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  • Quality Management in Stability Chambers
    Apr 07, 2023
    Stability test chamber is one of the indispensable and important equipment in pharmaceutical enterprises. In the process of drug production, the stability test chamber can test the stability of drugs under different temperature and humidity conditions to ensure the quality and safety of drugs. In order to ensure the normal operation of the stability test chamber and the accuracy of drug testing, strict quality management is required. First of all, in the selection process of the stability test chamber, the quality and performance of the equipment need to be considered. When purchasing a stability test chamber, it is necessary to ensure that the equipment complies with international standards and relevant regulations, such as the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP). At the same time, it is necessary to choose certified suppliers to ensure reliable equipment quality. Secondly, during the installation and maintenance of the stability test chamber, it is necessary to follow the relevant operating procedures and standardized processes. When installing the stability test chamber, it is necessary to operate according to the equipment manual and carry out strict safety inspection and verification. During the use of the stability test chamber, regular maintenance and maintenance are required, such as cleaning equipment, calibrating sensors, etc. Maintenance records and reports should be recorded in detail to facilitate traceability and supervision by managers. Third, in the drug testing process of the stability test chamber, it is necessary to follow the relevant testing procedures and standardized operations. Before drug testing, it is necessary to calibrate the temperature and humidity of the stability test chamber to ensure that the test results are accurate and reliable. During the test process, it is necessary to set and control the test conditions according to the characteristics of the drug and relevant standards. At the same time, it is necessary to record and deal with abnormal situations that occur during the test. Finally, data management and documentation control of walk in stability chamber are also important aspects of quality management. Test data needs to be effectively recorded and stored, and regularly reviewed and analyzed for data comparison and verification. At the same time, documents such as test reports, maintenance records, and equipment instruction manuals need to be effectively controlled and managed to ensure that relevant personnel can obtain and use these documents in a timely manner. To sum up, the quality management in the stability test chamber is a crucial part in the pharmaceutical production process. Measures such as reasonable model selection, standardized operating procedures, effective data management and document control are all necessary conditions to ensure the quality and reliability of environmental chamber manufacturers and drug testing.
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  • Sample Preparation and Handling in the Stability Chamber
    Mar 30, 2023
    The stability test chamber is a kind of equipment used to test the stability performance of electronic components and other equipment under different environmental conditions. Before stability testing, sample preparation and handling is a critical step that has a crucial impact on the accuracy and reliability of test results.   First, the selection and preparation of samples should be based on the test purpose and requirements. Different tests require different sample formats and quantities. For example, if it is necessary to test the thermal stability of materials, it is necessary to select representative samples, including material samples in various forms, such as films, powders, fibers, etc. Ease of preparation and handling also needs to be considered when selecting samples to ensure that the desired test environment can be accurately simulated in the constant temperature and humidity chamber.   Second, sample preparation and handling should comply with relevant standards and requirements. Sample preparation and handling may include multiple steps such as sample cutting, grinding, washing, drying, and more. These steps must follow relevant standards and methods to ensure that the surface of the sample is smooth, clean, free of impurities, etc. Otherwise, these factors may affect the accuracy of the test results.   Third, attention needs to be paid to the number and size of samples. The number and size of samples should be able to meet the requirements of the test, and can be properly arranged and placed in the photo stability chambers. The number and size of samples should also take into account the complexity and feasibility of the test. For complex tests, higher sample numbers and larger sample sizes may be required to obtain accurate and reliable test results.   Finally, sample handling should follow proper methods and procedures to ensure reliability and accuracy of test results. This may include preconditioning or stabilizing the sample for a period of time prior to testing to acclimate it to the desired testing environment. In addition, relevant safety regulations and operating procedures must be followed to ensure the safety of the laboratory and protect the health of testers.   In a word, the sample preparation and processing in the stability chambers is an important step in the stability test, which has a crucial impact on the accuracy and reliability of the test results. When selecting and preparing samples, it is necessary to consider the purpose and requirements of the test, and follow the relevant standards and methods. At the same time, it is necessary to pay attention to the number and size of the samples, and follow the appropriate methods and procedures to process the samples to ensure the accuracy and reliability of the test results.
