What should you consider when choosing a walk-in stability test chamber?
This issue focuses on: What aspects need to be considered when choosing a walk-in stability test chamber?
Drug stability refers to its ability to maintain physical, chemical, biological and microbiological properties. Stability research is based on the systematic study and understanding of raw materials or preparations and their production processes. Through designed experiments, the quality characteristics of raw materials or preparations are obtained under the influence of various environmental factors (such as temperature, humidity, light exposure, etc.). The law of time change, and based on this, provide supporting information for the determination of drug prescription, process, packaging, storage conditions and validity period/retest period.
Stability studies begin at the early stages of drug development and continue throughout the entire process. Stability research is an important part of the quality control study of raw materials or preparations. It is designed to reveal the stability characteristics of raw materials and preparations by designing a series of experiments.
When conducting drug stability studies in China, the main regulations and guidelines followed are: Current Pharmacopoeia Technical Guidelines for Stability Research of Chemical Drugs (APIs and Preparations), ICH-Q1A Stability Testing of New APIs and Preparations, and Q1B New Photostability testing of raw materials and pharmaceutical preparations. Guidance on new dosage forms and biotechnology products/biological products are ICH Q1C and ICH Q5C, respectively. The regulations and guidelines for computerized system verification are mainly the US FDA 21 CFR part 11.
The purpose of the stability test is to provide information on how the quality of the API or preparation changes over time under the influence of various environmental factors such as temperature, humidity, light, etc., and to establish the retest period of the API or preparation/biological Product expiry date and recommended storage conditions. Stability test chamber (or constant temperature and humidity chamber) is such a device that provides various environmental conditions required for drug stability testing, such as temperature, humidity and light, and is indispensable in stability research. Class I equipment.
In foreign countries, stability test chambers have been developed and produced for decades. According to volume, they are generally divided into Reach-In and Walk-In stability test chambers. In China, according to volume, they are divided into stability test chambers/constant temperature and humidity chambers and walk-in (stability test chambers/constant temperature and humidity chambers/constant temperature and humidity rooms, etc.).
Under normal circumstances, for the quality control department of pharmaceutical companies, a certain number of stability test chambers can meet the testing requirements for drug stability. For example, for pharmaceutical products, they are used for long-term/intermediate/accelerated/illumination tests respectively. But when the sample batch is larger or there are many types, the walk-in stability test chamber has greater advantages and is a better solution in terms of sample capacity, space utilization, usage management, and price. plan.
As the scale of each pharmaceutical company expands and the types of samples increase, it will gradually be discovered that the previous stability test chamber is no longer sufficient. Even if a few more units are purchased, they can only meet the sample test requirements in a short period of time. Therefore, from a long-term perspective, more and more pharmaceutical companies prefer walk-in stability test chambers.
Many pharmaceutical companies have used stability test chambers to conduct tests before. They know little about walk-in stability test chambers and have never even seen a real one. So how to choose a walk-in stability test chamber and what needs to be considered. What about aspects?
We have contacted the quality control and management departments of many pharmaceutical companies. Their main needs for walk-in stability test chambers are generally the same, which are mainly reflected in the following aspects:
1. Good temperature and humidity performance
Basically all pharmaceutical companies choose walk-in stability test chambers to meet their primary purpose of long-term testing of raw materials or preparations (25℃±2℃/60%RH±5%RH), and then accelerated testing (40℃ ±2℃/75%RH±5%RH), and used for intermediate tests (30℃±2℃/65%RH±5%RH) or fourth climate zone conditions (30℃±2℃/75%RH± 5%RH) is less.
2. High utilization rate
The utilization rate mainly measures the internal space utilization rate of the walk-in stability test chamber and the external space utilization rate of the walk-in stability test chamber (laboratory space utilization rate).
In terms of external space utilization, it is an ideal design to install a walk-in stability test chamber with two or even three sides against the wall to make full use of the height space. Because some laboratories have limited space and want to maximize the internal effective volume of the walk-in stability test chamber so that more samples can be placed. In this case, the method of using a top fan and top return air is A better choice can achieve up to three walls, which reduces the space occupied by maintenance channels and makes the utilization of external space higher.
In terms of internal space utilization, the lofted channels and return air channels are spaces that must be reserved. In addition, more shelves and samples can be placed in the other spaces to achieve higher internal space utilization. These spaces where shelves and samples can be placed can be called the effective internal volume of the walk-in stability test chamber. Generally speaking, the internal space utilization rate should reach more than 50%.
