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What a person wears while working tells you a lot about how dangerous their work is. In a laboratory people are typically covered from head to toe, and rarely do bare hands touch anything. It’s understandable when you consider that labs harbor a variety of highly toxic chemicals, volatile explosives and viruses that could start an epidemic.
The caliber of the staff is important at any laboratory but at all biomedical facilities security has to be a top priority. So much emphasis is put on laboratory safety that it’s easy to forget many biomedical samples are actually kept at biorepositories.
A secure biorepository is needed to store, process and deposit samples for later use. With so many delicate, yet potentially deadly materials under one roof, a biorepository has to take security and safety seriously, or we’re all at risk.
Meeting Regulatory Requirements
Regulatory requirements have been put in place to provide safety and security standards across all biorepositories. To date the FDA has created 30 guidances for Pharmaceutical Quality/Manufacturing Standards (CGMP). There is also a Code of Federal Regulations (CFR) that must be followed for recordkeeping, administrative practices, environmental protection and more.
Although these regulations have been created, some biorepositories are better at implementing and enforcing them than others. As the concern over terrorist activity and bio attacks increases, strict regulatory adherence becomes more critical.
Equipment That Protects Biomedical Samples
Biomedical sample storage requires specialized equipment that can control temperature and other environmental conditions. If the right equipment and strategies are not in place employees can become exposed to biomedical substances and/or the samples could be destroyed. Another key feature is equipment that properly secures the stored samples so that they can’t be easily accessed.
The sensitivity of the materials requires constant monitoring. Biorepository facilities must constantly monitor the temperature of storage containers. Regular maintenance is also needed to ensure that the equipment is calibrated and operating properly at all times. All of the monitoring should be recorded so that records can be reviewed in the event there is a change or equipment failure.
Back-up Storage and Power Supplies
Because the constant operation of specialized equipment is needed, all biorepositories should have back-up storage options available as well as a backup power supply to protect the samples. In the event of a power outage facilities have a limited amount of time to get the samples moved or the power restored. Biorepositories that have backups in place are able to react quickly so that no samples are compromised.
Stringent Inventory Control
A biorepository must carefully label, process and track samples so that there is never a question about where a sample is at any time. Secured biorepositories will have a 21 CFR, Part 11 compliant system in place for recording and tracking inventory. A strict inventory system will also thwart any attempts to steal or divert samples at all stages.
Biorepository employees must go through a rigorous vetting process and background check to ensure that they are qualified to handle biomedical samples. The more discerning the biorepository is the better. Secured biorepositories also use activity reports to track when an employee accesses an area and anytime they handle a sample. This creates a system of accountability and ensures that no samples are moved improperly.
Plans for Containing Contamination
A contamination is a worst-case scenario for a biorepository, but it is a possibility. Containing the contamination is critical for minimizing exposure that can compromise the safety of employees and the general public. All biorepositories should have systems in place for containing contamination within the facility, especially for biological agents within classified groups 2-4 that can transfer illnesses to humans.
Without biorepositories many life-changing experiments wouldn’t be possible. When the proper protocols are followed biorepositories are completely secure facilities that provide a vital service for research and science across many industries.