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ASTM and ISO Standards Oxygen and Water Vapor Transmission Testing of Pharma Packaging

ASTM and ISO Standards Oxygen and Water Vapor Transmission Testing of Pharma Packaging

50000 USD ($)/Set

Product Details:

  • Measuring Range 0.01~100,000 cc/m24h0.1MPa (Oxygen); 0.01~10,000 g/m24h (Water Vapor)
  • Display Type Touchscreen LCD display
  • Temperature 15C~55C (adjustable)
  • Number of Specimens 1~3 (simultaneous measurement available)
  • Application Pharmaceutical packaging material and container barrier property analysis
  • Humidity 10%~90% RH (adjustable)
  • Specimen Size 108 mm x 108 mm
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ASTM and ISO Standards Oxygen and Water Vapor Transmission Testing of Pharma Packaging Price And Quantity

  • 50000 USD ($)/Set
  • 1 Set
  • 50000.00 - 100000.00 USD ($)/Set
  • Coulometric sensor method for oxygen, Infrared sensor for water vapor
  • Temperature 15~35°C
  • Over-pressure and leakage alarms, password protection
  • Programmable and regulated
  • Meets international regulatory requirements for pharma applications
  • Coulometric oxygen sensor, Infrared water vapor sensor
  • Multi-language (English/International)
  • Digital; PC connectivity for data logging
  • Internally calibrated with traceable gases
  • ASTM D3985, ASTM F1307, ASTM F1249, ISO 15106-2, ISO 15996-1
  • High purity nitrogen or oxygen (minimum 99.5%)

ASTM and ISO Standards Oxygen and Water Vapor Transmission Testing of Pharma Packaging Product Specifications

  • Touchscreen LCD display
  • Up to 3 specimens per test
  • 0.01~100,000 cc/m24h0.1MPa (Oxygen); 0.01~10,000 g/m24h (Water Vapor)
  • Determination of oxygen and water vapor transmission rates for pharma and food packaging
  • 15C~55C (adjustable)
  • 1~3 (simultaneous measurement available)
  • Pharmaceutical packaging material and container barrier property analysis
  • 108 mm x 108 mm
  • 10%~90% RH (adjustable)
  • Approx. 450 mm
  • 0.001 cc/m24h0.1MPa / 0.001 g/m24h
  • 50Hz
  • 70 mm
  • Microprocessor controlled
  • AC 220V, 50Hz
  • 0.01 cc/m24h0.1MPa for Oxygen; 0.01 g/m24h for Water Vapor
  • <1 sec
  • 6 mm (OD)
  • Benchtop
  • 30 mm (standard)
  • RS232/USB
  • Oxygen & Water Vapor Transmission Rate Tester
  • Approx. 55 kg
  • 10~100 mm/min (adjustable)
  • 0.6 MPa
  • 220V AC, 50Hz
  • Automatic
  • Complies with ASTM D3985, ASTM F1307, ASTM F1249, ISO 15106, ISO 15996 standards
  • 0.01~100,000 cc/m24h0.1MPa (Oxygen); 0.01~10,000 g/m24h (Water Vapor)
  • Coulometric sensor method for oxygen, Infrared sensor for water vapor
  • Temperature 15~35°C
  • Over-pressure and leakage alarms, password protection
  • Programmable and regulated
  • Meets international regulatory requirements for pharma applications
  • Coulometric oxygen sensor, Infrared water vapor sensor
  • Multi-language (English/International)
  • Digital; PC connectivity for data logging
  • Internally calibrated with traceable gases
  • ASTM D3985, ASTM F1307, ASTM F1249, ISO 15106-2, ISO 15996-1
  • High purity nitrogen or oxygen (minimum 99.5%)

Product Description

Product Featuresnote1

OTR/WVTR tested in One Instrument

  • OTR WVTR mode, OTR mode and WVTR mode are available for selection.
  • OTR and WVTR tests can be automatically completed for each sample mounting.
  • Genuinely reflect the OTR WVTR performance of the same sample, avoiding effect on test data due to sample contamination arising from instrument switching.

Coulometric Oxygen Sensor

  • The instrument is equipped with a ppb level Coulometric Oxygen Sensor, as one of new Labthink technical achievements, which can obtain a lower limit of the test.
  • Designed according to ASTM D3985 with absolute value, and no calibration is permitted.
  • Longer service life, two times longer than that of a traditional Coulometric oxygen sensor.
  • Over limit alarm and automatic protection.

