SEAL

Behind the scenes
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Who are we?
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WHERE DO WE COME FROM?
Few people know that this distinguished gentleman Prospero Gandus
(my grandfather)
in
1885
founded Gandus
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WHERE DO WE COME FROM?
The production began with paper bags to contain the needles
for sewing machines.
Craftsmanship and precision, all Italian.
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WHERE DO WE COME FROM?
Since its foundation Gandus has been a
MANUFACTURER
But how was production in the nineteenth century?
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GANDUS IN 19TH CENTURY
19° century…
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GANDUS TODAY
… 20° century
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GANDUS TODAY
Divisions
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GANDUS TODAY
Bags
and
tubes
Sterilization
Automatic
sealers production
pouches sealers production
packaging systems production
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GANDUS TODAY
All our machines are designed in-house, making use of the latest
3D design software
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GANDUS TODAY
control electronics of our machines and
software operation are designed and developed directly
All the
from Gandus
know-how of the operation of our machines are all
The
resident in Gandus
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GANDUS TODAY
We want to build only very
high quality
machines
and to achieve this even the smallest mechanical component
must be made with the
utmost precision
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GANDUS TODAY
Our
technicians
assemble the sealers that you use every
care of a master watchmaker,
assembling hundreds of parts and components
day, working with the
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GANDUS TODAY
To get
wonderful products
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GANDUS TODAY
Our machines are small concentrates
of
high technology
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GANDUS TODAY
how many pieces
between mechanical
parts and components are needed to manufacture a
Gandus minirò H net Evo ?
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GANDUS TODAY
This is our world,
This is our way of thinking about design and production
in the equipment that we install worldwide
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..... AND TOMORROW ?
From a
great grand
father…
great grandchildren
To
Who will carry on this beautiful story
of Italian entrepreneurship
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ONE WORD: PERFECTION
Sealing machines and their
Validation Process
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Mr Nicola Guglielmini
Managing Director
Gandus Saldatrici Packaging Machines
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STERILIZATION PROCESS
Washing
|
Washing procedures
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STERILIZATION PROCESS
Washing
|
Packaging
|
Washing procedures
Packaging procedures
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STERILIZATION PROCESS
Washing
|
Packaging
|
Sterilization
|
Washing procedures
Packaging procedures
Sterilization procedures
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STERILIZATION PROCESS
Washing
|
Packaging
|
Sterilization
|
Aseptic
Washing procedures
Packaging procedures
Sterilization procedures
Aseptic presentation
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SAFETY IN STERILIZATION…
Washing
|
Packaging
|
Sterilization
|
Aseptic
The whole sterilization process is today fully ruled, to
get to the highest levels in quality and safety.
Washing procedures
Packaging procedures
Sterilization procedures
Aseptic
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SAFETY IN STERILIZATION… THE NEW STANDARD
Packing for finally sterilized medical devices
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SAFETY IN STERILIZATION…PACKAGING
Packaging is a key element
in the Sterilization process
Also sealing
has to be a reliable barrier
against microorganism
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SAFETY IN STERILIZATION…PACKAGING
A NOT correct seal
invalidates the whole Sterilization process
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GENERAL REQUIREMENTS FOR SEALING PROCESS
“
Only using machines
able to guarantee a
qualitative standard to
assure a steady sealing
integrity and the
repeatability of the
process
„
ISO standard
X
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GENERAL REQUIREMENTS FOR SEALING PROCESS
“
Only a sealing through
validatable ISO 11607-2
sealing devices
guarantees a perfect seal
tightness
„
X
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SEALING TECHNIQUES
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SEALING - TECHNIQUES
Impulse
process
Heat
transmission
Constant
heat
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SEALING – DIFFERENT KINDS
Two different kind of sealing
Static
Rotary
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SEALING – DIFFERENT KINDS
Static (ex.)
Rotary (ex.)
