Pharmaceutical stability testing with controlled climatic conditions
For stability testing in the pharmaceutical industry, temperature, humidity and storage conditions must be reliably controlled. Hornik plans and implements climatic chambers, climate test chambers and large-volume climate rooms for pharmaceutical applications where stable conditions, safe monitoring and correct technical design are essential.
Our solutions are tailored to each project, product, test scenario, room, usable volume and required climatic conditions. This creates systems that reliably support pharmaceutical stability studies, storage processes and quality-relevant testing procedures.
Stability testing in the pharmaceutical industry
Stability tests show how pharmaceutical products, active ingredients or dosage forms behave over a defined period under specific environmental conditions. Controlled temperature and humidity conditions are central to this process.
The aim is to store products under reproducible conditions and assess changes in a traceable way. Such tests are an important part of pharmaceutical development, quality assurance and product evaluation.
Suitable climatic chambers or climate rooms are required for technical implementation. What matters is not only reaching a specific temperature or humidity level, but keeping these conditions stable, monitored and documentable across the entire usable area.
Typical conditions for stability testing
Depending on the product, market, test objective and regulatory environment, different temperature and humidity conditions may be required. Stability tests are often divided into long-term tests, intermediate tests and accelerated tests.
Typical conditions can include:
Long-term tests
Controlled storage over longer periods.
25 °C / 60 % RHIntermediate tests
Test conditions between long-term and stress scenarios.
30 °C / 65 % RHAccelerated tests
Higher stress for evaluating possible changes.
40 °C / 75 % RHThe specific design must always be checked on a project basis. In addition to the target values, permissible deviations, measuring points, loading, airflow, documentation, alarms and service requirements are also important.
Hornik supports the technical clarification and selection of a suitable solution for the intended stability conditions.
Which climatic chamber solution fits your stability testing?
There is no single standard solution for stability testing. The right system depends on how many samples or products need to be stored, how much usable volume is required and how the testing process is organized.
Walk-in climatic chambers for large sample volumes
Walk-in climatic chambers are suitable when larger usable areas, extensive sample volumes or walk-in climate rooms are required. They offer more storage space and can be planned for pharmaceutical stability testing with larger storage or test volumes.
View walk-in climatic chambersslide.in climatic chambers for high loading capacity on a compact footprint
slide.in climatic chambers can be useful when many samples need to be organized in a limited area. Thanks to pull-out drawers and resource-efficient use of space, they are especially suitable for laboratory environments with limited room.
View slide.in climatic chambersWhat matters technically in stability testing
In pharmaceutical stability testing, reliable compliance with defined conditions is the key requirement. Temperature and humidity must not only be reached, but kept stable and monitored. Especially with larger loads or longer test periods, uniform distribution in the usable space is important.
Important technical points include:
- stable temperature and humidity conditions
- uniform distribution throughout the entire usable space
- suitable airflow
- suitable shelving system
- sufficient usable area
- safe alarm notification if limit values are exceeded
- operation via a clear control panel
- event log and historical values
- data export for operation, service or documentation
- maintenance, calibration and support
Depending on the project, additional requirements such as qualifications, user training or special service intervals may be relevant.
Planning a stability chamber for pharma
Planning begins with clear technical requirements. The decisive factors are which products or samples are to be tested, which climatic conditions are required and how long the tests should run.
Later use also plays an important role. A system for a few samples in a laboratory is planned differently from a large-volume climate room with shelving systems and extensive loading. Location, installation route, power supply, maintenance access and operating concept are equally important.
The following information is helpful for an initial assessment:
- Which products or samples are to be tested or stored?
- Which temperature and humidity conditions are planned?
- Is it a long-term, intermediate or accelerated test?
- How large is the planned sample volume?
- Is a compact chamber or a walk-in climate room required?
- Which requirements apply to alarms and data export?
- Should qualification, calibration or validation be included?
- Are there spatial requirements or existing laboratory structures?
On this basis, it is possible to assess which solution makes technical sense.
Stability testing and documentation
In pharmaceutical applications, traceable monitoring of operating parameters is especially important. Temperature, humidity, alarms, events and historical values should be recorded in a way that keeps operation and service transparent.
Depending on the configuration, systems with graphical display, event log, user management, password protection and USB data export can be used. These functions support process reliability and make later evaluation of operation easier.
The specific documentation requirement depends on the project, product and legal framework. Hornik therefore coordinates the technical equipment individually with the customer.
Service, maintenance and support
A stability chamber must work reliably over the long term. That is why service, maintenance and technical support are important parts of the project.
Depending on the need, Hornik supports customers with installation, maintenance, calibration, qualification services, user training as well as warranty and post-warranty support. The aim is stable operation throughout the entire usage phase.
Especially in pharmaceutical stability testing, it is important to identify possible deviations early and maintain systems regularly. A reliable service concept helps keep testing processes predictable and safe.
Why Hornik for pharmaceutical stability testing?
Hornik combines experience in climatic chamber construction with practical project implementation for laboratory, pharmaceutical and industrial environments. Our solutions are not selected superficially, but tailored to the application, room, product, usable volume and required climatic conditions.
This means we look not only at the chamber itself, but also at loading, shelving systems, temperature and humidity distribution, operation, alarms, documentation and service.
The result is a solution that can be used reliably in everyday pharmaceutical work and supports the technical requirements of the project.
Project process
Request and initial clarification
You describe the product, application, planned stability conditions and desired usable volume.
Technical coordination
We clarify temperature, humidity, loading, airflow, shelving systems, documentation, alarms and spatial conditions.
Design and quotation
Based on the requirements, a project-specific solution for your stability testing is developed.
Delivery and installation
The system is delivered, brought into place, installed and prepared for operation.
Commissioning and support
After commissioning, we support you with service, maintenance, calibration, qualification and user training.
Frequently asked questions about pharmaceutical stability testing
A stability test examines how a pharmaceutical product or active ingredient behaves over time under specific environmental conditions. Temperature, humidity and storage duration are central to this process.
Common conditions are 25 °C / 60 % RH for long-term tests, 30 °C / 65 % RH for intermediate tests and 40 °C / 75 % RH for accelerated tests. The specific selection depends on the product and the test objective.
This depends on sample quantity, usable volume, temperature and humidity range as well as documentation requirements. Walk-in climatic chambers can be useful for larger sample volumes.
A walk-in climatic chamber makes sense when large sample volumes, plenty of storage space or a walk-in climate room are required.
Important information includes the product or sample, test conditions, desired usable volume, sample quantity, location, documentation, alarms and service requirements.
Yes. Depending on the project, Hornik supports service, maintenance, calibration, qualification services and user training.
Are you planning stability testing for pharmaceutical products?
Send us your requirements for the product, test conditions, sample quantity and usable volume. We will check which climatic chamber or climate room solution makes sense for your stability testing.