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This article will take an in-depth look at stability chambers.
You will understand more about topics such as:
What are stability chambers?
How do stability chambers work?
Considerations when choosing stability chambers
Types of stability chambers
ICH guidelines for using stability chambers
Standard features of stability chambers
Areas of application for stability chambers
Industries that use stability chambers
And much more...
Chapter 1: What are Stability Chambers? How do They Work? Considerations When Choosing Them.
Stability chambers and rooms are climate-controlled environments that provide stable conditions for testing and storage. These specialized environmental chambers offer a precise, raised temperature or humidity to ascertain whether a product or its packaging degrades over time in the long term, immediately, or more quickly. Some stability chambers and test rooms have been created for the evaluation, determination, and testing of shelf life. Others are appropriate for testing stability, stability research, medication research, and biomedical storage. Typically, pharmaceutical and biotechnology products are kept in stability chambers and rooms. It's crucial to measure product stability, product degradation, packaging stability, and container stability to ensure compliance with published standards for testing drugs, drug substances, active pharmaceutical ingredients (APIs), foods, life science materials, medical devices, and biomedical supplies.
The International Conference on Harmonization (ICH) of Technical Standards for Registration of Pharmaceuticals for Human Use and the US Food and Drug Administration (FDA) both have requirements for stability chambers and stability rooms. The Q1A standard from the FDA is intended to give the industry direction when stability testing novel drug ingredients and products. Stress testing, batch selection, container closing methods, testing frequency, storage conditions, and stability commitment are all covered in the drug substance part of Q1A. Many of these identical subsections, along with photostability testing and labeling rules, are found in the drug product part of Q1A. When it comes to committing to stability, primary batches that are tested in stability chambers and rooms should use the same stability method as long-term studies.
To ascertain product stability, product degradation, and package stability, stability chambers and rooms with rapid stability testing are used. Drug stability, vitamin stability, container stability, pharmaceutical product stability, and food stability are all measured in specialized stability chambers and rooms. Some stability chambers and rooms include redundant heating and cooling capacities as well as stainless steel construction. Others are equipped with NIST-traceable sensors and instruments that adhere to National Institute of Standards and Technology (NIST) testing requirements. There are additional stability test chambers, stability cabinets, and stability enclosures that adhere to different criteria. These stability rooms and chambers frequently satisfy the National Science Foundation (NSF) requirements.
Considerations When Choosing Stability Chambers
Choosing the appropriate test chamber is essential to guarantee that the products and materials are tested properly. Therefore, when selecting a test chamber, one should keep a few aspects in mind, such as:
Testing Capabilities: Different test chambers have different capabilities. While some chambers are more adaptable, some are tailored to produce certain circumstances. Make sure the chamber chosen can produce the conditions required.
Safety Features: Some chambers are equipped with alarms and emergency shut-off valves. These characteristics can aid in preventing harm to materials and products.
Interfaces: Some chambers are equipped with interfaces that link the chamber to a computer or other electronics. These interfaces can control the chamber remotely or monitor its internal conditions.
Controls: The chamber's controls are crucial. Make sure the controls on the chamber are simple to operate and comprehend. The user does not want to have to make assumptions about what the chamber is doing.
Maintenance: Every test chamber needs maintenance to some extent. Make sure to pick a chamber that is simple to keep clean. One does not want to spend hours maintaining the cleanliness and functionality of the chamber.
Size: The chamber's dimensions are crucial, particularly if the user intends to test bulky goods or materials. Please confirm that the chamber has enough space to meet the requirements.
How Stability Chambers Work
A stability chamber operates under the straightforward premise that a stable relative humidity value will likewise be maintained by maintaining a steady temperature. The ratio of the amount of water in the air to the amount it is capable of holding is known as the "relative humidity." The amount of water that air can contain increases when the ambient temperature rises, which causes a proportional reduction in relative humidity. This change in relative humidity is how the parameters are automatically and simultaneously modified. It is very important to follow the ICH criteria, which say that the humidity and temperature in the stability chamber shouldn't change by more than 5% and 2–3 degrees, respectively.
