Diverse Stability Storage Conditions
Enhance the stability testing and stability storage of your drug product and ensure regulatory compliance with our support. Our team manages state-of-the-art laboratories equipped with fully secured stability storage chambers that are mapped and continuously monitored using a validated, continuous monitoring system. These facilities follow ICH guidelines to fulfill your requirements for stability storage and testing, whether they are compendial methods, your facility’s unique methods, or methods developed and validated by our own analysts.
We support studies for both short-term (accelerated) and long-term stability programs at all phases of drug development as well as photostability programs, reference standard programs, and retain storage programs for both research and development and commercial products.
Our chambers and monitoring system are supported by external back-up power generators in the event of power failure. Although our stability storage capabilities are geared toward providing pharmaceutical and biopharmaceutical stability storage, we also provide stability storage on medical devices and other types of products.
Supporting Various Circumstances
Our Services
- Marketed, Clinical Stability & Release Testing
- Protocol Drafting
- Storage and Distribution of Reference Standards
- Sample Retain Storage and Management
- Storage and Analysis of Controlled Substances
- Thermal Cycling Freeze/Thaw studies
- Photostability Studies (UV/VIS and temperature controlled)
- Storage Only
Stability Chambers and Set Points
- -20°C (+/- 5°C)
- -80°C (+/- 6°C)
- 5°C (+/- 3°C)
- 15°C/Ambient RH
- 25°C/40% RH (+/-2°C / +/-5% RH)
- 25°C/80% RH (+/-2°C / +/-5% RH)
- 30°C/35% RH (+/- 2°C / +/- 5% RH)
- 30°C/65%RH (+/- 2°C / +/- 5% RH)
- 30°C/75%RH (+/- 2°C / +/- 5% RH)
- 40°C (+/- 2C) NMT 25% RH
- 40°C/75% RH (+/- 2°C / +/- 5% RH)
- Light, Cycling, Custom Conditions
Secure Data Accessibility
Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort®. PacePort® is our secure client data access portal and web-based data delivery system where you have access to methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, instrument raw data, and additional information at any time, from any location.
The copies are offered in high-resolution and in color, giving your team easy and clear viewing for review. Scanned images are of sufficient quality that they are often used during quality and regulatory (US FDA) audits. The information available via PacePort® is thorough and complete, such that most, if not all, aspects of a data audit are available so your audit could be conducted remotely, guided by our Quality Assurance personnel.
Integrated Laboratory Services
Additional Resources
Diverse Stability Storage Conditions
Enhance the stability testing and stability storage of your drug product and ensure regulatory compliance with our support. Our team manages state-of-the-art laboratories equipped with fully secured stability storage chambers that are mapped and continuously monitored using a validated, continuous monitoring system. These facilities follow ICH guidelines to fulfill your requirements for stability storage and testing, whether they are compendial methods, your facility’s unique methods, or methods developed and validated by our own analysts.
We support studies for both short-term (accelerated) and long-term stability programs at all phases of drug development as well as photostability programs, reference standard programs, and retain storage programs for both research and development and commercial products.
Our chambers and monitoring system are supported by external back-up power generators in the event of power failure. Although our stability storage capabilities are geared toward providing pharmaceutical and biopharmaceutical stability storage, we also provide stability storage on medical devices and other types of products.
Supporting Various Circumstances
Our Services
- Marketed, Clinical Stability & Release Testing
- Protocol Drafting
- Storage and Distribution of Reference Standards
- Sample Retain Storage and Management
- Storage and Analysis of Controlled Substances
- Thermal Cycling Freeze/Thaw studies
- Photostability Studies (UV/VIS and temperature controlled)
- Storage Only
Stability Chambers and Set Points
- -20°C (+/- 5°C)
- -80°C (+/- 6°C)
- 5°C (+/- 3°C)
- 15°C/Ambient RH
- 25°C/40% RH (+/-2°C / +/-5% RH)
- 25°C/80% RH (+/-2°C / +/-5% RH)
- 30°C/35% RH (+/- 2°C / +/- 5% RH)
- 30°C/65%RH (+/- 2°C / +/- 5% RH)
- 30°C/75%RH (+/- 2°C / +/- 5% RH)
- 40°C (+/- 2C) NMT 25% RH
- 40°C/75% RH (+/- 2°C / +/- 5% RH)
- Light, Cycling, Custom Conditions
Secure Data Accessibility
Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort®. PacePort® is our secure client data access portal and web-based data delivery system where you have access to methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, instrument raw data, and additional information at any time, from any location.
The copies are offered in high-resolution and in color, giving your team easy and clear viewing for review. Scanned images are of sufficient quality that they are often used during quality and regulatory (US FDA) audits. The information available via PacePort® is thorough and complete, such that most, if not all, aspects of a data audit are available so your audit could be conducted remotely, guided by our Quality Assurance personnel.