![Page 1: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/1.jpg)
The Benefits of Integrating Metal Detection into Your Product Inspection Program for Consumer Safety
Antoine Dodier & Hitesh Hirani
![Page 2: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/2.jpg)
TitleLoma Systems1
2
3
4
Consumer Safety
Metal Contamination Prevention
Metal Detection Program
Agenda
Better controls with TRACS5
IQ4 and other Loma Systems Innovations6
![Page 3: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/3.jpg)
METAL DETECTION EVOLUTION
Since 1969 Loma has been helping to make quality product for safe consumption
![Page 4: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/4.jpg)
Title
Loma Systems
![Page 5: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/5.jpg)
Title
4th generation of Intelligent Metal Detection
1969 1984 1988 1995 2000 2001 2007 2008 2010 2012 2016 2017
Superscan
SuperscanMicro
ISC IQ2
IQ IQ3 Introduced
IQ3+
First Metal Detector
IQ3 Dual Line Display
Lock Insight
IQ3+E & HDE
![Page 6: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/6.jpg)
PROTECTING THE CONSUMERS
Up to 11 percent of recalls are due to foreign body contamination or product adulteration
![Page 7: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/7.jpg)
Title
Product recall
recalls 180,000 bottles of Option 2 emergency contraceptives
![Page 8: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/8.jpg)
Title
![Page 9: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/9.jpg)
Title
Metal Contamination Origin
Dry / Lubricant Mixing
Dry / Wet Granulation
Tablet Pressing
Tablet Coating
Metal to metal contact
Images Source: Pharmaceutical Technology Editors. “The Role of Powder Characterization in Continuous Manufacturing”. Volume 38, Issue 6. June 2014. www.pharmtech.com.
![Page 10: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/10.jpg)
Title
Preventing Adulteration of Products
• FDA regulation– USP <1>–Injections: “All articles intended for
parenteral administration shall be prepared in a manner designed to exclude particulate matter and other foreign matter. Units with visible particulates shall be rejected.”
– USP <788>–Particulate Matter in Injections: “The average number of particles present cannot exceed 3000 per container equal to or greater than 10 micrometers in size and 300 particles per container equal to or greater than 25 micrometers.”
– USP <797>–Pharmaceutical Compounding Sterile Preparations: “All units must be inspected and rejected when visible particulate matter is detected” (5).
– FDA <CPG Sec. 555.425>– “The product contains a hard or sharp foreign object that measures 7 mm to 25 mm, in length and ... is ready-to-eat,... should be considered adulterated within the meaning of 21 U.S.C. 342(a)(1).”
![Page 11: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/11.jpg)
Title
Nutraceutical Foods
• Food and Drug Administration regulated
• Global Food Safety requirements
![Page 12: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/12.jpg)
SETTING UP A METAL CONTAMINATION PREVENTION PROGRAM
IQ3 technology offers advancements in mechanics, electronics and software
![Page 13: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/13.jpg)
Title
Create your Engineering and Procedural controls
• Prevention– Quality design– Efficient and strict GMPs– Regular and thorough inspections
• Elimination– In-process filter– In-process magnets
• Ejection– Metal Detection Inspection Systems– Adequate Rejection with Failsafe Mechanical Actuator
Metal
![Page 14: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/14.jpg)
Title
Metal Detection Program
System type, location and rejection Control Point and System Validation Procedural Verification Preventative Maintenance and Calibration Due Diligence and Traceability
![Page 15: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/15.jpg)
Title
Setting up your controls points
In process inspection - elimination
![Page 16: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/16.jpg)
Title
Managing the zero risk expectation
End of line inspection – rejection
![Page 17: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/17.jpg)
Title
Managing the zero risk expectation
End of line inspection – rejection
![Page 18: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/18.jpg)
Title
Setting up your control points
End of line inspection – rejection
![Page 19: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/19.jpg)
Title
Setting up your control points
