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  • The necessity of medical stability chamber
    Jul 27, 2021
    Human beings are very dependent on drugs from birth. Poliomyelitis drops, vaccines, wound treatments, eye drops, medications for the elderly. There are different drugs for different life stages. These drugs are produced using chemical analysis, biotechnology, microbial cultures, etc. These medicines are just drops of life. If it is produced incorrectly, it can be devastating for the person who eats it, leading to his death. Different types of stability studies have been carried out for these aspects. Established a medical compliance agency. ICH, USFDA and other institutions were established. These pharmaceutical compliance agencies have established standards for manufacturers to follow. Unless these compliance agencies do not provide them with a license to do so, it can ensure that pharmaceutical manufacturers cannot market or sell their products. Before issuing a license, the pharmaceutical agency will check the QA analysis of the drugs produced. It is necessary to check the chemical composition, check the uniformity of the drug, and check the behavior of the drug under different climatic conditions. Pharmaceutical manufacturers need to check the behavior of their products through different stages of quality analysis. One of the stages is "stability". The stability of the product in different environments. Different environmental conditions, such as humidity, temperature, ultraviolet radiation, etc., are artificially generated in a stable room. Heat, humidity and light are all causes of product degradation. Regulatory committees, such as the Federal Drug and Food Administration (FDA), ensure that appropriate precautions are taken to maintain consumer safety. Establishing product integrity in different climatic zones is critical, because small changes in temperature and humidity will affect the drug. Carry out stability storage and test studies to simulate climate effects. These studies are based on where the product is sold. Understanding all the ways in which finished products or active pharmaceutical ingredients (APIs) are affected by degradation is critical to the storage of these products. Through these studies, XCH Biomedical can determine the shelf life of the drug, determine the best storage method for the drug, and ultimately help ensure the safety of consumers. What is a stability test chamber? Most stability test chambers are similar to a large scientific refrigerator. Their function is not to keep things cool, but to replicate changes in temperature, humidity, and light for a long time. For example, this is critical when a pharmaceutical company wants to bring a new product to the market. 1. Humidity test The accuracy and repeatability, reliability and durability of the parameters in continuous operation are the primary tasks of the humidity test chamber. The sturdy stainless steel interior should be corrosion resistant and designed to be easy to clean. The programming must be intuitive, and the documentation must meet the requirements of FDA 21 CFR Part 11. Calibration certificates, data loggers and verification documents should of course also be included. 2. Light In the case of light stability test according to ICH Q1B, light supplement temperature and humidity are used as additional parameters. Specify the light source and lighting level for each time unit. Visible light (VIS is similar to ISO 10977 (1993)) must reach an exposure time of at least 1.2 million lux per hour, and near ultraviolet light must be at least 200 hours/m² (320 nm to 400 nm). As with temperature and humidity, uniform light distribution on each shelf is critical. Here, the basic specifications are the intensity distance, and the type of sensor and reflector used 3. Accelerated research or forced degradation is used to predict the shelf life of products. Scientists accelerate the process and speed of decomposition/degradation by increasing the temperature and/or humidity of environmental conditions in a short period of time. These accelerations indicate that if it is introduced to extreme conditions in a short period of time, it will have an impact on the drug. Overall, this gives a general overview of the different characteristics of degradation, including physical, chemical, and microbiological.
