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  • Considerations Needed When Purchasing a Laboratory Oven
    Jan 17, 2023
    One of the essential pieces of equipment in any materials testing laboratory is an oven, also known as a oven. They remove surface moisture while heating the material. Drying chambers are used in a variety of different applications such as sterilization, annealing, aging tests and incubation. Choosing a laboratory drying oven is an important purchasing decision. With a large number of ovens available with different configurations and characteristics, it is important to understand how to evaluate an oven based on various specifications and capabilities. How to choose a drying oven for laboratory Read on to learn five factors to consider before purchasing a lab drying cabinet. 1. Heating method On the surface, each oven works basically the same way—heating and removing moisture from samples inside. Ovens, however, accomplish this differently. Ovens utilize three heating methods: infrared (IR) heating, convection heating, or a combination of the two. Ovens that use convection heating are equipped with fans that circulate hot air around the chamber to evenly heat the sample. Meanwhile, infrared ovens allow you to target specific areas for heating. They operate by line-of-sight heating, which means they transfer heat to the part of the object that is directly within the line-of-sight of the heater. Ovens with hybrid infrared convection heating systems tend to be favorites of professionals because they offer greater drying flexibility. 2. Oven structure How an oven is constructed determines its performance. When you're examining an oven you might want to buy, there are some important structural features to look out for. First, look at the materials used. Depending on your needs, you can choose an oven made of durable, non-corrosive and easy-to-clean stainless steel. Then, look at its insulation. A well-insulated oven prevents heat loss that could damage samples. If you are performing high temperature processes, choose a double wall oven to ensure it can withstand extreme heat. Also, to avoid any heat loss, choose doors with heavy-duty doors and safety hinges for a tight seal that keeps air out. Another factor to watch carefully are the controls. The oven with digital PID (Proportional, Integral, Derivative) control is programmable for more accurate testing and includes many features such as calibration routines and data logging. You may also want an oven with overheat protection to help keep you safe in the lab. They automatically shut off if the temperature exceeds a certain point, preventing fires and accidents. 3. Chamber size How large or small is your sample size? This will help you determine the size of the oven to buy. Choosing a chamber that is too small will be a hindrance to your productivity. At the same time, a device that is too large will make your lab feel cramped and cost more due to its higher heat output. So before looking for an oven to buy, measure the available space in your lab. Take note of the width and height to get a better idea of which ovens to consider and which might not fit. 4. Heating uniformity No matter how many are placed, the samples in the oven must receive the same heat treatment. Therefore, the heat should be consistent throughout the oven. This is known as heating or temperature uniformity. Several factors can affect the uniformity of heating in an oven, primarily the way the oven is constructed. If the insulation is inconsistent or there are small gaps in the oven door, cold air can seep in and disrupt the temperature in the room. These cold spots cause some samples to get hotter than others. For example, if you place samples that are subjected to varying degrees of heat, this can result in poor product quality or inconsistent and unreliable results. That's why it's in your best interest to look for an oven that distributes heat evenly. But how do you know if it exists? Usually, reputable manufacturers will provide information about the heating uniformity of their ovens on their official product pages online. For example, on the official page for Across International's 250C 3 Shelf Vacuum Oven, you'll find it clearly states that its temperature uniformity is ±7% of set point. 5. Recovery time Whenever you open the oven door to add or remove samples some heat is released. When this happens, the oven increases energy output to compensate for heat loss. The time it takes to return to the proper temperature is the recovery time of the oven. Ovens with shorter recovery times allow for greater accuracy and thermal uniformity, but at the cost of adding more load to the system. Depending on your specific use case, this may be a negligible or non-negotiable feature. If your samples have very complex heating requirements, it is best to purchase an oven with a short recovery time. Or, if your oven has a relatively long recovery time, it can prevent excessive heat loss. Being more careful when preparing samples can help limit how often the oven door is opened. Adding the proper amount of sample to the oven allows for better and even heat transfer. Invest in a high-quality vacuum oven with pump Since laboratory drying ovens play an important role in laboratory testing, taking the time to choose which oven to purchase will save you money and worry. It starts with understanding what exactly you need your oven to do. There is no perfect oven, only one that suits your needs. This will help you determine which heating method is right for you, what materials, sizes and widths you need in the oven's construction, and how it manages its internal energy system. Check out XCH Biomedical for high quality, durable and reliable laboratory vacuum oven. If you are still not sure which oven to buy for your laboratory, you can easily consult XCH Biomedical.