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  • Performance Verification and Calibration of Stability Chambers
    Mar 28, 2023
    The stability test chamber is a kind of equipment used to test the stability performance of electronic components and other equipment under different environmental conditions such as temperature and humidity. It can simulate various complex environmental conditions to verify the performance and reliability of the equipment. However, to ensure the accuracy and reliability of a stability chamber, performance verification and calibration are necessary. Performance verification is the process of checking that equipment meets specifications and design requirements, and is functioning properly. Performance verification is performed after equipment installation and commissioning to ensure that the equipment works as expected and can meet expected performance requirements. For the photostability chamber, the main purpose of performance verification is to determine whether it can maintain stability within a certain temperature and humidity range, and provide accurate measurement results under different test conditions. Calibration is the determination of a device's measurement accuracy by comparing the difference between the device's measurements to those of a known standard. The calibration process usually involves using an accurate standard device, comparing it to the device to be calibrated, and making necessary adjustments to ensure accurate measurements from the device to be calibrated. There are several key factors to consider during the performance verification and calibration of a stability test chamber. The first is the accuracy and consistency of the test environment. In order to ensure the accuracy and reliability of the stability test chamber, the test environment must be able to accurately simulate the required temperature, humidity and other conditions. Second, accurate and reliable measurement equipment must be used to compare the measurement results of the equipment to be calibrated and the standard equipment. Finally, a scientific and systematic approach is required to record and analyze the measurement results, and to make necessary adjustments and calibrations. Before performing performance verification and calibration, the specifications and performance requirements of the stability test chamber should be understood. These specifications and performance requirements typically include test temperature, humidity range, temperature and humidity accuracy, stability, etc. During performance verification and calibration, test methods and standards need to be defined against these requirements, and adjusted and calibrated as needed. In a word, the stability test chamber is an important test equipment for verifying the stable performance of electronic components and other equipment under different environmental conditions. Performance verification and calibration are critical steps to ensure the accuracy and reliability of stability chamber manufacturer and require a scientific and systematic approach.
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  • Design and Construction of Stability Test Chamber
    Mar 22, 2023
    The stability test chamber is a kind of equipment used to simulate and evaluate the stability of products under different environmental conditions. In pharmaceutical, cosmetic, food and other industries, stability test chambers are widely used to evaluate the stability and life of products. The design and construction of a stability test chamber is critical to ensuring the accuracy and reliability of test results. Stability chambers usually consist of a sealed room in which temperature, humidity, and airflow can be tightly controlled. Designers must consider some key factors, including temperature range, humidity range, air flow and other control parameters. Sensors and controllers used in stability test chambers must precisely measure and control these parameters to ensure the accuracy and reliability of test results. Temperature control in a photo stability chambers is usually one of the most important parameters. Many tests need to be performed at a constant temperature, so stability chambers must be able to precisely control and maintain the required temperature range. To achieve this goal, stability test chambers are usually equipped with high-quality temperature sensors and controllers. These sensors accurately measure the temperature in the test chamber and feed this data back to the controller. The controller can adjust the heating or cooling system as needed to ensure that the temperature of the test chamber remains within the desired range. Humidity control in the stability chamber is also very important. Many tests need to be performed under specific humidity conditions, so the stability test chamber must be able to precisely control and maintain the required humidity range. Walk in stability chamber are usually equipped with high-quality humidity sensors and controllers. These sensors accurately measure the humidity in the test chamber and feed this data back to the controller. The controller can adjust the humidification or dehumidification system as needed to ensure that the humidity in the test chamber remains within the desired range. Airflow control in a stability chamber is also very important. The airflow in the test chamber must be able to flow to ensure an even distribution of temperature and humidity. Stability chambers are usually equipped with fans and airflow controllers to ensure smooth and even distribution of airflow within the chamber.
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  • How to Determine the Accuracy of Temperature and Humidity in a Stability Chamber
    Mar 15, 2023
    A stability chamber is an essential piece of equipment in many industries, especially those involved in pharmaceuticals, food, and electronics. It is used to test the stability of products and ensure they meet the required standards over time. The accuracy of temperature and humidity within the chamber is crucial to ensure the validity of the test results. In this article, we will discuss how to determine the accuracy of temperature and humidity in a stability chamber. Calibration The first step in determining the accuracy of a stability chamber is calibration. Calibration is the process of comparing the readings of the stability chamber to a known standard. This is done by using a calibrated thermometer and hygrometer. The calibration should be performed at least once a year, or more often if required by industry regulations or company policy. Check the Placement of Sensors The placement of the sensors in the humidity and temperature controlled chamber is critical to obtaining accurate readings. The sensors should be placed in a representative location that reflects the temperature and humidity of the entire chamber. The sensors should not be placed near any heat sources or vents, which can affect their readings. Monitor the Stability Chamber Continuous monitoring of the stability chamber is necessary to ensure that the temperature and humidity remain within the required range. The stability chamber should be equipped with an alarm system that alerts personnel if the temperature or humidity goes outside the specified range. Perform Qualification Tests Qualification tests are designed to verify that the stability chamber is working correctly and consistently over time. The tests include temperature mapping, which involves placing temperature sensors throughout the chamber to ensure that the temperature is consistent throughout. Additionally, a humidity mapping test can be performed to ensure that the humidity is consistent throughout the chamber. Document the Results It is essential to document the results of all tests performed on the stability chamber. This documentation should include the date of the test, who performed the test, the equipment used, the results, and any corrective actions taken if necessary. In conclusion, the accuracy of temperature and humidity in a stability chamber manufacturer is crucial to ensure the validity of test results. By performing regular calibration, monitoring the stability chamber, performing qualification tests, and documenting the results, you can ensure that your stability chamber is accurate and reliable.
