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The Benefits of Integrating Metal Detection into Your Product Inspection Program for Consumer Safety

Antoine Dodier & Hitesh Hirani

TitleLoma Systems1

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3

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Consumer Safety

Metal Contamination Prevention

Metal Detection Program

Agenda

Better controls with TRACS5

IQ4 and other Loma Systems Innovations6

METAL DETECTION EVOLUTION

Since 1969 Loma has been helping to make quality product for safe consumption

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Loma Systems

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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

PROTECTING THE CONSUMERS

Up to 11 percent of recalls are due to foreign body contamination or product adulteration

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Product recall

recalls 180,000 bottles of Option 2 emergency contraceptives

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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.

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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).”

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Nutraceutical Foods

• Food and Drug Administration regulated

• Global Food Safety requirements

SETTING UP A METAL CONTAMINATION PREVENTION PROGRAM

IQ3 technology offers advancements in mechanics, electronics and software

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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

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Metal Detection Program

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

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Setting up your controls points

In process inspection - elimination

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Managing the zero risk expectation

End of line inspection – rejection

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Managing the zero risk expectation

End of line inspection – rejection

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Setting up your control points

End of line inspection – rejection

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Setting up your control points

End of line inspection – rejection

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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

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Documentation

Annual Calibration

IQ, OQ, PQ, Material Certificated

INNOVATION

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

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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

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Speed

• Reduce Learning Procedure by up to 90%

• Reduce setup time in the plant by 10%

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Intuitive

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

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Performance

State-of-the-art detection level

0.20 mm Ferrous0.30 mm Non Ferrous0.40 mm Stainless Steel

USER FRIENDLY

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

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Connectivity - TRACS

FACTORY LAN

OFFICE NETWORK

TRACSSERVER

(physical or virtual)

VIEWING TRACS

TRENDING-REPORTING-ANALYSIS-CAPTURE-SOFTWARE

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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

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

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• CSV Data Exports

• Batch Reports• Individual Pack

Weights

CSV Data Exporting

INDIVIDUAL PACK WEIGHTS

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OTHER INSPECTION SOLUTION

All food type and format must be safe for consumption, including pet food

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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

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Product Range

Packed products

Bulk flow products

Pipeline application

X-Ray

Sideshoot application

Improving product quality

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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

Helping the world to make food and drugs safe

Thank you!