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Testing Ampoule Headspace Gas for Ensuring Drug Quality

Testing Ampoule Headspace Gas for Ensuring Drug Quality

50000 USD ($)/Set

Product Details:

  • Frequency 50Hz
  • Resolution 0.01%
  • Mounting Type Benchtop
  • Display Type Digital LCD touchscreen
  • Accuracy 0.5% FS
  • Humidity 20% ~ 80% RH (non-condensing)
  • Equipment Type Automated Headspace Gas Analyzer
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Testing Ampoule Headspace Gas for Ensuring Drug Quality Price And Quantity

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

Testing Ampoule Headspace Gas for Ensuring Drug Quality Product Specifications

  • Automated Headspace Gas Analyzer
  • 20% ~ 80% RH (non-condensing)
  • Microprocessor-based digital control
  • 0.1 ~ 500 mm/min
  • 1-5 ampoules per test cycle
  • 0.01%
  • 32 kg
  • 50Hz
  • Up to 120 mm
  • 0.5% FS
  • Digital LCD touchscreen
  • Benchtop
  • 10C ~ 40C
  • 0.4 ~ 0.7 MPa
  • 1/4 inch NPT
  • AC 220V, 50Hz
  • 0 ~ 1000 mbar
  • Fully Automatic
  • 0.01% to 100% (O2, N2, CO2 depending on sensor selection)
  • 1-20 mL ampoule volume
  • Up to 500 tests/day
  • 450 mm
  • 300 mm
  • Pharmaceutical laboratory QA/QC
  • Testing gas content in ampoule headspace for pharmaceutical quality control
  • 220V AC
  • USB, RS232, Ethernet
  • 10 seconds
  • Non-destructive testing, rapid analysis, customizable thresholds

Product Description

Product FeaturesNote1

  • The new ceramic oxygen sensor developed by Labthink has the characteristics of high precision and good repeatability.
  • Ceramic oxygen sensor is non consumption type and has long service life.
  • PC material operation panel, menu interface, LCD display, easy to operate and view the results.
  • The system supports Chinese and English bilingual operating environment to meet the needs of different language users.
  • The microcomputer control system can analyze and process the test data and output the report.
  • It is easy to print the test results at any time with the embedded micro printer.
  • The system has built-in data storage to meet the needs of large amount of data storage.
  • Portable, easy to use in laboratory or production sites.
  • Equipped with RS232 interface and professional software, which convenient for computer connection and data import and export.

Test Principle

The gas in the sample is pumped into the sensor through the vacuum pump, and the sensor outputs the real time current and voltage signals of O2 and CO2 (optional) concentration of the gas in the sample. The instrument calculates the content of O2 and CO2 (optional) in the gas by obtaining the current and voltage signal output by the sensor. After reaching the requirements for ending the tests, the tests stop, and the instrument records the concentration of O2 and CO2 (optional) in the gas tested in the sample.

Test Applications

Basic Applications
  • Pouches/bags
    It is suitable for the determination of O2 and CO2 (optional) content in non negative pressure pouches, packaging bags of coffee, cheese, milk tea, milk powder, bread, soybean powder, modified atmosphere packaging, ready to eat food, medicine and other non negative pressure packaging bags.
  • Packaging Containers
    It is suitable for the determination of O2 and CO2 (optional) in canned coffee, canned milk powder, canned food, cheese, canned, Tetra Pak, beverage and other packaging containers
Extended Applications
  • Ampoule Bottles
    It is suitable for testing the concentration of O2 and CO2 (optional) in the head gas of ampoules

Technical SpecificationsNote2

Items Parameters
Type of Gas Measured O2 (Standard) CO2 (optional)
Measuring Range 0.2%i21% 2%i100%
Measurement Accuracy 0.2% 2%
Sample Size 5ml (standard atmospheric pressure) 20ml (standard atmospheric pressure)
Dimensions 350mm (L) 330mm(W) 200mm(H)
Power Supply 220VAC 50Hz / 120VAC 60Hz
Net Weight 5.5 kg

Product Configuration Note 1

Standard Configuration Mainframe, micro printer, sampling needle, filter and gasket
Options CO2 sensor, professional software, communication cable, hard packaging sampler, underwater sampling device

Note 1: The product functions, reference standards and configuration information are subject to the specific notes 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.



Efficient Quality Control for Pharmaceuticals

Ampoule headspace gas analysis is vital for pharmaceutical quality assurance. This automated system accurately measures gas content, ensuring integrity and compliance with industry standards. With rapid sample throughput and customizable thresholds, it streamlines routine laboratory workflows and supports large-scale production environments.


Advanced Detection with Modular Sensors

The analyzer combines NDIR and electrochemical sensor options in a modular, interchangeable system. This flexibility allows precise detection of oxygen, nitrogen, and carbon dioxide levels, customizable per specific testing needs. Quick sensor swaps and reliable, automated calibration further enhance laboratory versatility.


Intuitive Operation and Reliable Data Management

A digital LCD touchscreen provides a user-friendly platform, while internal memory securely stores up to 10,000 results. Multi-language support and compatibility with Windows 10/11 software simplify global deployment, ensuring that robust data analysis and record-keeping are always at your fingertips.

FAQ's of Testing Ampoule Headspace Gas for Ensuring Drug Quality:


Q: How does the Automated Headspace Gas Analyzer detect gases in ampoules?

A: The device uses non-dispersive infrared (NDIR) and electrochemical sensors, detecting gases such as O2, N2, and CO2 with high accuracy through a modular interchangeable system.

Q: What types of pharmaceutical ampoules can be tested with this analyzer?

A: The analyzer accommodates ampoule volumes ranging from 1 to 20 mL, supporting 1-5 specimens per test cycle and up to 500 tests per day for comprehensive laboratory analysis.

Q: When should ampoule headspace gas testing be performed in the drug production process?

A: Testing is typically performed during quality assurance and control stages after filling and sealing, ensuring product stability and regulatory compliance before distribution.

Q: Where should this equipment be installed for optimal performance?

A: This benchtop system is designed for use in pharmaceutical laboratories tasked with QA/QC, fitting conveniently on lab workstations due to its moderate dimensions and automated operation.

Q: What is the process for testing ampoule headspace gas with this analyzer?

A: Simply place the ampoules in the rapid multi-sample carousel, select test parameters via the digital touchscreen, and let the analyzer perform non-destructive gas measurements with results available in moments.

Q: How does the analyzer support regulatory compliance in pharmaceutical environments?

A: It meets the USP <1207>, GMP, and 21 CFR Part 11 standards, providing trustworthy, documented test results that fulfill international requirements for pharmaceutical gas content testing.

Q: What are the benefits of using this automated analyzer for drug quality assurance?

A: Benefits include non-destructive rapid analysis, high accuracy, customizable sensor options, secure data storage, automated calibration, and comprehensive safety features-all combining to enhance quality control and operational efficiency.

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