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  • Temperature Humidity Test Chamber
    Sep 07, 2021
    Temperature and humidity test is a general term. It is an engineering and manufacturing summary of a series of environmental stress tests, such as high/low temperature tests, moisture resistance tests, or temperature cycling tests. Procedures such as temperature and humidity deviation testing also belong to the umbrella. No matter what each test type is called, they all determine the performance or behavior of the complete system, subsystem, and individual components of the finished product under normal and harsh environmental conditions. In most cases, the extreme changes are temperature and humidity. However, other environmental factors such as sand, dust, corrosion and vibration also fall into the scope of performance testing. Technicians conduct temperature and humidity tests by immersing the product in an artificial environment. It involves a test room where temperature and humidity changes are induced, controlled, monitored and evaluated. The test chamber usually includes a vibrating table and equipment that regulates exposure to abrasives such as sand and dust. The size of the test room varies. Some chambers are small and are designed to test tiny components such as circuit boards and controllers. The medium-sized chamber allows larger objects or small products with multiple loads to be tested on a large scale. Sometimes, very large candidates like vehicles and machines need to be tested for temperature and humidity. Custom test chambers are usually built for these applications. Use temperature and humidity test chamber for stability test Whether it is used for medicines, cosmetics, textiles, food and beverages or electronic products, the stability test chamber is one of the processes used by companies to determine that their products remain safe and functional on the shelf or under certain environmental conditions. Almost no industry does not require stability testing. While focusing on evaluating the durability of the product, the stability test is also used to evaluate the accompanying packaging. These products change hands and the environment throughout the chain of custody. They should be kept safe and protected during transportation, storage and anticipated use. The list of products suitable for temperature and humidity testing is long. This actually depends on the expected working environment of the product. The type of test also depends on the industry in which it is applied. The following are some common industries where temperature and humidity tests are performed on a regular basis: aerospace car defense vitality telecommunications medical Each industry has its own unique products and individual specifications and test parameters. The list varies by industry and intended application. The following only lists some products and objects suitable for temperature and humidity testing: Electrical components Engine assembly Batteries and solar panels Medical diagnostic products Medicine container Military ammunition and weapons Adhesives and caulks Glass product Further considerations when purchasing a medicine stability test chamber There are a few things to keep in mind when buying a temperature and humidity cabinet for steady-state testing. Size really matters. If you test multiple products or a large product at the same time, this will determine what you need to use in a chamber. Another consideration is the type of testing you anticipate. For example, if you need to perform stability testing in addition to cyclic testing (or other iterative testing), it is best to invest in a chamber with power components to quickly change conditions. XCH Biomedical provides various types of medical temperature/humidity test chambers, including single, double, and three-chamber types, with three functions: temperature, humidity, and light. Alarm system, double room single control, safe and reliable. Low price. They come with installation and operating instructions, as well as installation and maintenance instructions.
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  • Photo Stability Test Chamber
    Dec 15, 2021
    Sunlight is a powerful force. The sun emits radiation in most of the electromagnetic spectrum, including a large amount of ultraviolet radiation. Although part of the solar radiation is absorbed by the earth’s atmosphere, there is still a considerable amount of radiation reaching the earth’s surface (as shown in the picture on the right). Ultraviolet rays can break the molecular bonds in the objects they strike. Most people are familiar with this effect on old paper products and other items. When they are exposed to sunlight, the chemical bonds are broken down, causing the color to fade. This discoloration effect is called photo degradation. However, the color of the object is not the only thing affected. The chemical properties of objects are affected, so these effects are extremely important to the pharmaceutical, cosmeceutical, and nutraceutical industries. There is a need to avoid chemical breakdown in drugs or vitamins, so it is important to ensure that drugs and nutrients remain stable during the expected shelf life of exposure to light. This is done by testing the light stability of the product. Light stability