Post on 24-Dec-2020
transcript
Behind the scenes
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Who are we?
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Few people know that this distinguished gentleman Prospero Gandus (my grandfather)
in1885 founded Gandus
WHERE DO WE COME FROM?
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The production began with paper bags to contain the needles for sewing machines.
Craftsmanship and precision, all Italian.
WHERE DO WE COME FROM?
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Since its foundation Gandus has been a
MANUFACTURER
But how was production in the nineteenth century?
WHERE DO WE COME FROM?
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19° century…
GANDUS IN 19TH CENTURY
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… 20° century
GANDUS TODAY
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GANDUS TODAY
Divisions
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Bags and tubes sealers production
Sterilization pouches sealers production
Automatic packaging systems production
GANDUS TODAY
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All our machines are designed in-house, making use of the latest
3D design software
GANDUS TODAY
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All the control electronics of our machines and
software operation are designed and developed directly
from Gandus
The know-how of the operation of our machines are all
resident in Gandus
GANDUS TODAY
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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
GANDUS TODAY
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Our technicians assemble the sealers that you use every
day, working with the care of a master watchmaker,
assembling hundreds of parts and components
GANDUS TODAY
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To get wonderful products
GANDUS TODAY
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Our machines are small concentrates
of high technology
GANDUS TODAY
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how many pieces between mechanical
parts and components are needed to manufacture a
Gandus minirò H net Evo ?
GANDUS TODAY
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This is our world,
This is our way of thinking about design and production in the equipment that we install worldwide
GANDUS TODAY
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From a
great grand father…
To great grandchildren Who will carry on this beautiful story of Italian entrepreneurship
..... AND TOMORROW ?
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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 procedures
Washing |
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STERILIZATION PROCESS
Washing procedures
Packaging procedures
Washing | Packaging |
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STERILIZATION PROCESS
Washing procedures
Packaging procedures
Sterilization procedures
Washing | Packaging | Sterilization |
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STERILIZATION PROCESS
Washing procedures
Packaging procedures
Sterilization procedures
Aseptic presentation
Washing | Packaging | Sterilization | Aseptic
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Washing procedures
Packaging procedures
Sterilization procedures
Aseptic
Washing | Packaging | Sterilization | Aseptic
The whole sterilization process is today fully ruled, to
get to the highest levels in quality and safety.
SAFETY IN STERILIZATION…
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Packing for finally sterilized medical devices
SAFETY IN STERILIZATION… THE NEW STANDARD
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Packaging is a key element in the Sterilization process
Also sealing has to be a reliable barrier
against microorganism
SAFETY IN STERILIZATION…PACKAGING
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A NOT correct seal invalidates the whole Sterilization process
SAFETY IN STERILIZATION…PACKAGING
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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
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Only a sealing through validatable ISO 11607-2 sealing devices guarantees a perfect seal tightness
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GENERAL REQUIREMENTS FOR SEALING PROCESS
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SEALING TECHNIQUES
SEALING - TECHNIQUES
Impulse process
Heat transmission
Constant heat
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SEALING – DIFFERENT KINDS
Two different kind of sealing
Rotary
Static
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SEALING – DIFFERENT KINDS
Static (ex.) Rotary (ex.)
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SEALING RESULT
Mix of 3 parameters
Managing the 3 parameters Sealer suitability
PROCESS CRITICAL PARAMETERS
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11607.2 – NORMS REQUIREMENTS
force
temperature
speed
11607.2 - Validation requirements for forming, sealing and assembly processes – it is necessary to use machines able to control and monitor critical parameters
In C°
in newton
in seconds on static machines in mt/min on rotary machines
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Par. 5.2.4 -
Steady parameters monitoring has to generate
in case any limit, defined by the manufacturer, is exceeded
Machine stops Acoustic / visual signals
11607.2 – NORMS REQUIREMENTS
Immediate ALARMS
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Check if the sealing machines you are using
• MONITOR THE SEALING PARAMETERS
• HAVE ALARMS ON
SEALING PROCESS AND MONITORING CHECK
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Validatable sealers allow you…
Monitoring
SEALING PROCESS AND MONITORING CHECK
…to methodically monitor the sealing parameters
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Gandus sealers allow you…
SEALING PROCESS AND MONITORING CHECK
…to monitor sealing parameters in real time
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…to export data on external devices or by connecting to a net
Validatable sealers allow you…
SEALING PROCESS AND MONITORING CHECK
Documentation
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…to easily export data on USB key
Gandus sealers allow you…
Avoiding the expensive dedicated hardwares
SEALING PROCESS AND MONITORING CHECK
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…to store data in digital or paper format
Validatable sealers allow you…
SEALING PROCESS AND MONITORING CHECK
Records
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…to store data on a simple excel sheet
Gandus sealers allow you…
Avoiding the expensive dedicated softwares
SEALING PROCESS AND MONITORING CHECK
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SEALING IS A SPECIAL PROCESS IT HAS TO BE VALIDATED
DO NOT FORGET...........
