Photostability Test Chamber

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.

Stability studies are typically performed on pharmaceuticals, food and beverages, beauty and cosmetic pharmacy issues and each ingredient to assess how they are affected by external factors such as light, heat, humidity, temperature, pressure, etc. Work to determine how these factors affect the drug. The test helps determine product shelf life and storage guidelines that are critical to consumer safety. Two common stability tests are real-time and accelerated. Live testing is done by storing the drug according to recommended conditions and inspecting or monitoring the product until it fails. Products are tested at 3, 6, 9 and 12 months in the first year, twice a year in the second year, and annually thereafter until the product fails to meet specifications and safety standards. Accelerated research requires storing products in manufacturing environments where different factors such as light or heat are accelerated to determine when a product fails. By performing accelerated studies, degradation can be predicted. XCH-TPS Photostability Test Chamber is equipped with visible light and near-ultraviolet lamp tube, Medicine Stability Chamber can independently control the type of light source, and can print and record visible light illumination and near-ultraviolet radiation in real time. Visible light and near-ultraviolet can be directly set, automatically adjusted and precisely controlled. Containers, closures or other packaging can also be tested for stability. cosmetic Thchamber Labs has received many testing requests from companies and organizations seeking stability testing, as follows: Packaging labs require plastic and polymer testing of HDPE bottles for stack load stability testing and wall thickness testing University research scientists need UK labs to test pharmaceutical compounds during stability tests on standard mouse chow. Food was formulated with this compound to a final concentration of 750 mg of drug per kg of food. To verify and establish formulation stability, we need to measure the drug concentration in the beads over a 6-month period. We need to take an initial measurement (the starting point) and then at least 2 more measurements; at the 3 month point and the 6 month point. Large companies need material labs required for UV stability testing of HDPE: orange HDPE jacket where we have to check the jacket for UV stability and jacket life European Product Safety Laboratories are required to conduct new cream testing for introduction to the EU and international markets, including safety assessment, stability testing, microbial contamination testing, challenge testing, shelf life prediction and any other testing deemed necessary. Cosmetic laboratories are required to conduct cosmetic stability testing and safety assessment testing, including compatibility and challenge testing. Nutraceutical Laboratory requires stability testing of vitamin packs sold as new water formulations. The company is sending products into large chain stores and needs to be tested for stability. See more stability testing requests If you are a product manufacturer or other organization requiring stability testing, please contact the Stability Chamber Manufacturer thchamber or submit an online testing request.

Which should I buy, Walk-in or Reach-in Stability Chamber? Many pharmaceutical manufacturers will ask this question. The name of the Stability Chamber tells you the difference, and the following points will add details. Let's treat it as pros and cons. XCH Biomedical Walk-in Stability Chamber Advantage Virtually unlimited size, so lots of shelf space/samples can be accommodated One Qualification Covers a Lot of Shelf Space Conditions in the Walk-in Stability Chamber tend to be more stable due to their larger size Shortcoming Faulty chambers can cause problems with large numbers of samples They are fixed. (XCH Biomedical can provide crane lifting support for some walk-in rooms) Installation often requires architectural, electrical and refrigeration skills Compressors add footprint or remoteness and therefore cost Identification requires additional probes Spare parts may vary by special build They usually require 3-phase power and an additional water supply Operator time indoors may be limited for safety reasons Siloed space is a necessary waste of footprint Reach-in Stability Chamber Photostability Test Chamber Advantage Can be easily delivered in one piece small footprints Can be moved easily, with casters as standard If one Reach-in Stability Chamber fails, the sample can usually be accommodated in the other Reach-in Stability Chamber Cold room service is easier, faster and cheaper due to smaller refrigeration system Since they are "off the shelf" or "series" products, spare parts are usually in stock They are single-phase powered They have no island space no lighting required They are usually in stock and available for urgent sale or rental Shortcoming Size is usually limited to 2000 liters Each unit must be individually qualified Conditions are slightly less stable than Walk-in Stability Chamber, but still several times better than ICH stability test limits. In conclusion So, as we can see, there are pros and cons between the two. We hope you find this information useful and that it will help you decide which is the best option for you, Walk-in or Reach-in Stability Chamber. Of course, this may also depend on budget, space and long-term plans, but if you would like to discuss further or have any questions, please do not hesitate to contact us.