affects product shelf life, handling and packaging. This test is an important part of the drug development process. Light stability studies are usually conducted in a continuous manner, first testing drugs/supplements. Then, the product is tested first in its direct packaging, followed by the final marketing packaging that will be placed on the retailer's shelf. These tests can be repeated repeatedly until they prove that the drug can be sufficiently protected from light. Pharmaceutical manufacturers must establish the stability of their drugs to light. But what makes drug molecules or preparations unstable to light, and how to give them proper protection? Why do drug molecules degrade under light? First, drug molecules can directly absorb light. For this reason, the spectrum of the light source must overlap with the absorption spectrum of the molecule to some extent. Therefore, molecules that can absorb light of 320 nm or higher are at risk of photostability. The second way light causes photodegradation is through a process called photosensitization. This is where another component of the formulation absorbs light energy and then transfers it to the drug molecule, leading to degradation. To illustrate this effect, Figure 4 shows the structure and UV absorption spectrum of Losartan. We do not want losartan to have a photodegradation risk, and it has been proven to be photostable in most formulations. However, in liquid oral preparations containing cherry flavoring, losartan is sensitive to light [2]. Of course, cherry flavoring is colored and can absorb light. In addition, in the presence of oxygen, degradation occurs faster. The photodegradation reaction usually proceeds through the oxidation pathway. All companies that develop or manufacture drugs require a robust light stability testing process to ensure product quality and regulatory compliance. Inadequate testing can lead to costly delays and lost revenue. The 1996 guideline CPMP/ICH/279/95 Q1B describes the process of light stability testing of new active substances and pharmaceutical products. The output of cool white fluorescent lamps is similar to the output specified in ISO 10977 (1993). The spectral distribution of UVA fluorescent lamps is 320 nm to 400 nm, and the maximum energy emission is between 350 nm and 370 nm. Most waves must be in the range of 320 nm to 360 nm and 360 nm to 400 nm. The sample should be exposed to at least 1.2 million lux-hours under visible light (VIS) and at least 200 watt-hours per square meter under UVA. For more information, please refer to thchamber Photo Stability Test Chamber product page.
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  • Ten reasons to choose a temperature and humidity test chamber
    Mar 31, 2022
    Why are humidity chambers or stability chambers used in various industries? They can be used to control humidity in test chambers. Their multifaceted use makes them popular in research settings. Here are ten reasons why a constant temperature and humidity chamber is useful. Humidity test chambers can be used to detect the effects of predefined environments, electronic components, industrial and biological materials. They can spot even the tiniest flaw in a product. Therefore, it is widely used in high-precision applications such as medicine and chemical industry. The humidity chamber is capable of detecting temperature and humidity ranges. Since the entire life cycle of a product depends on the accuracy of that chamber, the company makes them very precise. This chamber can be used to study cells in living organisms. The better the accuracy during the study; the more accurate the results. A high precision chamber does the job well. There is no better way to provide the optimum conditions needed to test vegetable and plant productivity. High-quality temperature and humidity test chambers can be applied to all types of test environments. Genetic research, pharmaceutical research, and academic research are fields that require a controlled environment during experimentation. Therefore, they require stability chambers or humidity chambers. Because they are connected to high-performance microprocessor-based systems; very high precision is achieved. Automatic data logging and collection is just a few clicks away in the smart room. These laboratories provide a stable temperature range and humidity controlled environment. Excellent humidity chamber function, better control system, worry-free operation and user-friendliness are their characteristics. The stability test chamber has a flexible design. They comply with international quality guidelines and validation protocols. Since most chambers offer on-site verification services, maintaining the accuracy of the results is not a daunting task. The modern room is stylish, beautifully designed and functional. Therefore, they serve consistently and accurately year after year. Despite modern features like Ethernet monitoring and control, stainless steel body and indoor lights, humidity chambers in India are still affordable. There are many competitive products now. Buyers can choose the one that best meets their needs. Thchamber offers humidity chambers with features and functionality to meet most application needs. However, if required, custom products can be developed according to user specifications.