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  • Stability Chamber Solutions in Laboratory
    Mar 07, 2023
    Stability Chamber are critical settings for research, testing, and analysis. However, maintaining a stable laboratory environment is essential for achieving accurate and reliable results. Factors such as temperature, humidity, lighting, air quality, and equipment calibration can all affect experimental outcomes. In this article, we will explore some solutions to ensure a stable laboratory environment. Temperature and Humidity Control Humidity environmental test chambers are crucial for maintaining stable conditions in a laboratory. High or low temperatures and humidity levels can negatively affect the quality of samples, the accuracy of instruments, and the reproducibility of experiments. Therefore, it is important to monitor and control these variables. Air conditioning systems, dehumidifiers, and humidifiers can help regulate the temperature and humidity of a laboratory. Lighting Lighting is another factor that can impact laboratory stability. Natural light, fluorescent lights, and other types of lighting can interfere with experiments and alter results. To minimize the effects of lighting on experiments, laboratories can use LED lighting, which emits less heat and radiation, and install light-tight curtains to block out natural light. Air Quality The quality of the air in a laboratory can also impact the accuracy of experiments. Airborne particles, such as dust, bacteria, and chemicals, can contaminate samples and alter results. Therefore, laboratories should have proper ventilation systems, air filters, and fume hoods to remove contaminants from the air. Equipment Calibration Proper calibration of laboratory equipment is critical for obtaining accurate results. Over time, equipment can drift from its original calibration, leading to errors in data. Laboratories should have a regular calibration schedule to ensure that equipment is functioning correctly. Regular Maintenance Regular maintenance of laboratory equipment and facilities can prevent breakdowns and ensure that experiments are conducted with consistency. Laboratories should have a maintenance plan in place that includes regular cleaning, equipment checks, and repair or replacement of any faulty equipment. Conclusion In conclusion, a walk in environmental chamber is essential for accurate and reliable results. Temperature and humidity control, lighting, air quality, equipment calibration, and regular maintenance are all critical factors to consider when ensuring a stable laboratory environment. By implementing these solutions, Stability Chamber can minimize the effects of external variables and achieve consistent and accurate results.
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  • What happens to my Stability Chamber when the lab loses power?
    Feb 28, 2023
    You may be using an environmental chamber for testing and suddenly lose power. This can be caused by something as simple as a broken power line or a more severe weather event such as a snowstorm, flood or tornado. Sudden loss of power can not only interrupt the test, but also damage your chamber. Fortunately, when your lab loses power, there are a few precautions you can take to avoid loss of power and potential chamber damage. Keep these in mind, especially when severe weather comes into the forecast for your area. When your test box loses power In the event of a power failure, your test chambers will shut down completely, as they require constant power to operate. If possible, you should disconnect the test chamber from the mains voltage as soon as possible to prevent any potential damage that may be caused by power surges when power is restored. A power outage in a room presents several dangers: The test chamber contains sensitive electrical components. Although manufacturers take precautions to protect system components from power outages, some components, such as the XChange board, can be damaged by multiple power surges. It's best to use a surge protector to prevent this from happening. Components can fail or degrade over time due to repeated power outages or power surges. Likewise, using a surge protector is a surefire way to protect the chamber and its electrical components. You also need to keep in mind the type of testing you are doing. For example, there are increased hazards when conducting battery tests. Power interruptions during battery testing increase the risk of hazardous events such as thermal runaway. Losing power mid-test also means the battery safety features will no longer work. Not only will this affect your test results, but it will leave your battery components vulnerable to damage, costing you money in the form of damaged products and delayed test times. So it's best to avoid battery testing in bad weather, or invest in a generator to keep your lab powered in the event of a power outage. Finally, remote testing techniques will not work during a power outage. This can present challenges if test room users are not in your lab when a large number of active rooms lose power. For example, you can no longer know what is going on in your room. In addition, test data may also be lost. This can be frustrating and delay your testing plans. After your test chamber is powered off Once power is restored to your