Stability Chamber Services

 

Stability Storage Capacity Available.  Qualified, FDA Inspected, Emergency Power Back-up, Rees System® Continuous Monitoring

 

Stability

Micelle BioPharma, Inc. offers turnkey stability storage and shipping services. Micelle experts can assist with study design, stability protocol generation, matrix and bracketing strategies, stability set-up, stability pulls, shipping to anywhere in the world and complete GMP documentation and traceability. Your stability program will be administered by Quality Assurance to insure full cGMP compliance throughout the study duration.

Study Types

  • Stability storage areas fully configurable to any climate zone and continuously monitored by the Rees Monitoring System®. Redundant continuous temperature/humidity monitoring. All chambers are walk-in style insuring no study design is too big.
  • Pre-formulation stability
  • Registration stability
  • Commercial stability
  • Excipient compatibility studies
  • Shipping excursion studies
  • Long-term stability studies
  • Accelerated stability studies
  • Freeze-thaw cycling

Highlights of Stability Services

  • Stability protocol generation, inventory control, capacity control, and stability pulls and shipment
  • Continuous chamber monitoring by Rees Monitoring System®
  • Facility has limited and controlled access and dual level electronic security
  • Facility and stability storage area FDA inspected and approved

Standard Conditions

We offer the following facility control conditions:

Facility

15,000 sq ft gated facility.
Site Security alarm and camera protected.
Access control system.
Emergency power generator.

Stability Chambers

  • (2) Room Temperature condition for ICH zone II : 25 °C / 60% RH condition chambers.
  • (1) Intermediate condition for ICH zone II : 30 °C / 65% RH condition chamber.
  • (1) Accelerated condition for ICH zone II : 40 °C / 75% RH condition chamber.
    Temperature/humidity conditions configurable to other climate zones at client request.
  • 24 hr. chamber monitoring.

Stability Chambers

  • (2) Room Temperature condition for ICH zone II : 25 °C / 60% RH condition chambers.
  • (1) Intermediate condition for ICH zone II : 30 °C / 65% RH condition chamber.
  • (1) Accelerated condition for ICH zone II : 40 °C / 75% RH condition chamber.
    Temperature/humidity conditions configurable to other climate zones at client request.
  • 24 hr. chamber monitoring.