The internal air circulation system of the walk-in stability test chamber uses a top-mounted fan. The design of air supply from two sides, especially four-side air supply and top return air, is also a better way to improve the utilization of internal space and make full use of the height direction. space, reducing the space occupied by the return air channel in the horizontal direction.
The walk-in stability test chamber is a user-customized equipment, and the required height can be customized according to the user's requirements. But the height direction is not higher, the better, because generally most of the people setting out in the laboratory are female employees, the shelf height is about 1.7m, and the internal effective height of the walk-in stability test chamber is 2m, so there is no need Ladders and other tools can complete the setting out work, reducing unnecessary risks.
3. The equipment is reliable and stable, with low failure rate
According to the current pharmacopoeia and ICH Q1A guidelines, stability tests under various conditions need to be carried out for half a year and one year, and there are different batches or different types of samples that need to be put in for testing, so the walk-in stability test chamber It needs to run continuously and continuously. The designed service life of the walk-in stability test chamber is about 15 years. How to ensure the reliability and stability of each component of the equipment and reduce the failure rate?
First of all, there is no doubt that ensuring the reliable and stable operation of the walk-in stability test chamber, as well as the low failure rate, is to use mature technology, as well as high-quality and high-quality components to manufacture the walk-in stability test chamber to high standards. .
Secondly, what needs to be considered is the insulation performance of the walk-in stability test chamber. Accurate data is mainly obtained through the power-off test during PQ verification.
Then, after-sales response speed, after-sales staffing and complete spare parts are also crucial.
4. Good safety
The safety of the walk-in stability test chamber is mainly reflected in the following three aspects:
1. Personnel safety: mainly includes internal safety door locks and anti-slip floors.
2. Data security: Data will not be lost if the power is off, controller password protection and software (FDA 21 CFR part 11) data integrity.
3. Equipment safety: high and low temperature independent thermostat controller, sound, light and remote alarm, automatic power off and fault diagnosis, etc.
5. Long service time and good after-sales service
As mentioned in the third item, the design service life of the walk-in stability test chamber is about 15 years, so mature technology, as well as high-quality and high-quality components are required to support and maintain the hardware life of the equipment.
In addition to the quality of the hardware itself, after-sales service has also become an important consideration for domestic companies when choosing products. Fast response speed, sufficient after-sales personnel, complete after-sales service system and spare parts warehouse, these are the main factors that need to be considered in the after-sales aspect when choosing a walk-in stability test chamber.
Like cars, walk-in stability test chambers also require maintenance and upkeep. These concepts were initially introduced to the country by European and American brands, and are increasingly accepted by many pharmaceutical companies. Therefore, annual inspection and maintenance of components such as humidifiers, compressors, pipes, and wiring are also necessary.
6. Has certain technological advancement and low power consumption
The technological advancement of the walk-in stability test chamber is mainly reflected in the internal air circulation system and the temperature and humidity PID control principle. As for the equipment itself, it is reflected in the aspects of heating/cooling and humidification/dehumidification. Advanced PID control can make the temperature and humidity reach the set temperature and humidity point faster, reduce overshoot and reduce power consumption.
When the temperature and humidity are stable and the equipment is running in balance, some walk-in stability test chambers can even achieve a consumption of no more than 1 kilowatt hour of electricity per hour and about 5L of water per day. The main reason is that they use advanced PID control principles. As well as EC variable frequency fans and variable frequency compressors.
7. High cost performance
This is an aspect that every business will be concerned about. Each company will decide to purchase a stability test chamber or a walk-in stability test chamber, a domestic brand or an imported brand, based on its own circumstances, such as product type, use and company benefits.
No matter what kind of equipment it is, the actual cost includes not only the equipment itself, but also maintenance, water and electricity consumption, and repair costs. If a piece of equipment uses average or inferior components, although the price is lower, the probability of problems and failures is higher, and the maintenance cost is also higher. Therefore, the chain reaction is: it is troublesome to use and affects the quality of the equipment. Use and increase labor costs, ultimately costing more than a piece of high-quality equipment.
Therefore, when many pharmaceutical companies now choose walk-in stability test chambers, they no longer use price as the main factor to measure. Instead, they use product performance, product quality, space utilization (design plan), after-sales service and maintenance costs. and other aspects should be considered comprehensively.