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  • Principles of the Stability Test Chamber
    Apr 15, 2022
    In Stability Testing - 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 for a specified period of time at the relevant temperature and humidity. This is done in a stabilization chamber, also known as a stabilization cabinet. Regulators in each market, such as the FDA in the US, HPRA in Ireland, specify the temperature and humidity conditions that should be used and the storage time of samples, such as a minimum of 6 to 12 months. During this time, the samples were tested and their potency and degradation were 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. Another condition is 5°C ±3°C for products intended to be stored in the refrigerator. For products intended to be stored in the refrigerator, test conditions are -20°C ±5°C. Intangible Cultural Heritage ICH, the International Conference on Harmonization of Technical Requirements for the Registration of Medicinal Products for Human Use, develops rules for operational stability testing. ICH Q1A states that conditions should be held constant at ±2°C and ±5%RH during stability testing. Additionally, if these conditions are not met for more than 24 hours, the exam may have to be extended, resulting in a lot of paperwork. If conditions deviate from ±2°C/±5%RH, even for a short time, this should be stated. This may be due to the door opening to "pull" the sample. Such events are usually recorded in the room log. If there is no obvious explanation, it may be necessary to seek help from a service engineer. If the chamber fails, a quick response from the supplier is required, and although he is expected to stock major spares, the auditor also likes the site to stock some. It is also recommended to have redundancy, i.e. have another chamber on site as a backup. The chamber must be fully validated and ready to 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 that temperature should be controlled 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 light stabilization room temperature, UV and visible light intensity will be recorded. The system must comply with US 21 CFR Part 11 regulations, whether it is a paper recorder or a computer system. 21 CFR Part 11 states that all relevant data collection and storage systems must be designed to prevent counterfeiting, corruption, untraceable changes, or data loss. For computer systems, formal testing (IQOQ-Installation Qualification, Operation Qualification) should be performed to demonstrate compliance. Chamber of Commerce Qualification Likewise, formal testing of the new chamber (IQOQ and PQ performance certification) is mandatory. During its lifetime, it should be regularly maintained (usually an annual preventive maintenance service with calibration checks) and preferably mapped with multiple probes per year (IPV - Instrument Performance Verification). PQ and IPV typically require at least one 24-hour monitoring run, unloaded, loaded, or both. During this run, the display conditions must remain at the set point ±2°C, ±5%RH. Test equipment for these tests must be traceable calibrated at least annually and meet the IQOQ standard of 21 CFR P11. Stability Test chamber Selection Considerations The following factors need to be considered: Reliability; is it known, used and trusted? There should be low fluctuations in temperature and humidity capacity; planning for future needs as well as current needs footprint; footprint may be limited Do you offer local service with quick response, spare parts inventory and refrigeration repair certification? The chamber shall have integrated controls including temperature limiters and error message logging It should refill automatically. Low user maintenance Almost no consumables required Sterile moisture is generated. Microorganisms must not be injected into the chamber It should be possible to lock the keyboard There should be an output when an error occurs, which can be monitored by the building management system Should be designed in accordance with GAMP; good automated manufacturing practice IQOQ, PM and IPV have traceable calibration, are 21 CFR Part 11 compliant and should be obtained from the supplier Thchamber.
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  • Stability Test Chamber Maintenance
    Jun 15, 2022