chamber, it is best practice to verify that all chamber functions are working as expected. If some functions do not function properly after a power outage, please contact your manufacturer for further assistance. You should keep them on call at all times, not only for routine maintenance, but for rare situations like unexpected power outages. If you are testing while the power is out, you will usually want to restart the entire test when power is restored. However, this depends on factors such as the internal conditions of the stability test chamber prior to the outage, the duration of the outage, and the specific tests you are running. Review the testing criteria you are using to inform your recovery decision. In most cases, a change in temperature or humidity conditions will affect your test and you will need to start over. Fortunately, there are some precautions you can take to ensure that downtime is minimized and damage to your photostability chamber is avoided. Preventive measures you can take If you anticipate that severe weather may threaten your laboratory's electrical supply, disconnect your test chamber from the mains voltage. It is recommended that you suspend any testing until you are confident that the threat to the power source has passed. If you are using remote testing capabilities, the lab should have a plan and system in place to handle sudden power outages. This will vary from lab to lab, but it is recommended to have an emergency power source such as a generator and a surge protector for the lab. Otherwise, you could lose important data and run the risk of adding unnecessary wear and tear to test chamber components. To ensure your lab is well-equipped to handle potential power outages, consult a trusted manufacturer for optimal lab design. In addition to preparing you for potential power outages, reliable manufacturer XCH Biomedical will provide you with layout recommendations for increased efficiency and safety. Ultimately, if you use surge protectors and maintain emergency power, your lab should be well protected against power threats, keeping your test schedule on schedule and your test equipment safe. Environmental chamber manufacturers XCH Biomedical is an industry leading laboratory designer and manufacturer. Contact us today to learn more about what you can do to prevent power outages in your environmental chamber and what to do if this happens.
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  • Stability Test Chamber: Ensuring the Reliability of Products
    Feb 22, 2023
    Stability test chambers are specialized equipment designed to evaluate the reliability and stability of products under various environmental conditions. These chambers simulate harsh environmental conditions like high and low temperatures, humidity, and light exposure that the products may encounter during their lifecycle. This testing process is essential to ensure that the product meets the required quality standards and performs reliably throughout its intended lifespan. The stability test chamber works by providing a controlled environment where the product is subjected to different stress factors, such as temperature, humidity, and light exposure. The chamber is fitted with sensors that monitor and control the conditions inside the chamber. The sensors transmit data to a computer, which analyzes and records the results. The product is placed inside the chamber, and the conditions are varied according to the test protocol. The stability test chamber is widely used in various industries, including pharmaceutical, medical, and food industries. In the pharmaceutical industry, stability testing is required by regulatory bodies to ensure the safety and efficacy of drugs. Stability testing is also crucial in the food industry, where it is used to evaluate the shelf life of food products and their resistance to microbial growth. The photostability chamber can also be used for accelerated testing, which involves exposing the product to harsh environmental conditions to speed up the testing process. Accelerated testing is useful in situations where the product lifespan is shorter than the traditional testing period. For instance, in the electronics industry, the lifespan of electronic components is relatively short. Therefore, accelerated testing is used to determine the performance of the components under harsh conditions and predict their lifespan. Stability test chambers are available in different sizes, depending on the product being tested. Some chambers are designed for small products like pharmaceuticals, while others are designed for large products like vehicles. Like walk in stability chamber. The chambers can also be customized to suit the specific needs of the user. In conclusion, the stability test chamber is an essential tool in the product development process. It plays a significant role in ensuring the reliability and safety of products by evaluating their resistance to harsh environmental conditions. The data obtained from stability testing is crucial in making informed decisions about the quality and performance of products. It is, therefore, important for manufacturers to invest in stability test chambers to ensure the quality and reliability of their products.
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  • Why are stability test chambers important?
