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ICH stability chamber temperature mapping guidelines
Stability chambers are essential components within pharmaceutical development, manufacture and commercialisation. Such chambers offer an invaluable service in drug stability assessment, providing the precise testing environment needed to ensure a pharmaceutical's safety, efficacy and quality throughout their respective shelf life.
To achieve reliable stability results, pharmaceutical manufacturers must adhere to the precise parameter conditions outlined by the International Council for Harmonisation (ICH). This means that a regular maintenance schedule is necessary to verify chamber performance.
We detail everything you need to know about stability chamber temperature mapping, to ensure your stability assessment remains in line with ICH guidelines.
ICH guidelines for stability chambers
The International Council for Harmonisation (ICH) provides universally recognised quality testing guidelines to ensure the quality, safety, and efficacy of our pharmaceutical products.
Based on Good Manufacturing Practice (GMP), the guidelines detail the appropriate conduct of stability testing and storage to ensure a product's quality, safety and efficacy throughout its shelf life. These principles have been widely adopted and closely align with regulatory bodies such as the FDA and EMA.
Specifically documented in ICH Q1A (R2), precise temperature and humidity conditions must be defined and consistently maintained for accurate and reliable stability data.
ICH’s defined parameter guidelines are categorised into climatic zones, which ensure that all pharmaceuticals are tested under conditions that closely mimic their real-world market environments. This guarantees that each pharmaceutical product remains stable and effective within the relevant climatic conditions.
Depending on the climatic zone of the manufacturer's target market as well as the type of stability testing method used, temperature and humidity conditions within the stability chamber must remain within their predetermined parameters, with deviations no more or less than 2°C, or 5% RH.
For long-term ICH testing conditions, these are:
- Zone I & II: 25°C ± 2°C with 60% RH ± 5% RH
- Zone III: 30°C ± 2°C with 35% RH ± 5% RH
- Zone IVA: 30°C ± 2°C with 65% RH ± 5% RH
- Zone IVb: at 30°C ± 2°C with 75% RH ± 5% RH.
For intermediate testing:
- 30°C ± 2°C with 65% RH ± 5% RH
For accelerated testing:
- 40°C ± 2°C / 75% RH ± 5% RH
To maintain long-term product integrity post market release, compliance with these parameters is undeniably crucial. This need for strict parameter control not only highlights the importance of reliable, highly accurate stability chambers for your pharmaceuticals, but also emphasises the need for regular maintenance of your chamber.
This is where temperature mapping comes in.
Temperature mapping for stability chambers
Stability chamber temperature mapping involves the documentation and validation of the required stability conditions within the chamber. Essentially, this process qualifies whether your chamber parameters remain consistently in line with its precise environmental requirements.
The aim is to evaluate the chamber's uniformity, identifying and rectifying any temperature deviations that could potentially affect chamber performance. Validation assurance is then achieved through thorough documentation.
Temperature mapping will take place during the initial qualification stage, or a requalification after relocation or chamber modification.
Steps for effective stability chamber temperature mapping
As is an essential validation process, temperature mapping involves a structured and systematic approach, with several features accounted for. This includes:
Pre-mapping preparation:
Before any thermal validation process is conducted, a protocol development plan must be established. This will be tailored to your specific project and will include outlined objectives, methods, acceptance criteria, and pre-determined project goals.
This also involves the appropriate selection of equipment through either direct purchase or a rental service. Equipment will include data loggers and sensors, which must be expertly calibrated and validated before use.
Mapping execution:
A primary test may also well as a primary test to ensure equipment functionality. It’s also important to run the chamber on empty to establish baseline conditions.
Sensor locations will involve strategic placement for accurate temperature variation assessment, using an appropriate number of sensors to assess the entire space.
The data loggers should automatically record data at regular intervals. The duration of the mapping project will be pre-determined, depending on the length required to take. For a stability chamber, this usually takes anywhere between 24 hours to a few days.
Data collection, analysis and documentation:
Data collection and analysis can then assess the uniformity and stability of the temperature distribution.
Per ICH guidelines, thorough documentation throughout the temperature mapping process must be completed. Reporting is a regulatory requirement by governmental agencies so a lack of necessary details can be difficult to demonstrate compliance and traceability.
If the analysis of the results finds that parameters deviate from standard set points throughout the chamber, additional protocol must be conducted to ensure ICH compliance. This includes sensor recalibration, root cause analysis and re-mapping procedures. All of which must be reported.
Ongoing monitoring:
Periodic assessment of your stability chamber will ensure that set parameters remain in line with ICH guidelines. It is generally advised to conduct a new temperature mapping study following the below action:
- Chamber relocation
- Seasonal changes (e.g. every 6 months)
- Chamber replacement
How Withnell Sensors can support you:
The team at Withnell Sensors can help you deliver the operational, regulatory and quality control requirements you need for your stability chamber.
To help you achieve ICH expectations, we offer temperature and humidity data loggers of various specifications. The AiroSensor for example, offers a cloud-based, automated temperature monitoring solution for seamless data capture, available for rental or purchase.
Our team go beyond providing equipment. If you already hold the necessary equipment, we can offer an expert calibration service for precise calibration of your data loggers and sensors.
Alternatively, we can offer an end-to-end temperature and humidity mapping service, including the development of an approved test plan, and the mapping study as well as concise reporting for ultimate ICH compliance.
For a stability chamber to remain in line with ICH expectations, a regular temperature mapping schedule is imperative to ensure the quality and safety of pharmaceutical products.
Ensure that your stability chamber meets ICH guidelines with Withnell Sensors.