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PROCESS CRITICAL PARAMETERS
SEALING RESULT
Mix of 3 parameters
Managing the 3 parameters
Sealer suitability
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11607.2 – NORMS REQUIREMENTS
11607.2 - Validation requirements for forming,
sealing and assembly processes – it is necessary to
use machines able to control and monitor critical
parameters
temperature
In C°
speed
in newton
force
in seconds on static machines
in mt/min on rotary machines
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11607.2 – NORMS REQUIREMENTS
Par. 5.2.4 Steady parameters monitoring has to generate
Immediate
ALARMS
in case any limit, defined by the manufacturer, is
exceeded
Machine stops
Acoustic / visual signals
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SEALING PROCESS AND MONITORING CHECK
Check if the sealing machines you are using
• MONITOR THE SEALING PARAMETERS
• HAVE ALARMS ON
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SEALING PROCESS AND MONITORING CHECK
Monitoring
Validatable sealers allow you…
…to methodically
monitor the sealing parameters
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SEALING PROCESS AND MONITORING CHECK
Gandus sealers allow you…
…to monitor sealing parameters in real
time
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SEALING PROCESS AND MONITORING CHECK
Documentation
Validatable sealers allow you…
…to
export data on external devices or by connecting to a net
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SEALING PROCESS AND MONITORING CHECK
Gandus sealers allow you…
…to easily
export data on USB key
Avoiding the expensive dedicated hardwares
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SEALING PROCESS AND MONITORING CHECK
Records
Validatable sealers allow you…
…to
store data in digital or paper format
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SEALING PROCESS AND MONITORING CHECK
Gandus sealers allow you…
…to
store data on a simple excel sheet
Avoiding the expensive dedicated softwares
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DO NOT FORGET...........
+
SEALING IS A SPECIAL PROCESS
IT HAS TO BE VALIDATED
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VALIDATION IS COMPOSED BY 3 PHASES...
Installation Qualification [IQ]
Operational Qualification [OQ]
Performance Qualification [PQ]
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3.6 INSTALLATION QUALIFICATION (IQ)
“
„
DEFINITION
Process of obtaining and documenting evidence
that equipment has been provided and installed in
accordance with its specification
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3.4 OPERATIONAL QUALIFICATION (OQ)
“
„
DEFINITION
Process of obtaining and documenting evidence
that installed equipment operates within
predetermined limits when used in accordance
with its operational procedures
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3.6 PERFORMANCE QUALIFICATION (PQ)
“
DEFINITION
Process to obtain the required
documentation to prove that the equipment
works according to the operational
procedures and that the produced SBS
conform to the established parameters and
consequently the “manufactured and
distributed” products fully satisfy the
required specifications
„
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PERIODIC CONTROLS
ON SEALERS
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PERIODIC CONTROLS
ISO
11607-2
EN 868-5
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PERIODIC CONTROLS
Periodic controls to be run on validatable heat
sealers are of two different kinds
Check the SEAL tightness
Check the machine SEALING parameters status
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PERIODIC CONTROLS
Tear and Peel test on pouches
Calibration on sealers
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TEAR AND PEEL TEST
 Tear and Peel test thermo sealed join on
pouches and packaging reels
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TEAR AND PEEL TEST
EN 868-5 specifies the controls to be run on the
pouch
Par. 4.5 - defines
test methods to be run on the heat seal
joint of pouches and packaging reels
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TEAR AND PEEL TEST
The dry strength of the SEALING
shall be not less than 1,5 N
for 15 mm width (test strip),
both before and after being subjected to the
sterilization process
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TEAR AND PEEL TEST
How to run the test?
Take dry samples of sealed pouches, both before and after
being subjected to the sterilization process and send them to a
Company able to run the test in compliance with the rule.
NOTE –test can also be offered by suppliers of packaging
material, as additional service.
The operator acts on strips of 15
mm through a calibrated
dynamometer, unique tool which
is accepted by the rule.
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TEAR AND PEEL TEST
Positive output
Calibration Certificate issue
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TEAR AND PEEL TEST
Negative output
The machine is not working properly
It is advisable to send the machine to the manufacturer
control on the sealing parameters status
possible maintenance
Calibration certificate issue
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TEAR AND PEEL TEST
It is advisable to run a NEW tightness test on
pouches and reels
Positive output
Calibration Certificate issue
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TEAR AND PEEL TEST
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CALIBRATION
Check the machine SEALING parameters status
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CALIBRATION
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CONTROL METHODS
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CONTROL METHODS
Control on the sealing parameters shall be run only
by authorized
and qualified personnel
By the manufacturer, who knows the machine
calibrations and tolerance ranges
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CONTROL METHODS
Components mechanical and
electric control
Controls through tools
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CONTROL METHODS
Temperature
Speed
Force
via thermometers and calibrated probes
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CONTROL METHODS
Temperature
Speed
Force
According to the in-feed functioning,
via calibrated laser speedometers
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CONTROL METHODS
Temperature
Speed
Force
Only on new machines, equipped with pressure
control
Load-cell functioning is
tested through certified
weights
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CONTROL OUTPUT
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CONTROL OUTPUT
Positive output
After the first control
After maintenance
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CONTROL OUTPUT
Negative output
Something is wrong
The machine needs to be maintained to recover the
correct functioning of the parameter
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GANDUS SALDATRICI PRODUCTS
SEALING DEVICES
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GANDUS MINIRO’ H-LAN TOUCH
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GANDUS MINIRO’ H-LAN
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GANDUS MINIRO’ H–NET EVO
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GANDUS MINIRO’ H-SEAL VP EVO
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GANDUS MINIRO’ H-DATA EVO
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GANDUS MINIRO’ POLY VP
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GANDUS MINIRO’ H-SEAL EVO
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GANDUS REBI VP EVO
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GANDUS MEDICAL H 460/610 ATDP
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GANDUS MEDICAL H 460/610
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GANDUS SI MED 520-720-1020
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GANDUS SI VACUUMMED 520-720-1020
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GANDUS DN 350
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GANDUS GD 301
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GANDUS SALDATRICI PRODUCTS
ROUTINE TESTS
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GANDUS SEAL CHECK IT
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GANDUS SEAL CHECK IT
Test system for the routine testing of sealing device and for Operational
Qualification according to EN ISO 11607-2:2006 process Validation
Guidelines of the WFHSS are advising to test each medical heat sealer at the
beginning of the day after the heat sealer has heated up. Based upon the
initial test the heat sealer can be released for the day.