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VALIDATION IS COMPOSED BY 3 PHASES...
Operational Qualification [OQ]
Performance Qualification [PQ]
Installation Qualification [IQ]
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3.6 INSTALLATION QUALIFICATION (IQ)
Process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification
DEFINITION
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Process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures
3.4 OPERATIONAL QUALIFICATION (OQ)
DEFINITION
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3.6 PERFORMANCE QUALIFICATION (PQ)
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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DEFINITION
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PERIODIC CONTROLS
ON SEALERS
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EN 868-5
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ISO 11607-2
PERIODIC CONTROLS
Periodic controls to be run on validatable heat sealers are of two different kinds
PERIODIC CONTROLS
Check the SEAL tightness
Check the machine SEALING parameters status
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Tear and Peel test on pouches
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PERIODIC CONTROLS
Calibration on sealers
Tear and Peel test thermo sealed join on pouches and packaging reels
TEAR AND PEEL TEST
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EN 868-5 specifies the controls to be run on the pouch
TEAR AND PEEL TEST
Par. 4.5 - defines
test methods to be run on the heat seal joint of pouches and packaging reels
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The dry strength of the SEALING
for 15 mm width (test strip),
both before and after being subjected to the sterilization process
shall be not less than 1,5 N
TEAR AND PEEL TEST
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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.
TEAR AND PEEL TEST
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Positive output
Calibration Certificate issue
TEAR AND PEEL TEST
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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
TEAR AND PEEL TEST
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It is advisable to run a NEW tightness test on pouches and reels
Positive output
Calibration Certificate issue
TEAR AND PEEL TEST
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TEAR AND PEEL TEST
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Check the machine SEALING parameters status
CALIBRATION
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CALIBRATION
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CONTROL METHODS
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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
Controls through tools
Components mechanical and electric control
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CONTROL METHODS
via thermometers and calibrated probes
CONTROL METHODS
Temperature Speed Force
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According to the in-feed functioning, via calibrated laser speedometers
CONTROL METHODS
Temperature
Speed Force
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Only on new machines, equipped with pressure control
CONTROL METHODS
Temperature Speed
Force
Load-cell functioning is tested through certified weights
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CONTROL OUTPUT
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Positive output
CONTROL OUTPUT
After maintenance After the first control
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Something is wrong
Negative output
The machine needs to be maintained to recover the correct functioning of the parameter
CONTROL OUTPUT
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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
The detection of problems in sealing area means the sealing is not tight, packaging is not safe
Compliance to standards Procedure: ISO 11607 - 2 Materials: ISO 868 – 3
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.
Heat sealer need calibration
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GANDUS SALDATRICI PRODUCTS
NEW ON STAGE
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GANDUS SALDATRICI
POUCH MAKER
Vseal.IT 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:
- the exact quantity of required pouches
- 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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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.
POUCH MAKER GANDUS Vseal.IT
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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.
POUCH MAKER GANDUS Vseal.IT
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Chevron Seal
POUCH MAKER GANDUS Vseal.IT
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correct pouch opening
POUCH MAKER GANDUS Vseal.IT
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GANDUS SALDATRICI
DAILY TEST
BlueTest.it
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DAILY TEST GANDUS BlueTest.IT
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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 ISO 11607-1/2, in the
parts that apply to it.
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.
DAILY TEST GANDUS BlueTest.IT
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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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