End of line inspection – rejection
![Page 20: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/20.jpg)
Title
Bullet proof your system
• Manage the false alarm• Validate your system• Demand inspection of
your packaging• Allow for changes
(variable frequency)• Test your system
• Performance Validation Systems
• Minimize the human error • Password protection / Biometrics• Quarantine your contaminated products
• Prove your due diligence• Reports
![Page 21: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/21.jpg)
Title
Documentation
Annual Calibration
IQ, OQ, PQ, Material Certificated
![Page 22: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/22.jpg)
INNOVATION
The ultimate in metal detection adaptability resides in the ability to change its frequency
![Page 23: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/23.jpg)
Title
Introducing the IQ4
7” Colour Touchscreen
Ultra-Resistant Mechanics
Variable Frequency Technology
New lip and seal
No protection cover
Updated electronicsand firmware
Modern User Interface
DDS Vector Diagram
PVS Improvements“Optimised for Aluminium”
Product Speed Control
Support for Biometrics
Optimised coil geometry
21CFR Part 11 Support
![Page 24: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/24.jpg)
Title
Speed
• Reduce Learning Procedure by up to 90%
• Reduce setup time in the plant by 10%
![Page 25: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/25.jpg)
Title
Intuitive
• Reduce Training time• Potentially eliminate start-up cost• Simple Digital Display Signal
![Page 26: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/26.jpg)
Title
Performance
State-of-the-art detection level
0.20 mm Ferrous0.30 mm Non Ferrous0.40 mm Stainless Steel
![Page 27: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/27.jpg)
USER FRIENDLY
IQ3+E and IQ4 platforms focus on ease of use of the metal detection software
![Page 28: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/28.jpg)
Title
Connectivity - TRACS
FACTORY LAN
OFFICE NETWORK
TRACSSERVER
(physical or virtual)
VIEWING TRACS
TRENDING-REPORTING-ANALYSIS-CAPTURE-SOFTWARE
![Page 29: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/29.jpg)
Title
TRACS: A Brief Overview
DASHBOARD MACHINESBATCHESStatus of all machines connected to TRACS configured in either a List or Tile view
BATCH CARD CONFIGURATION
List of all batches run by Machine Type (i.e. CW, Metal Detector, Combo or X-ray)
Detail batch reporting and graphical representation, showing details relevant to each type of machine
Machine IP addresses and Data Export
List of configured machines, current status and quick access to its last batch
![Page 30: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/30.jpg)
Title• Visual reporting of
batch• Key metrics
– Accepted– Metal Count– Average
Resultant– PVS Count– Packrate
Example Batch Card: Metal Detection & X-ray
METAL COUNT
PVS
![Page 31: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/31.jpg)
Title
• CSV Data Exports
• Batch Reports• Individual Pack
Weights
CSV Data Exporting
INDIVIDUAL PACK WEIGHTS
31
![Page 32: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/32.jpg)
OTHER INSPECTION SOLUTION
All food type and format must be safe for consumption, including pet food
![Page 33: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/33.jpg)
Title
Product Range
Light Weight Systems
Heavy Weight Systems
Checkweigher
Bottles Handling Systems
Combination system
Improving factory productivity
• 304 Stainless Steel
• Modular Design
• High Performance 250ppm, σ ≈ 0.05g
![Page 34: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/34.jpg)
Title
Product Range
Packed products
Bulk flow products
Pipeline application
X-Ray
Sideshoot application
Improving product quality
![Page 35: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/35.jpg)
Title
Our Development Philosophy
• IP69K, Full Stainless Steel (304 or 316), Common Components, Low Energy Consumption
• Variable Frequency, Modular Systems, Upgradable, Multi-lane
• Colour Touch Screen, Multi-lingual, USB Connectivity, OPC Communication
Durable
Flexible
User Friendly
Strategy
Future proof
![Page 36: The Benefits of Integrating Metal Detection into Your ...€¦ · – USP –Injections: “All articles intended for parenteral administration shall be prepared in a manner](https://reader033.vdocument.in/reader033/viewer/2022060319/5f0cd7177e708231d437642c/html5/thumbnails/36.jpg)
Helping the world to make food and drugs safe
Thank you!