The Gandus Saldatrici Seal CheckIT is one way to comply to the ISO 11607 - 2
requirements for Operational Qualification (OQ) and daily testing of your
Medical Heat sealers.
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GANDUS SEAL CHECK IT
How does it works?
Place in between the layers of medical pouches with the face up to the
laminate side of the pouch. The combination is then heat-sealed.
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GANDUS SEAL CHECK IT
By its unique printed pattern of the black area the inspection of the seal and the
detection of minor or bigger problems are easily detected.
The detection of problems in sealing area means the sealing is not tight,
packaging is not safe
Heat sealer need calibration
Compliance to standards
Procedure: ISO 11607 - 2
Materials: ISO 868 – 3
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GANDUS SALDATRICI PRODUCTS
NEW ON STAGE
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GANDUS SALDATRICI
POUCH MAKER
Vseal.IT
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POUCH MAKER GANDUS Vseal.IT
The only fully validatable medical pouch maker with Chevron
Seal for
automatic production of sterile medical pouches from standard reels.
CHEVRON SEAL means pelability, safety and correct pouch
opening.
Gandus Vseal.it furthermore allows to manufacture:
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the exact quantity of required pouches
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in the exact width and lenght
- exactly when pouches are needed, without havig to buy and store large
quantities ou pouches
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POUCH MAKER GANDUS Vseal.IT
Advantages:
- material saving you only produce the pouches you need and the
millimeter customization avoid any waste of material
- time saving whenever pouches are required, pouches are manufactured
- easiness and speed by recalling recipes the Vseal.it automatically set
itself according to your requirements.
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POUCH MAKER GANDUS Vseal.IT
The system is equipped by a film reel dispenser with automatic reel centering
settled by touch screen.
Gandus Vseal.it automatically controls sealing temperature, force and
speed.
In case one of the parameters exit the set range, it stops working and the display
visualizes the corresponding alarm.
Gandus Vseal.it can be interfaced with traceability
system on request.
Consistent output, Gandus Vseal.it can produce up to 20
pouches per
minute.
Accessories upon request: front work table with adjustable pouch tray.
FULLY VALIDATABLE TO THE EN ISO 11607-2 STANDARDS.
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POUCH MAKER GANDUS Vseal.IT
Chevron Seal
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POUCH MAKER GANDUS Vseal.IT
correct pouch opening
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GANDUS SALDATRICI
DAILY TEST
BlueTest.it
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DAILY TEST GANDUS BlueTest.IT
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DAILY TEST GANDUS BlueTest.IT
Gandus Saldatrici Indicator BlueTest.it is a new generation indicator test
for routine
testing of your sealing devices. Specially developed to
check the integrity of seals produced with your sealers.
It allows a safe, easy and quick ink test as it is a system for carrying out the
test according to standard ASTM F1929 and EN
parts that apply to it.
ISO 11607-1/2, in the
Safe – no damage of the seal because it does not use any pipette or other
objects to fill the pouch, and no risk of leakage or migration of blue
methylene.
Easy – easy to prepare and easy to check the result.
Quick – after no longer than 20 seconds you can see if your seal on 4 sides
is perfect and safe.
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DAILY TEST GANDUS BlueTest.IT
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DAILY TEST GANDUS BlueTest.IT
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Thank you for your kind attention
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