The chamber's inner body is lined with appropriate insulation, and the outer and inner bodies are constructed of corrosion-resistant stainless steel. Inside the chamber, several shelves are available for storing products that can be removed easily. Additionally, sensors that measure temperature and humidity inside the chamber are installed. Due to the controlled airflow inside the chamber, consistent humidity and temperature levels are maintained. For improved consistency of the necessary conditions, horizontal laminar airflow is suggested. With such a setup, the shelves will still receive a steady flow of air even when they are completely stocked with samples. The blowers that are linked maintain proper air circulation. Data loggers are used for data transmission and reception.
Adding a glass door, which allows one to observe what is going on inside without upsetting the temperature conditions within, is another highly beneficial feature. In addition, ports are accessible for routine exhaust air removal. Climate chambers, sometimes referred to as "environmental chambers," are used expressly to simulate a variety of climatic conditions for the testing of specific items. This type of chamber can supply any necessary environmental condition, whether dry or humid, rainy or corrosive. Their dimensions can range from being as large as a room to so small that they can also be reached from a bench.
Testing for photostability is necessary when determining how a product will behave when exposed to white light and UV radiation. This testing raises questions about safety because it deals with UV radiation, which is dangerous to people if it comes into close contact. Use chambers that turn off the UV light when the door is opened to give even more protection.
Chapter 2: Types of Stability Chambers
When there are fewer samples and the conditions are likely to change, reach-in chambers are tiny and practical.
When storing a lot of samples and needing to maintain storage conditions for a long time, walk-in chambers are better because they are larger.
Each necessary storage condition is to be maintained in a separate compartment. According to the International Commission on Harmonization (ICH), the recommended temperature and humidity levels for pharmaceutical stability studies are:
For stability data to be reliable, only constant environmental conditions may be used during product exposure. Therefore, automated data logging must be performed at regular intervals to fulfill this requirement, and stability chambers must undergo routine preventive maintenance procedures to ensure trouble-free operation throughout long exposure times.
A humidity chamber is a device that simulates various settings so that producers can test their goods in the most demanding situations. Producers can observe how their products respond to changes in humidity and can also test their goods in the most demanding situations. As a result, manufacturers are able to test their products' numerous characteristics under the most demanding circumstances. Humidity chambers are used to examine how different conditions affect things to determine how long they will last and when they will break down. Engineers can change their plans and choose stronger materials with the information they've collected.
Depending on the necessary information and the product type, testing can be carried out in a static or dynamic condition using various types of humidity chambers. To ascertain how a specimen will respond to increased moisture conditions over the course of weeks or months, humidity chambers are employed as extended testing chambers. The major elements of a humidity chamber are those that add heat and moisture. Several different techniques can be used to introduce spray or a bath of moisture into the chamber. The same idea holds for heat provided by coils or other heating components.
Most of the time, humidity chambers are created, built, and manufactured to meet the environment that the client demands. Despite the wide range of chamber types, the fundamental elements of heat and moisture are required to produce the required conditions. Temperature and humidity are the two variables that affect a product's stability, with humidity being second-most harmful. Manufacturers test the impact of humidity on their products because humidity variations affect expansion and contraction. Steam generators, atomizers, and water baths are the three fundamental techniques for producing artificial humidity.
An enclosure called an environmental chamber is used to test a product, component, part, or assembly under a range of situations. These extremely sophisticated tools may simulate the kinds of circumstances that a product might experience in use. The ones in the chamber are regulated by computer monitors that can quickly change the circumstances or slow them down to last for a long time.
The settings and specifications for testing are predetermined to provide the most accurate information about how a product performs in the conditions it would encounter during use. The testing settings are typically stricter than typical usage circumstances. Environmental chambers give producers useful information for refining their products and suggestions on modifying ones already on the market. These cutting-edge tools aid companies in creating longer-lasting, higher-quality products.
