The Benefits of Integrating Metal Detection into Your Product Inspection Program for Consumer Safety. Antoine Dodier & Hitesh Hirani

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1 The Benefits of Integrating Metal Detection into Your Product Inspection Program for Consumer Safety Antoine Dodier & Hitesh Hirani

2 Agenda 1 2 Loma Systems Consumer Safety Metal Contamination Prevention Metal Detection Program Better controls with TRACS IQ4 and other Loma Systems Innovations

3 Since 1969 Loma has been helping to make quality product for safe consumption METAL DETECTION EVOLUTION

4 Loma Systems

5 4 th generation of Intelligent Metal Detection First Metal Detector Superscan Micro IQ IQ3 Introduced IQ3 Dual Line Display IQ3+E & HDE Superscan ISC IQ2 IQ3+ Lock Insight

6 Up to 11 percent of recalls are due to foreign body contamination or product adulteration PROTECTING THE CONSUMERS

7 Product recall recalls 180,000 bottles of Option 2 emergency contraceptives

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9 Metal Contamination Origin Dry / Lubricant Mixing Dry / Wet Granulation Tablet Pressing Tablet Coating Images Source: Pharmaceutical Technology Editors. The Role of Powder Characterization in Continuous Manufacturing. Volume 38, Issue 6. June Metal to metal contact

10 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 > 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).

11 Nutraceutical Foods Food and Drug Administration regulated Global Food Safety requirements

12 IQ3 technology offers advancements in mechanics, electronics and software SETTING UP A METAL CONTAMINATION PREVENTION PROGRAM

13 Create your Engineering and Procedural controls Prevention Quality design Efficient and strict GMPs Regular and thorough inspections Metal Elimination In-process filter In-process magnets Ejection Metal Detection Inspection Systems Adequate Rejection with Failsafe Mechanical Actuator

14 Metal Detection Program System type, location and rejection Control Point and System Validation Procedural Verification Preventative Maintenance and Calibration Due Diligence and Traceability

15 Setting up your controls points In process inspection - elimination

16 Managing the zero risk expectation End of line inspection rejection

17 Managing the zero risk expectation End of line inspection rejection

18 Setting up your control points End of line inspection rejection

19 Setting up your control points End of line inspection rejection

20 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

21 Documentation Annual Calibration IQ, OQ, PQ, Material Certificated

22 The ultimate in metal detection adaptability resides in the ability to change its frequency INNOVATION

23 Introducing the IQ4 Ultra-Resistant Mechanics 7 Colour Touchscreen Modern User Interface Variable Frequency Technology Optimised coil geometry Updated electronics and firmware New lip and seal No protection cover 21CFR Part 11 Support DDS Vector Diagram PVS Improvements Optimised for Aluminium Product Speed Control Support for Biometrics

24 Speed Reduce Learning Procedure by up to 90% Reduce setup time in the plant by 10%

25 Intuitive Reduce Training time Potentially eliminate start-up cost Simple Digital Display Signal

26 Performance State-of-the-art detection level 0.20 mm Ferrous 0.30 mm Non Ferrous 0.40 mm Stainless Steel

27 IQ3+E and IQ4 platforms focus on ease of use of the metal detection software USER FRIENDLY

28 Connectivity - TRACS TRENDING-REPORTING-ANALYSIS-CAPTURE-SOFTWARE OFFICE NETWORK TRACS SERVER (physical or virtual) VIEWING TRACS FACTORY LAN

29 TRACS: A Brief Overview DASHBOARD Status of all machines connected to TRACS configured in either a List or Tile view BATCHES List of all batches run by Machine Type (i.e. CW, Metal Detector, Combo or X-ray) MACHINES List of configured machines, current status and quick access to its last batch BATCH CARD Detail batch reporting and graphical representation, showing details relevant to each type of machine CONFIGURATION Machine IP addresses and Data Export

30 Example Batch Card: Metal Detection & X-ray Visual reporting of batch Key metrics Accepted Metal Count Average Resultant PVS Count Packrate PVS METAL COUNT

31 31 CSV Data Exporting CSV Data Exports Batch Reports Individual Pack Weights INDIVIDUAL PACK WEIGHTS

32 All food type and format must be safe for consumption, including pet food OTHER INSPECTION SOLUTION

33 Product Range Checkweigher Light Weight Systems Improving factory productivity 304 Stainless Steel Heavy Weight Systems Modular Design Bottles Handling Systems High Performance 250ppm, σ 0.05g Combination system

34 Product Range X-Ray Packed products Improving product quality Bulk flow products Pipeline application Sideshoot application

35 Our Development Philosophy Strategy Durable IP69K, Full Stainless Steel (304 or 316), Common Components, Low Energy Consumption Flexible Variable Frequency, Modular Systems, Upgradable, Multi-lane User Friendly Colour Touch Screen, Multi-lingual, USB Connectivity, OPC Communication Future proof

36 Helping the world to make food and drugs safe Thank you!