Customer: Cardiff Hospital NHS (United Kingdom) Machine: Bench for leak test Model: Easy TS Page 1 of 7 Date: 6 th March 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
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
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
5. Technical Specifications Dimensions (LxWxH): Weight Electrical supply Power Supply Containers Diameter of container Volume Products Conductivity of the product Lasting of test High Voltage applied to the container Minimum detectable hole Area of inspection Conformity 400x350x650 mm. approx 15 kg. approx 230V 50Hz 1Ph 250W 1A Glass ampoules 9 25 mm 1 30 ml Liquids 3 µs/cm 30ms 200ms Up to 35 KV 5-10 micron Tip and bottom of the ampoule Machine is compliant to CE rules Page 5 of 7
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
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