Understanding and overcoming the challenges faced by ultra-low and cryogenic storage environments
In today's stringent regulatory environment, having a robust sample inventory management system is critical for ensuring compliance, traceability and operational efficiency, especially in fields like biopharma, biotech, research and clinical labs. As regulations become more focused on data integrity, transparency, and the prevention of errors, the ability to track, trace, and audit samples is essential.
Below are some of the key challenges encountered within ultra-low and cryogenic storage environments, solutions, and how those solutions are beneficial:
Space Management:
- Challenge: Cryogenic storage spaces are often limited and costly to run, therefore requiring optimised use.
- Solution: Regular inventory organisation and storage management systems help maximise space while ensuring samples are easily accessible when needed.
Audit Controls:
- Challenge: Accurate record-keeping and tracking of samples are essential for regulatory compliance and maintaining the integrity of research or biopharmaceutical production.
- Solution: Digital inventory management systems can automate many of these processes, reducing human error.
Temperature Integrity:
- Challenge: Maintaining consistent cryogenic temperatures is critical to preserve sample viability. Each time the storage is accessed, there's a risk of temperature fluctuation that could affect sample integrity.
- Solution: Efficient, proactive management practices can minimise door openings and temperature disturbances.
Sample Tracking:
- Challenge: Keeping precise records of sample locations, conditions, and movements is fundamental.
- Solution: Again, this is where sample management systems and tools come into their own, by removing much of the manual record keeping that can cause issues.
Let’s look at each aspect to understand the benefits that come from implementing the solutions above.
Space Management Enables:
Complete Traceability of Ownership: Maintaining a detailed, up-to-date inventory with traceability features is essential. Using a centralised digital inventory management system that records the history of each sample, including the original owner, transfer details, and current custodian, helps ensure that every sample can be accounted for accurately, even when personnel changes occur. Such systems can provide audit trails that help in compliance and accountability.
- Regular Capacity Reports: Implementing automated reporting tools can provide real-time insights into storage capacity. Regular capacity assessments can help managers anticipate space shortages well in advance. Integrating capacity reporting with forecasting tools allows for proactive planning, enabling you to predict when additional storage vessels will be required.
- Planning for New Vessels:Given the lead times associated with purchasing large cryo vessels, planning is vital. Regularly reviewing inventory turnover, growth trends, and storage usage patterns can help you make informed decisions on when to order new vessels. Establishing relationships with vendors and having contingency plans for additional storage, can also mitigate risks associated with delayed deliveries.
Audit Controls for Periodic Inventory Management Reconciliation:
- Regular Audits: Conducting regular audits will verify that physical samples match digital records. This helps to quickly identify any discrepancies and correct them before they lead to larger issues.
- Automated Audit Tools: Use of automated tools that integrate with inventory management systems can streamline the auditing process and minimise manual checks, increasing reliability of data.
- Implementation of a Scheduled Cycle-count Approach: This is an audit where only a subset of the inventory is checked as part of a planned rotation of audits at any given time rather than performing full audits all at once. This method reduces the frequency of opening storage vessels and exposes only a small number of samples to ambient temperatures at a time, thereby protecting the rest of the inventory.
- Cold Work Environments: If manual audits or sample handling are necessary, conducting these activities in cold rooms or environments that are kept at low temperatures can help reduce the temperature shock to samples. Portable cryogenic containers or temporary storage with dry ice can also be used to maintain low temperatures while samples are temporarily out of the main storage vessels.
Maintain Critical Temperature Integrity Via Limited Access & Duration
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- Organised Storage Layout: Creating an organised storage layout minimises the time spent searching for samples. Grouping samples logically, such as by project, owner, or usage frequency, ensures they are easy to find and access. Additionally, planning access for retrievals and deposits in batches, reduces the frequency of opening storage vessels. If multiple samples are needed, accessing them all in a single session will minimise temperature fluctuations associated with repeated door openings.
- Use of Automation and Robotics: Automated robotic retrieval systems can significantly reduce the need for manual access, which in turn, minimises temperature disturbances. These systems are designed to retrieve samples quickly and efficiently, reducing exposure to warmer temperatures. When used in conjunction with remote inventory management software solutions, this allows you to leverage remote monitoring and sample tracking, reducing the need for physical access to confirm the inventory.
- Controlled Access Protocols & Measures: By controlling, or limiting access to storage units to authorised personnel only and implementing strict protocols for when and how samples can be accessed, this reduces the risk of unnecessary temperature disturbances caused by frequent or improper access. To achieve this staff training in the proper handling techniques to minimise exposure times is invaluable, as it will ensure that all personnel understand the importance of maintaining temperature integrity and follow established protocols when accessing samples.
Sample tracking
When it comes to sample tracking, regulatory bodies require complete traceability of biological samples, including who accessed them, when, and where they are stored. Having an effective tracking system in place creates a detailed audit trail that meets these requirements, ensuring compliance with regulations such as FDA and GxP standards.
In cryogenic preservation environments, real-time tracking of sample locations, movements, and temperature changes can be crucial for long-term storage, sample viability and auditing purposes. This ensures that every interaction with a sample is recorded for future reference and compliance audits.
Having a digital map or inventory layout of where each sample is stored within the cryogenic vessel eliminates the guesswork involved in retrieval. This not only saves time but also helps laboratory staff work more efficiently.
To discover more, get in touch with the team today
In our next article, we will look at a system that helps you implement the solutions above to address these commonly encountered challenges.