    It would be great if you could set a testing schedule and always keep everything going according to plan - but that's not reality. If something looks wrong but the test room is still running, then maybe you can push forward and see it when you're done. Just know that all chamber systems are intertwined. Any rust or corrosion, water leaks, standing water or condensation, or air leaks are signs of a bigger, imminent repair in the future. It's important to address problems ahead of time as they arise. You can help maintain your test room by doing the following: Implement regular quarterly and annual maintenance. Run your test chamber to check performance before testing. Keep the manual and all information related to your test room nearby. Doing so will keep your test room up and running and help you catch problems before they become expensive fixes. Below are some of the more common test room maintenance checks so that you and the service team can resolve any issues that arise. Test Chamber Maintenance When you fix it early, you'll find that most chamber problems require relatively simple solutions. This is important for two reasons: You can do many maintenance tasks yourself, but it's always important to call your in-house service team, preferably someone familiar with HVAC and refrigeration. You can conduct inspections that provide context to evaluate repair options if necessary. Maintenance prevents a domino effect, where small problems turn into bigger, broader fixes. You should perform the following maintenance on a regular basis to keep your test chamber functioning properly. NOTE: Safety is paramount. The test chamber is connected to a live voltage. Any maintenance work on the electrical system should be performed by professionals. Before performing any maintenance, be sure to disconnect power to the chamber after proper lockout and tagout procedures. Electrical System: Check your electrical system for pitting and loose connections at relays, contacts, wiring harnesses, solenoids, sensor clips and compressor connections. Check that ground and phase are correct. Check all connections and terminals for electrical readings with a multimeter. View high voltage and control voltages and get necessary current readings. Test all control switches and lights for proper operation. Refrigeration system: Check oil level, look for leaks and build-up. Check various fan operations, cover ducts, duct supports and duct insulation. There should be no frost anywhere, the air handler should be sealed against leaks, and the shock absorbers should be checked. Clean the coil and straighten any bent fins. Check static and working pressures and discharges, as well as suction and liquid line temperatures. Since PSI information is specific to your chamber, measure the correct filter drier psi for limits. Test expansion tank operation, net oil pressure and high/low pressure safety checks. Humidity System: If you have a humidity chamber, check floats, water pipes and connections, and optional air dryer. Drain, clean and flush water pipes, steam generator and optional water tank. Check steam generator heater for pitting and verify water quality and pressure. Check dry air cleaning operation and filters. Circulation system: Check the pump and connecting lines for leaks. The drain tank should have only a small amount to remove sediment. Clean the pump and thoroughly clean the tank. Finally, check the overall structure of the test room: exterior, workspace and floor for punctures, tears and dents. Check all gaskets for degradation: doors, windows, ports, wiring and plugs. If you have a walk-in with panels, check the seal at each seam. Check the integrity of the panel lock or latch. Verify that door operation produces a smooth seal by inspecting latches and latches and hinges. Clean drain and condensate pumps. Clean and adjust airflow regulators, and vacuum or sweep electrical and mechanical machine areas to remove all dust and debris. Replace any missing or damaged safety labels and tags. Return the test box to the correct position, leaving 18 to 36 inches of space for optimal airflow for optimal box performance. By regularly checking your test room system, your tests will run painlessly. And the performance will always meet your expectations. Importance of Calibration In addition to the "physical" system, you should also examine the digital aspects of your room. Have an expert calibrate your chamber controller every six months or so. Regular calibration prevents "drift" that can lead to inaccurate test results. You'll avoid bad data and downtime to maintain your test plan. Remember that well-maintained Stability Test Chamber are often more durable than the controllers that enable you to operate them. The controller may require software updates and bug fixes. Don't wait to call the test room service If your test chamber is not functioning as expected, please contact your service team Stability Chamber Manufacturer Thchamber. While technicians can fix common problems in a short period of time, more complex performance issues may require in-depth solutions and may require chamber replacement. Stay ahead of the curve by performing regular maintenance, running your test box to the top and bottom of performance standards after testing or on a weekly basis (even when not in use), and staying in close contact with your service team. The more diligent you are, the more likely your Stability Chamber will remain in operation for years on end.
