ICH Stability Studies

Trusted Expertise, Continuous Monitoring, and Accurate Results

Microbac Laboratories supports The International Council for Harmonization Q1 guidelines for stability studies, offering comprehensive management from protocol writing to storage and testing of samples. Our storage chambers are monitored 24/7/365 for temperature and humidity, with alarms sent to dedicated teams and automatic backup power switchover, ensuring peace of mind for your stability study.

Why Choose Microbac for Stability Storage?

• ICH-Compliant Storage: All storage conditions align with ICH Q1 guidelines to support global regulatory requirements.

• Comprehensive Conditions:

  • 25°C/60%

  • 30°C/65%

  • 40°C/75% RH

  • 5°C

  • -20°C

  • -80°C

  • Ambient Storage 15°C - 30°C

  • Photostability

  • Custom Conditions

• Secure and Scalable Solutions: Our storage chambers are monitored 24/7/365 for temperature and humidity, with alarms sent to dedicated teams and automatic backup power switchover for continuous operation.

• Expert Support: With decades of experience, our team is ready to guide you through every phase of your stability study, offering protocol-driven studies and protocol writing services tailored to your needs.

• Expansive Capacity: From small-scale trials to large-scale studies, we have the space and infrastructure to meet your needs.

Our Services Include:

• Stability Program Management: Let our team handle the setup, monitoring, and reporting of your stability studies.

• Accelerated Aging Studies: Gain quick insights into product performance over time with customized accelerated testing.

• Custom Storage Solutions: Tailor conditions to match your product’s specific requirements.

• Sample Management and Testing: Seamlessly integrate with our analytical and microbiological testing services.

Industries We Serve

• Pharmaceuticals

• Biopharmaceuticals

• Medical Devices

• Consumer Health Products

• Cosmetics

Experience the Microbac Difference

Microbac Laboratories combines technical expertise with state-of-the-art facilities to deliver trusted stability storage solutions. Whether you’re conducting long-term studies or need quick-turnaround accelerated aging data, we’re here to help.

Certifications & Compliance

Microbac Laboratories is fully accredited, adhering to the latest FDA, EMA, and ICH standards.

Get Reliable Stability Storage

Take the next step in ensuring product stability with a trusted partner.