Laminated Film and Pouch Testing for Pharmaceuticals Ensuring Product Integrity

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.

Comprehensive Testing Capabilities

The Laminated Film and Pouch Testing Machine accommodates an array of test methods, including tensile, compression, burst, peel (configurable at 15, 90, and 180), and leak detection. It supports pharmaceutical applications needing stringent packaging integrity verification, helping industries meet global compliance and quality benchmarks such as ASTM and ISO standards.


Advanced Automation and User Safety

Fully automated with a microprocessor-based digital control system, this machine streamlines testing operations and prevents human error. Safety is prioritized through features like an emergency stop button and electrical interlocks. Users benefit from adjustable universal clamps, automatic calibration, variable test speeds, and ambient noise levels kept below 65 dB(A) for comfortable operation.


Data Management and Global Support

The device supports USB and RS232 interfaces, along with micro-printer compatibility for versatile data recording and reporting. Its programmable cycles and LCD digital display allow precise monitoring and documentation. With worldwide service support, pharmaceutical companies gain reliable assistance for installation, maintenance, and calibration.