Cardiff Hospital NHS Customer

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Cardiff Hospital NHS Customer
s.r.l.
                                                                                                            OFF18/2012

                                    Customer:
                               Cardiff Hospital NHS
                                 (United Kingdom)
                                                Machine:

                                  Bench for leak test
                                                Model:
                                               Easy TS

                                                                                           Date: 6th March 2012
                                                     Page 1 of 7

CONVEL s.r.l. - Via Prati, 11 36031 Dueville (VI) ITALY - Registro delle Imprese di Vicenza, C.F., P.IVA: 02435850249
  cap.soc. €24.000 int. versato - www.convel.biz info@convel.biz - Tel. +39-0444-361301 Fax +39-0444-1830680
Cardiff Hospital NHS Customer
s.r.l.
                                                                                                            OFF18/2012

      1. Introduction.

      Easy TS is a compact and reliable table top bench designed to perform the leak
      test in glass ampoules for pharmaceutical use
      This system is capable to detect microholes of the dimension of some micron that
      can compromise the sterility of the product.
      It can be installed in laboratory for non destructive quality test or it can be present
      in production lines for sampling test.
      The execution of the test is very fast (the electronic measurement takes about 0,1
      sec) and the use is absolutely simple and safe for the operator.

      2. Principles

      The test is based on the analysis of the current flowing in measurement circuit
      (Fig. 1) after the application of an high voltage between the two electrodes HV and
      LV. If the container is correctly sealed, the current flowing is very low because the
      glass of the container is a perfect isolator. In case of presence of a microfissure
      an electric spark is generated through the conductive liquid with a capacitive
      current very high and easily recognizable.

                                                                   Control
                                                                    board

                                      HV

                                                                                              LV

                                                     Figure 1 – Test circuit

      Necessary condition for the correct verification of the test is that internal surface of
      container in the tip and in the area around LV is wet by internal liquid.

      Test time is very short (around 50 ms) and there’s no mechanical stress to the
      container nor transfer of energy (less than 0,1 J) without any risk of contamination
      of the product. Not only one spark is generated but trains of pulses at adjustable
      power are generated at a fixed frequency for each container. Each single pulse
      has the effect to generate a current; the control board is used both to control the
      generation of pulses and to process the signal acquired.
                                                     Page 2 of 7

CONVEL s.r.l. - Via Prati, 11 36031 Dueville (VI) ITALY - Registro delle Imprese di Vicenza, C.F., P.IVA: 02435850249
  cap.soc. €24.000 int. versato - www.convel.biz info@convel.biz - Tel. +39-0444-361301 Fax +39-0444-1830680
Cardiff Hospital NHS Customer
s.r.l.
                                                                                                            OFF18/2012

      A special algorithm is applied enabling to send to PLC two analog values
      proportional to the peak current and to the average current; each one of the two
      value is compared with its own minimum threshold. If at least one of these two
      thresholds is exceeded, the container is considered rejected.

    2. Features

      Test is automatically performed by pressing the green pushbutton in the front
      panel: two lamps signal to the operator the result of the test; green lamp means
      ‘GOOD’, red lamp means ‘REJECT’.

                           Figure 2 – Panel detail with pushbuttons, lamps and display

      Only four parameters are needed for the setup: the power and duration of the
      sparks and the two thresholds (for average and peak current) for sensitivity
      adjustment.
      The value of the results are visualized on the display both in numerical and
      graphic way.
      These parameters can be memorized in receipts (up to four).
      Display visualizes also the number of sparks emitted and the number of positive
      and negative test with percentages.

      Operation is fast and very easy: operator simply puts the container in
      appropriate horizontal position between the electrodes and presses the
      pushbutton: no specific skills are required.

                                                     Page 3 of 7

CONVEL s.r.l. - Via Prati, 11 36031 Dueville (VI) ITALY - Registro delle Imprese di Vicenza, C.F., P.IVA: 02435850249
  cap.soc. €24.000 int. versato - www.convel.biz info@convel.biz - Tel. +39-0444-361301 Fax +39-0444-1830680
s.r.l.
                                                                                                            OFF18/2012

    3. Construction

      The base is made in stainless steel AISI 304/316L, while the external upper frame
      is in anodized aluminium.
      Plastic parts, that can be in contact with the leaked product, are in FDA approved
      plastic material (PE or POM C).
      Covers are in transparent lexan.
      The device is equipped with Siemens PLC and Interface panel
      The front door is protected by two key microswitches connected to a safety control
      unit. For safety purpose, the spark is not emitted when door is open.