Infrared Moisture Sensor

  • The instrument is equipped with Labthink patented infrared moisture sensor which can obtain a lower limit of the test.
  • Designed according to ASTM F1249.
  • Longer service life, non-consumable.
  • Over limit alarm and automatic protection.

Accurate Data

  • Brand new rainbow bridge structural test cell and 360 air circulation constant temperature technology ensure better temperature stability.
  • In the test process, the automatic control on flow, temperature and relative humidity is realized, reaching higher accuracy.
  • The test cell is equipped with a high-precision humidity sensor to monitor and record humidity changes in real time.

High Efficiency 6 Test Cells

  • Independent six sets of 50cm2 standard area test cells, which is three times the traditional oxygen transmission rate test instrument.
  • Six samples can be tested at the same time under the same conditions, with independent tests data.
  • In the same test cycle, the number of samples completed increases from 2 to 6.
  • Automatic sample clamping, saving time and effort, ensuring consistent clamping force and better sealing.

Intelligent Operation

  • The 12 Inch Touch panel of windows system is used for more convenient operation.
  • Automatic mode - after inputting test temperature and humidity and clicking one key, the test proceeds automatically.
  • Intelligent test cell hood which opens and closes automatically with sound and light alert.

Safe and Reliable

  • Safe Running: Labthinks high-end industrial computer is embedded to eliminate the system failure caused by computer virus and ensure the operation reliability and data storage security.
  • Safe Operation: equipped with optical and other intelligent sensors as well as intelligent sound and light alarms to ensure the operation safety.
  • Safe Performance: the instrument uses global renowned brand components with stable and reliable performance.

Space Saving

  • The width of the instrument is only 1/3 of the traditional six-cell instrument, saving laboratory space.

Powerful Functions

  • Professional test mode provides flexible and plentiful control functions to meet the needs of scientific research.
  • Display oxygen/water vapor transmission rate curve, oxygen/water vapor transmission coefficient curve, temperature curve and humidity curve.
  • Wide temperature range, allowing the barrier test at different temperatures (customized).
  • The gas purification device independently developed by Labthink can remove trace oxygen in nitrogen, providing oxygen-free carrier gas (optional).

Testing Principle

The pre-treated sample is clamped between the test chambers, oxygen or nitrogen with stable relative humidity flows on one side of the film, and the high purity nitrogen flows on the other side; oxygen or water molecules diffuse through the film into high-purity nitrogen on the other side, and are carried to the sensor by the flowing nitrogen. By analyzing the oxygen or water vapor concentration measured by the sensor, the oxygen or water vapor transmission rate can be calculated.

Reference Standards

ASTM D3985, ASTM F1307, GB/T 19789, GB/T 31354, DIN 53380-3, JIS K7126-2-B, YBB 00082003-2015

ASTM F1249, ISO 15106-2, GB/T 26253, JIS K7129, YBB00092003-2015

Test Applications

Applications
  • Films
    The oxygen and water vapor transmission rate tests of various plastic films, paper-plastic composite films, co-extrusion films, aluminized films, aluminum foil composite films, glass fiber aluminum foil paper composite films and other film-like materials.
  • Sheets
    The oxygen and water vapor transmission rate tests of PP sheet, PVC sheet, PVDC sheet, metal foil, rubber sheet, silicon sheet and other sheet materials.

Technical Specifications

Table 1: Test Parameters Note2

Parameter/Model Model C406H
OTR Test Range cc/(m2day) (Standard area 50cm2) 0.02 200
cc/(m2day) (MASK area 1cm2) 1 10000 (Optional)
cc/(m2day) (MASK area 5cm2) 0.2 2000 (Optional)
OTR Resolution cc/(m2day) 0.0001
OTR Repeatability cc/(m2day) 0.02 or 1%, whichever is greater
WVTR Test Range g/(m2day) (Standard area 50cm2) 0.02 40
g/(m2day) (MASK area 5cm2) 0.2 400 (Optional)
g/(m2day) (MASK area 1cm2) 1 2000 (Optional)
WVTR Resolution g/(m2day) 0.0001
WVTR Repeatability g/(m2day) 0.02 or 2%, whichever is greater
Temperature range C 15 - 50
5 60 (Customized)
Temperature fluctuation C 0.15
Humidity range %RH (Within standard temperature range) 0%, 5 - 902%, 100%
Extended functions GP-01 Gas Purification Unit Optional
DataShieldTM Note3 Optional
Computer System required by GMP Optional
CFR21 Part11 Optional

Table 2: Technical Specifications

Test Chamber 6 test chambers
Specimen Size 4.6 x 4.6i1411.7cm11.7cm)
Specimen Thickness 120 Mili143mmi14
Standard Test Area 50 cm2
Carrier Gas 99.999% high purity nitrogen, 99.5% oxygen (gas source is out of supply scope)
Carrier Gas Pressure 40.6 PSI / 280 kPa
Port Size 1/8 inch metal tubing
Power Supply 120VAC10% 60Hz / 220VAC10% 50Hzi14either one of twoi14
Instrument Dimensions 23.6 H x 19.2 W x 25.9 D (60cm 49cm 66cm)
Net weight 220Lbsi14100kgi14

Configurations

Standard Configurations
Mainframe, tablet, sampler, vacuum grease, polyurethane pipe of 6 mm in diameter
Optional Parts
GP-01 Gas Purification Unit, air compressor, CFR21Part11, GMP computer system requirements and DataShieldTM Data ShieldNote3
Remarks
1. The gas supply port of the instrument isI 6 mm polyurethane pipe (pressure 79.7 psi / 550 kPa);
2. Customers will need to prepare for gas supply and distilled water.

Note 1: All the product features are subject to detailed descriptions in the "Technical Parameters.
Note 2: The parameters in the table are measured by professional operators in Labthink Laboratory according to the requirements and conditions of relevant laboratory environmental standards.
Note 3: DataShieldTM Data Shield System provides safe and reliable data application support. The system can be shared by multiple Labthink products. Please purchase separately as needed.



Advanced Transmission Rate Testing for Pharma Packaging

Utilize this benchtop tester for comprehensive measurement of oxygen and water vapor transmission through pharmaceutical packaging. Designed to meet ASTM and ISO international standards, the instrument delivers accurate, reliable, and repeatable results, critical for quality assurance and regulatory compliance across global markets. With simultaneous multi-sample testing, programmable controls, and high-resolution sensors, it's the trusted solution for both manufacturers and exporters of pharma packaging.


Unmatched Performance and Regulatory Compliance

The device integrates advanced coulometric and infrared sensors, offering exceptionally accurate detection of gas transmission rates. Engineered to operate efficiently in a controlled environment (temperature 15~35C, humidity 10%~90%), it provides digital output, data logging, and multilingual support. Built-in safety features enhance user protection, supporting compliance with stringent pharma regulatory requirements. The precision and automation streamline lab workflows, yielding rapid and dependable results.

FAQ's of ASTM and ISO Standards Oxygen and Water Vapor Transmission Testing of Pharma Packaging:


Q: How does this tester measure oxygen and water vapor transmission rates in pharmaceutical packaging?

A: The tester utilizes a coulometric sensor for oxygen and an infrared sensor for water vapor to precisely measure the transmission rates. Samples are conditioned in a regulated chamber, and the system follows recognized ASTM and ISO standards, ensuring highly accurate and reproducible results.

Q: What packaging materials or containers can be analyzed using this instrument?

A: This device is suitable for analyzing a wide variety of pharmaceutical packaging materials, such as films, laminates, vials, and bottles. It assesses the barrier properties against oxygen and water vapor, helping ensure optimal product protection during storage and distribution.

Q: Where is this tester typically installed, and what is its mounting type?

A: The tester is designed as a benchtop unit, making it ideal for laboratory environments in pharmaceutical companies, packaging manufacturers, and regulatory/compliance testing facilities. Its compact form ensures easy installation on standard workbenches.

Q: When is it necessary to perform oxygen and water vapor transmission testing on packaging?

A: Transmission testing is essential during packaging material development, quality control, and before regulatory submission, ensuring that containers and films meet the stringent barrier requirements stipulated for pharmaceutical products.

Q: What is the process for conducting a test, and can multiple samples be measured simultaneously?

A: The process involves conditioning the sample as per programmable settings, placing it in the chamber, and initiating the fully automated test. The system can handle up to three specimens simultaneously, with data digitally logged for analysis. Calibration is performed internally with traceable gases.

Q: How does this equipment benefit pharma manufacturers and exporters?

A: By providing accurate, rapid, and standards-compliant test results, the system supports product safety, aids regulatory submissions, reduces the risk of packaging failures, and streamlines the quality assurance process, which is vital for both domestic and international distribution.

Q: What are the key safety and usability features of this tester?

A: Safety features include over-pressure and leakage alarms plus password protection. Usability is enhanced with touchscreen operation, multi-language support, microprocessor control, and digital data output compatible with PC connectivity, facilitating efficient and secure lab operations.

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