Pharmaceutical Stability & Storage

Formal stability studies – including ongoing, long-term, accelerated, and intermediate – are carried out on primary and/or commitment batches according to an established stability protocol to establish or confirm the re-test period of an API or the shelf life of a finished product.

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Our Lab Dedicated to Pharmaceutical Stability & Storage

Climate Chambers

Our laboratory is equipped with advanced stability chambers designed to meet the rigorous requirements of pharmaceutical stability testing. Each chamber is carefully monitored and controlled to ensure precise environmental conditions.

Capabilities

ICH-compliant storage: Our stability chambers are fully compliant with ICH guidelines, providing reliable and accurate storage conditions for pharmaceutical products.
Key features include:
– 58 m³ walk-in rooms (2 units): spacious walk-in rooms that can accommodate large volumes of samples.
– 44 m³ walk-in rooms (2 units): includes one room specifically equipped for low humidity conditions.
– 22 m³ walk-in rooms (7 units): multiple rooms to handle diverse stability testing needs.
– 1.5 m³ cabinets (5 units) for customized conditions.
– Photostability chambers: compliant with ICH Q1B Option 1 and 2 to assess light exposure effects.
– Cabinets of various dimensions: customizable storage solutions to meet specific client requirements, covering the complete range of ICH climatic conditions.

The Team

Expertise in stability testing: Our team of scientists and technicians possesses extensive experience in pharmaceutical stability testing, ensuring that all tests are conducted accurately and efficiently.
Commitment to quality: We maintain the highest standards of quality control, adhering to regulatory guidelines and employing stringent testing protocols to guarantee reliable results.

Additional Features

Climate control: Each stability chamber is equipped with sophisticated climate control systems to maintain consistent temperature and humidity levels, ensuring the integrity of stored samples.
Monitoring and reporting: Real-time monitoring systems ensure any deviations from set conditions are promptly addressed. Comprehensive reporting is provided for complete transparency and traceability.

Our stability chambers are designed to support a wide range of pharmaceutical products, ensuring their safety and efficacy throughout their shelf life. Whether you require standard ICH conditions or customized storage solutions, our facilities are equipped to meet your needs.

Our Pharmaceutical Stability & Storage Services

The following storage conditions are available:

25°C ± 2°C / 60% RH ± 5% RH
30°C ± 2°C / 65% RH ± 5% RH
30°C ± 2°C / 75% RH ± 5% RH
40°C ± 2°C / 75% RH ± 5% RH
40°C ± 2°C / <25% RH
2 – 8°C
– 15°C (-20°C ± 5°C)
– 70°C (-75°C ± 10°C)
Photostability (according to ICH Q1B, options 1 and 2)
Transport Stability (freeze and thaw, cycle test)
In-Use Stability
Customer-specific conditions available

Freeze-thaw cycle assesses the stability and integrity of pharmaceuticals under varying thermal conditions. It helps ensure that the products maintain their effectiveness, safety, and quality even after exposure to adverse storage or transport conditions.

All conditions are continually monitored and recorded with back-up systems, ensuring a totally secure and controlled environment. Access, alarms, and changes are tracked via audit trail and electronic signature according to Annex 11 of EU GMP and Part 11 of 21 CFR.

Forced Degradation Studies

Forced degradation, also known as stress testing, plays a key role in the development of stability-indicating and analytical methods, establishing operating conditions and the design of formulations. Purposeful degradation can be a useful tool in predicting the stability of a medicinal substance or product with effects on purity, potency, and safety. The nature of the stress testing depends on the specific substance and product type involved (e.g., solid oral dosage forms, lyophilized powders, or liquid formulations).

Mérieux NutriSciences | Pharma & HealthCare performs these studies on finished products, active pharmaceutical ingredients (APIs), and placebos if needed, evaluating the following stress conditions, to detect potential degradation products and validate the stability-indicating properties of the analytical procedure: