The world of pharmaceutical storage and transportation is extremely complex. Maintaining samples at the correct temperature is paramount to preserving their efficacy and integrity.
Cold storage container transportation is something that many labs rely on in the pharmaceutical industry. It is also an important consideration for companies operating under food and drug administration throughout the US.
Storing sterile pharmaceutical product vials at -80°C can extend their shelf life. This is especially relevant for temperature-sensitive treatments like cell and gene therapies and live viral vaccines. In the wake of the pandemic, this work has proved to be more important than ever before.
Whilst the shelf life can be extended, challenges such as closure integrity failures may still arise due to the extremely low temperatures that are needed throughout the supply chain.
That supply chain may feature air transportation, as well as shipping by boat and overland. This means that there are a range of challenges to consider when moving samples from point A to point B. Low temperatures are a requirement from start to finish for most of these samples and products.
At Aport, we are always keeping an eye on any developments across a wide range of industries which rely on temperature-controlled transportation and cold chain logistics.
A recent example that came to our attention involved a vaccine-focused biotechnology company.
The case study concerned highlighted the critical importance of temperature control in safeguarding pharmaceutical samples. Temperature control is a critical aspect of both storing and shipping pharmaceuticals.
This is something we’re well aware of at Aport. Our advice and services regularly address a range of challenges that our clients face.
The company concerned in this example observed an alarming overpressure phenomenon in liquid vaccine products stored at -80°C. Temperature and humidity play a significant role in determining pressure.
This prompted a comprehensive investigation in collaboration with LIGHTHOUSE. LIGHTHOUSE is a renowned expert in pharmaceutical quality control.
Quality control testing was conducted by LIGHTHOUSE with some interesting findings.
Glass vials of the liquid vaccine exhibited overpressure when thawed from a temperature range of -80°C to room temperature. The presence of overpressure posed a significant safety hazard to staff teams and logistics partners.
This was evidenced by the forceful ejection of vaccine product when the rubber stopper was pierced with a syringe needle.
This prompted LIGHTHOUSE to delve into the root cause of this issue. The hypothesis was a container closure problem during cold storage at -80°C. This was identified as the probable explanation for the observed overpressure in the vaccine vials.
LIGHTHOUSE carried out a meticulous investigation utilizing state-of-the-art headspace analysis systems to test this hypothesis.
These systems enabled the team to conduct rapid and non-destructive assessments of the headspace gas conditions within the sealed vials. This then shed new light on the underlying mechanisms which were driving the overpressure phenomenon.
LIGHTHOUSE carried out a series of in-depth studies to explore the intricacies of the container closure dynamics when under extreme cold storage conditions. This was done through close collaboration with the biotechnology company.
By leveraging cutting-edge technology and expertise, LIGHTHOUSE aimed to pinpoint the exact factors contributing to the overpressure issue in real-time. This enabled them to propose tailored solutions to mitigate the risk of similar occurrences in the future.
The insights from the headspace analysis studies provided vital data on the gas behaviour within the sealed vials during cold storage. This offered a comprehensive understanding of the container closure integrity challenges at ultra-low temperatures.
Armed with this knowledge, the collaborative efforts between LIGHTHOUSE and the biotechnology company moved the investigation forward.
This resulted in actionable recommendations to enhance the safety and reliability of pharmaceutical product storage and pharmaceutical transportation practices. These findings are significant for the wider industry, as well as other lab based industries which rely on cold chain logistics.
The landscape of pharmaceutical quality control is extremely complex. The delicate balance between cold storage requirements and container closure integrity is a critical focal point for ensuring the potency and safety of sensitive medical products and samples.
All parties need to consider body temperature and heat and whether prolonged exposure to the wrong temperature would compromise any samples. A constant and reliable power supply is also of paramount importance when transporting pharmaceutical products.
Meticulous investigations like this require the use of advanced analytical techniques. Experts like the teams at LIGHTHOUSE play a pivotal role in safeguarding the integrity of pharmaceutical samples, which advances the industry’s standards of quality control.
That’s what we do at Aport too.
We safeguard the integrity of our clients’ samples and help elevate the standards of logistics management for a wide range of lab-based companies and organizations across the pharmaceutical industry.
The collaboration between a wide range of companies is critical as the pharmaceutical landscape continues to evolve.
Pharmaceutical companies, quality control specialists like LIGHTHOUSE, and logistics experts like Aport must collaborate to prioritize temperature control and container integrity for the storage and transportation of critical pharmaceutical products and samples.
