Pharmaceutical Stability Testing Guidelines

2025-03-14

Introduction:
To ensure the quality of pharmaceutical products, stability testing must be conducted to estimate their shelf life and storage conditions. Stability testing primarily investigates the impact of environmental factors such as temperature, humidity, and light on the quality of pharmaceuticals over time. By studying the degradation curve of the product, the effective shelf life can be determined, ensuring the efficacy and safety of the drug during its use.

Pharmaceutical Stability Testing

Storage Conditions for Pharmaceuticals

General Storage Conditions

Test Type	Storage Conditions(Note 2)
Long-term Testing	25°C ± 2°C / 60% ± 5% RH or 30°C ± 2°C / 65% ± 5% RH
Accelerated Testing	40°C ± 2°C / 75% ± 5% RH
Intermediate Testing (Note 1)	30°C ± 2°C / 65% ± 5% RH

Note 1: If the long-term testing condition is already set at 30°C ± 2°C / 65% ± 5% RH, intermediate testing is not required. However, if the long-term condition is 25°C ± 2°C / 60% ± 5% RH and significant changes are observed during accelerated testing, intermediate testing should be added. The evaluation should be based on the criteria for "significant changes."

Note 2: For impermeable containers such as glass ampoules, humidity conditions may be exempt unless otherwise specified. However, all test items specified in the stability testing protocol must still be performed for intermediate testing. Accelerated testing data must cover at least six months, while intermediate and long-term stability testing must cover a minimum of twelve months.

Storage in Refrigerators

Test Type	Storage Conditions
Long-term Testing	5°C ± 3°C
Accelerated Testing	25°C ± 2°C / 60% ± 5% RH

Storage in Freezers

Test Type	Storage Conditions
Long-term Testing	-20°C ± 5°C
Accelerated Testing	5°C ± 3°C

Stability Testing for Formulations in Semi-Permeable Containers

For formulations containing water or solvents that may experience solvent loss, stability testing should be conducted under low relative humidity (RH) conditions when stored in semi-permeable containers. Long-term or intermediate testing should be performed for 12 months, and accelerated testing for 6 months, to demonstrate that the product can withstand low RH environments.

Test Type	Storage Conditions
Long-term Testing	25°C ± 2°C / 40% ± 5% RH or 30°C ± 2°C / 35% ± 5% RH
Accelerated Testing	40°C ± 2°C / ≤25% RH
Intermediate Testing (Note 1)	30°C ± 2°C / 35% ± 5% RH

Note 1: If the long-term testing condition is set at 30°C ± 2°C / 35% ± 5% RH, intermediate testing is not required.

Calculation of Water Loss Rate at 40°C

The following table provides the water loss rate ratio at 40°C under different relative humidity conditions:

Substitute RH (A)	Reference RH (R)	Water Loss Rate Ratio ([1-R]/[1-A])
60% RH	25% RH	1.9
60% RH	40% RH	1.5
65% RH	35% RH	1.9
75% RH	25% RH	3.0

Explanation: For aqueous pharmaceuticals stored in semi-permeable containers, the water loss rate at 25% RH is three times that at 75% RH.

This document provides a comprehensive framework for conducting stability testing under various storage conditions to ensure the quality, efficacy, and safety of pharmaceutical products throughout their shelf life.

These experiments can be achieved through our high and low temperature humid heat test chamber, more customized requirements please contact us.

#Pharmaceutical Stability Testing Chamber #medicine storage test chamber #Stability Evaluation Test Chamber #Pharmaceutical Quality Test Chamber #Drug Temperature Test Chamber

The Introduction of Walk-in Temperature Test Chamber

2025-03-14

Walk-in Temperature Test Chamber is a large laboratory that admit operator to walk in it, primarily used for environmental testing. It is commonly used for testing large parts, semi-finished products, and finished products to simulate real-world environmental temperatures, and is widely used in industries such as electrical engineering, electrical appliances, instruments, electronics, security, communication, sensors, automation, industrial control, precision machinery, etc. The Walk-in Temperature Test Chamber is equipped with a φ 50mm test hole with a plug on the side of the box. The plug material is low foaming silicone rubber, which can withstand high and low temperatures and has insulation effect. The heater adopts a porcelain frame nickel chromium wire electric heater, which has low thermal inertia and long service life. The instrument outputs a controllable pulse duty cycle PID signal, which is controlled by a solid-state relay to make the control smoother and more reliable.