In the pharmaceutical industry, stability testing helps demonstrate how drug quality changes over time under various environmental conditions, including temperature, humidity, and light. This testing must be done before the drug can reach the market. To test the quality of a drug at a specific temperature and humidity, a batch of the drug of interest is placed in a Constant Temperature Humidity Chamber for a specified period of time. Samples are checked periodically for quality analysis. Because stability testing can span anywhere from a week to six months to a year or more, the stability chambers used must be reliable and consistent. Another type of stability testing focuses on photostability, or how a drug is affected when exposed to certain amounts of light and ultraviolet light over time. For this type of testing, a stability chamber that meets specific guidelines and is capable of emitting the required light and UV light over time is required. Complying with ICH guidelines requires stability chamber with consistent performance Stability testing guidelines are outlined by the International Committee for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and are followed by regulatory agencies worldwide, including the Food and Drug Administration (FDA), European Commission (EC), and Health Canada. Six ICH Guidelines (Q1A to Q1F) provide specific details for adequate testing. These guidelines are very specific, requiring that the temperature in the stabilization chamber not deviate by more than 2 or 3°C, depending on the conditions, and the humidity not deviate by more than 5%. Therefore, a stability chamber for such tests needs to have the low temperature and humidity excursions observed during prolonged testing. The temperature also needs to be uniform throughout the unit. Stabilization chambers that use traditional non-directional airflow systems use fans mounted on top of the unit to push air down through wire shelves. When racks are filled with samples, this air flow is blocked, causing changes in temperature conditions throughout the chamber. This inconsistency may affect stability conditions and overall stability testing. In contrast, a stabilization chamber that uses a horizontal laminar airflow system includes a positive-pressure feed chamber on one side of the chamber and a negative-pressure return chamber on the other side to create horizontal airflow directly across the surface of each shelf. Using this method means that even when the racks are full of samples, they receive a steady flow of conditioned air, resulting in optimal temperature uniformity throughout the chamber and across all samples. The horizontal laminar airflow system also increases the capacity of the stabilization chamber by ensuring temperature uniformity, even when the racks are full, enabling testing of larger sample batches. Reliable unit will maintain performance during long-term stability testing Samples can be tested in a stabilization chamber for a week, six months, a year or longer, depending on the type of testing performed. If one chamber fails, pharmaceutical labs could lose months of work and will be pushed backwards in their timelines, prolonging the time it takes for a drug to reach the market. Stability chambers used for stability testing in the pharmaceutical industry must be durable and rigorously tested for their long-term performance. Additional features help pharmaceutical labs feel safe when using the stability chamber. For example, high and low temperature alerts can warn users when temperatures deviate. Even better, remote monitoring systems allow users to keep track of what's going on in the room even when they're not in the lab. Requirements for Photostability Test Chamber Photostability testing evaluates whether drug products undergo unacceptable changes when exposed to a combination of white light and ultraviolet (UV) light. Stability chambers used for this type of testing need to provide ideal light emission to meet the ICH requirements of Guideline Q1B - they must be able to maintain more than 1.2 million lux hours of light and emit more than 200 watts of UV energy to the sample. Unlike stability testing for temperature and humidity, light stability testing can be completed in as little as a week, and specific units can be programmed to turn off the light when the desired exposure level is reached. One issue to consider when performing photostability testing is safety. Exposure to UV rays can cause damage to human eyes and should be avoided. A chamber with lights that automatically shut off when the door is opened will help prevent UV exposure and keep your workers safe. Other potential uses In the rare case that your pharmaceutical laboratory does not perform stability testing, the stability chamber can be used for other applications. For example, because they maintain a constant temperature and humidity, they are ideal containers for samples that need to maintain stablity conditions. Stability testing in the pharmaceutical industry is a time-intensive investment, and selecting the right instrument should not be taken lightly. Stability chambers for testing the stability of pharmaceuticals under different temperatures, humidity and light need to be reliable, stablity and comply with ICH guidelines.

