Manual Metal Detector

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1.0 Purpose 
 
 The purpose of this procedure is to define the process for the Setup, Operation, Cleaning, and
 
 Calibration of the Manual Metal Detectors (to include Pipeline). 
 
 2.0 Scope 
 
 This procedure applies to the Manual Metal Detectors in operation at Ion Labs, Inc.
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of all personnel operating the manual metal detector 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. 
 
 4.0 Definitions 
 
 4.1 QC — Quality Control 
 
 5.0 References 
 
 5.1 B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment
 
 6.0 Procedure 
 
 6.1 Setup, Operation, and Calibration Verification 
 
 6.1.1 Calibration verification will be performed prior to each use using a calibration
 sample kit. Annual calibration will be performed with a QC-Controlled
 Calibration sample kit. The sample kit will consist of the following test pieces
 for tablets, capsules, powders: 
 
 6.1.1.1 1.50mm Ferrous Red 
 
 6.1.1.2 2.00mm Ferrous Red 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Manual Metal Detector B-630 5 Page 2 of 3 
 
 6.1.1.3 2.00 Aluminum Yellow 
 
 6.1.1.4 3.00mm Aluminum Yellow 
 
 6.1.1.5 2.00mm SS316 Blue (Stainless Steel) 
 
 6.1.1.6 3.00mm $S$316 Blue (Stainless Steel) 
 
 6.1.2 Calibration verification will be performed prior to each use using a calibration
 sample kit. Annual calibration will be performed with a QC-Controlled
 Calibration sample kit. The sample kit will consist of the following test pieces
 
 for liquids (Pipeline): 
 
 6.1.2.1 1.00mm Ferrous Red 
 
 6.1.2.2 1.50mm Ferrous Red 
 
 6.1.2.3. 1.50mm Non-Ferrous Yellow 
 
 6.1.2.4 2.00mm Non-Ferrous Yellow 
 
 6.1.2.5 2.00mm $S316 Blue (Stainless Steel) 
 
 6.1.2.6 2.50mm $S316 Blue (Stainless Steel) 
 
 Note: Refer to the machine manual for setup and operation instructions.
 
 6.1.3 Turn the power on. 
 
 This machine is pre-setup for sensitivity and does not require adjustments. If
 adjustments are needed, contact Maintenance department. 
 
 The machine will go through a system startup that will take a minute.
 
 6.1.6 Pass the calibration sample kit through the center of the machine. The samples
 contain different metals and should activate the machine to alert that metal is
 present. The sample should be automatically discarded into the reject container
 below the machine. If this process does not happen, contact the department
 supervisor and refer to the troubleshooting section of the machine manual.
 
 When the calibration samples have successfully passed, the machine is ready for
 operation. 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Manual Metal Detector B-630 Page 3 of 3 
 
 Note: Document calibration sample results in batch record as required at start-
 
 up or additional customer requirements. 
 
 6.1.8 Production will perform hourly metal checks after startup and record the checks
 in the batch record. 
 
 6.1.9 QC will perform metal checks as deemed necessary per a risk assessment.
 
 6.1.10 During operation, if metal is detected, the product will be discarded into the
 
 reject container. The rejected product is to be accounted for in the waste section
 of the batch production record and disposed of. Immediately contact Quality
 Control department for investigation. 
 
 6.1.11 Annual external metal detector validation will be performed annually by Loma
 Systems, Inc. 
 
 6.2 Cleaning 
 
 6.2.1 Remove all materials and paperwork from the previous batch. 
 
 6.2.2 Refer to SOP B-111 Cleaning of Manufacturing/Production Areas and
 Equipment to follow the cleaning process applicable to equipment type.
 
 6.2.3. Document the cleaning in the cleaning log book. 
 
 6.2.4 Contact a QC inspector to verify equipment cleanliness and to initial/date the
 cleaning log book. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 2 | 09/04/15 | Biennial Review: updated SOP format. Added note in Section 6.1.5. | 15-0731 | P. Zittere |
| 3 | 06/21/16 | Add calibration information Scheduled review: Removed obsolete definitions. Added reference ; : le to SOP B-111. Added required sample pieces. he eoe A BUNS 5 12//06/21 nee vn for calibration sample kits for liquids (Pipeline Metal CC-21-0452 J. Mireles | 16-0624 | D. Popp |