Bristol-Myers Squibb



Background
Bristol-Myers Squibb (BMS) is a leading global biopharmaceutical company headquartered in New York City. It specializes in discovering, developing, and delivering innovative medicines for patients with serious diseases. These diseases include cancer, cardiovascular disease, hepatitis B and hepatitis C, HIV/AIDS, and rhematoid arthritis. BMS is committed to operate using high ethical standards, and it strives to be economically, socially, and environmentally sustainable.

To ensure the safe transport of BMS products used by millions of patients, qualifications of a variety of shipping containers were necessary. The shipping temperatures of the products ranged from refrigerated to deep frozen to cryogenic. BMS approached Modality Solutions to qualify these various shipping containers.

Objectives
The focus of our engagement was to:
  • Conduct a Proof of Concept (POC) study for a deep frozen shipping container
  • Qualify refrigerated, deep frozen, and cryogenic shipping containers
  • Conduct a characterization of dry ice sublimation rates study Value to Bristol-Myers Squibb
The management team identified the value of the project in the following areas:
  • Access to experience for designing and executing passive shipping container installation qualification (IQ)/operational qualification (OQ) test plans
  • Learning opportunity across BMS to better understand current best practices for cold chain

Methodology
The assistance provided to BMS consisted of the following:
  • Conducted a POC study for a deep frozen shipping container. To determine the suitability of the selected deep frozen shipping container for the shipment of frozen product, a POC study was designed and conducted. This study demonstrated how long the configuration could protect frozen product while exposed to a constant extreme elevated ambient temperature and was conducted in Modality Solutionsí Advantage Transport Simulation LaboratoryTM (TSL). The protocol and report was written by Modality Solutions and approved by BMS.
  • Qualified refrigerated, deep frozen, and cryogenic shipping containers. An OQ study was conducted for each shipping container being qualified. In the case of the cryogenic shipping container, a baseline IQ was conducted, followed by confirmatory qualifications for the remaining cyrogenic shipping containers. A handling and physical study was performed on the refrigerated and deep frozen shipping container systems, according to ISTA 3E procedures to ensure the capability of the shipping containers to protect desired refrigerated and frozen payloads, respectively, from transportation hazards. All protocols and reports were written by Modality Solutions and approved by BMS.
  • Conducted a characterization of dry ice sublimation rates study. To investigate unexpected temperature drops and shortened durations of internal temperatures seen in the field, a characterization of dry ice sumblimation rates study was conducted for a deep frozen shipping container. This study examined the effects of low pressure on dry ice sublimation rates. When the reduced levels of pressure did not appear to cause sublimation rates that explained field data, the scope of the characterization testing was expanded to include a study on the effects of orientation of the shipping container. It was determined that these changes in container orientation did affect dry ice sublimation rates. This study was conducted in Modality Solutionsí TSL, and the protocol and report was written by Modality Solutions and approved by BMS.

Results
All handling and physical studies completed for the refrigerated and deep frozen shipping containers met the acceptance criteria, verifying each containerís capability to safely protect product from transportation hazards. Through the characterization of dry ice sumblimation rates study, it was confirmed that orientation of the shipping container while in transit will affect internal temperature drops and internal temperature durations. The results from all OQ studies completed for the various shipping containers will support the preparation of Performance Qualification (PQ) activities completed by BMS.