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  • Why choose XCH Biomedical as a laboratory equipment supplier
    Jan 13, 2023
    Does it matter where you buy your Temperature and humidity Equipment? Not all lab equipment suppliers are created equal. Here's why you should get a quote from XCH Biomedical: Competitive price Since XCH Biomedical acts as the manufacturer, you get the best price possible - unlike a distributor who buys a product and then charges you a premium. Not only do we offer great prices, but we also offer premium equipment packages. Give the right advice We work with a number of laboratory equipment consultants and construction and engineering firms to advise on new builds or refurbishments. But no matter what, we are your resource. Even after projects are complete, companies keep calling us for ideas and advice on equipment purchases and we are happy to help. 50+ years of experience We've sold thousands of pieces of lab equipment, which means we know how to avoid common challenges and pitfalls that can arise during the buying process. If you need help purchasing a single piece of equipment or an entire laboratory for new construction, let our experience save you time, money and hassle. No unexpected costs We believe in total transparency, which means we will not charge you anything during the process. Our pricing is pre-determined and our goal is to help you understand the complete cost from ordering and delivery to setup and training. Training Our experienced, factory-trained representatives have the expertise to answer your questions and help you select exactly the products you need. They can also help you set up your equipment, provide training for you and your lab technicians, and answer questions throughout the product's lifecycle. One stop supplier With our extensive experience in laboratory equipment, including stability chamber, high and low temperature test chamber, Lab Biochemical Incubator, lab drying oven, etc. customer service is our top priority. Whether your laboratory requires a single replacement unit or an entire equipment package, XCH Biomedical is your one-stop supplier for all your laboratory equipment needs.
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  • Stability Test Standard
    Jan 06, 2023
    In Stability Testing - An Overview, we look at Stability Testing Requirements - Chamber Selection, Validation Requirements, IQOQPQ and IPV Considerations. In order to demonstrate the shelf life of a drug in a certain market, the manufacturer must store it at the relevant temperature and humidity for a specified period of time. This is done in what is also known as a stabilization chamber. Regulatory agencies in each market, such as FDA in the US, HPRA in Ireland, specify the temperature and humidity conditions that should be used and how long samples should be stored, such as a minimum of 6 to 12 months. During this time, samples were tested and their potency and degradation measured and recorded. This is called a stability test. The most common conditions are 25°C/60%RH. For new products, accelerated conditions may be 40°C/75%RH. Other conditions include 30°C/65%RH, 30°C/35%RH and 25°C/40%RH. For products intended to be stored in a blood bank Refrigerator, another condition is 5°C ±3°C. For products intended to be stored in a refrigerator, the test condition is -20°C ±5°C. ICH, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use, has developed rules for running stability tests. ICH Q1A states that during stability testing, conditions should be kept constant at ±2°C and ±5%RH. Also, if these conditions are not met for more than 24 hours, the test may need to be extended, creating a lot of paperwork. If conditions deviate from ±2°C/±5%RH, even for a short period of time should be accounted for. Probably due to the door opening to "pull" the sample. Events like this are usually logged in the room log. If no explanation is apparent, it may be necessary to seek assistance from a service engineer. In the event of a failure in the laboratory, a quick response from the supplier is required and although he should stock major spare parts, the auditor would also like to have some stocked on-site as well. It is also recommended to have redundancy, ie another room on site as a backup. The chamber must be fully validated and ready for use. Photostability Test Chamber To demonstrate shelf life under ambient light conditions, samples may be exposed to precise doses of UV and visible light in specially designed chambers. ICH Q1B specifies temperature control to prevent localized hot spots. Surveillance and 21 CFR Part 11 Indoor conditions should be independently monitored. This usually requires temperature and humidity transmitters connected to the recording system. In the Photostability chamber temperature, UV and visible light intensities will be recorded. This system must comply with the regulations of 21 CFR part 11 in the United States, whether it is a paper recorder or a computer system. 21 CFR Part 11 states that all related data collection and storage systems must be designed to prevent counterfeiting, corruption, untraceable alteration, or loss of data. In the case of computer systems, formal testing (IQOQ-Installation Qualification, Operation Qualification) should be performed to demonstrate compliance. Stability chamber Qualification Likewise, formal testing (IQOQ and PQ performance qualification) must be performed on new Stability chamber. During its useful life it should be maintained regularly (usually annual preventive maintenance service and calibration checks) and preferably mapped with several probes per year (IPV - Instrument Performance Verification). PQ and IPV typically require at least one 24-hour surveillance run, empty, loaded, or both. During this run, conditions must be shown to remain within ±2°C, ±5%RH of the set point. Test equipment used for these tests must be traceably calibrated at least annually and meet the IQOQ standards of 21 CFR P11.