    4. Size change

      Size change is performed, without any tools, changing the position of the electrode
      close to the tip, according to the height of the ampoule.
      Required time: 1 minute only.

                                                     Page 4 of 7

CONVEL s.r.l. - Via Prati, 11 36031 Dueville (VI) ITALY - Registro delle Imprese di Vicenza, C.F., P.IVA: 02435850249
  cap.soc. €24.000 int. versato - www.convel.biz info@convel.biz - Tel. +39-0444-361301 Fax +39-0444-1830680
s.r.l.
                                                                                                            OFF18/2012

    5. Technical Specifications

          Dimensions (LxWxH):                                      400x350x650 mm. approx

          Weight                                                   15 kg. approx

          Electrical supply                                        230V 50Hz 1Ph

          Power Supply                                             250W – 1A

          Containers                                               Glass ampoules

          Diameter of container                                    9 – 25 mm

          Volume                                                   1 – 30 ml

          Products                                                 Liquids

          Conductivity of the product                              ≥ 3 µS/cm

          Lasting of test                                          30ms – 200ms

          High Voltage applied to the container                    Up to 35 KV

          Minimum detectable hole                                  5 - 10 micron

          Area of inspection                                       Tip and bottom of the ampoule

          Conformity                                               Machine is compliant to CE rules

                                                     Page 5 of 7

CONVEL s.r.l. - Via Prati, 11 36031 Dueville (VI) ITALY - Registro delle Imprese di Vicenza, C.F., P.IVA: 02435850249
  cap.soc. €24.000 int. versato - www.convel.biz info@convel.biz - Tel. +39-0444-361301 Fax +39-0444-1830680
s.r.l.
                                                                                                            OFF18/2012

    6. Prices

     DESCRIPTION                                                                                   PRICE

      Nr. 1 Bench for offline leak test Easy TS including:
        − Siemens panel interface for parameters setup and
             visualization of results.
        − Siemens PLC
        − ‘Start test’ pushbutton and lamps for immediate
             visualization of the result
        − One size able to test ampoules up to 30 ml with
             adjusting sliding electrode
        − Emergency pushbutton
        − Two emergency microswitches on front door
        − Electrodes setup for inspection of tip and bottom
        − User and maintenance manual
        − Packing                                           €                                       22.300

    7. Training

    Although the device is very simple to be used, a short training with test performed
    together with a Convel technician is very useful and recommended. The training can
    be performed in Convel, free of charge, lasting one full day.

    8. Payment

      30% down payment at order by T/T transfer
      70% at delivery by T/T transfer
      Payment is in euro

    9. Delivery time

      60 days from the order, definition of all technical details and reception of samples.
      Delay in reception of samples can affect the delivery time

    10. Delivery terms

      Ex works Dueville (Incoterms 2000)

                                                     Page 6 of 7

CONVEL s.r.l. - Via Prati, 11 36031 Dueville (VI) ITALY - Registro delle Imprese di Vicenza, C.F., P.IVA: 02435850249
  cap.soc. €24.000 int. versato - www.convel.biz info@convel.biz - Tel. +39-0444-361301 Fax +39-0444-1830680
s.r.l.
                                                                                                            OFF18/2012

    11. Warranty
      The bench is guaranteed 12 months from installation date against malfunctioning
      coming from defective mechanical or electric parts that will be replaced free of charge.
      Malfunctioning due to customer misuse will be on customer’ charge.

    12. Validity
      90 days from the date of the offer

    13. Conditions
       The customer shall guarantee a fluctuation of machine power supply within 10%.
       All external surfaces of the containers must be dry and clean.
       Customer understands that efficiency of the test is conditioned by conductivity of
        liquids.
       Convel takes the right to verify that the conductivity of the liquid is inside the
        requested range.
       Convel takes the right to verify that geometry of the cap enables the test conditions
       Customer must provide about 50 samples for each product and size at the
        order.

    14. Layout (dimensions are in mm)

                                                     Page 7 of 7

CONVEL s.r.l. - Via Prati, 11 36031 Dueville (VI) ITALY - Registro delle Imprese di Vicenza, C.F., P.IVA: 02435850249
  cap.soc. €24.000 int. versato - www.convel.biz info@convel.biz - Tel. +39-0444-361301 Fax +39-0444-1830680
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