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E-mail
mocon.china@ametek.com
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Phone
15221486284
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Address
A1 and A4, 2nd Floor, Building 1, No. 526 Fute East 3rd Road, Shanghai Pilot Free Trade Zone
Product Categories
Ametek Membrane Kang
Medical Device Sealing Tester
NegotiableUpdate on 01/11
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Overview
The Lipke series medical device sealing tester is a desktop instrument designed to perform many currently acceptable leak testing methods. It can measure the packaging integrity of flexible packaging, rigid packaging, porous packaging, and composite packaging used for food and drug packaging. It has a wide range of standard features, available accessories and services, and complies with different ISO and ASTM standards.
Product Details
The Lipke series medical device sealing tester is a desktop instrument designed to perform many currently acceptable leak testing methods. It can measure the packaging integrity of flexible packaging, rigid packaging, porous packaging, and composite packaging used for food and drug packaging. It has a wide range of standard features, available accessories and services, and complies with different ISO and ASTM standards.
Lippke 4000 and Lippke 4500Medical Device Sealing TesterIt is designed specifically for users and provides precise, definable, and reproducible test results.
Lipke 4000 is an independent testing system with an integrated user interface that can be used in production and laboratory environments.
Lipke 4500 is a PC based system that provides data, graphics, statistical analysis, and data output functions.
feature
1. Multi language user interface
2. Complies with ASTM standards:
ASTM F1140: Explosion and Creep of Medical Packaging (Without Limiting Plates)
ASTM F2054: Fracture Test (with Limiting Plate)
ASTM F2095: Pressure Attenuation Leakage Test (with or without restriction plate)
ASTM F2096: Bubble Leakage Test (with Water Tank)
3. Other:
ISO 11607: Packaging for terminally sterilized medical devices
21 CFR Part 11: Protect your data and ensure that all records are truthful and error free.
4. Optional testing function:
Creep and leakage
Creep and rupture
Creep, leakage, and rupture
Lipke series medical device sealing tester performance advantages:
1) Sealing strength test: Inflate the packaging at a set rate to increase pressure until the packaging seal ruptures. (The rupture test complies with ASTM F2054)
2) Leakage test: Inflate the packaging to a predetermined pressure and maintain it at that pressure for the required testing time. Pressure loss is a quantifiable and reproducible test (pressure management and leakage testing according to ASTM F2095).
3) Creep test: Generate a constant pressure inside the packaging, close to the rupture limit, and maintain it for a certain period of time. Evaluate the sealing performance when subjected to pressure within a set time. Optional testing modes: creep and creep failure. ASTM F1140.
4) Multiple testing: The optional multi testing function can test the same package in up to three different testing modes. Each mode is completed on one sample, reducing sample loss. The testing modes are: creep and leakage, expansion and rupture, creep, leakage and rupture.
5) Bubble test: an optional test for Lipke 4500. Place the packaging in water, then pressurize the packaging to the predetermined pressure and keep it there for the predetermined time. (Bubble test in accordance with ASTM F2096)
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Lippke 4000 and Lippke 4500Medical Device Sealing TesterIt is designed specifically for users and provides precise, definable, and reproducible test results.
Lipke 4000 is an independent testing system with an integrated user interface that can be used in production and laboratory environments.
Lipke 4500 is a PC based system that provides data, graphics, statistical analysis, and data output functions.
feature
1. Multi language user interface
2. Complies with ASTM standards:
ASTM F1140: Explosion and Creep of Medical Packaging (Without Limiting Plates)
ASTM F2054: Fracture Test (with Limiting Plate)
ASTM F2095: Pressure Attenuation Leakage Test (with or without restriction plate)
ASTM F2096: Bubble Leakage Test (with Water Tank)
3. Other:
ISO 11607: Packaging for terminally sterilized medical devices
21 CFR Part 11: Protect your data and ensure that all records are truthful and error free.
4. Optional testing function:
Creep and leakage
Creep and rupture
Creep, leakage, and rupture
Lipke series medical device sealing tester performance advantages:
1) Sealing strength test: Inflate the packaging at a set rate to increase pressure until the packaging seal ruptures. (The rupture test complies with ASTM F2054)
2) Leakage test: Inflate the packaging to a predetermined pressure and maintain it at that pressure for the required testing time. Pressure loss is a quantifiable and reproducible test (pressure management and leakage testing according to ASTM F2095).
3) Creep test: Generate a constant pressure inside the packaging, close to the rupture limit, and maintain it for a certain period of time. Evaluate the sealing performance when subjected to pressure within a set time. Optional testing modes: creep and creep failure. ASTM F1140.
4) Multiple testing: The optional multi testing function can test the same package in up to three different testing modes. Each mode is completed on one sample, reducing sample loss. The testing modes are: creep and leakage, expansion and rupture, creep, leakage and rupture.
5) Bubble test: an optional test for Lipke 4500. Place the packaging in water, then pressurize the packaging to the predetermined pressure and keep it there for the predetermined time. (Bubble test in accordance with ASTM F2096)
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| model | Lippke 4000 | Lippke 4500 |
| power supply | 103-264 VAC | 103-264 VAC |
| size | 13.5x10.3x5.1 inch (Width x Depth x Height), 34.4x26.2x13 cm | 13.5x10.3x5.1 inch (Width x Depth x Height), 34.4x26.2x13 cm |
| weight | 14.3 pounds/ 6.5 kg | 14. Pound/ 6.5 kg |
| display | Integrated display screen | External PC display screen |
| General Technical Parameters | ||
| Input air pressure | 4.0-8.0 bar | |
| power frequency | 47-63 Hz | |
| Test time | 1-10000 seconds | |
| pressure unit | mbar， Millimeter mercury (mmHg), Pound per square inch (psi) | |
| Number of test programs | 500 pieces | |
| ambient temperature | +15℃-+40℃（+59 deg. F – 104 deg. F） | |
| ambient humidity | 0%-90% non-condensing | |
| Test scope (two types) | 1)10...1，000 mbar/0.145 ... 14.5 psi 2) 200 ... 3，000 mbar/2.9 ...43.5 psi | |
| resolution | 1)0.1 mbar/0.0015 psi 2) 1 mbar/0.015 psi | |
| Testing accuracy | 1)±0.5 mbar/0.007 psi or 1%***2) ±1%** | |
| Test repeatability | 1)±0.5 mbar/0.007 psi or 1%***2) ±1%** | |
| output interface | RS232 port | |
| execute | CE | |
| meet the standard | ASTM F-1140， F-2054， F-2095， F-2096， 21 CFR Part 11， ISO 11607 | |
