Customized Environmental Chamber Walk In For Pharmaceutical Industry

1. Product Name and Purpose

2. Product Features

• Pharmaceutical-Grade Construction and Materials
  • The chamber is constructed with materials that meet the strictest pharmaceutical standards. The interior is made of non-reactive, easy-to-clean, and sterile surfaces, typically stainless steel or specialized polymers, to prevent any contamination of the tested pharmaceutical samples. The exterior is robust and corrosion-resistant, providing a durable enclosure. The insulation used is of the highest quality, ensuring minimal heat transfer and excellent temperature and humidity control. The chamber is designed with a seamless and hygienic interior, eliminating any crevices or corners where contaminants could accumulate.
  • The door of the chamber is a critical component, featuring a hermetic seal and a smooth, easy-to-clean surface. It is equipped with a reliable locking mechanism and a large viewing window, usually made of tempered glass with anti-fog and anti-static properties. The window allows for continuous visual monitoring of the samples without compromising the internal environment. The door also has a safety interlock system to prevent accidental opening during testing.
• Precision Environmental Control Systems
  • The temperature control system is highly accurate and reliable. It can maintain a wide temperature range, typically from 2°C to 8°C for refrigerated storage conditions, 15°C to 25°C for room temperature simulations, and up to 40°C for accelerated stability testing. The accuracy is within ±0.3°C, ensuring that the slightest temperature variations are precisely controlled. The system utilizes advanced refrigeration and heating technologies, along with a sophisticated feedback loop and multiple temperature sensors strategically placed throughout the chamber.
  • The humidity control system is equally precise. It can adjust the relative humidity from 10% to 95% RH, with an accuracy of ±2% RH. The chamber is equipped with a high-efficiency humidifier and dehumidifier, which work in harmony to achieve rapid and accurate humidity adjustments. Special care is taken to prevent condensation, which could potentially damage pharmaceutical samples. The system also features a dew point control function, which is crucial for maintaining the integrity of drugs and their packaging.
  • In addition to temperature and humidity, the chamber can be customized to control other parameters relevant to the pharmaceutical industry. For example, it can maintain a specific air quality by filtering out particulate matter and controlling gas composition, such as oxygen and carbon dioxide levels. This is essential for testing the stability of drugs that may be sensitive to oxidation or other chemical reactions in the presence of certain gases.
• Advanced Instrumentation and Data Acquisition
  • The chamber is outfitted with a comprehensive suite of sensors. Temperature sensors are distributed evenly to ensure a homogeneous thermal environment and detect any temperature gradients. Humidity sensors provide real-time data on the relative humidity levels. Air quality sensors monitor particulate matter, gas concentrations, and other relevant parameters. These sensors are connected to a state-of-the-art data acquisition system that records and stores all the measured data. 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, designed with the specific needs of pharmaceutical professionals in mind. It allows for easy programming and monitoring of environmental parameters, as well as the creation of complex test sequences. The panel displays all the relevant information, including current temperature, humidity, air quality, 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. The data acquisition system can be integrated with laboratory information management systems (LIMS) and other software used in the pharmaceutical industry, facilitating seamless data transfer and analysis.

