SUS304 Constant Temperature Humidity Chamber For Pharmaceutical Industry

1. Product Name and Purpose

2. Product Features

• Premium and Hygienic Chamber Construction
  • The chamber is constructed with pharmaceutical-grade materials that are not only highly durable but also inert and easy to clean. The interior surfaces are smooth and seamless, minimizing the risk of contamination and ensuring a sterile testing environment. The insulation used in the chamber walls is of the highest quality, providing excellent thermal and moisture resistance. This insulation helps in maintaining accurate temperature and humidity control, preventing any external factors from interfering with the internal test conditions.
  • The door of the chamber is designed with a hermetic sealing mechanism, ensuring an airtight enclosure. It is equipped with a safety interlock system and a heavy-duty hinge, allowing for easy access while maintaining the integrity of the internal environment. The door also features a large, UV-resistant viewing window, enabling operators to monitor the samples without disturbing the test conditions.
• Precision Temperature and Humidity Control Systems
  • The temperature control system is highly advanced and accurate. It can maintain a wide temperature range, typically from -40°C to +80°C, with an accuracy of ±0.1°C. The system utilizes a combination of heating and refrigeration elements, along with a sophisticated feedback loop and temperature sensors strategically placed throughout the chamber. This ensures uniform temperature distribution and rapid temperature change capabilities, allowing for efficient thermal cycling experiments.
  • The humidity control system is equally precise. It can adjust the relative humidity from 5% to 95% RH, with an accuracy of ±1% RH. The chamber is equipped with a high-efficiency humidifier and dehumidifier, which work in tandem to achieve rapid and accurate humidity adjustments. The system also features a dew point control function, which is crucial for testing applications where condensation needs to be precisely managed.
• Advanced Instrumentation and Data Acquisition
  • The chamber is outfitted with a suite of high-quality sensors. Temperature sensors are distributed evenly within the chamber to monitor any temperature gradients and ensure a homogeneous thermal environment. Humidity sensors provide real-time data on the relative humidity levels. These sensors are connected to a state-of-the-art data acquisition system that records and stores all the measured parameters. The data can be accessed and analyzed in real-time or retrieved later for in-depth studies.
  • The control panel of the chamber is user-friendly and intuitive. It allows operators to easily set the desired temperature and humidity levels, as well as program complex test sequences. The panel displays all the relevant information, including current temperature, humidity, and the status of the control systems. It also has built-in alarms and safety features to alert operators in case of any abnormal conditions or system failures.

3. Specific Parameters

• Model	JTC-80	JTC-150	JTC-225	JTC-408	JTC-800	JTC-1000
  Inside dimension(W x D x H) mm	40 x 50 x40	50 x 60 x 50	50 x 75 x 60	60 x 85 x 80	100 x 100 x 80	100 x 100 x 100
  Outside dimension(W x D x H) mm	95 x 140 x 95	105 x 150 x 105	105 x 165 x 115	115 x 175 x 140	155 x 190 x 140	155 x 190 x 160
  Internal material	#304 Stainless Steel
  External material	Powder coated #304 Stainless Steel
  Temperature range	+ 150℃~ - 70 ℃
  Humidity range	10% ~ 98% R. H
  Temperature Uniformity ℃	0.01
  Humidity Uniformity % R. H.	0.1
  Temperature stability ℃	±0.3
  Humidity stability % R. H.	±2
  High temperature ℃	100	100	100	100	100	100
  Heating time (min)	20	30	30	30	30	30
  Low temperature	0, -40, -70	0, -40, -70	0, -40, -70	0, -40, -70	0, -40, -70	0, -40, -70
  Cooling time (min)	20, 50, 70	20, 50, 70	20, 50, 70	20, 50, 70	20, 50, 70	20, 50, 70
  Air circulation system	Mechanical convection system
  Cooling system	Imported compressor, fin evaporator, gas condenser
  Heating system	Sus304 Stainless steel High-speed heater
  Humidification system	Steam Generator
  Humidification water supply	Reservoir, Sensor-controller solenoid valve, recovery-recycle system
  Controller	Touch panel
  Electrical power requirements	Please contact us for requirements of specific models
  Accessories	Multi-layer enhanced glass window,test hole, action indicator light, case lighting barrier shelf x2
  Safety device	Circuit system load protection, compressor load protection, control system load protection, humidifier load protection, overtemperature load protection, fault warning light

