A Comprehensive Guide for Pharmaceutical Laminated Films and Pouches Packaging

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

• Using 360 air circulation constant temperature technology, the temperature stability is better.
• Equipped with high-precision temperature and humidity sensor, to monitor and record temperature and humidity changes in real time.
• In the test process, the automatic control on flow, temperature and relative humidity is realized, reaching higher accuracy.
• Higher test repeatability of 0.01 cc / (m2day) can be achieved.

High Efficiency Three-cell

• Independent three sets of 50cm2 standard area test cells, in line with parallel sample detection required by standards.
• Three 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 3.
• 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.
• New drawer type test cell, one key automatic in-and-out with sound and light reminder.

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.

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 C403H
OTR Test Range	cc/(m2day) (Standard area 50cm2)	0.01 200
	cc/(m2day) (MASK area 5cm2)	0.2 2000 (Optional)
	cc/(m2day) (MASK area 1cm2)	1 10000 (Optional)
OTR Resolution	cc/(m2day)	0.0001
OTR Repeatability	cc/(m2day)	0.01 or 1%, whichever is greater
WVTR Test Range	g/(m2day) (Standard area 50cm2)	0.005 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)	0.005 or 2%, whichever is greater
Temperature range	C	15 - 50 5 60 (Customized)
Temperature fluctuation	C	0.05
Humidity range	%RH (Within standard temperature range)	0%, 5 - 902%
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	3 test chambers
Specimen Size	4.4 x 4.4i1411.2cm11.2cm)
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 19.6 W x 27.5 D (60cm 50cm 70cm)
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.

Exceptional Material Compatibility

The machine accommodates a wide range of pharmaceutical packaging materials such as Aluminum Foil, PET, PE, CPP, and custom laminates, allowing for versatile quality and performance testing. Its programmable settings enable users to test multiple layers and specimen sizes, making it suitable for diverse product types in the pharmaceutical sector.


Compliance and Accurate Data Management

Certified to meet ASTM F88 and ISO 11607-1 standards, this equipment provides reliable, traceable test results. Data output is easily managed via USB or RS232 interfaces, exporting results in Excel or CSV formats for further analysis and reporting. The device stores up to 5,000 records, ensuring secure and organized archiving.


Integrated Environmental and Safety Controls

With built-in temperature and humidity sensors, the system maintains optimal test conditions between 15-45C and 20%-70% RH. Safety is prioritized through emergency stop and overload protection features, giving users assurance and compliance with rigorous industry standards during every test cycle.