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Precision test instruments for quality control of pharmaceutical and medical packaging

Precision test instruments for quality control of pharmaceutical and medical packaging

50000 USD ($)/Set

Product Details:

  • Equipment Type Precision test instrument
  • Specimen Size cut as per standard
  • Temperature 15C - 35C
  • Features Auto-calibration, Overload protection, Data storage
  • Port Size Standard 6 mm
  • Mounting Type Bench-top
  • Power Supply AC 220V 10% 50Hz
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Precision test instruments for quality control of pharmaceutical and medical packaging Price And Quantity

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

Precision test instruments for quality control of pharmaceutical and medical packaging Product Specifications

  • Standard
  • Lab and industrial quality control
  • Pharmaceutical and medical packaging quality control
  • Digital LCD
  • 65 kg
  • RS232/USB
  • 0.01 N
  • 220 V AC
  • 0-100 N
  • 50 Hz
  • 250 mm
  • 0-100 N
  • 80% RH
  • 30-300 mm
  • 1 second
  • Precision test instrument
  • 50-500 mm/min
  • Auto-calibration, Overload protection, Data storage
  • 100 mm (adjustable)
  • 15C - 35C
  • cut as per standard
  • Microprocessor based digital control
  • Standard 6 mm
  • AC 220V 10% 50Hz
  • Bench-top
  • 0.6 MPa
  • 1% of reading
  • 1 to 3 specimens
  • Semi-automatic

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.



Robust Construction for Enduring Performance

Built with a combination of corrosion-resistant stainless steel and ABS plastic, our test instruments are designed to withstand demanding laboratory and industrial environments. This sturdy build ensures both safety and reliability, supporting precise measurements over the long term.


Comprehensive Compliance and Versatile Testing

The device strictly complies with ISO, ASTM, and GMP standards, guaranteeing dependable results. Users can perform a host of critical tests-seal strength, burst, tensile, and peel-on pharmaceutical and medical packaging, backed by both automatic and manual calibration methods.


Smart Operation and Enhanced Safety

Control is facilitated by a digital microprocessor, coupled with an intuitive 4-inch LCD and multilingual support. Key features include an emergency stop button, overload protection, and automatic calibration to foster operator safety and ease of use, while data export and storage simplify quality documentation.

FAQ's of Precision test instruments for quality control of pharmaceutical and medical packaging:


Q: How can operators perform calibration on the precision test instrument?

A: Operators can calibrate the instrument either automatically or manually, depending on their preference or standard operating procedures. This ensures measurement accuracy is maintained and aligns with industry compliance requirements.

Q: What tests can this instrument perform on pharmaceutical and medical packaging?

A: This device supports seal strength, burst, tensile, and peel tests, providing comprehensive quality assessment for packaging according to ISO, ASTM, and GMP standards.

Q: When should the emergency stop button be used?

A: The emergency stop button should be pressed immediately in any situation where operator safety or specimen integrity is at risk during testing. This feature halts all functions instantly to prevent damage or injury.

Q: Where is operator training conducted for these instruments?

A: Operator training is available both onsite at your facility and remotely via online sessions, ensuring users can competently and efficiently utilize the equipment and its features.

Q: What is the process for exporting test data?

A: Test results can be exported in CSV format, compatible with most PC systems, via RS232/USB interfaces. Proprietary software that supports Windows operating systems assists with storage and analysis, simplifying traceability and reporting.

Q: Can this instrument be used in varying laboratory environments?

A: Yes, it is designed for humidity levels up to 80% RH and temperatures between 15C and 35C, accommodating a wide range of standard lab conditions with stable performance and low ambient noise (65 dB).

Q: What are the key benefits of using this test instrument for quality control?

A: Key advantages include reliable accuracy (1%), automated and manual calibration, in-depth test options, safety features like the emergency stop, quick data output, multilingual operation, and robust construction for lasting use in pharmaceutical and medical packaging labs.

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