How to Achieve Vivarium Compliance
Written by Moises Eilemberg
CEO of XiltriX North America
Companies are on the lookout for regulatory compliance standards when updating SOPs and other processes. We have provided some consultative information about facility regulations when it comes to vivarium monitoring compliance. Comprehensive environmental monitoring systems equip clients with the necessary tools to continuously monitor vivarium conditions during and between clinical trials, ensuring lab compliance standards. When clinical trials yield positive results, it is essential to demonstrate that animals were consistently housed in well-regulated environments throughout the entire process. This substantiates the outcomes and provides the essential data needed for quality control and compliance reporting.
To meet all regulatory compliance standards effectively, certain lab regulations need to be adopted in SOPs. Depending on the jurisdiction (whether the California Dept of Health or the USDA at the Federal level), different regulatory bodies have standards of care for laboratory animals, all of which contain provisions for the careful regulation and monitoring of environmental conditions.
We created these helpful guidelines with detailed information to help both new and experienced companies better understand the regulatory requirements of owning and operating a vivarium. Several include references from the AAALAC (the key national accreditation body promoting the responsible use of animals in science) in their accreditation requirements. Of course, to demonstrate compliance with any of these standards, any animal facility needs not only to adhere to the environmental requirements and ensure that appropriate personnel would know if there are environmental parameter excursions, but also be able to prove it in an inspection.
Also, GxP facilities must validate their environmental monitoring system, this means it is necessary to prove compliance by ensuring the data is accurate and can be carefully inspected. That's where continuous monitoring and measuring of environmental data comes in.
Vivarium Compliance Guides
Guide for the Care and Use of Laboratory Animals
- Institute for Laboratory Animal Research
- To prevent animal loss or physiological changes caused by system malfunction, it is advisable for personnel to use automated monitoring systems.
- These systems notify personnel of deviations in environmental conditions, such as temperature and photoperiod.
- It is important for personnel to verify the function and accuracy of these systems regularly.
Guide for the Care and Use of Agricultural Animals in Research and Teaching
- American Society of Animal Science
- The continuous functioning of the ventilation system in enclosed animal houses directly influences both the environmental temperature and air quality.
- It is advised to install an automatic warning system that alerts animal care and security personnel to ensure prompt awareness of power failures and out-of-tolerance environmental conditions.
- It is crucial to have an onsite generator readily accessible for emergencies.
Guidelines For Accommodation And Care Of Animals
-Appendix A of the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes (ETS No. 123)
- It is highly advised to implement appropriate protection measures in technologically dependent animal facilities to safeguard against hazards such as fires, unauthorized access, and equipment failures.
- These facilities heavily rely on electrical or mechanical equipment for environmental control and protection, thus necessitating the presence of standby systems to maintain essential services and emergency lighting.
- It is crucial to ensure the proper functioning of alarm systems and prevent any operational failures.
- Monitoring devices and alarms should be installed in heating and ventilation systems to promptly identify and address any faults.
USDA Animal Care "Blue Book"
- United States Department of Agriculture
- Indoor housing facilities must regulate ambient temperatures adequately through heating or cooling systems to ensure the animals are protected from temperature extremes, maintain their health, and prevent discomfort.
- The ambient temperature must remain within a range that is compatible with the well-being and comfort of the animals, without allowing it to drop below or rise above acceptable levels.
These guides are meant to provide a basic understanding of regulatory compliance standards as an organization adopts them in its SOPs. If your company is looking for a better way to monitor a vivarium while staying within the means of regulatory compliance like those described above, XiltriX offers a powerful vivarium monitoring solution. By taking a consultative approach and going beyond basic safeguards, XiltriX provides the software and hardware to measure data, enabling precise experiment replication and maintaining compliance throughout the entire process. With a commitment to continuous monitoring and measuring of environmental data, XiltriX empowers clients to substantiate outcomes, provide essential data for quality control, and comply with local and facility compliance regulations. By adopting these standards, validating the system's integrity, and adhering to accreditation requirements, XiltriX offers a trusted and FDA 21 CFR Part 11-compliant environmental monitoring system that keeps a pulse on your operations. Find out more: