Catálogos LF-LASER LF-S LF-SMH LF-TRM LF-BLI PK-IS PK-V PK-A PK-VS PK-VF PK-SY LVA SQZ LDB RLD-400A. Probadoras de estanqueidad en envases Pharma

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1 Catálogos Probadoras de estanqueidad en envases Pharma LF-LASER LF-S LF-SMH LF-TRM LF-BLI PK-IS PK-V PK-A PK-VS PK-VF PK-SY LVA SQZ LDB RLD-400A / Bauness 1950 (C1431DNL) Buenos Aires, Argentina

2 LF-LASER Headspace Moisture and Vacuum Level Analysis The Inspection Machine is used for off-line TDLAS Laser based Oxygen or Moisture Level Analysis into sealed Containers headspace. It performs the contact-less and non intrusively Inspection on one Container at a time. On pressing the Cycle Start button the Leak Testing process is run. The absorbed fraction of Laser light energy is corresponding to headspace oxygen or moisture concentration. displays the status on the screen. Vials, Ampoules Lyophilised Laboratory Headspace Gas Analyser Headspace Gas Analysis 4 Cpm 10,75 x 54 x 35 mm 10,75 x 54 x 120 mm from 1.00 to 1.00 Reliability guaranteed above 99% Precise measurement of vacuum and moisture level in vial High repeatitivity Very low noise levels Easy cleaning Low energy consumption Almost maintenance-free Simple to use Low investment cost - Very fast pay back High sensitivity Displaying recording and printing of the tests carried out Validation documentation to comply with FDA protocols Software based on SCADA platform configurable to comply with CFR21 part II norms

3 LF-S BenchTop Single-Head Testing Machine Leak The Leak Testing Machine is used for off-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process on one Container at a time by means of a Testing Chamber under Vacuum or Pressure. On pressing the Cycle Start button the Leak Testing process is run. displays the status on the screen. Bottles, Vials, Ampoules, Pre Syringes, Carpoules, BFS, FFS, Flowrapped Device, IV Bags Empty, Lyophilised, Liquid, Powder, Semi-solid Laboratory Leak Tester Vacuum Decay, Pressure Decay 4 Cpm 4 x 250 x 3 mm 4 x 250 x 300 mm from 1.00 to Fully automated test cycle sequencing with Containers manual loading and unloading - High leak detection sensitivity - Fast reliable and repeatable test results - Compact and robust design - Easy-to-use and enhanced HMI integrated functions - System autodiagnostics available - Maintenance-free - Cost-effective solution - Low power consumption - ASTM F test method and FDA standard - Complete and efficient regulatory compliance provided by Validation Package

4 LF-SMH BenchTop Multi-Head Testing Machine Leak The Leak Testing Machine is used for off-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process on five Container at a time by means of a Testing Section under Vacuum or Pressure. The Leak Testing Machine is made up of one Front Section with five bottom parts where Containers are manually loaded and unloaded, and one Testing Section where the Mobile Upper Part with vertical movement is closed over the five bottom parts. Containers are transported throughout the Sections by means of a rotating table with 180 degrees indexing motion. displays the status and the bottom part position on the screen. Flowrapped Device, Bottles, Vials, MDI, MDPI, IV Bags, Pouches, Stick Packs Liquid, Powder, Semi-solid Laboratory Leak Tester Vacuum Decay 20 Cpm 5 x 86 x 5 mm 30 x 86 x 170 mm from 5.00 to 5.00 Reliability guaranteed above 99% Precise detection of micro leaks High repeatitivity Very low noise levels Easy cleaning Low energy consumption Almost maintenance-free Simple to use Low investment cost - Very fast pay back High sensitivity Displaying recording and printing of the tests carried out Leak testing method according to ASTM F Validation documentation to comply with FDA protocols Real Time software based on soft Plc platformsharing data with as simple HMI application via OPC technology.

5 LF-TRM Off-line Leak Testing Machine for Prefilled Syringes Nests The Leak Testing Machine is used for off-line Non-Destructive Integrity Testing of Nests (Trays) of pre-filled syringes. It performs the Leak Testing process on one Nest at a time by means of a Testing Section under Vacuum. displays the status on the screen. PFS Nest Empty Liquid Laboratory Leak Tester Vacuum Decay 6 Cpm 60 x 260 x 30 mm 60 x 230 x 100 mm from 1.00 to 1.00 Reliability guaranteed above 99% Precise detection of micro leaks High repeatitivity Very low noise levels Easy cleaning Low energy consumption Almost maintenance-free Simple to use Low investment cost - Very fast pay back High sensitivity Displaying recording and printing of the tests carried out Leak testing method according to ASTM F Validation documentation to comply with FDA protocols Real Time software based on soft Plc platformsharing data with as simple HMI application via OPC technology.