According to ICH Q1B FDA Photostability Testing of New Medication Substances and Products, pharmaceutical companies must test drug products for light sensitivity in photostability chambers. Photostability chambers come in two sizes: a small benchtop and a roomy upright type with even light, temperature, and humidity distribution.
The cool white and ultraviolet-A fluorescent lamps used in the photostability testing chambers have power levels that enable photostability tests to be completed in less than 100 hours. The best conditions for testing photostability are high quality, new product features, accurate sensors, and easy-to-use controls on a touchscreen.
Thermal Shock Test Chambers
The ability of many items to endure abrupt changes in temperature and environment is one of the main problems. An engineer has some idea of the kinds of conditions that the product is intended to withstand when they are creating it. Therefore, it is critical to understand the likely situations a product will face to understand what it can do.
Manufacturers perform thermal shock testing of proposed items to accomplish this goal and better understand them. This one is the harshest and most taxing of the numerous test types, The test involves exposing a specimen to various environmental changes quickly, followed by temperature variations of 30 °C or more per minute. Testing of this kind is intended for applications that will do heavy work.
Anechoic Stability Chambers
The term "anechoic" describes the absence of echoes. This kind of chamber is the size of a room and is coated with substances that can block electromagnetic and sound radiation. Anechoic chambers are made to muffle noises in the chamber vicinity and contain waves inside the chamber.
Sound is muffled to keep outside disturbances from influencing test results. Anechoic testing is done to find out how much noise a product makes. Automobiles, microwaves, buses, airplanes, and computers are some of the things that are evaluated.
To generate a low-pressure environment, air and other gasses are expelled from the enclosed space in a vacuum chamber. This testing is done to see how a technology or product works in a vacuum. Products in the aerospace and defense industries must undergo this testing.
Vacuum chamber sizes range from small enough to fit on a counter to large enough to fill an entire room. All instruments, gauges, and parts used on airplanes or spacecraft must be tested in a vacuum chamber.
Mechanical or electrodynamic shaking is used to conduct vibration testing, typically done in conjunction with climatic testing. Vertical, horizontal, or along three separate axes are all possible shaking directions. Vibration testing is typically incorporated into highly accelerated life tests (HALT) and highly accelerated stress screen (HASS) testing during the development of new products to ascertain the viability of a new product under the most demanding circumstances. In addition, vibration testing is frequently integrated with environmental tests to assess a product's resistance to typical operating conditions.
Salt Spray Chambers
A salt spray chamber creates an extremely corrosive atmosphere to investigate the effects of prolonged exposure to salt-soaked materials. The temperature in a salt spray chamber must be stable to maintain the salt spray concentration. The ideal operating temperature for salt spray chambers is 35 °C. Testing with salt spray is done to determine how well coatings and finishes are held up under corrosive circumstances.
Chapter 3: ICH Guidelines and Standard Features for Stability Chambers
ICH Guidelines for Stability Chambers
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use established the guidelines for stability testing, and regulatory agencies all over the world—including the Food & Drug Administration (FDA), the European Commission (EC), and Health Canada—follow them. The specifics for sufficient testing are laid forth in six ICH guidelines, Q1A through Q1F. According to these strict guidelines, the humidity in the stability chamber cannot vary by more than 5%, and temperature variations cannot exceed 2 or 3°C, depending on the circumstance. Because of this, stability chambers used for this kind of testing must have low temperature and humidity deviations recorded over a significant amount of testing time.
Additionally, the unit's temperature must be consistent. Traditional non-directed airflow systems for stability chambers use a fan mounted at the top of the apparatus to force air downward through wire shelves. This airflow will be obstructed when the shelves are full of samples, resulting in uneven temperatures throughout the chamber. This inconsistency could jeopardize the stability conditions and the stability testing process.