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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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  • 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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  • 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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  • New Technologies and Methods in Stability Chambers
    Apr 13, 2023
    The stability test chamber is a kind of equipment widely used in pharmaceutical, food, chemical and other industries. It is mainly used to test the stability of products under different environmental conditions such as temperature and humidity to evaluate the quality and stability of products. . With the development of science and technology and the continuous increase of application requirements, the technology and methods of stability test chambers are also constantly updated and improved. This article will introduce some new technologies and methods to improve the performance and efficiency of stability test chambers. 1. New technology Time-of-flight mass spectrometry Time-of-flight mass spectrometry is a high-precision and high-sensitivity mass spectrometry analysis technology, which can quickly and accurately analyze the gas components in the stability test chamber. In this technology, the sample is ionized and introduced into the mass spectrometer, and the ion is separated and detected according to the mass-to-charge ratio by using the acceleration time difference of the ion in the electric field. This technology has the advantages of high resolution, high throughput, multi-element simultaneous detection, etc. It can accurately analyze and detect trace gases in the test chamber, and provides more accurate data support for the stability test of the test chamber. Artificial intelligence technology Artificial intelligence technology is a technology that has developed rapidly in recent years. It can simulate human intelligence and analyze, learn and predict data. In the stability test chamber, artificial intelligence technology can realize the automatic control and optimization of the test chamber by learning historical data and analyzing environmental conditions. For example, artificial intelligence technology can be used to adaptively control the temperature, humidity and other environmental parameters in the test chamber, and adjust the environmental conditions in the test chamber according to the characteristics and stability requirements of the product to improve the efficiency and accuracy of the test. 2. New method Multifactorial design Multi-factor design is a statistical method, which can consider the influence of multiple factors as a whole, and study the interaction between these factors by designing experiments. In the stability test chamber, multi-factor design can determine the degree of influence of various environmental parameters in the test chamber on product stability through statistical analysis methods, and optimize and adjust these parameters. For example, the orthogonal test design method can be used to optimize the combination of environmental parameters such as temperature and humidity in the test chamber to improve the efficiency and stability of the test. Data mining Data mining is a technology that automatically discovers, extracts and recognizes patterns from large amounts of data, and it can help people extract valuable information and knowledge from complex data. In the stability test chamber, data mining can be applied to the analysis and prediction of test results. For example, data mining technology can be used to explore and analyze the relationship between environmental parameters such as temperature and humidity in the test chamber and product stability, so as to predict the stability performance of products under different environmental conditions. Bayesian network A Bayesian network is a probabilistic graphical model that can be used to model and reason about relationships between multiple variables. In the stability test chamber, the Bayesian network can be used to analyze the relationship between the test results and the environmental parameters, and optimize the adjustment of the constant temperature and humidity chamber in the test chamber according to these relationships. For example, the Bayesian network can be used to model and analyze environmental parameters such as temperature and humidity in the test chamber, so as to determine the degree of influence of these parameters on product stability, optimize the environmental conditions in the test chamber, and improve the efficiency of the test. efficiency and accuracy. In short, with the continuous advancement of science and technology, the technology and methods of walk in stability chamber are also constantly updated and improved. The application of new technologies and methods can not only improve the performance and efficiency of the test chamber, but also improve the accuracy and reliability of the test, providing strong support for the development of pharmaceutical, food, chemical and other industries.
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  • The Importance of Stability Testing for Drug Safety
    Apr 21, 2023
    In the pharmaceutical industry, stability testing is critical to ensuring that manufactured drugs are safe and effective for use. The importance of the stability chamber, which plays an important role in drug stability test chamber, cannot be overemphasized. Stability chambers are designed to maintain constant temperature and humidity levels to simulate real-world conditions to which drugs will be exposed during storage and transport. This helps determine the shelf life of the drug and ensures that the drug remains potent during the shelf life. In addition to determining the shelf life of drugs, stability chambers are used to test the effects of other environmental factors, such as light and radiation, on drugs. This helps to ensure that the medicine maintains its quality and potency even under adverse conditions. The pharmaceutical industry isn't the only one benefiting from stabilization rooms. Other industries, such as the automotive industry, the cosmetics industry, and packaging, also rely on stabilization boxes to ensure their products remain stable and effective during storage and transport. When it comes to stability test chambers, there are a variety of options on the market. Thchamber is a company that provides top-of-the-line stabilization chamber solutions. Their stability chambers are designed to meet the rigorous demands of stability chambers in pharmaceutical. They meet FDA/ICH stability standards and provide out-of-the-box control and consistent temperature and humidity. Stability chamber manufacturer Thchamber stability chambers are built to specific guidelines, structural integrity and measurement equipment to accurately record test data and keep the chamber running smoothly through rigorous testing cycles over many years. Their chambers are equipped with sensors that detect temperature and humidity levels, and they have controlled airflow to ensure consistent temperature and humidity throughout the chamber. Proper maintenance and inspection of stability chambers is critical to the pharmaceutical industry to ensure drugs are tested correctly. Thchamber offers maintenance and calibration services to ensure its stability chambers are always performing at optimal levels. In conclusion, the stability chamber is an essential tool in the pharmaceutical industry and other industries where product stability is critical. Thchamber offers top-of-the-line stabilization chamber solutions that meet the highest standards of quality and accuracy. Investing in a Thchamber stability chamber can help companies ensure their products remain stable and effective throughout their shelf life, and ultimately help protect the health and well-being of consumers.