6 LF-BLI BenchTop Lid Deflection Leak Testing Machine The Measurement System is based on the detection of the Container flexible lidding material displacement, induced by the Vacuum generation into a Testing Chamber. The deformation measurement is carried out by a dedicated Pressure Sensing System which is in contact with the Container. Container is then classified Conforming or Non Conforming according to acquired lidding movement. The HMI clearly displays on the screen both the test result status and in case of Non Conformity the location of the failure. Blisters, Pouches Liquid, Powder, Semi-solid Laboratory Leak Tester Lid Deflection 4 Cpm 5 x 215 x 2 mm 5 x 230 x 15 mm from 1.00 to 1.00 Reliability guaranteed above 99% Precise detection of micro leaks High repeatability 1 Universal Test Head for all types of blister packs Easy cleaning Low energy consumption Almost maintenance free Simple to use Low investment cost - Very fast pay back Displayingrecording and printing of the tests carried out Validation documentation to comply with FDA protocols

7 PK-IS In-Line Indexing Motion Leak Testing Machine The Leak Testing Machine is used for in-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process continuously by means of a Testing Group under Vacuum. The Leak Testing Machine is made up of one Loading Section where Containers are automatically loaded, the Testing Group where the Mobile Upper Part with vertical movement is closed over the bottom part, one Reject Section for automatic ejection of Non Conforming Containers and one unloading Section where Conforming Containers are automatically unloaded. A rotating table with 90 degrees indexing motion supports the Container transport throughout Testing area. displays the status and the bottom part position on the screen. BFS, FFS Liquid Indexed Leak Tester Vacuum Decay 20 Cpm 0,00 x 140,00 x 0,00 mm 0,00 x 20,00 x 0,00 mm from 0.00 to 2.00 Precise detection of micro leaks Guaranteed reliability of more than 99.9% High repeatability Easy cleaning Low energy consumption Low maintenance User-friendly Displaying recording and printing of tests carried out Leak testing method according to ASTM F Validation documentation to comply with FDA protocols Software based on SCADA platform configurable to comply with CFR21 part II norms.

8 PK-V In-Line High Production Speed Leak Testing Machine The Leak Testing Machine is used for in-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process in continuous operation by means of Testing Chambers under Vacuum or optionally Pressure which are installed on to a rotating Central Carousel. Following Leak Testing process, the Containers are automatically unloaded from Testing Area and they are managed according to the result. displays the status. Vials, Bottles, BFS Lyophilised, Liquid, Powder, Semi-solid Rotative Leak Tester Vacuum Decay, Pressure Decay 200 Cpm 16,00 x 145,00 x 39,00 mm 16,00 x 16,00 x 250,00 mm from to Reliability guaranteed above 99%- Precise detection of micro leakshigh repeatitivity- Very low noise levels- Easy cleaning- Low energy consumption- Low maintenance- User friendliness- High sensitivity- No compressed air required- Displaying recording

9 PK-A Off-Line High Testing Machine Speed Leak The Leak Testing Machine is used for in-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process in continuous operation by means of Testing Chambers under Pressure or optionally Vacuum which are installed on to a rotating Central Carousel. Following Leak Testing process, the Containers are automatically unloaded from Testing Area and they are managed according to the result. displays the status. Ampoules, Vials, Carpoules Lyophilised, Liquid, Powder, Semi-solid Rotative Leak Tester Vacuum Decay, Pressure Decay 450 Cpm 10,00 x 25,00 x 35,00 mm 10,00 x 10,00 x 108,00 mm from to Reliability guaranteed above 99% Precise detection of micro leaks High repeatitivity Very low noise levels Easy cleaning Low energy consumption Low maintenance User friendliness High sensitivity Displaying recording and printing of the tests carried out Leak testing method according to ASTM F Validation documentation to comply with FDA protocols Software based on SCADA platform configurable to comply with CFR21 part II norms

10 PK-VS In-Line BFS/FFS Leak Testing Machine The Leak Testing Machine is used for in-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process in continuous operation by means of Testing Chambers under Vacuum which are installed on to a rotating Central Carousel. Following Leak Testing process, the Containers are automatically unloaded from Testing Area and they are managed according to the result. displays the status. BFS, FFS Liquid Rotative Leak Tester Vacuum Decay 82 Cpm 5,00 x 150,00 x 8,00 mm 5,00 x 5,00 x 45,00 mm from 6.00 to High speed leak testing Non Destructive Rapid and accurate analysis 100% control and not statistical Homogeneous leak detection Easy validation and leakage certification Automatic cleaning pocket to avoid false rejects No alteration of product s properties Easy access and cleaning Low energy consumption Displaying recording and printing of the tests results Software based on SCADA platform configurable to comply with CFR21 part II norms

11 PK-VF In-Line Leak Testing Machine for Flow Wrapped Applications The Leak Testing Machine is used for in-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process in continuous operation by means of Testing Chambers under Vacuum which are installed on to a rotating Central Carousel. Following Leak Testing process, the Containers are automatically unloaded from Testing Area and they are managed according to the result. displays the status. Flowrapped Device Liquid, Powder, Semi-solid Rotative Leak Tester Vacuum Decay 70 Cpm 50 x 180 x 30 mm 50 x 100 x 100 mm from to High speed leak testing Non Destructive Rapid and accurate analysis 100% control and not statistical Homogeneous leak detection Easy validation and leakage certification Automatic cleaning pocket to avoid false rejects No alteration of product s properties Easy access and cleaning Low energy consumption Displaying recording and printing of the tests results Software based on SCADA platform configurable to comply with CFR21 part II norms

