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leak detection instrument designed for testing pharmaceuticals Packages

leak detection instrument designed for testing pharmaceuticals Packages

50000 USD ($)/Set

Product Details:

  • Power Supply 220V, 50/60 Hz
  • Automation Grade Semi-Automatic
  • Operating Voltage 220V AC
  • Test Range 0 250 kPa
  • Measuring Range 0 250 kPa
  • Max Height 220 mm
  • Response Time 2 seconds
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leak detection instrument designed for testing pharmaceuticals Packages Price And Quantity

  • 1 Set
  • 50000 USD ($)/Set
  • 50000.00 - 100000.00 USD ($)/Set

leak detection instrument designed for testing pharmaceuticals Packages Product Specifications

  • Digital Touch Screen
  • 10C 50C
  • Testing pharmaceutical packages (blister packs, ampoules, vials, bottles, strips, etc.)
  • 1 3 per cycle
  • up to 3 liters
  • 60 mm
  • LCD Digital Display
  • Bench-top
  • RS-232, USB
  • 20 cycles/minute
  • Leak Detection Instrument
  • 1 kPa
  • 50/60 Hz
  • 8 mm
  • User programmable test programs, real-time data acquisition, alarm notification, easy calibration, cycle counter display
  • 0.1 kPa
  • Leak integrity testing for pharmaceuticals packaging
  • 0.2 0.6 MPa
  • 220V, 50/60 Hz
  • Semi-Automatic
  • 220V AC
  • 12 kg
  • 150 mm
  • 0 250 kPa
  • 0 250 kPa
  • 2 seconds
  • 220 mm
  • 20% 85% RH
  • up to 150 mm

Product Description

Product FeaturesNote1

Multiple Test Modes & Intelligent Statistics of Qualified Specimens

  • Negative pressure method
  • Multiple test modes including standard, multi-grade vacuum and methylthionine chloride mode
  • Automatic test with traditional methylthionine chloride
  • Vacuum degree, test time and infiltration time can be adjusted and test parameters can be saved automatically so that the tests with same test parameters can be started quickly
  • Automatic constant pressure compensation ensures that the tests can be performed under preset vacuum conditions
  • Real-time display of test curves, easy to observe the test results
  • Automatic statistics of qualified specimens
  • Main components and parts are supplied by well-known global manufacturers, with guaranteed performance

Brand New Patented Intelligent Touch Operating System

  • Industrial grade touch screen, one-button operation, simplified operating interface, remote upgrade and maintenance
  • Chinese and English operating interface
  • Measurement unit conversion
  • Automatic data storage and power failure memory to prevent data loss
  • Storage up to 1200 test records (standard mode)
  • Multiple-level user management and login with password
  • Micro-printer and USB ports for data transmission (optional)
  • The instrument conforms to the requirements of GMP (optional)
  • Labthinks unique DataShiledTM System for data management and connecting with information system (optional)

Test Principle

Firstly submerge the specimen in the water in the vacuum chamber, and then evacuate the vacuum chamber to form differential pressure between the inside and outside of specimen. The seal property can be obtained by observing the steady progression of bubbles from the specimen or observing how the specimen expands and restores to its original shape after vacuum release.

Test StandardNote1

ASTM D3078, GB/T 15171

Applications

Basic Applications
  • Glass Bottles, Pipes, Cans and Boxes
  • Plastic Bottles, Pipes, Cans and Boxes
  • Metal Bottles, Pipes, Cans and Boxes
  • Paper Plastic Composite Bags and Boxes
Extended Applications
  • Pen Refills
  • Electronic Components
  • Medical Instruments

Technical Specifications

Specifications C660B
Vacuum Degree 0 -90 KPa/ 0 -13 psi
Accuracy 0.25% FS
Resolution 0.1 KPa / 0.01 psi
Vacuum Chamber
Effective Sizes
I270 mm x 210 mm (H) (standard)
I360 mm x 585 mm (H) (optional)
I460 mm x 330 mm (H) (optional)
Note: customization is available for other sizes
Gas Supply Air (outside of supply scope)
Gas Supply Pressure 0.5 MPa 0.7 Mpa (73psi 101psi)
Instrument Dimension 334 mm (L) x 230 mm (W) x 170 mm (H)
Power Supply 220VAC10% 50Hz / 120VAC10% 60Hz
Net Weight Instrument: 6.5 kg Standard Vacuum Chamber: 9kg

Configurations

Standard Configurations
Instrument, Standard Vacuum Chamber (I270 mm x 210 mm), I6 PU Tubing (1m)
Optional Parts
Micro Printer, Professional Software, Customized Vacuum Chamber, Air Compressor, GMP System, DataShieldTM Note3
Note
1. The gas supply port of the instrument isI6 mm PU Tubing;
2. Customers need to prepare gas supply.

