Repository Services
The safety and integrity of our client’s materials is assured by maintaining controlled temperature conditions. We offer a wide range of storage conditions such as Controlled Room Temperature (20–25°C) and Humidity Stability Chambers (25°C/60%RH, 30°C/60%RH and 40°C/75%RH) as per ICH guidelines, Walk-in Refrigerator and standalone units (2–8°C), Walk-in Freezer and standalone units (<-20°C), Ultra low Freezer (both <-40°C and <-70°C) and Liquid Nitrogen Vapor Phase (<-150°C, LNVP).
At SBS:
- The repository which houses all the CTUs is climate controlled.
- CTUs are validated to meet the current Good Manufacturing Practices (cGMPs) requirements per FDA/ICH guidelines.
- The warehouse HVAC system and CTUs are redundantly and continuously monitored by systems capable of automated alerts.
- Back-up storage capability is available for each storage condition.
- Material movement is captured by a paper trail and a validated Clinical Trials Inventory System (CTIMS).
- Validated Shipping Containers (VSCs) are available to ensure temperature compliance during transit or transportation.
- IATA-certified and well-trained staff is available to handle dangerous goods.
- Export and import of materials follow domestic and international regulations.