Walk-in Temperature Test Chamber

Performance and characteristics of Walk-in Temperature Test Chamber:

1.It has an extremely wide temperature and humidity control range, which can meet various needs for users. By adopting a unique balanced temperature and humidity control method, a safe and precise temperature and humidity environment can be achieved. It has stable and balanced heating and humidification performance, can achieve high-precision temperature and humidity control.

2.Equipped with intelligent temperature regulators, temperature and humidity are displayed using LED digital display. The high and low temperature damp heat test chamber can be optionally equipped with a temperature and humidity recorder.

3. Automatic selection of refrigeration circuit, the automatic control device has the performance of automatically selecting and operating to the refrigeration circuit according to set value of temperature, realizing direct start of the refrigeration machine and direct cooling under high temperature conditions.

4. The inner door is equipped with a large observation window, which facilitates the observation of the test samples’ experimental status.

5. Equipped with advanced safety and protection devices - residual current circuit breaker, over temperature protector, phase loss protector, and water cut-off protector.

We can customer High and low temperature test chambers, low temperature test chambers, constant temperature and humidity test chambers, high and low temperature damp heat test chambers, high and low temperature alternating damp heat test chambers, salt spray corrosion test chambers. above test chambers can be customized according to your requirements.

Therefore, Walk-in Temperature Test Chamber is suitable for enterprises with high demand on environmental testing and operational space.

#Walk-in Temperature Test Chamber #Walk-in Environmental Chamber #Large experimental equipment

Ultraviolet Light Accelerated Aging Test chamber Humid Condensation Environment and Water Spray System

2025-03-14

In many outdoor environments, materials can be exposed to humidity for up to 12 hours a day. Research shows that the main factor causing this outdoor humidity is dew, rather than rainwater. The Accelerated Aging Test chamber simulates the outdoor humid erosion through its unique condensation function. During the condensation cycle of the test, the water in the reservoir at the bottom of the test chamber is heated to generate hot steam, which fills the entire test chamber. The hot steam maintains the relative humidity in the test chamber at 100% and keeps a relatively high temperature. The sample is fixed on the side wall of the test chamber, so that the test surface of the sample is exposed to the ambient air inside the test chamber. The outer side of the sample is exposed to the natural environment, which has a cooling effect, resulting in a temperature difference between the inner and outer surfaces of the sample. This temperature difference leads to the continuous generation of condensed liquid water on the test surface of the sample throughout the condensation cycle.

Since the exposure time to humidity during outdoor exposure can be as long as more than ten hours a day, a typical condensation cycle generally lasts for several hours. The Accelerated Aging Tester provides two methods for simulating humidity. The most widely used method is the condensation method, which is the best way to simulate outdoor humid erosion. All Accelerated Aging Tester models can run the condensation cycle. Because some application conditions also require the use of water spray to achieve the actual effect, some models can run both the condensation cycle and the water spray cycle.

For certain applications, water spray can better simulate the final usage environmental conditions. Water spray is very effective in simulating the thermal shock or mechanical erosion caused by sudden temperature changes and the scouring of rainwater. Under certain actual application conditions, for example, in the sunlight, when the accumulated heat dissipates rapidly due to a sudden shower, the temperature of the material will change sharply, resulting in thermal shock, which is a test for many materials. The water spray of the chamber can simulate thermal shock and/or stress corrosion. The spray system has 12 nozzles, with 6 nozzles on each side of the test chamber. The spray system can run for a few minutes and then be turned off. This short period of water spraying can quickly cool the sample, creating the conditions for thermal shock.

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Uneven Temperature Distribution in High and Low Temperature Humid Test Chambers

2025-03-14

The High and Low Temperature Humid Test Chambers is the main equipment in temperature and humidity environment testing, mainly used for evaluating the temperature and humidity tolerance of products, so as to ensure that our products can work and operate normally under any environmental conditions. However, if the temperature uniformity exceeds the allowable deviation range during environmental testing in the Chambers, the data obtained from the test is unreliable and cannot be used as the ultimate tolerance for high and low temperature testing of materials. So what are the reasons that can cause temperature uniformity to exceed the allowable deviation range?