3. Specific Parameters

• Model	WIV-6	WIC-11	WIC-15	WIC-48	WIC-66	WIC-1000
  Inside dimension(W x D x H) mm	200 x 220 x 150	250 x 220 x 200	350 x 220 x 200	500 x 240 x 400	500 x 240 x 400	100 x 100 x 100
  Outside dimension(W x D x H) mm	280 x 260 x 180	350 x 260 x 230	455 x 260 x 230	610 x 280 x 430	680 x 280 x 530	155 x 190 x 160
  Internal material	#304 Stainless Steel
  External material	Powder coated #304 Stainless Steel
  Temperature range	+ 150℃~ - 70 ℃
  Humidity range	20% ~ 98% R. H
  Temperature resolution ℃	0.01
  Humidity resolution % R. H.	0.1
  Temperature stability ℃	±0.5
  Humidity stability % R. H.	±2
  Heating time	30min
  Cooling time	-40℃/50min, -20℃/30min
  Air circulation system	Mechanical convection system
  Cooling system	Sirocco Fan
  Heating system	Sus316 Stainless steel Efficient 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
  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 Environments
  • The main function of this customized chamber is to provide a highly accurate and realistic simulation of the environmental conditions that pharmaceutical products encounter during their lifecycle. By precisely controlling temperature, humidity, air quality, and other parameters, it allows manufacturers to evaluate how drugs will behave in different storage, transportation, and usage scenarios. For example, testing a new drug formulation under various temperature and humidity conditions can help determine its shelf life and the need for special packaging or storage requirements.
  • The ability to create complex environmental profiles, such as cyclic temperature and humidity changes, is also a valuable function. This can mimic the seasonal variations or the temperature and humidity changes during the shipping process. For instance, a drug that is transported from a cold storage facility to a warm and humid destination can be tested under such conditions to ensure its stability and efficacy throughout the journey.
• Enhanced Drug Quality and Safety
  • Through comprehensive testing in the chamber, pharmaceutical companies can identify and address potential issues in their products. For example, if a drug shows signs of degradation under specific temperature and humidity conditions, the company can modify the formulation, packaging, or storage instructions to enhance its resistance. This leads to the development of more stable and reliable drugs, reducing the risk of ineffective or harmful medications reaching the market.
  • The test chamber also plays a crucial role in regulatory compliance. The pharmaceutical industry is highly regulated, and accurate environmental testing data is required to obtain regulatory approvals. By using this chamber to conduct tests in accordance with international and national regulatory standards, such as those set by the FDA, EMA, and ICH, manufacturers can prove that their products meet the necessary quality and safety criteria.
• Research and Development Support
  • The chamber serves as a powerful tool for pharmaceutical research and development. It allows scientists to study the effects of environmental factors on new drug candidates and formulations. For example, by testing a new drug molecule under different temperature and humidity conditions, researchers can gain insights into its chemical stability and potential degradation pathways. This information can be used to optimize the drug's chemical structure and formulation, leading to the development of more effective and stable drugs.

5. Production and Quality Assurance

• Stringent Manufacturing Process
  • The Customized Walk-In Environmental Chamber for the Pharmaceutical Industry is manufactured under the most rigorous quality control procedures. Each component, from the sterile interior surfaces to the advanced environmental control systems, is carefully sourced and 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, air quality sensors, and control systems is a critical and regular part of the manufacturing process. It is performed using traceable reference standards that meet pharmaceutical industry requirements 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 chamber has obtained relevant quality certifications, such as ISO 17025 for testing and calibration laboratories and compliance with GMP (Good Manufacturing Practice) guidelines. It has been validated by independent pharmaceutical testing laboratories and regulatory authorities. It has been proven to provide accurate and reliable test results, conforming to the relevant international and national 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 Stability Testing
  • A pharmaceutical company used the Customized Walk-In Environmental Chamber to test a new antibiotic formulation. The tests revealed that the drug was sensitive to high humidity, which could lead to a significant reduction in potency. By adjusting the packaging to include a desiccant and optimizing the storage conditions, they were able to maintain the drug's efficacy for a longer period, ensuring its effectiveness in treating infections.
  • An R&D institution in the pharmaceutical field utilized the chamber to study the long-term effects of temperature and humidity on a new cancer drug. The data obtained helped them develop a more stable formulation that could withstand a wider range of environmental conditions, improving the drug's shelf life and making it more accessible to patients in different regions.
• Vaccine Storage and Transportation Studies
  • A vaccine manufacturer used the test chamber to evaluate the stability of a new COVID-19 vaccine during transportation. The temperature and humidity cycling tests identified potential issues with the vaccine's vial seals, which could lead to leakage and loss of potency. By improving the seal design and packaging, they were able to ensure the safe and effective delivery of the vaccine to different parts of the world.
  • A research organization focused on vaccine development used the Customized Walk-In Environmental Chamber to study the impact of temperature excursions on different vaccine formulations. The results led to the development of new temperature-tolerant vaccine formulations and improved cold chain management strategies, reducing the risk of vaccine wastage.
• Medical Device Environmental Testing
  • A medical device company used the chamber to test the durability of a new insulin pump under different temperature and humidity conditions. The tests showed that the pump's electronics were sensitive to high humidity, which could cause malfunctions. By improving the device's waterproofing and using more humidity-resistant components, they were able to enhance the pump's reliability and safety for patients.
  • An R&D team in the medical device industry utilized the chamber to study the effects of temperature and humidity on the accuracy of a new blood glucose meter. The data obtained led to the development of a calibration algorithm that compensated for environmental changes, ensuring accurate readings in different environmental conditions.

7. Service and Support

• Pre-Sales Technical Consultation
  Our team of pharmaceutical experts and engineers provides in-depth technical consultations to help customers understand the capabilities and suitability of the Customized Walk-In Environmental 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 Customized Walk-In Environmental 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.