METAL DETECTION DEVISES–MD AND X-RAYS• Vandana Gadre

EXTRANEOUS MATTER

Any object/material which may become part of theproduct being produced, which is not designed to be apart of such product.

SOURCES OF EXTRANEOUS MATTER•

Ingredients naturally occurring agricultural material – stems, shell,••

Personal effects/GMP - pens, coins, hair, pair of glasses..
Maintenance•••••

Equipment - design relatedTools
Environment
Sanitation
Formula – forming hard pieces•

Procedures and practices - transfers

fruit pits, powder agglomerates, stonesSAMPLE CONCEPT WITH (IM)PERFECT SHAPESEXTRANEOUS
MATTERCONTROL PLAN

Prerequisite Programs GMP’s• Control of Wooden Pallets• Control of soft Plastic

Glass & Brittle Plastic
Program• Magnets• Inventory• Metal Detector• X Ray• Other..

• Gasket Controls• Hair coverings…

Extraneous Matter ControlDevices• Sieves

Preventive Maintenance
Program

Ext Matter Complaints• Yearly basis EMCP review
against complaints• Is the plan working or whatchanges are required?

VALIDATION – VERIFICATION – MONITORING - CALIBRATIONVALIDATIONCALIBRATION

Operational functionality
Can it consistently detect and rejectcorrect FRR and POD limits

Conducted before first production
and if any issues or aftermaintenanceTechnical functionality
Air pressure, Electrical integrity

Conducted usually annually

Belt tracking. Sensor

VERIFICATIONAre you actually doing what you say
you are going to do

Review and trending of results
Confirm devices operationalfunctionality
6mthly / yearly

MONITORING

Ensuring the system continues todetect and reject in accordancewith the documented standard

Ongoing at a frequency todemonstrate control - Can you holdproduct if something goes wrong?

ScopeMD and X ray Validation

Can be used for single pack, bulk products, throat or gravity fall Metal Detectors and X-RayFrequency
1.
2.
3.
4.

Prior to first production/ commercialization, ideally during installation
Post major modification or repairs
Major change in the product intrinsic properties that influence the sensitivity of the device
Device with bad performance eg. increased FRR

Pre-requisites
1.
2.
3.

The equipment is set up at its optimal settings according to supplier specs & in compliance with QP test piecetypes and size.
Test piece sizes are available in 3 different sizes per type and sizes smaller than or equal to MDLZ QP andequipment specification
The personal performing validation should be trained; in case of external equipment supplier, also certified.

VALIDATION PROTOCOLPART A : ESTABLISHING THE RIGHT SENSITIVITY
STEP 2 OF
VALIDATIONENSURE
Optimal settings fornormal operation
Functioning Rejection
deviceSETTING•To start with target pieces
on which the device wasordered•Pass through the device
10 times each test pieceplaced on / in a product /product flow

•If “No" is recorded onwhen passing the largest
pieces, readjust settings
and repeat Step 1.

•Order should be withinrecommended sensitivity
as per QP)•Record each result invalidation report.
Yes = Detected& Rejected•Ensure you are runningthe device on the best
possible sensitivity.

STEP 1 OF
VALIDATIONNOTE : Validation without product ( Design Constraints)
Same protocols with product only minimum 10% times it has to be done withproduct to ensure that with product or without validation results are consistent•If all 10 passes are
successful (= Yes), passsmaller test piece 10times & evaluate•Once the device is set
with the smallest piecesize giving 10 successful
detections & rejections (=Yes), go to Second part ofthe validation

STEP 3 OF
VALIDATIONDetermining FRR & POD
Add 20 pieces from the smallest test contaminant, evenly distributed in X quantityof foreign body free product- Use standard line speed and product flow
Determination of X :For bulk : Identify the finished product weight (gms or kg) in each SKU.
Multiply FP product weight by the number of pieces packed(example 200-2000 pieces/kg)
For packed product: use 200 - 1000 good product
Alternative place 20 targeted contaminants in min 200 good packages / bulk product
When 20 contaminants are successfully detected and rejected, calculate the False
Reject Rate and Probability of detection using "FRR and POD Report" sheet
If result does not meet 100 % POD or is above 0,1% FRR readjust the settings andreturn to Part A Step 1