1. The differences test objects in the High and Low Temperature Humid Test Chamber: If test samples that to a great extent affect the overall camber’s internal heat convection, it will inevitably affect the uniformity of internal sample’s temperature. For example, if LED lighting products are test, the products themselves emit light and heat, becoming a thermal load, which will has a significant impact on temperature uniformity.

2. The volume of the tested object: If the volume of the test object is too large, or the placing position in the chamber is inappropriate, it will obstruct the air convection inside and also cause significant temperature uniformity deviation. For Placing the test product next to the air duct seriously affects the circulation of air, and of course, the uniformity of temperature will be greatly affected.

3. The internal structure design of the chamber: This aspect is mainly reflected in sheet metal design and processing, such as the design of air ducts, the placement of heating pipes, and the size of fan power. All of these will affect the temperature uniformity inside the camber.

4. Design of the camber’s inner wall: Due to the different structures about the inner wall of the test chamber, the temperature of the inner wall will also be uneven, which will affect the heat convection inside the working chamber and cause deviation in the internal temperature uniformity.

the capacity test for high and low temperature humid test chamber

5. The six sides of the camber have uneven heat dissipation: Due to the different heat transfer coefficients on the front, back, left, right, top, and bottom surfaces of the camber’s wall, some sides have threading holes, others have testing holes, etc., which will cause local heat dissipation and transfer, resulting in uneven temperature distribution of the camber and uneven radiative convective heat transfer on the wall, final affecting temperature uniformity.

6. The leakproofness of camber’s door: The sealing of the camber and door is not strict, for example, the sealing strip is not customized and has seams between door and wall, the door will leaks the air, which is going to affects the temperature uniformity of the hole camber.

In summary, those may the culprit affected the temperature uniformity inside the test chamber, we suggest that you can investigate from these aspects one by one, which will surely solve your confusion and difficulties.

#Test Chamber #High and Low Temperature Humid Test Chambers #Uneven Temperature Distribution in Camber #safe of chamber

Use conditions of High and Low Temperature and Low Pressure Test Chamber

2025-03-14

Condition one: environmental condition　　

1. Temperature: 15 ℃~35 ℃;　　

2. Relative humidity: not exceeding 85%;　　

3. Atmospheric pressure: 80kPa~106kPa

4. There is no strong vibration or corrosive gas around;

5. No direct sunlight exposure or direct radiation from other cold or heat sources;

6. There is no strong airflow around, and when the surrounding air needs to be forced to flow, the airflow should not be directly blown onto the equipment.

7.No magnetic field surrounding of the test chamber that may interference control circuit.

8.There is no high concentration of dust and corrosive substances around.

Condition two: Power supply condition

1. AC Voltage: 220V ± 22V or 380V ± 38V;

2. Frequency: 50Hz ± 0.5Hz.

Part of the High and Low Temperature and Low Pressure Test Chamber

Usage Conditions three: Water Supply Conditions

It is recommended to use tap water or circulating water that meets the following conditions:

1.Water Temperature: Not exceeding 30℃;

2.Water Pressure: 0.1MPa to 0.3MPa;

3.Water Quality: Complies with industrial water standards.

Usage Conditions four: load for test chamber

The test chamber load must simultaneously meet the following conditions:

1. Total Mass of Load: The mass of the load per cubic meter of workspace volume should not exceed 80 kg;

2. Total Volume of Load: The total volume of the load should not exceed 1/5 of the workspace volume;

3. Load Placement: On any cross-section perpendicular to the main airflow direction, the total area of the load should not exceed 1/3 of the workspace cross-sectional area. The load must not obstruct airflow.