12 PK-SY In-Line High Speed Leak Testing Machine for Prefilled Syringes The Leak Testing Machine is used for in-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process in continuous operation by means of Testing Chambers under Vacuum which are installed on to a rotating Central Carousel. Following Leak Testing process, the Containers are automatically unloaded from Testing Area and they are managed according to the result. displays the status. Pre Syringes Liquid Rotative Leak Tester Vacuum Decay 600 Cpm 16 x 27 x 40 mm 16 x 16 x 110 mm from to High speed leak testing Non Destructive Rapid and accurate analysis 100% control and not statistical Homogeneous leak detection Easy validation and leakage certification Automatic cleaning pocket to avoid false rejects No alteration of product s properties Easy access and cleaning Low energy consumption Displaying recording and printing of the tests results Software based on SCADA platform configurable to comply with CFR21 part II norms

13 LVA In-Line High Speed Inspection Machine Laser The Inspection Machine is used for in-line TDLAS Laser based Oxygen or Moisture Level Analysis into sealed Containers headspace. Containers transfer from Infeed to Outfeed is managed by means of automatic systems. It performs the contact-less and non intrusively Inspection in continuous operation The absorbed fraction of Laser light energy is corresponding to headspace oxygen or moisture concentration. displays the status on the screen. Vials Lyophilised Rotative Headspace Gas Analyser Headspace Gas Analysis 500 Cpm 14 x 45 x 40 mm 0 x 0 x 70 mm from 1.00 to 2.00 Non Destructive Rapid and accurate analysis system Reliability guaranteed above 99% Precise measurement of vacuum and moisture level in vial Easy cleaning Displaying recording and printing of the tests carried out Validation documentation to comply with FDA protocols Software based on GMP and SCADA platform configurable to comply with CFR21 part II norms

14 RLD-400A In-line Leak Testing Machine for Aerosol Cans The Leak Testing Machine is used for in-line Non-Destructive Aerosol Cans Integrity Testing. It performs the Leak Testing process in continuous operation by means of Testing Chambers under Vacuum or optionally Pressure which are installed on to a rotating Central Carousel. Following Leak Testing process, the Aerosol Cans are automatically unloaded from Testing Area and they are managed according to the result. displays the status. Monobloc Liquid Rotative Leak Tester Vacuum Decay 200 Cpm 35 x 65 x 70 mm 35 x 65 x 330 mm from 8.00 to Easy management. Low energy consumption. Testing head movement by cam. Low maintenance due to automatic calibration. Noise levels well within allowed limits. Reliability guaranteed above 99.9%. Alarm display. Ejection station for bad containers. Wide range of optional devices that allow the machine to be personalized based on the specific needs of each customer.

15 SQZ In-line Leak Testing Machine for Stick Packs The Leak Testing Machine is used for in-line Non-Destructive Form/fill/seal Stick Pack Closure Integrity Testing. It uses the Force Decay Measurement Method which is accomplished respectively by Container lanes smooth-pressing and successive position level acquisition. The Container lane proportional reaction is then corresponding to the Container status. Following Leak Testing process, the Containers are automatically unloaded from Testing Area and they are managed according to the result. displays the status. Stick Packs Liquid, Powder, Semi-solid Linear Leak Tester Force Decay 180 Cpm 25 x 150 x 2 mm 10 x 10 x 10 mm from 3.00 to 20.00

16 LDB Off-Line Leak Testing Machine for hermetically form filled sealed Package systems <ul></ul> The Leak Testing Machine is used for off-line Non-Destructive Container Closure Integrity Testing by means of a Force Decay based Measurement System. A suitable number of Package Holders and Testing Independent Units are installed onto a Central Carousel. The Packages to be tested are first to be manually hanged onto Holders, then Central Carousel is 180 degrees automatically rotated to bring each and every loaded Package in correspondence of the reference Testing Unit. Purpose of such Testing Units is to analyse the force level variation following Package smooth mechanical pressing. Each Testing Unit is made up of: 1.Plate connected to a step motor for mechanical pressing 2.Package support coupled to a load cell 3.Acquisition Board displays the status.the Measurement System provides both a gross and a fine leak Following Leak Testing process, the Non Conforming Containers are automatically unloaded from Testing Units and they are transferred at Leak Testing Machine exit by means of a dedicated reject conveyor. Conforming Containers are to be manually unloaded following a further Central Carousel 180 degrees rotation. 40 Cpm 5 x 10 x 2 mm 23 x 45 x 15 mm from 4.00 to 4.00 IV Bags Liquid Indexed Leak Tester