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.

In modern manufacturing, product stability and reliability are of paramount importance. In order to ensure the performance of the product under various environmental conditions, the stability test chamber has become an indispensable tool. This article will introduce the features and benefits of a stability test chamber and its importance in ensuring product quality. The stability test chamber is a professional equipment designed to simulate various extreme environmental conditions, such as temperature, humidity, pressure and light, etc., to test the performance and durability of products. It is widely used in industries such as electronics, automotive, aerospace, medical devices, cosmetics, and food, helping manufacturers understand how products perform under various conditions, and to improve and optimize them. The Photostability Test Chamber is very powerful. It can simulate extremely cold low temperature environment to ensure product reliability in cold regions. At the same time, it can also simulate high temperature and high humidity conditions to test the stability of products in hot and humid environments. In addition, the stability test chamber can also simulate environmental conditions such as high altitude, low air pressure, vibration and shock to evaluate the durability and shock resistance of the product. There are many advantages to using a stability chamber for product testing. First, its ability to provide accurate and repeatable test results enables manufacturers to accurately evaluate and compare products. Secondly, the stability test chamber has good temperature and humidity control capabilities, which can accurately simulate various environmental conditions to ensure the accuracy and reliability of the test. In addition, it can conduct long-term stability tests to evaluate the long-lasting performance and life of the product. Environmental chamber manufacturers play a vital role in ensuring product quality. By conducting stability testing during product development and manufacturing, manufacturers are able to identify and resolve potential issues early, improving product reliability and durability. This helps reduce after-sales service and repair costs, and enhances consumer confidence and satisfaction with the product. In addition, stability testing helps to develop more precise product specifications and standards, ensuring product compliance with industry and regulatory requirements. In a word, the stability test chamber is an indispensable tool in modern manufacturing, which helps manufacturers evaluate the stability and reliability of products by simulating various environmental conditions. It is powerful and capable of simulating various extreme environmental conditions such as temperature, humidity, pressure and light to provide accurate and reliable test results. Stability test chambers are used in a wide range of applications, covering multiple industries. In the electronics industry, it can test the performance and reliability of electronic components and equipment under different temperatures and humidity to ensure their stability in actual use. In the automotive industry, stability test chambers simulate vehicle operation under extreme temperature conditions to evaluate the durability and performance of automotive components. In the field of medical equipment, it can simulate different environmental conditions to ensure the reliability and safety of medical equipment under various harsh conditions. The operation and control of the stability chambers for sale has also become more and more intelligent and convenient. Modern stability test chambers are equipped with advanced control systems and user-friendly interfaces, making operation and monitoring simple and intuitive. Users can easily set the desired temperature, humidity and other parameters, and monitor changes during the test in real time. With the continuous development of technology, the stability test chamber is also constantly innovating and improving. Some new stability test chambers are also energy efficient and environmentally friendly to reduce energy consumption and environmental impact. In a highly competitive market environment, product stability and reliability are of paramount importance to manufacturers. Stability test chambers are a key tool that can help manufacturers evaluate and improve product performance and durability. It can not only save costs and improve efficiency, but also enhance consumers' confidence and satisfaction with products. To sum up, the stability test chamber has an important position and role in modern manufacturing. It provides manufacturers with accurate and reliable test results by simulating various environmental conditions to ensure product stability and reliability. With the continuous development of technology, the stability test chamber will continue to innovate and evolve, providing manufacturers with better product quality assurance.