#High and Low Temperature Test Chamber #High and Low Temperature and Low Pressure Test Chamber #Environmental Test Equipment Chamber #Temperature Test Chamber #Low Pressure Test Chamber #Environmental Monitoring Equipment Chamber

Vacuum First, Then Heat Proper Drying Oven Operation

2025-03-14

Why Should You Evacuate Before Heating in a Vacuum Drying Oven？

1) Protect the Vacuum Pump：

If you heat the oven before evacuating, the heated air will be drawn out by the vacuum pump. This process transfers heat to the pump, potentially causing it to overheat. Overheating can reduce the efficiency of the vacuum pump and may even damage it.

2) Preventing Damage to the Vacuum Gauge:

If heating the oven first, heated air would directed toward the Vacuum Gauge and cause this instrument to overheat. If the temperature exceeds the gauge's operational limits, it may lead to inaccurate readings or permanent damage.

a vacuum drying oven

3)Avoiding Safety Hazards:

The tested material is placed in the vacuum chamber that can remove extracted gases from the material. If the tested material is heated first, the gas will expand when it encounters heat. Due to the excellent sealing of the vacuum chamber, the immense pressure generated by the expanding gas could cause the tempered glass of the observation window to shatter.

The correct procedure is to evacuate air first and then heat. If the vacuum level drops after reaching the desired temperature, you can briefly re-evacuate. This method helps extend the lifespan of the equipment.

Conclusion:

To ensure safety, maintain equipment efficiency, and prolong the lifespan of vacuum drying oven, always follow the correct procedure: evacuate air first, then heat. This simple step can prevent potential hazards and costly damages.

#Drying Oven #vacuum oven #safety for vacuum drying oven #high temperature shock

What is a Temperature Forcing System about Dragon

2025-03-14

We have cooperated with the German company - Froilabo and brought in the dragon because it can control the temperature like the dragon in the fantasy story. Dragon, A high-precision temperature forcing system that can rapidly heat and cool samples to determine their durability and resistance against precise thermal environments.

In this blog discover what a temperature forcing system is, and how our Dragon can help you by providing precise thermal testing for a wide variety of applications.

Key points:

A temperature forcing system is used to test a samples resilience and durability under different temperature conditions.
Thermal testing is crucial to ensure products are safe to use and meet required safety standards and regulations.
A temperature forcing system is suitable for a wide variety of applications, which includes heating electronic components, electronic characterization, and performing climatic simulations.
Dragon is the perfect solution for all your thermal testing needs, and features high performance and accuracy at all steps of analysis.

What is a temperature forcing system?

A temperature forcing system is used to evaluate a samples performance under different temperature conditions. By subjecting samples to rapid temperature changes, you can test them for their resilience and durability.

These systems are crucial for several reasons:

Improve safety: By subjecting devices to rapid temperature changes, you can ensure they meet your required safety standards and regulations.
Efficient product development: By testing different components early in the design and development phase, you can identify any potential issues early and rectify it quickly.
Assess reliability and performance: By testing your samples performance you can ensure your devices can withstand extreme temperatures.

How does a temperature forcing system work?

A temperature forcing system works by using a direct temperature-controlled stream of hot or cold air to provide a precise thermal environment for your samples. The Dragon provides a temperature range from -70oC to +250oC, to ensure sample function and viability at a wide range of temperatures.

Scientist using Dragon

Do I need a temperature forcing system?

Anyone who requires precise thermal testing would benefit from a temperature forcing system, and with Dragon it couldn’t be easier. All you have to do is create a method and Dragon does the rest.

In many industries, it’s essential to characterize and verify product performance when subjected to temperature variations. Dragon provides the perfect solution – our versatile and stable thermal unit is perfect for a wide range of applications.

Applications of the Dragon include:

Heating electronic components
Heating printed circuit boards
Performing climatic simulations
Electronic characterization
Temperature cycling and targeted freezing applications

Discover the Dragon, the one stop solution for all your thermal testing needs:

Excellent temperature stability: Delivering precision at every step of your testing, with a temperature range from -70oC to +250o
Rapid temperature changes: Our Dragon effortlessly shifts from -55oC to +125oC in a matter of seconds (something even the mystical dragon can’t yet achieve)
Digital connections: Connect your computer to your Dragon for simple method creation and run monitoring.
Easy manoeuvring: It can still move with ease using the guide handle and 4 wheels to easily transport to your desired location.
Adaptable to your needs: Our versatile product contains an adjustable airflow between 2.2 l/sec and 8.4 l/sec and three different working methods – manual, automatic and programmable.
Compliance at every step: Dragon has been tested in accordance to and complies with the European norm in force: EN60068-3-11.