4. Product Functions

• Accurate Simulation of Pharmaceutical Storage and Usage Conditions
  • The primary function of the test chamber is to provide a highly accurate and realistic simulation of the environmental conditions that pharmaceutical products encounter. By precisely controlling temperature and humidity, it allows manufacturers to predict how their drugs will perform during storage, transportation, and patient use. For example, a manufacturer of ophthalmic solutions can use the chamber to test the stability of the product under different temperature and humidity conditions, ensuring that the active ingredient remains potent and the solution is sterile.
  • The ability to conduct combined temperature, humidity, and light testing (if equipped with a light source) is a game-changer. In real-world scenarios, drugs are often exposed to a combination of these factors. For instance, a packaged tablet on a pharmacy shelf is subject to ambient temperature, humidity, and light. The chamber can evaluate the combined effect of these stressors on the tablet's dissolution rate, chemical stability, and physical integrity.
• Enhanced Drug Quality and Shelf Life Optimization
  • Through rigorous testing in the chamber, pharmaceutical companies can identify potential weaknesses in their products and make improvements. For example, if a drug formulation shows signs of degradation under high humidity and light, the company can explore alternative excipients or packaging materials that offer better protection. This leads to the development of more stable and higher-quality pharmaceutical products with extended shelf lives, reducing waste and ensuring a continuous supply of effective medications.
  • The test chamber also helps in optimizing storage and distribution conditions. Pharmaceutical manufacturers can determine the ideal temperature and humidity settings for their warehouses and distribution channels, ensuring that the products reach patients in the best possible condition.
• Compliance with Stringent Pharmaceutical Regulations
  • The pharmaceutical industry is one of the most highly regulated sectors, and compliance with standards such as Good Manufacturing Practice (GMP) and International Conference on Harmonization (ICH) guidelines is mandatory. The Constant Temperature Humidity Test Chamber is a crucial tool for ensuring compliance. It enables manufacturers to conduct tests that meet the requirements of regulatory bodies, providing evidence of product stability and safety. For example, in the approval process of a new drug, regulatory authorities rely on stability data obtained from such testing to assess the product's suitability for market release.
  • By using the chamber to conduct tests in accordance with industry standards, pharmaceutical companies can enhance their reputation for quality and reliability, building trust among healthcare providers and patients.

5. Production and Quality Assurance

• Stringent Manufacturing Process
  • The Constant Temperature Humidity Test Chamber for the Pharmaceutical Industry is manufactured under strict quality control procedures. Each component, from the heating and refrigeration units to the light sources (if applicable) and sensors, is sourced from reputable suppliers and rigorously inspected for quality and performance. The assembly process is carried out by highly trained technicians in a cleanroom environment, ensuring the proper installation and functionality of all parts.
  • The calibration of the temperature, humidity, and light sensors (if present) and control systems is a critical and regular part of the manufacturing process. It is performed using traceable reference standards to guarantee the accuracy and reproducibility of the test results. Rigorous quality audits and inspections are conducted at various stages of production to maintain the highest level of product quality.
• Quality Certification and Validation
  Our test chamber has obtained relevant quality certifications and has been validated by independent pharmaceutical testing laboratories. It has been proven to provide accurate and reliable test results, conforming to the relevant pharmaceutical industry standards. We also continuously update and improve our product based on the latest technological advancements and customer feedback to ensure its long-term performance and compliance.

6. Application Areas and Success Stories

• Drug Formulation Development
  • A pharmaceutical research company used the Constant Temperature Humidity Test Chamber to develop a new formulation of an anti-cancer drug. The tests revealed that the original formulation was unstable under high humidity and light, leading to a significant loss of potency. By incorporating a new antioxidant and using a light-protective packaging material, they were able to improve the drug's stability and increase its shelf life by 75%, potentially improving patient outcomes.
  • A biotech firm utilized the chamber to optimize the formulation of a gene therapy product. The temperature and humidity cycling tests helped them identify the ideal storage conditions and formulation components that maximized the product's stability and transfection efficiency.
• Quality Control and Batch Release
  • A major pharmaceutical manufacturer used the test chamber to conduct stability testing on a new batch of antibiotics. The chamber's precise environmental control allowed them to monitor the drug's potency and chemical integrity over time. Any deviations from the expected stability profile were detected early, enabling the company to take corrective actions and ensure that only high-quality batches were released to the market.
  • A contract manufacturing organization (CMO) used the chamber to test the stability of generic drugs. The photostability testing (if applicable) helped them identify potential issues with the packaging and formulation of the generics, ensuring that they were bioequivalent and stable as the brand-name counterparts.
• Packaging Evaluation
  • A pharmaceutical packaging company used the Constant Temperature Humidity Test Chamber to evaluate the performance of a new type of blister pack. The tests under different temperature, humidity, and light conditions (if relevant) helped them determine the pack's ability to protect the drugs from environmental stressors. They were able to optimize the blister material and design, enhancing the shelf life and integrity of the packaged pharmaceuticals.
  • A drug delivery device manufacturer used the chamber to test the compatibility of their device with a specific drug formulation. The temperature and humidity testing ensured that the device functioned properly and that the drug remained stable during storage and use, improving the overall safety and efficacy of the drug-device combination.

7. Service and Support

• Pre-Sales Technical Consultation
  Our team of experts provides in-depth technical consultations to help pharmaceutical customers understand the capabilities and suitability of the Constant Temperature Humidity Test Chamber for their specific testing needs. We offer demonstrations and training to familiarize customers with the operation and functionality of the equipment before purchase. We also assist in selecting the appropriate test methods and accessories based on the pharmaceutical products to be tested.
• After-Sales Service and Maintenance
  We offer comprehensive after-sales service, including on-site installation and commissioning. Our technicians are available for regular maintenance, calibration, and emergency repairs. We provide spare parts and upgrades to keep the test chamber operating at peak performance. We also offer service contracts that include preventive maintenance and priority technical support, ensuring the long-term reliability and availability of the equipment.
• Training and Technical Support
  We conduct training programs for new users to ensure they can effectively operate the Constant Temperature Humidity 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 and compliance with relevant pharmaceutical standards. We also provide software updates and support for the data acquisition and analysis systems, enabling customers to take full advantage of the latest features and technologies.