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  • Contamination Control in Medical Laboratories
    Dec 27, 2022
    In a medical laboratory, the risk of contamination of cell cultures is incalculable – no matter how meticulous the work. It is certainly not unheard of for risks to be miscalculated, and contamination often results in culture loss. Therefore, in this blog, we would like to shed light on how to systematically detect and avoid contamination in cell lines. Every medical laboratory is under threat day in and day out Microbial contamination in cell cultures—including those purchased from third parties—is not uncommon in laboratories. In fact, the opposite is true: Many cell lines grown in the laboratory are infected with mycoplasma. Tiny fungal spores are ubiquitous and can spread through the air. Of course, when working in a sterile environment, there is room for human error. It's easy to make a mistake. Horror scenarios in cell culture labs - contamination of all types: Microbial contamination (bacteria, mycoplasma, fungi, yeast, etc.) virus contamination protein contamination (prions) Chemical contamination (leachables and extractables from plastics, heavy metals, etc.) Cross-contamination with other cell cultures Where does pollution come from? 1. How "clean" is the original culture? Problems often start with the source material. Even with all possible efforts in the production of media, some materials cannot be rendered completely sterile. Therefore, there is always a risk of mycoplasma escaping the sterile filter. Prions can even survive steam sterilization at 121 °C. 2. Is the working laboratory really a sterile environment? One of the main causes of laboratory contamination is the human body. For example, many instances of cross-contamination could be avoided if lab technicians avoided handling multiple production lines at the same time on the sterile bench. One culture can quickly infect another if the liquid is not handled properly. Also, rushing things through is the worst enemy of dull work. The door of the laboratory incubator should not be opened without reason, and of course it should not be left open for a long time. No matter how much time pressure they may be under, lab technicians should only work on one cell line at a time. When unpacking disposable pipettes under the bench, the cap must be set aside after unscrewing. 3. Are you using the correct laboratory equipment? Of course, even equipment used in medical laboratories is entirely possible to cause contamination in cell culture. Therefore, we recommend: Use plasticizer-free plastic containers Choose a suitable location for the incubator (location near the washbasin may lead to soap contamination) Use incubator accessories made of sterilized copper When antibiotics are used, antibiotic-free lines should be bred from time to time. (This is because antibiotics can mask the contamination and the infection can spread.) What investigative methods can be used to track which infections? One of the most dangerous things about mycoplasma infections is that they often go undetected for a long time. In principle, pollution events can be controlled and tracked by a variety of methods, some very sophisticated and others less so. An experienced lab technician can tell if cross-contamination has occurred simply by looking under a microscope. If we extract all the DNA from a cell culture, the PCR method can be used to detect its mycoplasma DNA content. Laboratories performing viral transduction or bioassays should also check for viral contamination. Laboratories manufacturing drugs for novel therapeutics should check for low risk of bacteria, spores, fungi, mycoplasma, HIV, HCV, and BSE. How should pollution be dealt with? Every instance of contamination must be documented and graded. If nothing else, medical labs that keep pollution problems under wraps are jeopardizing their good reputations. Of course, special cleaning measures must also be taken in case of contamination: in the case of fungal infections, it is advisable to check that the laboratory is regularly disinfected with an alcohol-based agent As a general rule, regular spray or wipe disinfection of the scientific incubator interior with an alcohol-based solution helps to avoid contamination Monthly hot air sterilization is standard medical practice in many laboratories For sensitive stem cells, it is only in rare cases that infected cell lines can be treated with antibiotics. In most cases the solution is expensive - the culture has to be scrapped and the work has to be started from scratch in conclusion: Being able to consistently detect, validate and deal with contamination is absolutely essential, especially in medical laboratories that work with highly sensitive stem cells and do not use antibiotics. Transparent monitoring is essential. Covering up contamination or allowing it to spread only increases the danger and is unnecessary. The Constant Temperature Incubator should always be the safest component of the entire process step; if a sample is contaminated, then in most cases this occurs either upstream or downstream of the cooling incubator cultivation.