Learn more about the dragon by visiting our dedicated Dragon product page.

#temperature test equipment-Dragon #products' temperature test-Dragon #temperature forcing system-Dragon #thermal testing-Dragon

What is Thermal Shock Test Chamber

2025-03-14

The Thermal Shock Test Chamber is a specialized experimental equipment used to test the performance of materials, electronic components, devices, and other products in extreme temperature conditions. It can simulate environmental changes from extreme cold to extreme heat, through rapid temperature transitions, observing and evaluating the stability and reliability of samples under such harsh conditions. This type of experiment is particularly in manufacturing industrial, electronic devices, and scientific research fields, as many products will facing drastic temperature changes in daily use.

It is extremely important to ensure the normal operation of electronic products in different environments during the designing and manufacturing, especially in the fields of aerospace, automotive electronics, communication equipment, etc. Products must be able to withstand various harsh weather and temperature changes. Through high and low temperature cyclic tests, engineers can reveal potential defects when using, also providing important references for subsequent product improvement and innovation.

The Thermal Shock Test Chamber consists of two main parts: the environmental control system of high and low temperatures. The temperature variation can generally be between -70 ℃ and 150 ℃ in the chamber, and the specific temperature range can be adjusted according to different needs. The experimental process will with multiple cycles, and each cycles contain rapid temperature changes that the sample to intense impacts between high and low temperatures. This type of testing can detect the physical properties of samples, including their tensile strength, elasticity, hardness, and even detect potential issues in thermal fatigue and material aging.

In addition, the design of this testing equipment is also very sophisticated, often equipped with advanced monitoring systems that can record temperature changes and sample reactions in testing process, making the evaluation work more accurate and efficient. With the development of technology, the technology of Thermal Shock Test Chamber is also constantly updated, which not only improves the accuracy and speed of testing, but also enhances the safety and reliability of use.

In summary, Thermal Shock Test Chamber is an indispensable tool in modern material and product research. It provides us with an effective means to ensure that products can always maintain superior performance and stable quality in changing environments. It is an important link in promoting technological progress and industrial development. Through such experiments process, we can gain a deeper understanding of the characteristics and behavior of materials, thereby promoting the birth of safer and more reliable products.

#Thermal Shock Test Chamber #Temperature Cycling Shock Test Chamber #Equipment environment test #Experimental Detection #Electronic Products environmental test

Six Major Framework Structures and Operational Principles of Constant Temperature and Humidity Test Chambers

2025-03-14

Refrigeration System

The refrigeration system is one of the critical components of a comprehensive test chamber. Generally, refrigeration methods include mechanical refrigeration and auxiliary liquid nitrogen refrigeration. Mechanical refrigeration employs a vapor compression cycle, primarily consisting of a compressor, condenser, throttle mechanism, and evaporator. If the required low temperature reaches -55°C, single-stage refrigeration is insufficient. Therefore, Labcompanion's constant temperature and humidity chambers typically use a cascade refrigeration system. The refrigeration system is divided into two parts: the high-temperature section and the low-temperature section, each of which is a relatively independent refrigeration system. In the high-temperature section, the refrigerant evaporates and absorbs heat from the low-temperature section's refrigerant, causing it to vaporize. In the low-temperature section, the refrigerant evaporates and absorbs heat from the air inside the chamber to achieve cooling. The high-temperature and low-temperature sections are connected by an evaporative condenser, which serves as the condenser for the high-temperature section and the evaporator for the low-temperature section.

Heating System

The heating system of the test chamber is relatively simple compared to the refrigeration system. It mainly consists of high-power resistance wires. Due to the high heating rate required by the test chamber, the heating system is designed with significant power, and heaters are also installed on the chamber's base plate.