  With the development of science and technology, product quality has become one of the key factors for enterprise competition. In industries such as medicine, food, and chemicals, stability test chambers, as an important testing equipment, play an irreplaceable role in product development and production processes. This article will discuss the definition, principle and importance of stability test chamber in product quality assurance.   What is a Photostability Test Chamber? Stability test chamber is a device used to simulate environmental conditions and conduct long-term stability testing of products. It can simulate various environmental factors, such as temperature, humidity, light, etc., to evaluate the stability and durability of products under different conditions. By testing in a controlled environment, manufacturers can better understand how a product will perform in real-world use and identify potential issues early.   The principle of walk in stability chamber The working principle of the stability test chamber is mainly based on control system and sensor technology. The control system can accurately adjust the temperature, humidity and other parameters in the test chamber to keep them within the set range. At the same time, the sensor can monitor environmental conditions in real time and feed data back to the control system to ensure the accuracy and stability of the testing process.   The role of stability chamber manufacturer in product quality assurance Evaluate product stability: Stability test chambers can simulate the long-term use of products under different environmental conditions and help manufacturers evaluate the stability and durability of products. Through long-term stability testing, potential problems of the product in specific environments can be discovered, and corrections and improvements can be made early.   Verify product performance: During the product development process, the stability test chamber can be used to verify whether the product's performance meets the design requirements. By testing under different conditions such as temperature and humidity, manufacturers can understand how products perform under various conditions and optimize product designs.   Guarantee product quality: By conducting stability testing on products, manufacturers can detect potential quality problems early and take measures to resolve them, thereby ensuring product quality and reliability. This helps reduce the risk of product recalls and complaints and improves the company's reputation and competitiveness.   Cost saving: The stability test chamber can conduct long-term testing in a controlled environment, avoiding uncontrollable factors that may be encountered in actual use. This helps reduce trial and error costs during product development and production, and improves production efficiency and product market competitiveness.   As an important testing equipment, the stability test chamber plays an irreplaceable role in product quality assurance. By simulating various environmental conditions and evaluating product stability and durability, it can help manufacturers detect potential quality problems early and improve product reliability and market competitiveness. Therefore, manufacturers should pay attention to the application of stability test chambers and continuously optimize test methods to ensure the continuous improvement of product quality and user satisfaction.

  Introduction: temperature stability chamber is a commonly used experimental equipment used to simulate and evaluate the stability and durability of products under different environmental conditions. This article will introduce the basic principles of stability test chambers, common application areas, and its importance in scientific research and industrial production. 1. Basic principle: The stability test chamber simulates the use of products under different environmental conditions by controlling parameters such as temperature, humidity, and lighting. The basic principle is to use technical means such as heating, cooling, humidification, and dehumidification to adjust the environmental parameters inside the Photostability Test Chamber to evaluate product stability.   2. Application fields: Stability test chambers are widely used in various industries. In the electronics industry, stability test chambers are often used to test the performance of electronic products under different temperature and humidity conditions; in the pharmaceutical industry, stability test chambers are used to evaluate the stability and shelf life of drugs under different environmental conditions; in the food industry , Stability test chamber is used to simulate the environmental conditions of food during transportation and storage.   3. Importance: Stability test chambers play a vital role in product development, quality control and production processes. By simulating real environmental conditions in the stability test chamber, possible product problems can be discovered and solved in advance, ensuring product stability and reliability, thereby reducing product development cycles and production costs.   4. Example: As an example, an automobile manufacturer uses a stability test chamber to test the performance of automobile parts under extreme temperature conditions. By simulating environmental conditions such as high and low temperatures in the test chamber, the durability and reliability of components can be evaluated to ensure that the car can operate normally under various climate conditions.   Stability test chamber is a very important experimental equipment, which is crucial for the stability and durability evaluation of products. By understanding the basic principles and applications of stability test chambers, we can make better use of this technical means, improve product quality and reliability, and promote the development of scientific research and industrial production.