A positive pressure feed plenum is located on one side of the chamber, and a negative pressure return plenum is located on the other to create horizontal airflow directed across the surface of each shelf in stability chambers that use a horizontal laminar airflow system. By employing this technique, it is possible to maintain optimal temperature uniformity throughout the chamber and across all samples, even when the shelves are completely stocked. Furthermore, by maintaining temperature uniformity even when the shelves are full, horizontal laminar airflow systems also increase the stability chambers' capacity and enable testing of larger sample batches.
Standard Features for Stability Chambers
Stable-state testing is centered on temperature reliability that has been fine-tuned. Time is lost if one can't be certain that the humidity and temperature will remain constant throughout a test for shelf life or durability. Effective chambers should have open ceramic-core nichrome heaters in their heating systems to maintain temperature control at 0.5°C.
A temperature range of -20°C to 94°C (-4°F to 201°F) should be possible inside the chamber for testing purposes.
The acceptable humidity range should be 20% to 95% RH (relative humidity). Some chambers have optional features, like a high humidity sensor that increases the humidity range to 98% RH. In contrast, one can install a desiccant air dryer to assist the chamber in achieving humidity levels as low as 5% RH.
The cooling system is normally a mechanical, single-stage, self-contained, small refrigeration system in a stability chamber.
Remote monitoring is one of the test chambers' more inventive, recent improvements. When a product or DUT is undergoing stability testing, it must soak for several hours, which can take a while if someone is required to keep an eye on it. As an alternative, remote monitoring technology allows engineers to leave the testing facility while keeping tabs on the test results. Testing can be stopped if a mistake is found.
stainless steel and powder-coated mild steel or stainless steel on the inside and outside of a double-walled modular construction with 3" thick PUF insulation
inside a lockable gasketed full-length observation glass door
a positive sealing handle and hinges with a lock and key arrangement
heavy-duty door latches and hinges to maintain a tight seal
stainless steel racks and trays with a 65 mm port hole and rubber seal for sensors to be inserted for validation
interior lighting for the workspace
nichrome wire air heaters in a U form
humidity system with an arrangement for the water level in the reservoir tank and an evaporation tray
compressor with a modern by-pass system for continuous compressor operation
PLC-based control system with 7" color touchscreen HMI and CFC Free R 134 A/R 404 (Eco Friendly) refrigerant
When temperature overshoots and undershoots, a safety controller sensor will cut off the supply and sound an audible and visual alarm.
web-based internet surveillance
I.Q., OQ, P.Q., documents, operations, and maintenance manuals fully furnished
operates at 23 volts, one phase, 50 Hz
full alarm and safety system
compliance with 21 CFR Part 11 data management software that is window-based
standby humidification and refrigeration systems (except for 90 ltrs.)
Sensors, a printer interface, and a data storage facility are all included in the 4-point temperature and 4-point humidity scanner.
system of mobile alerts
security alarm system door access system
Chapter 4: Applications of, and Industries That Use, Stability Chambers
Applications of Stability Chambers
Stability chambers have many different uses. They are essential to the successful completion of a certain product's manufacture. Stability chambers are employed in pharmaceutical, food technology, biomedical storage, life science, and other industries for research and product development. A product prototype with a flaw is tested in a stability chamber before full-scale manufacturing. For example, humidity capsules regulate the humidity levels in a chamber. Before testing, these capsules are punctured and put in the chamber. The test compartment is then filled with the test material, and the chamber is sealed with a unique sensor cap. This cap communicates and gathers crucial information for studying the exam material. There are many sizes of chambers, and while some are simple, others can do many tasks. Therefore, any company considering purchasing a stability chamber should consider its requirements and the quantity of space the facility has to accommodate such machinery.
Temperature testing includes thermal shock testing. A product is exposed to different temperature gradients throughout its lifetime. In typical temperature testing, the product is exposed to one temperature for a protracted period. Thermal shock testing promptly and without hesitation transitions the product through various temperatures. The test's objectives are to look into potential expansion and contraction issues and pinpoint the product's failure point. Environmental testing of this kind is seen to be the most rigorous.