Control System

The control system is the core of the comprehensive test chamber, determining critical indicators such as heating rate and precision. Most modern test chambers use PID controllers, while a few employ a combination of PID and fuzzy control. Since the control system is primarily based on software, it generally operates without issues during use.

control system for labcompanion's chamber

Humidity System

The humidity system is divided into two subsystems: humidification and dehumidification. Humidification is typically achieved through steam injection, where low-pressure steam is directly introduced into the test space. This method offers strong humidification capacity, rapid response, and precise control, especially during cooling processes where forced humidification is necessary.

Dehumidification can be achieved through two methods: mechanical refrigeration and desiccant dehumidification. Mechanical refrigeration dehumidification works by cooling the air below its dew point, causing excess moisture to condense and thus reducing humidity. Desiccant dehumidification involves pumping air out of the chamber, injecting dry air, and recycling the moist air through a desiccant for drying before reintroducing it into the chamber. Most comprehensive test chambers use the former method, while the latter is reserved for specialized applications requiring dew points below 0°C, albeit at a higher cost.

Sensors

Sensors primarily include temperature and humidity sensors. Platinum resistance thermometers and thermocouples are commonly used for temperature measurement. Humidity measurement methods include the dry-wet bulb thermometer and solid-state electronic sensors. Due to the lower accuracy of the dry-wet bulb method, solid-state sensors are increasingly replacing it in modern constant temperature and humidity chambers.

Air Circulation System

The air circulation system typically consists of a centrifugal fan and a motor that drives it. This system ensures the continuous circulation of air within the test chamber, maintaining uniform temperature and humidity distribution.

#Constant Temperature and Humidity Chamber #Test Chamber #High-Precision Chamber #Temperature Sensor #Major Structures for Chamber #Major Operation for Chamber

Things to be Mentioned in Angle Steel Telecom Tower Maintenance

2025-03-13

Maintaining an angle steel telecom tower is essential to ensure its structural integrity, operational efficiency, and longevity. Here are some key aspects to consider and mention in the maintenance of an angle steel telecom tower:

1. Visual Inspections: Regular visual inspections should be conducted to check for signs of damage, corrosion, rust, loose bolts, or any other structural issues that may compromise the tower's stability.
2. Structural Integrity: Ensure that the tower structure is sound and free from any deformities, cracks, or structural weaknesses that could affect its ability to support antennas and other equipment.
3. Guy Wires and Anchors: Inspect and maintain the guy wires and anchors that support the tower to ensure they are properly tensioned, anchored securely, and in good condition.
4. Antenna and Equipment Maintenance: Check the condition of antennas, coaxial cables, lightning arrestors, and other equipment mounted on the tower to ensure they are functioning properly and are free from damage.
5. Paint and Coating Inspection: Monitor the condition of the tower's paint or coating to prevent corrosion and rust. Touch up any areas where the paint has chipped or worn off to maintain the tower's protective layer.
6. Lighting System: Verify the functionality of the tower's lighting system, including aviation lights and obstruction lights, to ensure compliance with aviation safety regulations and visibility requirements.
7. Grounding System: Inspect the tower's grounding system to ensure it is properly installed and maintained, providing protection against lightning strikes and electrical surges.
8. Environmental Considerations: Consider environmental factors such as weather conditions, seismic activity, and local wildlife that may impact the tower's maintenance needs and longevity.
9. Documentation: Keep detailed records of maintenance activities, inspections, repairs, and any modifications made to the tower to track its maintenance history and compliance with regulatory requirements.
10. Safety Procedures: Prioritize safety during maintenance activities by following proper procedures, using appropriate personal protective equipment, and adhering to safety guidelines to prevent accidents and injuries.
11. Professional Inspection: Periodically engage qualified professionals to conduct thorough inspections, structural assessments, and maintenance tasks to ensure the tower's compliance with industry standards and regulations.

By addressing these key aspects in the maintenance of an angle steel telecom tower, you can help ensure its continued functionality, safety, and reliability for supporting communication equipment and services. Regular maintenance and proactive care are crucial for maximizing the lifespan and performance of the tower in the long run.

Learn more at www.alttower.com

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telecom tower supplier

#angle steel tower #4 leg angle steel tower #angle steel telecom tower