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 Compliance and AccuracyDesigned for high-precision analysis, this barrier analyzer adheres to leading global standards (ASTM and ISO), ensuring reliable and consistent OTR and WVTR values. Its accuracy is as fine as 0.1 cc/m2/day for OTR and 0.01 g/m2/24h for WVTR, with a resolution of 0.01 cc/m2/day. Such meticulous measurement assists pharmaceutical manufacturers in meeting strict regulatory quality benchmarks.
Efficient and Flexible Testing WorkflowWith programmable environmental controls, automatic and manual modes, and adjustable test speeds, the analyzer offers operational flexibility. It supports multiple specimens per run, various test widths and strokes, and quick data response times. User-friendly interfaces and real-time fault or calibration alerts optimize laboratory productivity and reliability.
Seamless Data Management and ExportInternal memory ensures secure storage of test results, while USB and RS232 export options allow efficient data transfer to laboratory information systems. The clear digital LCD touchscreen provides intuitive control and display of test parameters and results, supporting robust quality assurance and traceability for pharmaceutical packaging processes.
FAQ's of Pharmaceutical Packaging Composite Films Barrier OTR and WVTR Analysis:
Q: How does the analyzer test the OTR and WVTR of pharmaceutical packaging films?
A: This device utilizes electrochemical and infrared sensors to measure oxygen and water vapor permeability according to standards ASTM D3985, ISO 15105-2 (OTR), and ASTM F1249, ISO 15106-2 (WVTR). Samples are conditioned under programmable environmental controls, and results are accurately recorded and displayed on a digital LCD touch screen.
Q: What types of films and sample sizes can be analyzed with this instrument?
A: The analyzer accommodates multiple film layers and supports specimens with a diameter of 97 mm or dimensions of 100 mm x 100 mm. Its adjustable test width (up to 30 mm) and stroke (up to 70 mm) cater to various composite pharmaceutical packaging films.
Q: When should OTR and WVTR testing be performed for packaging films?
A: Permeability tests should be conducted during the development, quality control, and validation phases of packaging films to ensure compliance with regulatory standards and to optimize product shelf life and integrity.
Q: Where is the optimal environment to operate this analyzer?
A: This equipment is specifically designed for laboratory use, including environments maintained according to GMP clean-room standards, due to its robust construction and controlled environmental adaptability (humidity: 30%-90% RH, temperature: 15C-55C).
Q: What is the process for conducting barrier analysis on the instrument?
A: Researchers place prepared packaging film samples into specimen holders, select the desired test method and environmental conditions, and initiate the fully automatic or manual test. Results are viewable on the touch screen and can be stored internally or exported via USB or RS232 interface.
Q: How does the alarm system enhance laboratory safety and efficiency?
A: The built-in alarm system provides real-time alerts for faults and calibration issues, minimizing the risk of erroneous results or equipment downtime, and supporting robust quality management protocols.
Q: What are the primary benefits of using this pharmaceutical films barrier analyzer?
A: Key advantages include precise and wide-range barrier measurement, streamlined data management, high sensitivity, operational stability, flexible automation modes, and full compliance with global testing standards. This ensures reliable packaging performance and regulatory adherence for pharmaceutical manufacturers.