B-212

Deduster Vibration Machine

Section B — Manufacturing Revision 4 3 pages

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1.0 Purpose 
 
 The purpose of this procedure is to define the process for the operation and cleaning of the
 deduster vibration machine. 
 
 2.0 Scope 
 
 This procedure applies to the deduster vibration machine in operation at Ion Labs, Inc.
 
 3.0 Responsibility 
 
 Sul It is the responsibility of Production (Compression) 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 
 
 None 
 
 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
 
 5.3 B-103, Small Parts Cleaning and General Sanitation 
 
 
 

[SOP 

 Standard Operating Procedure SOPNo | Rev 
 Deduster Vibration Machine B-212 4 Page 2 of 3 
 
 6.0 Procedure 
 
 6.1 Set-up and Operation 
 
 6.1.1 Ensure the deduster stands at the proper height (adjust if needed) and that the
 adjustable slope matches to catch the tablets exiting the two discharge chutes on
 
 the tablet press. 
 
 6.1.2 Ensure the screens are in place and ready to vibrate the tablets as needed.
 
 6.13 Ensure the unit is plugged into the electrical outlet to power up.
 
 6.1.4 Begin feeding tablets through inlet chute to ensure they vibrate as they should
 and fall into the discharge properly and into a bucket from there.
 
 6.2 Cleaning 
 
 6.2.1 Prepare cleaning agents as outlined in SOP B-105 Preparation of Cleaning and
 
 Sanitizing Chemicals for Production. 
 
 6.2.2 Follow SOP B-111 Cleaning of Manufacturing/Production Areas and
 
 Equipment and SOP B-103 Small Parts Cleaning and General Sanitation to
 ensure proper cleaning and sanitization are performed for this type of equipment
 
 and that these activities are properly documented. 
 
 Giz0d Disassembly and unique cleaning steps for this piece of equipment are as
 follows: 
 
 6.2.3.1 Remove the screens, the infeed, and discharge to clean and sanitize.
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Deduster Vibration Machine B-212 a base sors 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 08/26/10 | New - - | - | - |
| 1 | 03/26/13 | Updated SOP format | 13-208 | B. Mosall |
| 2 | 01/27/16 | Biennial Review: Changed the SOP format. Scheduled review: Removed obsolete definitions. Added reference . 3 S1/1619 to SOP B-111. Revised section 6.2. De ele, eee Addition set-up & operational instructions added and disassembly | 15-0933 | P. Zittere |
| 4 | 03/07/23 | for cleaning. Updated logo and format. Revised responsibilities CC- section. Revised cleaning section and added reference to cleaning procedures. | 23-0112 | M. Busse |