Medical Devices And Drugs Constant Climate Chamber ISO

1. Product Name and Purpose

2. Product Features

Precise Climatic Control

• Wide Temperature Range
  • The chamber is capable of achieving a broad temperature range suitable for medical testing. It typically spans from - 20°C to + 60°C. This wide range is essential as different medical devices and drugs have specific temperature requirements. For example, some drugs need to be stored at low temperatures, such as - 20°C for certain biologics, while others can be stored at room temperature or slightly higher. Medical devices like electronic monitors may need to be tested at various temperatures to ensure their proper functioning. The temperature control is highly precise, with an accuracy of ±0.1°C. This precision is crucial for accurate and reliable testing, as even small temperature variations can affect the performance and stability of medical products.
• Accurate Humidity Regulation
  • Humidity levels within the chamber can be precisely regulated from 10% to 95% relative humidity. High humidity can cause corrosion in medical devices, especially those with metal components, and can also lead to the degradation of drugs, such as the growth of mold or the breakdown of active ingredients. Low humidity, on the other hand, can cause some drugs to dry out or change their physical properties. The humidity control accuracy is within ±2% relative humidity, ensuring that the test environment closely mimics the real - world humidity conditions that medical devices and drugs may encounter.

Stable and Uniform Environment

• Uniform Climatic Distribution
  • The interior of the constant climatic test chamber is designed to provide a uniform distribution of temperature and humidity throughout the test volume. Advanced air circulation systems, humidity - generating and - regulating mechanisms, and multiple sensors work in harmony to ensure that the temperature variation within the chamber is typically within ±0.5°C, and the humidity variation is within ±3% relative humidity. This uniformity is vital for accurate testing, as it ensures that all samples of medical devices and drugs are exposed to the same environmental conditions, eliminating any biases in the test results.
• Long - Term Stability
  • The chamber is capable of maintaining stable climatic conditions over long periods. This is essential for conducting long - term stability tests on medical devices and drugs, which may require continuous exposure to specific temperature and humidity conditions for months or even years. The chamber's stability ensures that the test conditions remain constant throughout the test, providing reliable and comparable results for accurate assessment of product shelf - life and quality degradation.

Multiple Test Modes and Customization

• Programmable Test Profiles
  • Operators have the flexibility to create programmable test profiles that simulate the complex and variable environmental conditions that medical devices and drugs experience during their lifecycle. These profiles can include cyclic changes in temperature and humidity to mimic seasonal variations, sudden changes to simulate extreme weather events during transportation, or custom - tailored profiles based on specific product requirements. For example, a test profile can be designed to simulate the temperature and humidity changes that a drug may experience during a long - distance shipment from a manufacturing facility in a temperate region to a tropical destination.
  • The ability to create customized test profiles allows manufacturers to test their products under conditions that are highly relevant to their actual storage and distribution scenarios. This provides more accurate and meaningful test results, enabling them to make informed decisions about product packaging, storage conditions, and shelf - life extension strategies.
• Optional Test Accessories
  • The constant climatic test chamber can be equipped with a variety of optional test accessories to meet specific testing requirements. For medical devices, sensors can be added to monitor parameters such as electrical conductivity, mechanical stress, and fluid flow. For drugs, analytical instruments can be integrated to test properties like drug purity, dissolution rate, and chemical stability. Additionally, vibration tables can be installed to simulate the mechanical vibrations that medical products may experience during transportation.

User - Friendly Operation and Monitoring

• Intuitive Control Interface
  • The chamber is equipped with an intuitive control interface that simplifies the operation process. The interface allows operators to easily set and adjust test parameters, such as temperature, humidity, test duration, and test profiles. It also provides a clear display of the current test status, including the actual temperature and humidity values, elapsed test time, and any error messages. The user - friendly design ensures that even operators with limited technical expertise can efficiently conduct tests on medical devices and drugs.
• Remote Monitoring and Control
  • Many models of the constant climatic test chamber offer remote monitoring and control capabilities. This feature is highly beneficial for medical device manufacturers, pharmaceutical companies, and quality control teams, as it allows them to monitor the test progress and adjust the test parameters from a remote location, such as an office or a control center. This is especially useful for long - term tests or when multiple tests are being conducted simultaneously. Remote monitoring and control enable timely intervention in case of any issues, ensuring the smooth and efficient operation of the testing process.

3. Specific Parameters

• Volume and Dimensions	Nominal internal volume: 80L
  	Inner chamber size (depth x width x height): 400 x 400 x 500mm
  	Overall equipment size (depth x width x height): 850 x 900 x 1000mm (subject to actual design and production)
  Temperature and Humidity Range	Temperature range: -20°C to +60°C
  	Humidity range: 10%RH to 98%RH (relative humidity)
  Temperature and Humidity Control Precision	Temperature fluctuation: ±0.5°C
  	Temperature deviation: ≤±1.0°C
  	Temperature uniformity: ±2.0°C
  	Humidity accuracy: ±2% relative humidity and ±0.5°C temperature accuracy
  	Relative humidity deviation: ≤±5.0%RH
  	Humidity fluctuation: ≤±1%RH
  	Humidity uniformity: 5%RH
  Heating and Cooling Rate	The average rate of temperature rise and fall within the range of 5°C to +40°C is ≥3°C/min
  Working Noise	The noise level is ≤75dB when measured 1 meter in front of the machine, 1.2 meters above the ground
  Compliance with Testing Standards	Complies with multiple national and military testing standards, such as GB/T 2423.1-2008 (IEC68-2-1), GB/T 2423.2-2008 (IEC68-2-2), GB/T 2423.3-2008 (IEC68-2-3), GJB360.8-2009 (MIL-STD.202F), GJB150.3-2009 (MIL-STD-810D), GJB150.4-2009 (MIL-STD-810D), and GJB150.9-2009 (MIL-STD-810D)