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  • Thchamber Drying Chamber Guide
    Dec 14, 2022
    Drying ovens are used in laboratories or industry to heat materials and remove their moisture content. It is usually used where a drying process is required, such as food, agricultural products, pharmaceuticals, etc. There are different types of drying ovens on the market, such as hot air oven, vacuum oven with pump, dry heat oven, etc. Drying ovens are used to speed up the drying process by creating optimal evaporation conditions. The material is dried by convective heating that circulates air around the material by using a hot air oven. This type of drying is effective and efficient for large batches. Drying Oven: Definition A drying oven is an oven used to remove moisture from objects or materials. The stove uses heat to evaporate water and vents the resulting steam outside. They are often used on materials that are sensitive to water damage, such as electronic components or chemicals. You can also use them to remove moisture from food to extend its shelf life. Some ovens are also equipped with a dehumidifier, which helps to further reduce the relative humidity inside the oven. By keeping humidity low, the drying process can occur faster and more efficiently. Drying Oven application: Drying chambers are used in different applications such as scientific research, food processing, agriculture and many more. The sample under test is exposed to a preset temperature for a specific time set by the user. It is used for drying chemicals, pharmaceuticals and other substances. Aging or tempering of plastic and electronic components can also be done in these ovens. In agriculture, seeds and crop products are dried using laboratory ovens for longer storage. Stability testing in the food industry is done using these ovens. Drapes and gloves are also heated in these ovens so they can be sterilized. Drying Oven working process: This equipment is an oven used to remove moisture from materials. The chamber walls are exposed to a specific temperature at atmospheric pressure. Thermal energy enters the chamber load naturally or through forced convection and radiation. The surface heating system provides support from the back of the interior walls. The drying process goes faster as the temperature and air dries. The drying oven dries and heats the sample at the same time, allowing the sample to dry quickly and evenly. This process helps to measure the moisture content of the product being manufactured. Liquid content and content volatiles are removed during the drying process. Drying chambers are used in different applications such as scientific research, food processing, agriculture and many more. The weighed sample is exposed to a preset temperature for a specific time set by the user. You can find the resulting loss on drying with the aid of percent weight loss or moisture analysis. These methods are used to remove moisture from food. Dehydration helps preserve food and makes it easier to carry when traveling. Ovens of different capacities and dimensions are available upon request. Please contact vacuum oven manufacturer thchamber with your drying cabinet needs and one of our experts will be in touch shortly. Get in touch now!
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  • About Environmental chambers - XCH Biomedical
    Dec 05, 2022
    Environmental chambers have been used to research products for decades, with countless applications in aerospace, artificial intelligence, automotive, electronics, solar cells, medical, industrial, and consumer research. In these industries, samples or materials to be tested must be exposed to defined changes in environmental factors in order to study their effects and even prepare for future research. The conditions that an environmental chamber can replicate are: temperature set point (or change), relative humidity or moisture in the form of rain, electromagnetic radiation, vibration, weathering, salt spray, sun exposure/UV degradation, and vacuum. The type of testing involved will determine the chamber type; chambers come in a variety of sizes and are designed with different features and options. Environmental chamber humidity control and specimen incubators Prepared specimens or materials are placed in chambers and then subjected to specified levels of environmental stimuli to determine how responsive they are. The resulting by-products were also measured and studied. Chamber of Commerce Type Humidity or temperature chambers are used for climatic testing, while vibration and stress chambers are often used for mechanical testing, such as evaluating a product's performance under vibration or shock. "Pressure" is usually tested using a pressure variable or a vacuum. Stress and vibration chambers are also used in electronics, solar or fuel cells, and automotive products, where testing requirements are very demanding. The goal is to go beyond "normal" to measure the limitations of materials. Highly Accelerated Life Testing, formally known as HALT testing, is used to discover potential defects and ultimately improve products at the design stage. The chamber will simulate various stimuli such as vibration, aging, humidity, voltage and thermal cycling, which can cause many flaws in design or production. Instead, a compliance test known as HASS (Highly Accelerated Stress Screening) is performed during production to identify defects prior to commercialization. These tests use temperature and humidity variables to find potential defects. Environmental test chambers for manufacturing and production have been used for decades and are capable of generating pressures far greater than normal for commercial products. chamber design Environmental chambers can be designed as walk in environmental chamber, bench-top, floor-standing, reach-in or drive-in configurations. Depending on the function they perform, they can range in size from portable devices to gigantic rooms, such as the vacuum chamber at NASA's Space Power Facility, which is the largest of its kind. Floor-standing and table-top darkrooms are the most widely used. While most chambers are made of steel, the materials used for the inner and outer walls vary by application. When used in food packaging or pharmaceutical applications, the chamber may have glass doors for visual access. The intended application of the chamber also affects the types of heaters, coolers, condensers, evaporators, controllers, sensors and other modules used. Newer test chambers have evolved to keep pace with product testing requirements, such as those used in biological and military applications. These chambers are usually custom-made to meet all necessary environmental testing requirements and the equipment used for the measurements is very accurate and reliable. The newer design of the photostable stability chambers in pharmaceutical has a smaller footprint and is easier to handle than its predecessor. Their user interface resembles a touchscreen Windows monitor rather than traditional scrolling electronics. If they are network enabled, they can be programmed and operated online
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  • Why use Stability Chambers in the pharmaceutical industry?