The second factor affecting how quickly products deteriorate is humidity—all types of moisture cause serious harm to materials, substances, and goods. Since humidity contains both moisture and temperature, this is especially true of humidity.
Determine the precise lifespan of a product with an accelerated aging test. The product is stressed in an accelerated aging test to simulate the aging process. Before environmental chambers were invented, a sample was used for extended periods to examine the aging process. Test chambers can expedite the procedure and provide information and predictions about the product's lifespan.
How a sample responds to high pressure and vacuum conditions is the goal of altitude testing. When doing an altitude test in a typical environmental chamber, temperatures can vary from -65° C to 150° C at elevations between -200 ft and over 100,000 ft. Equipment used in space missions or air transport undergoes altitude testing.
Another test used to assess how sunshine affects a product is UV weathering. Long-term solar radiation exposure can have various negative impacts, including the fading of garments, the weakening of polymers, and the cracking of cement. However, electromagnetic radiation, made up of UV waves and invisible and emitted by the sun, harms products.
Corrosion testing or salt spraying may be used to determine how corrosion will impact a product's performance. Samples are subjected to a highly concentrated saline environment for a predefined period during this test. Coatings, paints, and other materials that may be exposed to corrosive environments are among the products examined. When the timing of the application of the saline solution is rapidly advanced, salt spray testing can also be a part of the accelerated aging process.
Industries That Use Stability Chambers
Pharmaceutical Industry: The pharmaceutical sector is concerned with creating, investigating, and promoting medications that may benefit medical research. Since many people in various regions of the world will need these medications, guaranteeing proper drug production becomes a top issue. Individuals who take poorly made medicines may experience side effects and dangerous symptoms. Drug stability testing under various circumstances is therefore crucial. In this field, stability chambers are employed for this purpose. They support the testing of medications under various temperature, humidity, pH, radiation, and other conditions. They also determine how long a product will continue to function effectively. Stability chamber testing is also used to confirm the integrity of the product's packaging. The testing prevents a significant amount of time and loss by highlighting medication errors that could make them harmful in specific environmental situations. This testing also establishes a drug's expiration date. The shelf life of a drug is the length of time from the date of manufacturing that the medication will stay effective when stored under specific conditions. This number must be determined using stability chambers and displayed on the package for the consumer's knowledge. These chambers store medicine samples under both stable conditions and uniform temperatures, and those that are impossible to get naturally. To ensure accurate drug testing, the pharmaceutical business should take regular chamber maintenance and inspection seriously.
Electrical Industry: Determining the humid conditions that cause component failure is crucial in developing electrical components and full systems. The humidity ranges from 60% to 85% in the test conditions. The testing serves multiple purposes, including predicting how products will function in difficult operational circumstances and during storage and delivery. It is not necessary to check humidity at low temperatures while testing devices. Humidity affects a product's performance as soon as the temperature exceeds 50°C. In addition, humidity needs to be measured to prevent condensation on electronic devices.
Military: Products for the military must be tested in the wind, rain, dust, and extremely hot temperatures.
Stability chambers may simulate high moisture environments in a safe setting and offer valuable information on a weapon or component's resilience to adverse circumstances. The designations MIL-STD, MIL-SPEC, or MilSpecs are used to identify the military or defense standards used by the United States. Following these codes guarantees that military-related items adhere to the necessary standards for dependability, compatibility, and interoperability. The standards specify the ideal heat-to-moisture ratio for the intended use of a part, mechanism, or assembly in the condition of humidity. Depending on the environment that is defined, different testing circumstances apply. MIL-STD 810 G, which applies to materials deployed in warm or humid situations, is the specific standard governing humidity.
