Stability Test Chamber

The operation of a stability chamber is based on the basic idea that by maintaining a constant temperature and humidity chamber, a constant relative humidity value will be maintained as well. The ratio of how much water is in the air to how much it might theoretically store is known as relative humidity. With a rise in current temperature, the amount of water that air can contain increases, resulting in a drop in relative humidity. This is how both settings are automatically modified at the same time. The temperature in the stability chamber should not vary more than two to three degrees, and the humidity should not fluctuate more than 5%. The chamber’s outer and inner bodies are comprised of corrosion-resistant stainless steel, with the inner body insulated properly. Inside the chamber, there are several shelves for storing products that may be readily removed. Sensors are also fitted to the chamber to detect temperature and humidity levels. The controlled airflow inside the chamber ensures that temperature and humidity remain consistent. For improved uniformity of essential conditions, horizontal laminar airflow is suggested. Even when the shelves are fully loaded with samples, they will receive a continuous flow of air using this system. The linked blowers ensure that the sir is circulated properly. Receiving and transferring data is done with data loggers. Stability chambers have a wide range of applications. They play a vital role in the final stages of product production. It is also used in the automotive industry, cosmetics industry, packaging, biological or microbiological testing, research and various other fields. The Pharmaceuticals segment is responsible for creating, researching and marketing medicines that benefit medical science. Since these treatments will benefit large numbers of people in many parts of the world, proper drug production becomes a top priority. When individuals manufacture and ingest defective medicines, side effects and dangerous symptoms can occur. Therefore, it is necessary to conduct drug stability testing in various environments. In the pharmaceutical industry, the stability chamber is used for this purpose only. They assist in drug testing under various variables such as temperature, humidity, pH, radiation, etc. They are also used to see how long a product will last before needing to be replaced. Stability chamber testing also reveals information about the integrity of product packaging. This test can save you a lot of time and money by alerting you to errors in your medicine that could make it harmful in a particular setting. This test can also be used to determine the expiration date of a drug. The shelf life of a drug is the amount of time a drug remains effective from the date of manufacture when stored under specific conditions. This value must be determined using a stability test chamber and displayed on the packaging for consumer awareness. These chambers are also used to store pharmaceutical samples that require stable conditions that cannot be obtained through natural sources, as they maintain the required stable and uniform temperature. Proper maintenance and inspection of chambers should be a priority in the pharmaceutical sector to ensure correct drug testing. At last, Who provides the best stability chamber solution? Environmental Chamber Manufacturer Thchamber stability chambers have been carefully constructed and developed to meet the stringent requirements of climate testing and stability investigations. The chamber features FDA/ICH stability standards to provide out-of-the-box control and consistent temperature and humidity. Thchamber stability chamber has specific guidelines, structural integrity and measurement equipment that allow accurate recording of test data to keep the chamber running smoothly through rigorous testing cycles over many years.

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.

Stability testing is an essential part of the drug development process—maintaining the quality of active pharmaceutical ingredients (APIs) and drug products, while providing accurate shelf life. Stability testing enables pharmaceutical companies to determine the most suitable packaging and/or container closure systems for drug product storage and distribution. "Stability storage and testing play an important role in drug development from discovery to commercialization and beyond," said Scott Jedrey, Director of Quality Operations at Alcami. “With testing at each stage, whether physical or chemical, data can be collected, trended and reviewed. Based on this data, a decision is made whether to move on to the next stage, which includes more testing and more patients for clinical trials "Products must have purity, potency and safety at every stage of the drug development process in order to receive very important agency approvals." There are several important factors to consider when designing and conducting stability studies, with safety, quality and product efficacy being the most important. Drug development companies have the ability to identify and trend shelf life and its impact on efficacy by exposing samples to various temperatures, humidity levels, and light over time. Analytical methods for valid Stability Chamber testing vary by drug product. The design of a stability study must consider product form, container type, and packaging. For example, commercially released products have been tested to study the effect of conditions on the drug product and packaging container on degradation. In the case of a multi-dose product, in-use stability testing can be used. The purpose of an in-use stability study is to simulate the use of the product in practice, taking into account the fill level of the container, any dilution/reconstitution prior to use, holding time prior to use, and various diluents that may be used. for management. Degradation factors, including physical, chemical, and microbial causes, are important to study. Physical factors include changes in the physical properties of the drug, such as appearance, properties, hardness, friability, and particle size found in tablets, capsules, and semisolids. From a chemical point of view, scientists want to separate compounds into elements, simpler compounds, or change the chemical properties of drugs through hydrolysis, oxidation, isomerization, polymerization, or photodegradation. Understanding all the ways in which a finished product or API may be affected by degradation is critical to successful stability testing. For example, Stability Lab studies aim to simulate climate impacts. These studies are based on a variety of product factors, such as expected mode of transport, environmental temperature and humidity test chamber exposure to light and atmosphere, and distribution location. From these studies, scientists are better able to determine the shelf life of drugs, decide the best way to store them, and ultimately help keep consumers safe. Finally, microbial contamination of the product, depending on the type of microorganism and its level of toxicity, may also play a role in the design and function of these studies. Summarize The quality of APIs and pharmaceutical products can be safeguarded by determining appropriate storage, shelf life and distribution methods. Stability Chamber Manufacturer Thchamber has extensive experience in establishing stability programs at all stages of the drug product life cycle, from early stages to the need for drug stability testing.

