Stability Studies at Espi Industries & Chemicals: Ensuring Reliability in Every Dose
Welcome to ESPI’s Stability Studies section, where we redefine reliability through comprehensive stability testing and storage services. Our commitment goes beyond routine testing; we are your partners in ensuring that every pharmaceutical product meets and exceeds stability expectations.
Complete Stability Testing Services:
Espi takes pride in offering complete stability testing services tailored to your product’s specific requirements. From generating stability protocols to compiling and evaluating data, we cover every aspect with precision. Our dedicated team ensures that the stability data we generate is not just compliant but exceeds the standards required for regulatory submissions.
Key Stability Studies:
1. New Drug (R&D) Stability: For products in the research and development phase, our stability studies provide crucial insights. We navigate the complexities of new drug stability, ensuring that the formulations stand the test of time and changing conditions.
2. Commercial Stability: Once a product hits the market, maintaining stability becomes paramount. Our commercial stability studies are designed to track and ensure the longevity of pharmaceutical products in real-world conditions.
3. Container and Closure Stability: The integrity of the container and closure is as critical as the formulation itself. Our specialized studies in container and closure stability guarantee that the entire packaging system contributes to the product’s stability.
State-of-the-Art Stability Storage:
Espi’s commitment to reliability is reflected in our stability storage facilities. The facility boasts of six stability chambers, including one walk-in chamber, each of which is connected to a double power backup to ensure uninterrupted operations even during power breakdowns. The chambers are linked to a central computer, meticulously recording all necessary data. Alarms are integrated into the systems, providing instant alerts in case of excursions beyond set limits.
Beyond Routine Testing:
Espi goes beyond routine stability testing. We undertake specialized stability testing for our principals, generating data for scenarios such as changes in vendors or alterations in packing components. This proactive approach ensures that our stability studies contribute not just to product compliance but also to strategic decision-making in the pharmaceutical supply chain.
Exceeding Expectations in Stability:
At Espi Industries & Chemicals, stability is not just a phase; it’s a commitment. Our stability studies go beyond industry standards, ensuring that every pharmaceutical product stands the test of time, environmental changes, and evolving regulatory landscapes. Partner with Espi for stability studies that redefine reliability in every dose.