1. Product Name and Purpose

2. Product Features

• Ergonomic and Secure Chamber Design
  • The chamber is constructed with pharmaceutical-grade, inert materials that are impervious to chemical reactions and easy to sanitize. The interior is crafted with smooth, seamless surfaces to prevent the accumulation of contaminants and ensure the purity of the testing environment. The insulation is top-notch, providing an optimal thermal and moisture barrier. This not only aids in precise temperature and humidity control but also minimizes the risk of condensation, which could potentially affect the drug samples.
  • The door is engineered with a sophisticated sealing mechanism that guarantees an airtight and light-tight closure. It is equipped with a fail-safe locking system and a safety interlock, preventing any unauthorized access or accidental disruption of the testing process. A large, UV-resistant viewing window allows for visual inspection of the samples without compromising the internal conditions.
• Precision Environmental Control Systems
  • The temperature control system is a paragon of accuracy, capable of maintaining a wide temperature spectrum. It can be adjusted from a frigid -40°C, simulating arctic storage or cold chain transportation, to a sweltering +80°C, replicating extreme tropical or industrial storage conditions. The temperature stability is within ±0.1°C, ensuring the most minute temperature variations are accounted for. The system also features rapid temperature change capabilities, enabling efficient thermal cycling for accelerated testing.
  • The humidity control system is equally remarkable. It can modulate the relative humidity from a bone-dry 5% RH to a humid 95% RH, mimicking a vast array of global climates. The humidity accuracy is within ±1% RH, providing a consistent and reliable moisture environment. The chamber employs advanced humidification and dehumidification technologies, such as ultrasonic humidifiers and desiccant dehumidifiers, to achieve rapid and precise humidity adjustments.
  • The photostability system is a technological tour de force. It houses a comprehensive array of light sources, including ultraviolet (UV) lamps with varying wavelengths (UV-A, UV-B, and UV-C) and a full spectrum of visible light. The intensity of each light source can be calibrated with pinpoint precision, from a faint glow to a bright sun-like illumination. The light exposure time can be programmed from a few seconds to months, allowing for in-depth studies of photodegradation kinetics. The light distribution within the chamber is optimized for uniform exposure, ensuring that all samples receive the same light dosage.
• Advanced Instrumentation and Data Acquisition
  • The chamber is outfitted with a suite of high-precision sensors. Temperature sensors are strategically positioned to monitor any thermal gradients and ensure homogeneous temperature distribution. Humidity sensors are ultra-sensitive, providing real-time data on moisture levels. Light sensors are calibrated to measure the intensity and spectrum of the light sources accurately. These sensors are interfaced with a cutting-edge data acquisition system that records all parameters in real-time.
  • The data acquisition system is capable of generating detailed reports and graphical representations. It can plot temperature and humidity profiles over time, as well as light intensity and exposure duration. This wealth of data is invaluable for analyzing the behavior of pharmaceutical products under different environmental conditions. The control panel is user-friendly and intuitive, allowing operators to effortlessly set and adjust test parameters and monitor the progress of the tests.

3. Specific Parameters

• Temperature Range(℃)	Without Illumination:0~65
  	With Illumination:10~60
  Temperature Fluctuation	High±0.5℃,Low±2℃
  Temperature Uniformity (℃)	±2
  Humidity Range(RH)	30~95%
  Humidity Stability(RH)	±3%RH
  Temperature Resolution(℃)	0.1
  Illumination(LX)	0~6000 adjustable
  Illumination Difference((LX)	≤±500
  Timing Range	1~99 hours/period
  Cooling System	Imported compressor
  Controller	Programmable (LCD display)
  Sensor	PT100
  	Capacitance sensor
  Ambient Temperature	RT+5~30℃
  Power Supply	AC 220V± 10% ,50HZ
  Power Rating(W)	1650
  Chamber Volume(L)	175
  Chamber Size(W × D × H)mm	450×420×930(Support Customized)
  Shelf	3
  Printer	Yes
  Safety Device	Compressor overheating and over pressure protection,Fan overheating protection, Over temperature
  	protection, Overload protection,water shortage protection

4. Product Functions

• Accurate Simulation of Pharmaceutical Storage and Use 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, humidity, and light, 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 light conditions, ensuring that the active ingredient remains potent and the solution is sterile.
  • The ability to conduct combined temperature, humidity, and light testing 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 Climatic Stability Photostability 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 Climatic Stability Photostability 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 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 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 Climatic Stability Photostability 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 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 Climatic Stability Photostability Test Chamber to evaluate the performance of a new type of blister pack. The tests under different temperature, humidity, and light conditions 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 Climatic Stability Photostability 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 Climatic Stability Photostability 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.