Stability testing is a study designed to provide information on how an active pharmaceutical ingredient or finished pharmaceutical product is affected by temperature, humidity, climate and light over time. The duration of follow-up inspections, expiration dates and recommended storage conditions for active pharmaceutical ingredients are based on these data, and stability chambers are essential when conducting these studies. Stability Chamber - Survival of the Fittest Accuracy and repeatability of parameters in continuous operation, reliability and durability are the top priorities of the stabilization chamber. The solid stainless steel interior should be corrosion resistant and designed to be easy to clean. Programming must be intuitive, and calibration certificates, data loggers and validation documentation should of course be included. Basic requirements for stability chambers in the pharmaceutical industry What technical solutions are currently available to meet these requirements? What factors must I pay special attention to? What are the advantages and disadvantages of various technical solutions? This blog provides you with initial insights. 1. Temperature and humidity test chamber The temperature humidity chamber provides a quick overview of all achievable temperature and humidity values. The performance range of different stabilization chambers varies widely. For example, some models satisfy the conditions of five climatic zones I to IVb in addition to all the climatic conditions specified in the ICH guidelines. Such models are very generic and can be combined with each other as generic backups if desired. Other models only simulate certain climatic conditions, so their application is very limited. 2. Horizontal or vertical airflow With horizontal airflow, the air spreads evenly on each shelf regardless of the shelf's position in the stabilization chamber. Optimum temperature and humidity distribution is achieved when loading the chamber. This is especially true in the case of double-sided horizontal airflow. In the case of vertical airflow, i.e. from bottom to top, the air diffuses through the shelves, starting at the bottom, going up the middle, and finally reaching the top shelf. Each shelf basically blocks air distribution. 3. Humidifying water It's not just the type of humidification that matters - the water supplied to the stabilization chamber must also be of good quality. Connecting to an on-site water supply and drainage facility is one option, while using bulk tanks to supply fresh water and collect wastewater directly in the stabilization chamber is another option. The latter option allows the chamber to be installed away from the on-site water supply. In both cases, the ion exchanger will prepare the fresh water to the desired quality. 4. Continuous operation The stability chamber operates continuously for more than 8,000 hours per year. Robust designs, durable materials and components developed for maximum reliability are the foundations, ensuring these demanding operating times will last for years. In order to minimize the risk of time-consuming cross-contamination and stabilize indoor biocontamination, an easy-to-clean interior is absolutely necessary. High-alloy stainless steel, removable shelves, steam humidification and the absence of synthetic materials inside are just some of the key aspects. Some models also have an extended temperature range of up to 100°C, which means sterilization is possible. 5. Programming and Documentation An important factor regarding approval applications is the availability of complete and end-to-end documentation of all relevant parameters for each operational state. Needless to say, calibration certificates for temperature, climate, data loggers (process documentation independent data records), and verification documents with IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification). If you have any questions about our stability chamber, you are welcome to contact us at thchamber.com.

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.

Stability chamber are used to test products and evaluate their shelf life, such as electronic components, industrial accessories, pharmaceuticals, etc. It enables researchers to modify parameters such as humidity and temperature for rigorous examination under various conditions. There is no doubt that various products require different test conditions, but it is practically impossible to roam around to experience different climatic conditions. This is where stability chambers come in handy to make researchers' jobs easier. With these systems, researchers can track changes in product quality under alternating environmental exposures. Types of Stability chambers Generally, there are two types of Stability chambers: Reach in Chambers: They are small and used to test small quantities of products. One of the main benefits of using these chambers is their convenience. Walk-in rooms: As the name suggests, these rooms are larger in size and you can walk in. They are used to test high-volume projects that require precise conditions over long periods of time. Walk-in test chambers are used to record product performance under the following conditions: wet/wet conditions rain arid area exposed to the sun elevated temperature conditions significant environmental change Besides these two, there are other types of rooms, although not very popular in the real world: a) Environmental Room b) Accelerated laboratory c) Temperature and humidity chamber d) Photostability Chamber The function of the stability chamber The working of these chambers is based on the simple principle that by maintaining a standard temperature, a stable value of relative humidity will also be maintained. Simply put, relative humidity is the ratio of the current water in the air to the optimum it can be kept in. When the temperature increases, the capacity of the water that the air can hold increases. At the same time, the relative humidity is significantly reduced. In this way, both parameters are modified at the same time. All Stability chambers comply with the ICh regulations, which stipulate that the temperature deviation must not exceed 2 to 3 degrees and the humidity change must not exceed 5%. The inner and outer bodies are made of corrosion-resistant stainless steel. The inner body is also lined with a suitable insulating layer. The chamber includes a number of shelves for items that can be quickly removed. Sensors are attached to these chambers to identify temperature and humidity levels. Horizontal laminar airflow is the preferred solution to more accurately homogenize the desired conditions. With this system installed, they will receive consistent airflow even when racks are full of samples. The presence of an additional blower maintains proper circulation of the air. Data loggers are also used to receive and transmit information. Application of Stability Chamber Stability chambers have a wide range of uses. They are critical when completing the manufacture of a specific product. Therefore, it has a wide range of uses in the automotive industry, pharmaceutical industry, packaging, cosmetic industry, research work, biological or microbiological testing, etc. There are various types of Stability chambers on the market. However, you need to choose the right one according to your needs. If there is any guidance, it is advisable to consult an expert rather than make all decisions yourself. Do you want to purchase a high quality Stability chamber for all your research needs? If you feel that way, then Stability Chamber Manufacturer thchamber.com is the place for you.