Battery Manufacturers: It is crucial to test a battery’s ability to withstand the elements to ensure they perform at a high level. The durability, susceptibility to corrosion, and overall performance of batteries are crucial aspects that must be considered. Batteries are quickly cycled through a variety of environmental conditions in stability chambers. Special fixtures in stability chambers for batteries enable testing more than 50 batteries in a single testing cycle. Researchers can compile a wide range of data on the many designs by testing various battery combinations in a single test cycle. Battery testing chambers require additional electrical wires to be connected to the batteries during testing, in contrast to other stability chambers. Shelves or unique fixtures are also provided to enable the testing of several batteries. A stability chamber must be checked for unique battery fixtures and wires to confirm that it can test batteries.
Plastics Industry: Plastics are susceptible to discoloration, surface crazing, chalking, and brittleness from moisture and humidity exposure. These elements must be tested since they may cause a plastic product to malfunction. The amount of damp heat cycles applied to plastic depends on the product's durability needs. For their plastic parts, automotive manufacturers have a set of norms and specifications. Stability chambers are designed to imitate those situations to study how the product's components behave under adverse circumstances. For automotive applications, the degree of testing depends on where the component is positioned in the car.
A climate chamber is an enclosed space that provides a controlled set of circumstances for testing the impact of various environmental and climatic conditions on industrial goods, commercial products, electronic devices, materials, and biological matter...
An environmental chamber is an enclosure used to test the effects of a variety of conditions on a product, component, part, or assembly. These highly technical pieces of equipment are capable of simulating the types of conditions a product may face while in use...
A humidity chamber is a mechanism that examines how products react when exposed to variations in humidity. This type of environmental testing is used by manufacturers to test the various parameters of their products in the harshest of conditions...
A temperature chamber is a controlled environment capable of producing conditions that a product will encounter during its use. These highly controlled technical tools are able to produce the types of hazards, uses, and atmospheres a product may endure...
A test chamber is a managed and controlled environment used to test the endurance, stability, and practicality of equipment, products, and chemicals. They are a controlled enclosure that mimics the effects of environmental conditions that a product may encounter during its usage...
Thermal Shock Chambers
Thermal shock chambers are climatic chambers for thermal shock testing that are utilized to put the material to serious shocks. This is accomplished through the repeated and sudden passage to low temperature areas from...
A vacuum chamber removes air and pressure from a confined enclosure to test the effects of a vacuum on parts, materials, components, and assemblies. It can also be used to test the performance of applications for manufacturing operations...
Types of Environmental Test Chambers
The purpose of an environmental testing chamber is to examine the effects of a variety of climactic, physical, and other unique conditions on a product. They are designed to create environments that a product may encounter during its use...
A cleanroom is a specially designed enclosed space where airborne particulates have been limited or removed by a highly sophisticated filtration system. They are used by industries that require a highly controlled and monitored environment for the production...
Cleanroom products are specially designed and engineered to prevent the contamination and pollution of highly sensitive cleanroom environments. For a cleanroom to receive its level of classification, it is required to be cleaned, constructed, and sanitized to meet a list of qualifying conditions and standards....
Modular Clean Rooms
A modular clean room is a prefabricated, controlled environment that is constructed to limit the presence of sub-micron particulates. These specially designed rooms are assembled using prefabricated panels inserted into a frame. They are purchased as a kit to be assembled or can be constructed by a technician...
A portable cleanroom is a compact system that requires little space, provides mobility, is cost effective, and offers exceptional clean and filtered airflow to create an uncontaminated and sanitized environment. They are a modular designed room where...
A softwall cleanroom is a confined controlled space with a metal frame, clear panel walls, an entrance, high efficiency particulate air (HEPA) filters, and exceptional lighting that is designed to provide a contaminant and particulate matter free workspace...
Types of Cleanrooms
A cleanroom is a specially designed and configured room that has been constructed to eliminate dust particulates and atmospheric contaminants. They are commonly used for scientific research, pharmaceutical production, and other industries that produce products that can be damaged by unsanitary or polluted conditions...