Semi-Automatic Labeler

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1.0 Purpose 
 
 The purpose of this procedure is to define the process of setup, operation and cleaning for the
 
 semi-automatic labeler. 
 
 2.0 Scope 
 
 This procedure applies to all semi-automatic labelers in operation at Ion Labs, Inc.
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of the 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. 
 
 4.0 Definitions 
 
 None 
 
 5.0 References 
 
 5.1 B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment
 
 6.0 Procedure 
 
 6.1 Setup 
 
 6.1.1 Ensure that the unit is plugged into a power source. 
 
 6.1.2 Ensure that the unit is plugged into a compressed air source.
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 B-609 4 Page 2 of 3 
 Semi-Automatic Labeler 
 6.1.3 Obtain the approved labels that have been issued to the BPR.
 
 6.1.4 Hand thread the roll of labels from the left spindle through the hot stamp section
 
 for application of the batch number and expiration date (where applicable).
 
 6.1.5 Verify that the batch number and expiration have been changed to match the
 
 current BPR. 
 
 6.1.6 Jog the labels forward through the hot stamp section after the stamp unit has
 
 heated. 
 
 6.1.6.1 Adjust the stamp head left or right until the batch number and
 
 expiration date is located in the proper place on the label.
 
 6.1.7. Move the label web from the hot stamp unit into the applier section, removing a
 
 few labels to allow the web to be empty as it is set and locked into the take up
 
 spool. 
 
 6.2 Operation 
 
 6.2.1 Turn on the main power switch. 
 
 6.2.2 Ensure that the label feed switch is on. 
 
 6.2.3. Place a container in the application section holding table.
 
 6.2.4 Continue removing and replacing the containers one-by-one on the application
 
 table. 
 
 6.3 Cleaning 
 
 6.3.1 Refer to SOP B-111 Cleaning of Manufacturing/Production Areas and
 Equipment to follow the cleaning procedure applicable to this type of
 
 equipment. 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev ee 
 Semie- Automatiec Labeler B-= 60? 7 : 0 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 08/27/10 | New - - 04/29/13 Updated SOP format 13-281 B. Mosall | - | - |
| 2 | 01/27/16 | Biennial Review: Changed the SOP format. Scheduled review: Removed obsolete definitions. Added reference bah : OH 22it) = to SOP B11. Revised section's 3. aa BUTS | 15-0938 | P. Zittere |
| 4 | 04/18/22 | Scheduled review: Updated logo. Revised cleaning section. CC- | 22-0191 | K. Burris |