Protecting perishable property

A malfunction or loss of power to refrigerators, bioreactors or freezers can be devastating to Life Sciences organizations such as biotech firms. Drug discovery companies, as well as contract manufacturing or research organizations, are no less immune from spoilage risk. Incidents arising from a Change in Controlled Environment (CICE) can be very costly beyond just the monetary value. CICE losses can result in missed R&D project milestones or adverse customer relationships. A successful risk management program integrates a planned approach to minimize the impact of losing critical cell lines or other sensitive property.

The first step is to understand the significance of perishable property and the risks associated with the controlled environments. Values may range from a few hundred dollars to millions of dollars, often requiring months of replacement lead time. This can negatively impact revenue and relationships.

The initial risk assessment should include the following steps:

• Itemize the perishable property stored and/or work in process for each bioreactor and in each refrigeration, freezer or cryo storage unit.
• Identify critical temperature thresholds.
• Determine how long it will take the unit to reach the critical temperature or excursion in the event of power loss or other failure (refer to the manufacturer guidelines).
• Calculate property replacement cost, including time to recreate the material.
• Estimate the impact on operations, business relationships, contractual responsibilities, and ensuing revenue implications if the temperature range is not maintained.
• Evaluate current control methods, including maintenance programs.

There are a number of solutions available to manage CICE. Duplication and separation of critical sensitive materials and process equipment is a key to minimizing the impact of the loss of a bioreactor, refrigeration, freezer or cryo unit. The level of robustness in terms of needed countermeasures depends on the risk assessment outcome.

• Duplicate refrigerated contents in multiple refrigeration units.
• Ensure that additional freezers and coolers have sufficient capacity to store all of the contents of a failed unit.
• Place additional refrigeration units on separate circuit breakers.
• Depending on the critical nature of the material stored and the likelihood of a widespread power failure, consider the duplication of critical stock in a separate fire area, a separate building or at a separate distinct location.
• Backup processing equipment should be on separate circuit breakers.

Spoilage incidents can result from power supply issues or human error. Examples include contractors turning off the electrical power without realizing the consequences, personnel mistakenly leaving a freezer door open or individuals forgetting to plug a unit back in after relocation. Each of these actions can lead to the loss of controlled environmental conditions.

Consider the following best practices to avoid these common mistakes:

• Hardwire CICE storage and process units into the electrical system rather than using a plug and socket.
• Good contractor selection and close supervision is essential for any business, and critical considerations should be highlighted as part of the contractor orientation process.
• Use infrared thermography to scan for abnormal operating temperatures in electrical and mechanical systems.
• Where the preservation of sensitive stock is essential, employ reliable backup power supplies and refrigeration commensurate with the risk.
• Voltage surge protection should be considered for the building as a whole or for critical refrigeration units.
• While it may seem obvious, it is considered a best practice to label cold storage and bioreactor units.

In the event of a refrigeration, freezer or bioreactor unit failure, it is important that early detection of a temperature excursion is achieved so that corrective action can be taken.

Here are some important factors to consider:

• Bioreactors may have other critical operating parameters in addition to temperature that require monitoring: pH, Dissolved Oxygen Levels, Stirring/Agitation, Dissolved Solids, Cell Density, Pressure, etc.
• Automatic bioreactor equipment and monitor systems should be checked to ensure any critical spare parts such as a system control chip is kept on hand.
• Manual monitoring at scheduled times for cold storage is only as reliable as the individual taking the measurement, so an automatic alarm and monitoring system connected to a central monitoring station is generally more reliable for monitoring all types of temperature and other parameter excursions.
• If an automatic dialer type alarm system is used, it is imperative that the dialer does not stop calling the responder list until a person is reached.
• It is recommended that consideration be given to updating older automatic dialer type alarms with more modern technology, such as Cloud Based Monitoring Systems
• Determine who will respond to temperature excursion alarm signals, and the emergency response plan. Ensure that an engineering response coordinated with the CICE product owner and solution can be achieved within the critical hold time. 

Fire personnel are trained to shut down power on arrival at a site. Pre-planning with the fire department could avoid this. By letting them know there is temperature-sensitive property on site, responders can be trained to maintain electricity to critical areas, thus minimizing damage.

Liquid nitrogen dewars provide different exposures than refrigerators and freezers and require some different solutions. They are not always reliant on the electrical supply and are portable and flexible, which is why they often contain critical stocks and raw materials. However, the very low temperatures involved often give a false sense of security.

Liquid nitrogen level and dewar temperature should be monitored via alarms with remote notifications systems to alert personnel to potential temperature excursions.

The following resources are located on the Chubb Risk Consulting Library:

• Protecting Perishable Property
• Change in Controlled Environment Emergency Planning Worksheet
• Protecting Perishable Assets With Constant IoT Monitoring and Smart Alerts
• Chubb x Elemental Machines Webpage