Data Matrix Batch traceability at the filling line

guineanscarletElectronics - Devices

Nov 27, 2013 (3 years and 10 months ago)

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GTS
-

Facilities Technologies


Data Matrix Batch traceability at the filling line



June 18
, 2010

Bernard PIERRE

The involved subpart of the filling process


Syringes are filled with diluents


Those syringes are autoclaved (sterilization)


Then, the syringes continue their way to the next step of filling.


Datamatrix, the context…

Operations on Syringes at the filling line :

Empty trays are loaded with syringes automatically, a batch of syringes is spread
over several trays

Loaded trays are manually stored on trolleys

Trolleys are then put in autoclave

After autoclaving process, trolleys are taken out of the autoclave and stored aside

Operators take the trays from the trolleys and place them on a conveyor to be
unloaded

The syringes are taken out from the trays automatically


Manual

Intervention

Manual

Intervention

Autoclave

Syringes

Syringes

The issue…

When the syringes are loaded on the trays, GSK needs to keep track
of which batch of product is in which tray

When the syringes are unloaded from the trays, GSK needs to make
sure that they are unloading the right batch at that specific moment.

Remark : Process
-
wide, it is a temporary «

marking

» of trays to keep
a track of batches, not a a serialization amongst the whole production
line (no historian Data Base)


The identification of trays is mandatory,



using an easy to read unique ID on an
“autoclavable” media

The Investigated Solutions:



OCR, RFid tags, Data Matrix

OCR

Reading Existing numbering of trays

Asset: No marking nor tags are
needed : based on existing
identification

Rejected due to : No redundancy,
risk of confusion (“3” & “8”)






RFID

Radio identification Wireless device
placed on trays

Asset : Built
-
in Storage capacity

Rejected due to : Limited
autoclave resistance


The solution: DataMatrix…

DataMatrix : A Structured,

coded
«

sticker

»,

embedding
high density
of information

and readable with the
highest confidence level
.

Various method of engraving

Laser

Micro
-
impact

Scratching, stickers, inkjet

Stainless steel surfaces are
perfect

Redundancy of information

(+ vs. character recognition or barcode)

High temperature, pressure and
humidity proof

(+ vs. RFID tags)

NO Local storage of data at all

Unique ID for trays, external logic

Temporary DB storage required


…within the right process:


Manual

Intervention

Manual

Intervention

HMI

HMI

Autoclave

Data Matrix

Camera

«

Loading process

»:

Operators enter the batch
number via the HMI

Trays linked to the batch n
°


«

Unloading Process

»:

System check if tray is from
the right batch

If not, the tray is stopped

Syringes

Syringes

=> Avoid risks linked to manual intervention

Additional features


URB

The improvements:


Duplicated on 3 lines

Polycarbonate trays

Subgroup counters

Automated reports

Activation/deactivation
of trays (maintenance)

An, of course, full audit
trailed data.

Conclusion

A simple but effective solution has fulfilled
the customers needs !

Expertise is mandatory to avoid the technological run to
the newest devices instead of the best implementation !

A perfect coordination between internal customer, project
management and vendor allowed a fast implementation


Thanks you !