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.

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.

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.

Companies buy walk-in stability test chamber for different reasons. The most obvious need is size. Large or odd-shaped products are not necessarily suitable for the scope of the floor model test chamber, especially when you consider the airflow ratio (the volume of the product and the volume of the work space are one to three). Other companies choose walk-in test chambers to accommodate a large number of products (thousands of mobile phones, for example), or to allow engineers to observe products up close during testing. The former case can improve the test efficiency, the latter case is only possible in a huge internal working space. The walk-in stability test chamber can be customized according to the volume and shape, performance, air quality (if people stay in the chamber), etc. You can even add an anteroom to separate the test chamber space from the laboratory. So, although you can find similar performance in floor-standing models (or desktops for that matter), you can only achieve this level of customization through a walk-in test chamber. Advantage The size is almost unlimited, so a lot of shelf space/samples can be accommodated A qualification covers a lot of shelf space Due to the larger size, the conditions of walk-in test chamber tend to be more stable Shortcoming A defective chamber can cause problems with a large number of samples Installation usually requires construction, electronics and refrigeration skills The compressor will increase the floor space or the distance, so it will increase the cost Identification requires additional probes Spare parts may be unique to the special construction They usually require three-phase power and additional water supply For safety reasons, the time the operator spends indoors may be limited Island space is necessary footprint waste There are many factors to consider when researching a walk-in test test chamber. With such a large capital purchase, you cannot ignore any details. Consult your entire team. Work hard to understand your testing requirements. Most importantly, contact an experienced test chamber manufacturer who can build a customized solution within your budget. Learn more about XCH Biomedical custom walk-in constant stability chamebr series.

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.

What is a stability test chamber? Most stability test chambers are similar to a large scientific refrigerator. Their function is not to keep the contents cool, but to replicate changes in temperature, humidity, and light for a long time. This is crucial when a pharmaceutical company wants to bring a new product to the market. Changes in temperature, humidity, and light are closely related to the recommended shelf life of medicines. If you check your medicine cabinet, you will most likely find the "expiration date" on prescriptions and headache medicines. We will focus on medicines here, but they are equally applicable to many products whose performance and reliability must remain unchanged under many climatic conditions around the world. Before you buy a test room, you must first determine the standard you want to test. These will determine the specific test room you need. When you need to pick up the phone, you will also know what you are looking for. I hope the manufacturer has stock and can give it to you in time. However, the inventory exceeds the availability. Check the manufacturer's website. Are the sizes and types of the listed models different-temperature and humidity, temperature control, etc.? Does it come with a standard and high-performance test chamber? What are its customization options and upgrades? These may not apply to you, but more products show that the manufacturer has a solid team of engineers behind its products, and has done a good enough job in sales, it is worth choosing a variety of test boxes. The best test room manufacturers maintain communication for a long time after the initial transaction and provide support when needed. Many provide free replacement parts and services during the warranty period after your purchase. Also, look for the types of troubleshooting available so that you don't always have to rely on external services to keep running and identify the problem before you bring in the service team. However, the real difference lies in the long-term maintenance plan. You must perform preventive quarterly and annual maintenance to keep your test room running. Look for factory service employees instead of HVAC technicians. If you can cooperate with the manufacturer's service department for maintenance, that would be an advantage. They understand the intricate details of environmental test chambers, which are much more complicated than typical HVAC maintenance and repairs. In addition, working with factory services can help you build a working relationship that you can turn to when problems or problems arise. Want to know what the best environmental test chamber manufacturer must provide? Contact XCH Biomedical to learn how we use the latest laboratory technology and solutions to provide services to companies from all walks of life. XCH Biomedical R & D Technical Team The company is backed by scientific research institutes, exerts its own talent advantages, and continuously applies the latest achievements to products. The R&D team led by researchers and Ph.D. thermal engineering has always been serious and rigorous; we understand that you are under pressure to quickly introduce new products to the market. Products must be tested under various conditions to ensure their quality and reliability. Products and Services 1. Biological field: Use biotechnology to conduct environmental tests on new products. Provide sophisticated experiment and test equipment to ensure product reliability. 2. Medical field: From syringes, vaccines to pacemakers, the medical industry needs to understand the limitations of temperature, use and storage, and strictly control the manufacturing and research and development of products. We provide various environmental test chambers and test chambers for stability testing and storage of products or tools in the medical field to ensure effectiveness and reliability.