    Nov 24, 2022
    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.
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  • Choosing the Right Equipment for Drug Stability Testing
    Nov 17, 2022
    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.
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  • Key Stability Testing Factors You Should Consider
    Nov 09, 2022
    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.
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  • What is the purpose of laboratory drying oven
    Oct 27, 2022
    Many applications require laboratory drying ovens to remove moisture from samples. They are a necessity in many environmental, clinical and biological laboratories and forced air and come in many different forms. This blog will explain what laboratory drying ovens are and what they are used for. Standard Drying Oven vs Laboratory Drying Oven Standard drying ovens are designed to remove moisture from the oven chamber to dry samples as quickly as possible. This type of oven brings fresh, dry air into the chamber while removing moist air. This dries the sample quickly, however, it requires an airflow system that can extract moisture from the air. Laboratory drying ovens are designed to heat samples only. This means that the oven will continuously circulate the same air around the chamber and provide heating only. Both oven options are effective and used to meet different requirements. The Importance of Laboratory Drying Ovens Laboratory drying ovens are an invaluable aspect of everyday workflow, and their use can range from simple glassware drying to complex controlled heating applications. Laboratory drying ovens provide temperature stability and reproducibility for all application needs. Gravity convection ovens work on the basis of the rising temperature distribution of warm air. These laboratory drying boxes do not use fans to actively distribute air indoors and have very low turbulence. Mechanical convection ovens use an integrated fan to actively move air from the room, creating an even temperature distribution in the room. This means optimum temperature uniformity and highly reproducible results. Uses of laboratory drying ovens Laboratory drying ovens can be used to control the temperature and keep it safe. They are also frequently used in testing and drying biological samples and in forensic laboratories to assist in the development of fingerprints. In addition, laboratory drying ovens can be used in environmental studies to dry samples before and after weighing to determine the moisture content of the samples. XCH Biomedical Laboratory Vacuum Drying Oven At XCH Biomedical, our laboratory drying ovens are designed to provide the highest level of performance and reliability in an energy-efficient, compact package and are available in benchtop or floor-standing configurations, providing greater flexibility in laboratory organization and layout . Manufactured to strict quality, assembly and design standards, our laboratory drying ovens are designed to include robust steel cabinets that are coated with epoxy powder for durability and protection. XCH Biomedical laboratory drying cabinets feature durable and easy-to-use latches. Temperature distribution throughout the oven allows full use of all shelf space, with additional shelves available on request. If you would like to know more about our laboratory drying cabinets, please contact us now for more information on vacuum oven manufacturer Thchamber.
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  • Stability testing of active pharmaceutical ingredients and finished drugs
    Oct 17, 2022
    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.