Note 1: The described test standard, applications and product features should be in line with Technical Specifications.
Note 2: The parameters in the table are measured by professional operators in Labthink laboratory under strictly controlled laboratory conditions.
Note 3: DataShieldTM provides safe and reliable data application support. Multiple Labthink instruments can share one single DataShieldTM system which can be configured as required.



Advanced Leak Detection Technology

The instrument features two comprehensive leak test methods-vacuum decay and bubble emission. With a wide measuring range of 0-250 kPa, 1 kPa accuracy, and a resolution of 0.1 kPa, it pinpoints even minute package leaks. The built-in vacuum pump delivers stable performance and a fast response in 2 seconds, complemented by user programmable test programs for tailored assessments.


Robust and User-Friendly Design

Manufactured from corrosion-resistant stainless steel, the instrument withstands harsh laboratory and production environments. Its intuitive LCD digital display and digital touch screen controls make operation streamlined and straightforward. The semi-automatic process, real-time data acquisition, and cycle counter display optimize productivity and ease-of-use, while its compact, bench-top mounting ensures space efficiency.


Compliant, Safe, and Low Maintenance

Meeting USP and ASTM standards, this leak detection device upholds industry requirements for pharmaceutical packaging quality. It is equipped with safety mechanisms, such as automated shut-off and over-pressure protection. The maintenance-free vacuum pump, low overall maintenance needs, and quiet operation (<40 dB(A)) ensure reliability and workplace comfort.

FAQ's of leak detection instrument designed for testing pharmaceuticals Packages:


Q: How does this instrument perform leak detection on pharmaceutical packages?

A: The instrument utilizes vacuum decay and bubble emission test methodologies to identify leaks in pharmaceutical packaging. It precisely measures pressure changes within the test chamber, indicating possible leaks when the vacuum cannot be maintained. Bubble emission further visually detects leaks by observing for escaping bubbles when air or inert gas is used.

Q: What types of packaging can be tested with this leak detection instrument?

A: It is designed for a wide variety of pharmaceutical packages, including blister packs, ampoules, vials, bottles, and strips. The instrument accommodates specimen sizes up to 150 mm and capacities up to 3 liters, making it suitable for both small and large samples.

Q: What benefits does built-in data storage provide?

A: The instrument's internal memory allows for storage of up to 500 test records. This facilitates efficient record-keeping, traceability, and compliance, ensuring that test results can be accessed for analysis and audits without additional external devices.

Q: When should calibration be performed, and how is it managed?

A: Calibration should be performed periodically based on your laboratory's SOP or regulatory requirements. The instrument is supplied with a calibration certificate and features easy calibration procedures, allowing users to maintain measurement accuracy with minimal downtime.

Q: Where is this instrument best utilized within pharmaceutical processes?

A: It is ideally suited for quality control laboratories, manufacturing lines, and R&D departments in pharmaceutical companies. Its compact bench-top design and semi-automatic operation support rapid integration and streamlined package integrity testing at various stages of production.

Q: What is the process for operating the leak detection instrument?

A: After loading up to three specimens into the chamber and selecting a user-programmed test program via the digital touch screen, the instrument automatically performs leak testing using air or inert gas. Results are displayed on the LCD and stored in internal memory, with alarms and automated shut-off features ensuring safe operation throughout the cycle.

Q: How does using this instrument benefit pharmaceutical packaging manufacturers?

A: Manufacturers benefit from enhanced package integrity assurance, faster testing speeds (up to 20 cycles/minute), regulatory compliance with USP and ASTM standards, and improved data management. The instrument's robust safety features, low maintenance design, and high accuracy contribute to increased productivity and reduced total cost of ownership.

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