Behind the scenes - DND Commerce...2016/05/31 · Gandus Vseal.it can be interfaced with...

Behind the scenes

1

Who are we?

2

Few people know that this distinguished gentleman Prospero Gandus (my grandfather)

in1885 founded Gandus

WHERE DO WE COME FROM?

3

The production began with paper bags to contain the needles for sewing machines.

Craftsmanship and precision, all Italian.


4

Since its foundation Gandus has been a

MANUFACTURER

But how was production in the nineteenth century?


5

19° century…

GANDUS IN 19TH CENTURY

6

… 20° century

GANDUS TODAY

7

GANDUS TODAY

Divisions

10

Bags and tubes sealers production

Sterilization pouches sealers production

Automatic packaging systems production

GANDUS TODAY

11

All our machines are designed in-house, making use of the latest

3D design software

GANDUS TODAY

12

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

13

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

14

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

15

To get wonderful products

GANDUS TODAY

16

Our machines are small concentrates

of high technology

GANDUS TODAY

17

how many pieces between mechanical

parts and components are needed to manufacture a

Gandus minirò H net Evo ?

GANDUS TODAY

18

This is our world,

This is our way of thinking about design and production in the equipment that we install worldwide

GANDUS TODAY

20

From a

great grand father…

To great grandchildren Who will carry on this beautiful story of Italian entrepreneurship

..... AND TOMORROW ?

21

ONE WORD: PERFECTION

Sealing machines and their Validation Process

23

Mr Nicola Guglielmini

Managing Director

Gandus Saldatrici Packaging Machines

24

STERILIZATION PROCESS

Washing procedures

Washing |

26


Washing procedures

Packaging procedures

Washing | Packaging |

27


Washing procedures


Sterilization procedures

Washing | Packaging | Sterilization |

28


Washing procedures



Aseptic presentation

Washing | Packaging | Sterilization | Aseptic

29

Washing 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…

31

Packing for finally sterilized medical devices

SAFETY IN STERILIZATION… THE NEW STANDARD

32

Packaging is a key element in the Sterilization process

Also sealing has to be a reliable barrier

against microorganism

SAFETY IN STERILIZATION…PACKAGING

33

A NOT correct seal invalidates the whole Sterilization process

SAFETY IN STERILIZATION…PACKAGING

34

Only using machines able to guarantee a qualitative standard to assure a steady sealing integrity and the repeatability of the process

ISO standard

X

“

„

GENERAL REQUIREMENTS FOR SEALING PROCESS

35

Only a sealing through validatable ISO 11607-2 sealing devices guarantees a perfect seal tightness

“ „

X

GENERAL REQUIREMENTS FOR SEALING PROCESS

36

37

SEALING TECHNIQUES

SEALING - TECHNIQUES

Impulse process

Heat transmission

Constant heat

38

SEALING – DIFFERENT KINDS

Two different kind of sealing

Rotary

Static

39

SEALING – DIFFERENT KINDS

Static (ex.) Rotary (ex.)

40

SEALING RESULT

Mix of 3 parameters

Managing the 3 parameters Sealer suitability

PROCESS CRITICAL PARAMETERS

41

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

42

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

43

Check if the sealing machines you are using

• MONITOR THE SEALING PARAMETERS

• HAVE ALARMS ON

SEALING PROCESS AND MONITORING CHECK

44

Validatable sealers allow you…

Monitoring


…to methodically monitor the sealing parameters

45

Gandus sealers allow you…


…to monitor sealing parameters in real time

46

…to export data on external devices or by connecting to a net



Documentation

47

…to easily export data on USB key


Avoiding the expensive dedicated hardwares


48

…to store data in digital or paper format



Records

49

…to store data on a simple excel sheet


Avoiding the expensive dedicated softwares


50

SEALING IS A SPECIAL PROCESS IT HAS TO BE VALIDATED

DO NOT FORGET...........

+

51

VALIDATION IS COMPOSED BY 3 PHASES...

Operational Qualification [OQ]

Performance Qualification [PQ]

Installation Qualification [IQ]

52

3.6 INSTALLATION QUALIFICATION (IQ)

Process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification

DEFINITION

53

“ „

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

54

“ „

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

“ „

DEFINITION

55

PERIODIC CONTROLS

ON SEALERS

56

EN 868-5

57

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

58

Tear and Peel test on pouches

59

PERIODIC CONTROLS

Calibration on sealers

Tear and Peel test thermo sealed join on pouches and packaging reels

TEAR AND PEEL TEST

60

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

61

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

62

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

63

Positive output

Calibration Certificate issue

TEAR AND PEEL TEST

64

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

65

It is advisable to run a NEW tightness test on pouches and reels

Positive output

Calibration Certificate issue

TEAR AND PEEL TEST

66

TEAR AND PEEL TEST

67

Check the machine SEALING parameters status

CALIBRATION

68

CALIBRATION

69

CONTROL METHODS

70

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

71

CONTROL METHODS

Controls through tools

Components mechanical and electric control

72

CONTROL METHODS

via thermometers and calibrated probes

CONTROL METHODS

Temperature Speed Force

73

According to the in-feed functioning, via calibrated laser speedometers

CONTROL METHODS

Temperature

Speed Force

74

Only on new machines, equipped with pressure control

CONTROL METHODS

Temperature Speed

Force

Load-cell functioning is tested through certified weights

75

CONTROL OUTPUT

76

Positive output

CONTROL OUTPUT

After maintenance After the first control

77

Something is wrong

Negative output

The machine needs to be maintained to recover the correct functioning of the parameter

CONTROL OUTPUT

78

GANDUS SALDATRICI PRODUCTS

SEALING DEVICES

79

GANDUS MINIRO’ H-LAN TOUCH

80

GANDUS MINIRO’ H-LAN

81

GANDUS MINIRO’ H–NET EVO

82

GANDUS MINIRO’ H-SEAL VP EVO

83

GANDUS MINIRO’ H-DATA EVO

84

GANDUS MINIRO’ POLY VP

85

GANDUS MINIRO’ H-SEAL EVO

86

GANDUS REBI VP EVO

87

GANDUS MEDICAL H 460/610 ATDP

88

GANDUS MEDICAL H 460/610

89

GANDUS SI MED 520-720-1020

90

GANDUS SI VACUUMMED 520-720-1020

91

GANDUS DN 350

92

GANDUS GD 301

93


ROUTINE TESTS

94

GANDUS SEAL CHECK IT

95


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.

96


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.

97


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

98


NEW ON STAGE

99

GANDUS SALDATRICI

POUCH MAKER

Vseal.IT Vseal.IT

10

0

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

10

3

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.


10

4

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.


10

5

Chevron Seal


10

6

correct pouch opening


10

7

GANDUS SALDATRICI

DAILY TEST

BlueTest.it

10

8

DAILY TEST GANDUS BlueTest.IT

11

0

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.


11

1


11

2


11

3

Thank you for your kind attention

11

4

Behind the scenes - DND Commerce...2016/05/31 · Gandus Vseal.it can be interfaced with...

Documents

Transcript of Behind the scenes - DND Commerce...2016/05/31 · Gandus Vseal.it can be interfaced with...