    Feb 13, 2023
    Stability test chamber play a vital role in ensuring the quality and safety of products. By simulating real-world storage conditions. A Stability chamber is a type of environmental chamber used in the pharmaceutical, cosmetic, and food industries to simulate and control storage conditions for products. The purpose of a stability chamber is to determine the shelf life of a product and to ensure that it remains within acceptable quality limits during its intended storage time. Stability chambers are designed to simulate different temperature and humidity conditions, and can be programmed to maintain specific conditions for extended periods of time. They typically have a temperature range of between 5°C and 60°C, and a humidity range of 20% to 80%. The temperature and humidity are monitored and controlled using sensors and actuators, and the data is recorded and analyzed to determine the stability of the product. In pharmaceuticals, stability chambers are used to test the humidity and temperature controlled chamber of drugs, vaccines, and other medical products. This is critical to ensure the safety and efficacy of these products over time, and to ensure that they remain within their shelf life. Stability chambers are used to store samples at specific conditions, and the samples are periodically tested to determine any changes in the product's quality. In the cosmetic industry, stability chambers are used to test the stability of skin care and cosmetic products. This helps manufacturers determine the shelf life of their products, and to ensure that they remain stable and effective over time. In the food industry, stability chambers are used to test the stability of food products, such as packaged food and beverages. This helps manufacturers to determine the shelf life of their products, and to ensure that they remain fresh and safe to consume over time. Stability chambers are critical to ensuring the quality and safety of products. They help manufacturers to determine the shelf life of their products, and to ensure that they remain within acceptable quality limits during storage. This helps to ensure that consumers receive safe, high-quality products that meet their needs and expectations. You can access stability chamber manufacturer to know more details.
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  • Types of Stability Chamber requirements
    Feb 06, 2023
    Stability Chambers are specialized enclosures that create a controlled temperature and humidity environment. Industries as diverse as pharmaceuticals, packaging, environmental testing and controlled storage use immersion or walk-in test chambers for stability testing. These test rooms are designed to find defects or weaknesses in products under different conditions by providing a controlled testing environment. Stability chamber qualification requirements fall under the category of installation, operation, and performance. Stability test chambers are subject to these three qualification tests before being put into operation. Stability Room Qualification Requirements To be certified to perform stability testing, an environmental chamber must go through a three-part qualification process. Qualifications must also include calibration records for all instruments used and evidence of their calibration status. The three qualification types are Installation Qualification (IQ) Operation Qualification (OQ) Performance Qualification (PQ) Together, these three stability chamber qualification requirements and tests support and document proper operation. Installation Qualification (IQ) Overview: The first qualification verifies that the stability chamber complies with its design specifications. All parts have been counted and checked for proper fit. Appropriate documentation must also be provided, including user manuals and any certifications and standard operating procedures (SOPs). Requirements: All components must be properly installed and functional for the stability chamber to pass installation qualification. If the chamber has a control panel with a human machine interface (HMI) or other guidance devices such as buttons and selector switches, they must function as designed. All alignment and safety equipment also needs to pass inspection. Operation Qualification (OQ) Overview: Run qualification tests to stabilize the room's functions and verify that systems and subsystems operate as expected within the normal operating range—including testing all doors, switches, controls, and alarms. REQUIREMENTS: The operational qualification test verifies that the temperature and humidity inside the chamber are equalized. To ensure accurate temperature and humidity readings, the operator waits a few minutes for them to stabilize, then runs the test for the specified time. Conduct Open Doors studies prior to completing operational qualifications. The test consists of opening the door for short periods of time while recording temperature and humidity at short intervals. The door opening test was repeated at least three times to calculate the average recovery time of the chamber. Performance Qualification (PQ) Overview: Performance qualification verifies that the stable chamber meets performance specifications at full load. Typically, testing is performed at the operating set point of the chamber, loading a mock product to replicate a typical environment. Measure temperature and relative humidity uniformity using thermocouples and relative humidity (RH) sensors. Requirements: The stability chamber must operate at full capacity for at least 24 hours to pass performance qualification. After the initial study is complete, the trial will be repeated with an open door study to calculate its mean recovery time. The stability laboratory qualification and performance process is conducted annually using the same procedures as past testing. After each reaccreditation, the results should be compared to previous years to track the Chamber's overall performance. XCH Biomedical Stability chambers in pharmaceutical XCH Biomedical designs and manufactures a wide range of climatic test chambers in compliance with ICH guidelines, including stability chambers, temperature and humidity chamber, walk in environmental chamber,Incubator For Bacterial Culture and vacuum drying oven. You can click to view our full product line.