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  • Walk-in stability test chamber: a key tool to ensure product safety and stability
    May 17, 2023
    In the field of modern technology and engineering, walk-in stability chambers (Walk-In Stability Chambers) play a vital role. They are a device specially designed to simulate and evaluate the stability and reliability of products under different temperature and humidity conditions. The wide availability of walk-in stability test chamber enables various industries to verify the performance of their products under various environmental conditions, ensuring that their quality and performance meet expectations. The walk in stability chamber is a large piece of equipment with a spacious interior that allows accommodating multiple products for simultaneous testing. Its design takes into account factors such as temperature, humidity, airflow and light to provide an accurate and repeatable test environment. Whether the pharmaceutical industry needs to evaluate the stability of drugs under different storage conditions, or electronics manufacturers need to verify the performance of their products at extreme temperatures, the walk-in stability test chamber can provide a comprehensive solution. The working principle of the walk-in stability test chamber is based on precise control of environmental parameters. Temperature and humidity sensors monitor the chamber environment, while an automatic control system ensures parameters are stable within set limits. This high-precision control system enables the walk-in stability test chamber to simulate extreme conditions and long-term use environments in order to verify product stability and durability. At the same time, they are also capable of recording and storing data during testing for subsequent analysis and reference. Walk-in stability test chambers are used in a wide range of applications, covering many key industries. In the field of medicine, stability testing is crucial to determine the shelf life of a drug under various conditions. Pharmaceutical companies can use walk-in stability chambers to simulate different storage conditions and evaluate drug stability, decomposition rates, and quality changes. In the food industry, these boxes can be used to test food for factors such as shelf life, mass loss and microbial growth. In addition, automakers can use walk-in stability test chambers to evaluate the performance of vehicle components under various temperature and humidity conditions and to verify their durability and reliability. The strength of the environmental test chamber manufacturers lies not only in providing a reliable testing environment, but also in its highly flexible configuration. According to specific needs, walk-in stability test chambers can be custom configured according to specific needs. Users can choose parameters such as different sizes, temperature ranges, humidity ranges and control accuracy to meet their unique testing requirements. In addition, walk-in stability test chambers can be equipped with various additional features, such as shaking tables, gas control systems and lighting equipment, to simulate more realistic environmental conditions. In addition to product stability testing, walk-in stability test chamber can also be used for other applications such as reliability testing and quality control. By simulating different environmental conditions, they can expose potential problems of products in extreme cases, helping manufacturers identify and solve possible defects, thereby improving product reliability and quality. However, the effective use of a walk-in stability tester requires attention to a few key factors. First, proper operation and maintenance are key to ensuring the accuracy and repeatability of test results. Users need to follow the operation manual and recommended maintenance procedures, calibrate the instrument regularly, and keep the equipment clean and tidy. In addition, the energy efficiency of walk-in stability test chambers is also an important consideration. Since they are usually large devices, energy consumption is high. Manufacturers should strive to improve the design of equipment to increase energy efficiency and reduce environmental impact. In a word, the walk-in stability test chamber is a key tool to ensure the safety and stability of products. They provide an accurate, repeatable test environment capable of simulating different temperature and humidity conditions and evaluating product stability and reliability. Widespread applications in industries such as medicine, food, automotive, etc. prove its importance. With proper configuration and proper operation and maintenance, walk-in stability test chambers will continue to play a key role in helping manufacturers ensure that their products perform as expected in a variety of environmental conditions.
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