Defining Scientific Perishable Property: How to Evaluate and Protect it
Examples of Perishable Property
Life Science organizations often maintain or work with perishable property critical to the company’s ongoing operations. Perishable property refers to a business’s personal property that is susceptible to spoilage, rapid decay, or deterioration, often due to an unwanted change in environmental conditions. Examples of perishable property used by life science companies include:
- Biological property (cells, blood product, human/animal tissue samples, necropsy samples, microorganisms, etc.)
- Select drug products, including clinical samples
- Chemical libraries
- General work in progress/media/raw materials
- Scientific animals
Evaluating your Perishable Property
Perishable property often is stored in environmentally controlled spaces such as cryogenic vessels, freezers, refrigerators, incubators, or other temperature and humidity-controlled rooms or production equipment. Other perishable property may be stored at ambient temperature but is still susceptible to loss from rapid or extreme changes in temperature.
In assessing the risk of loss to perishable property, experienced risk managers ask the following:
- How perishable is the property? What on-site materials will degrade quickly due to a loss of environmental control?
- How critical are these materials to ongoing operations?
- What is the value of the material?
- What would be the operational impact if materials were lost?
- How easy is it to replace the material (for example, is the material standard reagent/material that can be ordered from vendors, or does it need to be recreated? Could supply chain issues, such as business interruption at suppliers, impact the ability to obtain additional materials)?
- Will replacements require revalidation, and how long will this take?
Common Causes of Spoilage: How to Protect Your Perishables
Perishable products commonly require very specific environments, such as a specified temperature or humidity, to remain stable; therefore, a change in such environments could negatively impact the product’s viability.
Listed below are generalized potential causes of spoilage and the suggested practices that can be implemented to protect your perishable property:
Temperature Monitoring, Alarms, and Response Protocols
Lack of emergency notifications or protocols and lack of employee response training can increase the risk of perishable property spoilage. Strongly consider:
- Implementing monitoring and alarms for equipment failure and loss of temperature control. Alarms should be both local and provide remote notification to appropriate staff of alarm conditions.
- Implementing written emergency response protocols for responding to alarms
- Training and emergency drills to test the efficacy of protocols.
- Maintaining redundant, vacant units for rapid re-location of materials when a piece of equipment fails.
Back-up Power or Generator
Electrical service interruptions due to power outages or natural disasters can increase the likelihood of property damage or spoilage. Strongly consider:
- Running an electrical load analysis of the equipment to determine the power consumption and load demands on a generator.
- Installing a permanent self-starting generator that will maintain power to a heating or air conditioning unit, thereby ensuring ambient room temperature during a power loss event.
Power surges can cause damage to electrical equipment. Strongly consider installing surge suppressors on the main electrical switchgear or on individual environmental control units.
Back-up Cryogenic Gas
For perishable properties stored in cryogenic gas, storage units should have backup cryogenic gas supplies with automatic switch over with low-level gas alarms.
Preventative and Maintenance Programs for Critical Equipment
Insufficient equipment maintenance can lead to equipment failure. Equipment that could impact perishable property includes but is not limited to, temperature-controlled units, emergency generators, and room HVAC (temperature control, humidification and/or air exchanges). Strongly consider:
- Implementing preventative routine maintenance programs/protocols for necessary equipment that will help avoid malfunction and failure.
- Keeping a substantial inventory of parts for critical equipment, such as supplies for HVAC ventilation and refrigeration systems, including fans, blowers, and motors.
- Having key vendor emergency service contracts set in practice before the product development stage. This should include vendors for equipment repairs and fuel for emergency generators.
Storing Highly Critical Materials
Storing all of your highly critical perishable property in one unit and/or location increases the risk of losing all the material if the equipment fails or if the facility is impacted by fire, natural disaster, or other property loss. Strongly consider:
- Storing duplicated copies of the material at secondary or tertiary locations and confirming that the alternative locations have similar controls for the protection of property.
Each company has its own individual circumstances, and protection practices should be tailored based on the critical nature of the property and how it is stored. Berkley Life Sciences Risk Management Resources is available to provide guidance as you develop your environmental control response procedures or additional information on best practices and controls to protect perishable property.
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This material is provided to you for general informational purposes only. Maintaining safe operations and a safe facility in accordance with all laws is your responsibility. We make no representation or warranty, express or implied, that our activities or advice will place you in compliance with the law; that your premises or operations are safe; or that the information provided is complete, free from errors or timely. We are not liable for any direct, indirect, special, incidental or consequential damages resulting from the use or misuse of this information. You are not entitled to rely upon this information or any loss control activities provided by us and you may not delegate any of your legal responsibilities to us. All loss control activities are conducted solely for the purpose of, and in accordance with, our underwriting activities.
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