4. Product Functions

• Shelf - Life Determination
  • By subjecting medical devices and drugs to constant temperature and humidity conditions, the chamber helps manufacturers determine the shelf - life of their products. This is crucial for setting expiration dates and ensuring that products are safe and effective when used by patients. For example, if a drug shows signs of degradation or loss of potency after a certain period at a given temperature and humidity, the manufacturer can adjust the storage conditions or packaging to extend its shelf - life.
• Packaging Evaluation
  • The chamber is used to evaluate the effectiveness of packaging materials in protecting medical devices and drugs. It can test how well the packaging prevents moisture ingress or egress, oxygen penetration, and other environmental factors that can affect product quality. Based on the test results, manufacturers can select the most suitable packaging materials and designs to ensure product integrity and stability.
• Quality Control
  • The constant climatic test chamber is an essential tool for quality control in the medical industry. By testing medical devices and drugs before they are released to the market, manufacturers can ensure that they meet the strict quality standards set by regulatory authorities. This helps to prevent the distribution of defective products, protect the brand reputation, and ensure patient safety.
• Compliance Testing
  • The medical industry is highly regulated, and there are numerous international and national standards and regulations regarding the storage, transportation, and stability of medical devices and drugs. The constant climatic test chamber enables manufacturers to conduct compliance testing to ensure that their products meet these requirements. For example, there are specific guidelines for the temperature and humidity conditions under which different types of drugs and medical devices should be stored, and the chamber can be used to verify compliance with these guidelines.

5. Production and Quality Assurance

• Stringent Manufacturing Process
  • The manufacturing of the constant climatic test chamber follows strict quality control procedures. Each component, from the chamber's body and insulation materials to the temperature and humidity sensors, control electronics, and air circulation systems, is sourced from reliable suppliers and undergoes thorough inspection and testing.
  • The assembly process is carried out by highly skilled technicians in a clean and controlled environment. The chamber is calibrated and verified at multiple stages during production to ensure its accuracy and performance. This includes testing the temperature and humidity control systems, air circulation performance, and overall chamber integrity.
• Quality Certification and Validation
  • Our constant climatic test chamber has obtained relevant quality certifications, such as ISO standards for environmental testing equipment and medical - specific certifications. It has also been validated by independent testing laboratories to ensure that it meets industry standards and provides accurate and reliable test results.
  • We continuously update and improve our product based on the latest technological advancements and customer feedback. This ensures that our constant climatic test chamber remains at the forefront of environmental testing technology for medical devices and drugs.

6. Application Areas and Success Stories

• Medical Device Testing
  • A medical device company was developing a new type of insulin pump. The pump was tested in the constant climatic test chamber to evaluate its performance under different temperature and humidity conditions. The testing revealed that the pump's battery life was significantly reduced at high temperatures and high humidity. Based on this result, the company improved the pump's battery design and added better insulation to protect it from environmental factors. The new pump passed all subsequent tests and was approved for market release, ensuring reliable performance for diabetic patients.
• Drug Stability Testing
  • A pharmaceutical company was conducting stability testing on a new oral medication. The drug samples were placed in the constant climatic test chamber and exposed to various temperature and humidity conditions for an extended period. The testing showed that the drug's active ingredient degraded rapidly at high humidity levels. The company then reformulated the drug with a more stable formulation and improved the packaging to prevent moisture ingress. The new formulation passed all the stability tests and was ready for commercial production.
• Biologic Product Testing
  • A biotech company was developing a new monoclonal antibody product. The product was highly sensitive to temperature and humidity changes. The company used the constant climatic test chamber to simulate the transportation and storage conditions that the product would encounter. The testing identified that the product needed to be stored at a specific low temperature and humidity range to maintain its efficacy. Based on this result, the company developed a specialized cold - chain packaging system to ensure the product's integrity during distribution.

7. Service and Support

• Pre - Sales Technical Consultation
  • Our team of medical industry testing experts provides in - depth technical consultations to help customers understand the capabilities and suitability of the constant climatic test chamber for their specific testing needs. We offer demonstrations and training sessions to familiarize customers with the operation and functionality of the chamber before purchase. We also assist in selecting the appropriate chamber model and test parameters based on the customer's requirements.
• After - Sales Service and Maintenance
  • We offer comprehensive after - sales service, including on - site installation and commissioning. Our team of experienced technicians is available for regular maintenance, calibration, and emergency repairs. We provide genuine spare parts and timely upgrades to ensure the long - term performance and reliability of the chamber.
  • We also offer service contracts that include preventive maintenance and priority technical support. Our goal is to ensure that our customers' constant climatic test chambers are always in optimal working condition, providing accurate and reliable test results.
• Training and Technical Support
  • We conduct training programs for new users to ensure that they can effectively operate the constant climatic test chamber and interpret the test results. Our technical support team is available 24/7 to answer questions, provide troubleshooting assistance, and offer guidance on test method optimization.
  • We also provide software updates and support for the control and monitoring systems of the chamber to keep it up - to - date with the latest features and technologies.