3 Hopper Assembly

6.2.4.4 Machine Settings

6.3 Cleaning

6.3.1 Prepare cleaning agents as outlined in SOP B-105 Preparation of Cleaning and
Sanitizing Chemicals for Production.

6.3.2 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.

6.3.3 Refer to SOP B-103 Small Parts Cleaning and General Sanitation to follow
appropriate cleaning steps for small parts.

6.3.4 For required disassembly of this equipment, work backwards from the applicable
steps in section 6.1.

[SOP

Standard Operating Procedure SOP No | Rev Dak aiGiehe
Powder Fi°l lers B-a6 21 5 ag:e oo

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 09/02/10 | New : : | - | - |
| 1 | 05/03/13 | Updated SOP format. | 13-297 | B. Mosall |
| 2 | 09/04/14 | Added not for allergen materials. Updated SOP format. 3 9/02/16 Biennial review: Corrected numbers in step 6.4.8. Revised 16-0801 K. Burris equipment identification after minor and major cleaning. Scheduled review: Removed obsolete definitions. Added : 4 ds as reference to SOP B-111 and SOP B-103. peter K. Burts Scheduled review: Revised section 6. Included new : bec definitions and changed SOP title. Ceo is RaieN | 14-0688 | K. Burris |