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  • Use and maintenance of high and low temperature humidity test chamber
    Oct 08, 2022
    With the development of people in the fields of military, aerospace and navigation, many equipment will work in high temperature, temperature and humidity test chamber. In this environment, equipment will face greater challenges. The stability of the equipment has an important influence on the operation of the equipment. The high and low temperature humidity test chamber (hereinafter referred to as the high and low temperature humidity test chamber) is used to test the performance of materials in aerospace and marine products under high temperature, damp heat and other environments. Its structure and working principle have certain particularities. 1. Use a high and low temperature test chamber Before conducting environmental experiments, it is necessary to master the properties, experimental procedures, experimental conditions and experimental techniques of the tested samples. At the same time, it is necessary to master the use technology of the equipment, clearly understand the structure of the equipment, especially the performance and operation of the controller. At the same time, the staff must read the operation manual in detail many times to avoid operation errors, which will cause the equipment to fail to operate normally, cause errors in the test data, and damage the samples during the test. In order to ensure the accuracy of the experimental data in the experiment, it is necessary to select reasonable equipment for the experiment. The selection of high and low temperature humidity chambers should be determined according to the actual conditions of the experimental samples. The volume between the laboratory and the test subject should always be in a reasonable ratio. When conducting experiments on the heated sample, its volume should be less than 10% of the effective volume of the experimental calibration. The proportion of the unheated test sample to the effective volume of the laboratory should be 20%. The location of the sample should not cause the air outlet and air outlet to be blocked, and at the same time, keep a certain distance from the humidity sensor to ensure that the temperature is normal during the experiment. The following points should be paid attention to in the use of high and low temperature humid chambers: (1) During use, ensure that the high and low humidity heating box is safely grounded to avoid casualties caused by electrostatic induction. (2) Do not touch the box with your hands during operation. (3) Unless the chamber door cannot be opened due to special reasons during the operation of the equipment, the following adverse consequences may occur: 1) The temperature inside the door is still very high 2) High temperature and high humidity will flush out of the chamber. 3) High temperature may cause fire alarm. 4) Lighting should be turned off unless necessary. 5) Try to avoid repeated opening within 15 minutes during use. 6) When the high and low temperature humidity box is running at low temperature, it is best to dry the equipment at 60°C for 30 minutes, and then open the door to prevent the evaporator from freezing or affecting the measurement time of subsequent experiments. 7) During operation, in order to ensure the safety of equipment and operators, over-temperature protectors and circuit breakers should be checked regularly. 8) In addition to full-time personnel, professional electricians are also required to participate in the maintenance and inspection of the equipment. 2. Repair and maintenance of common problems Frequently asked questions about maintenance of high and low temperature and humidity chambers During the high temperature test, if the test temperature does not reach the temperature value required by the test, the electrical system should be checked and the cause of the failure should be eliminated one by one. If the temperature rises slowly, check the air circulation system and observe the opening status of the adjustment plate in the air circulation system. If the temperature rises too fast, the rotation of the air circulation channel needs to be detected. If the temperature rises too fast, the PID tuning parameters need to be adjusted. If the temperature rises directly to the over-temperature protection, it can be concluded that the controller is faulty, and the control instrument should be replaced in time. When the low temperature does not meet the experimental requirements, it is necessary to observe the temperature change. Whether the temperature rises after falling to a certain value or whether the temperature drops slowly. The former is generally caused by the harsh environment of the drying equipment. The location and ambient temperature of the equipment should be observed. If it cannot meet the working requirements of the equipment, it should be adjusted in time. If the latter, the equipment should be checked to see if the laboratory is dry before low temperature testing. If the workshop is dry, put the test samples into the laboratory, and check whether there are too many samples stacked in the laboratory, which causes the laboratory ventilation cycle to fail to meet the requirements. 2.2 Equipment maintenance content The main contents of equipment maintenance include preventive maintenance and predictive maintenance. Of the two types of preventive maintenance, the maintenance that needs to be done once a week includes cleaning the drip tray and the laboratory body for condensed water. Maintenance required by customers in special areas includes: cleaning humidification water pipes, flushing systems or medium cooling water pipes. Maintenance that needs to be done every six months includes cleaning the air cooling equipment (condenser), maintenance that needs to be done every year, cleaning the scale inside the humidifier, cleaning the AC (high current) contactor for maintenance of the electrical control cabinet. At the same time, the lubricating oil used by the compressor should be replaced every 2-3 years. Predictive maintenance mainly includes weekly maintenance, monthly maintenance and quarterly maintenance. Weekly maintenance includes: checking the balance pressure and suction and discharge pressure of the compressor, checking the color of the oil in the compressor, and checking the oil body. Monthly maintenance included. Check the compressor discharge and suction temperatures, the liquid mirror and discharge temperatures in the condenser, and the temperature difference between the incoming and outgoing water in the cold water pipe. Check the heating rate and cooling rate of the device. Check the operating current of the compressor motor quarterly. Regular maintenance of the equipment can not only improve the stability of the equipment during operation and the accuracy of the experiment, but also prolong the service life of the equipment to a certain extent. Therefore, attention should be paid to the maintenance of high and low temperature humidity chambers in the future. 3. Conclusion Environmental Chamber Manufacturer is a special refrigeration equipment, its use, maintenance and repair should start from refrigeration, electrical control, thermal engineering and so on. In the process of use, attention should be paid to the usage specifications. When repairing, the faults that may be caused by the operation should be eliminated first, and then the faults existing in the equipment itself should be repaired. After the equipment fails, it should be repaired on the basis of mastering the structure and working principle of the equipment. In addition, the maintenance of the equipment must be carried out on time, and the maintenance of the equipment cannot be ignored because the equipment has not failed for a period of time.
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