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  • Why choose XCH Biomedical as a laboratory equipment supplier
    Jan 13, 2023
    Does it matter where you buy your Temperature and humidity Equipment? Not all lab equipment suppliers are created equal. Here's why you should get a quote from XCH Biomedical: Competitive price Since XCH Biomedical acts as the manufacturer, you get the best price possible - unlike a distributor who buys a product and then charges you a premium. Not only do we offer great prices, but we also offer premium equipment packages. Give the right advice We work with a number of laboratory equipment consultants and construction and engineering firms to advise on new builds or refurbishments. But no matter what, we are your resource. Even after projects are complete, companies keep calling us for ideas and advice on equipment purchases and we are happy to help. 50+ years of experience We've sold thousands of pieces of lab equipment, which means we know how to avoid common challenges and pitfalls that can arise during the buying process. If you need help purchasing a single piece of equipment or an entire laboratory for new construction, let our experience save you time, money and hassle. No unexpected costs We believe in total transparency, which means we will not charge you anything during the process. Our pricing is pre-determined and our goal is to help you understand the complete cost from ordering and delivery to setup and training. Training Our experienced, factory-trained representatives have the expertise to answer your questions and help you select exactly the products you need. They can also help you set up your equipment, provide training for you and your lab technicians, and answer questions throughout the product's lifecycle. One stop supplier With our extensive experience in laboratory equipment, including stability chamber, high and low temperature test chamber, Lab Biochemical Incubator, lab drying oven, etc. customer service is our top priority. Whether your laboratory requires a single replacement unit or an entire equipment package, XCH Biomedical is your one-stop supplier for all your laboratory equipment needs.
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  • Stability Test Standard
    Jan 06, 2023
    In Stability Testing - An Overview, we look at Stability Testing Requirements - Chamber Selection, Validation Requirements, IQOQPQ and IPV Considerations. In order to demonstrate the shelf life of a drug in a certain market, the manufacturer must store it at the relevant temperature and humidity for a specified period of time. This is done in what is also known as a stabilization chamber. Regulatory agencies in each market, such as FDA in the US, HPRA in Ireland, specify the temperature and humidity conditions that should be used and how long samples should be stored, such as a minimum of 6 to 12 months. During this time, samples were tested and their potency and degradation measured and recorded. This is called a stability test. The most common conditions are 25°C/60%RH. For new products, accelerated conditions may be 40°C/75%RH. Other conditions include 30°C/65%RH, 30°C/35%RH and 25°C/40%RH. For products intended to be stored in a blood bank Refrigerator, another condition is 5°C ±3°C. For products intended to be stored in a refrigerator, the test condition is -20°C ±5°C. ICH, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use, has developed rules for running stability tests. ICH Q1A states that during stability testing, conditions should be kept constant at ±2°C and ±5%RH. Also, if these conditions are not met for more than 24 hours, the test may need to be extended, creating a lot of paperwork. If conditions deviate from ±2°C/±5%RH, even for a short period of time should be accounted for. Probably due to the door opening to "pull" the sample. Events like this are usually logged in the room log. If no explanation is apparent, it may be necessary to seek assistance from a service engineer. In the event of a failure in the laboratory, a quick response from the supplier is required and although he should stock major spare parts, the auditor would also like to have some stocked on-site as well. It is also recommended to have redundancy, ie another room on site as a backup. The chamber must be fully validated and ready for use. Photostability Test Chamber To demonstrate shelf life under ambient light conditions, samples may be exposed to precise doses of UV and visible light in specially designed chambers. ICH Q1B specifies temperature control to prevent localized hot spots. Surveillance and 21 CFR Part 11 Indoor conditions should be independently monitored. This usually requires temperature and humidity transmitters connected to the recording system. In the Photostability chamber temperature, UV and visible light intensities will be recorded. This system must comply with the regulations of 21 CFR part 11 in the United States, whether it is a paper recorder or a computer system. 21 CFR Part 11 states that all related data collection and storage systems must be designed to prevent counterfeiting, corruption, untraceable alteration, or loss of data. In the case of computer systems, formal testing (IQOQ-Installation Qualification, Operation Qualification) should be performed to demonstrate compliance. Stability chamber Qualification Likewise, formal testing (IQOQ and PQ performance qualification) must be performed on new Stability chamber. During its useful life it should be maintained regularly (usually annual preventive maintenance service and calibration checks) and preferably mapped with several probes per year (IPV - Instrument Performance Verification). PQ and IPV typically require at least one 24-hour surveillance run, empty, loaded, or both. During this run, conditions must be shown to remain within ±2°C, ±5%RH of the set point. Test equipment used for these tests must be traceably calibrated at least annually and meet the IQOQ standards of 21 CFR P11.
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