POD & FRR CALCULATIONS
POD

FRR

Pass 30 times each Validation Sample
The POD limit is defined by the smallest dimension achieving a POD of 30/30(detected & rejected)
Calculation:- POD = 100 × Rejected Test Samples
Total Test Samples Inspected
Measured during production by adding/ not adding known amount ofcontaminants with product amount equivalent to (200 – 2000 SKU). Evaluateeach rejected product and classify it as a False Reject or not
Recommended target: not more than 0.1%
Calculation:- FRR= 100 × (Total Reject – Correct Reject)
Total Inspected

AirInterlock

In case air push is used as a reject mechanism, Validation shall include
Air pressure interlock with belt / line stoppage if pressure goesbeyond 4-6 bar and other failsafe interlocks

FILLING THE FORMATWORST CASESCENARIOSMETAL POSITION IN APERTURE
Where is the least sensitive position in MD aperture?

Position1
2
3

Place check stamp here

METAL POSITION IN APERTURE
Where is the least sensitive position in MD aperture?

Position1
2
3

Place check stamp here

Worst Case scenarios considerations for MD
1. While doing the validation test piece need to be kept as close as possible to the center of aperture.

2. Back to back contaminants.

3. Emergency Stop / Power Failure :- Such situation should be simulated to know the reaction of the detection &rejection device. (Similar For X- Ray)4. For long packs ( Leading and Trailing Edge) (Similar for X- Ray)Worst Case scenarios considerations for X ray
For Product Packed in Jars/Glass containers

For Product packed in Pouches

Horizontal Seal Top
Side Edges
At the Vertical Seal
Horizontal Seal Bottom

Worst Case scenarios considerations for X ray….contd.
Jar Inspections (Packaging variations)

Blind Spot Formation

PM variations if not covered properly
during the validation can lead to huge image
fluctuation and in turn High FRR / Failure
to detect the right contaminant.

For tin cans or glass jars, the packaging will appear darker on X-Ray pictures
than the product. Then it becomes difficult for the picture analyzer software
to distinguish between the contaminant and the product and the chances are
there that the X ray can miss the real contaminant
Due to inspection geometry (focal spot position) of the X-Ray lateral viewequipment, the total volume of a rigid container cannot be always inspected,
as shown below on a tin can example:

Bottomvariation

Detector

Inclusion
size andnumbers
Acceptable“in specification”
Not to be rejected

Not-inspectedarea

Not acceptable“out of specification”
Can be rejected

Fixedlimit

FOCAL SPOTX AND Y LIMITS AND REJECTED PRODUCT HANDLINGX and YA limit for rejections shall be defined over a defined time frame (X number of confirmed metals in Y period of time). If thislimit is exceeded the rejects shall be investigated to understand cause and source.
Eg not more than 2 confirmed metal pieces in 4 hours-RejectedProducthandling

FAILSAFE
CONTROLS

reject mechanism shall divert 100% of the product into an identified bin or container to prevent re-entry
into the process or product flow- bin shall be secured to prevent any potential metal positive material from being mixed with goodproducts- Product rejected shall not be directly packed without further investigation and re-evaluationo rejected products and internal metal finds shall be fully investigated to determine if metal is present.
o for rejected product during monitoring activities only - this shall be repassed through the metal
detection equipment prior to further use
o if a detection system fails to detect a test piece, the material produced since the last successful test
shall be placed on hold.
Fail-safe devices which form part of metal detection/rejection systems (such as compressed air pressure
used for rejection flap operation, bin full sensors etc.) shall be tested at the start of every shift. Testing shallbe carried out by passing a test pack down the line while temporarily interrupting the electrical supply tothe reject device solenoid (e.g., by using a key switch held by an authorized person) and observing that thereject mechanism does not operate, and that the conveyor belt then stops.