The FSMA Rule on Sanitary Transportation is one of seven foundational rules proposed by the FDA to create a risk-based framework for food safety. The overall objective of the rule is to prevent practices during transportation that create hazards, such as failure of refrigeration, inadequate cleaning of vehicles, and inappropriate packing materials. Ultimately, the rule was put in place to minimize the potential of a...
The CDC does not recommend the transport of vaccines - with good reason. However, there are ways to do it safely in an emergency situation.
Refrigerated and frozen vaccines must maintain their optimal temperature values to preserve their potency. Transporting them only multiplies the opportunities for temperature loss due to the potential of uninsulated packaging, warm storage spaces in transport vehicles, or...
When the Food Safety Modernization Act (FSMA) passed in 2011, it shifted U.S. food safety policy from a reactive afterthought to a proactive mission. That is, rather than responding to contamination after the fact, the law mandates preventing problems during manufacturing and transport before they occur. FSMA also provides the FDA with new enforcement authorities to achieve higher rates of compliance and tools to...
What is a temperature excursion? In the pharmaceutical industry, it refers to any temperature reading outside recommended ranges from the manufacturer’s package insert. Why is it important? Because out-of-range storage temperatures or inappropriate conditions for any vaccine can negatively impact the efficacy, and will require immediate action.
Over the last couple of years, restaurants have begun adopting wireless sensors and digital checklists to improve food safety. This has marked the beginning of the digital food safety era. However, organizations are still figuring out how digital systems impact their restaurants. What we have seen at TempAlert is that the impact of digital food safety goes far beyond food safety. Here is what we have observed from...
What is the vaccine cold chain? The short answer is: the maintenance of a temperature-controlled environment to ensure vaccines are transported and supplied in optimal condition. The cold chain begins with the refrigerated storage unit at the manufacturing plant, extends through delivery by distribution vehicles to the provider facility, to storage at the pharmacy or hospital, and ends with administration of the...
