#Thermo King to launch pharmaceutical transport and storage solutions

View PharmaSolutions brochure

Thermo King announced the launch of its Cold Storage Solutions unit intended to meet the unique requirements of global pharmaceutical companies developing COVID-19 vaccines.

Those firms in final-stage clinical trials anticipate they will require strict temperature controls to safeguard their products, down to temperatures as low as minus 70 degrees Celsius. Thermo King’s solutions can enable these companies and their distributors to ensure the efficacy of their products through the entire cold chain, from air transport to marine, rail, trailer, last-mile delivery and at storage points along the way, according to the Swords, Ireland-based company.

“Considering the urgent, global need for a COVID-19 vaccine, the world can’t afford breaks in the cold chain,” Dave Regnery, president of parent company Trane Technologies, said in a release.

Besides launching Cold Storage Solutions, the company noted it has helped customers identify ways to maximize the range of dry ice, which often is used in vaccine transport and storage but has certain limitations. A container using dry ice to keep a product frozen may require re-icing if it sits for an extended length of time or is exposed to extreme ambient weather. — Transport Topics

FDA announces enforcement of produce safety

The “Produce Safety Rule” is part of the agency’s ongoing efforts to implement the FDA Food Safety Modernization Act. The first major compliance date for large farms, other than sprout operations, is set to begin on January 26, 2018. However, the FDA has announced that routine inspections associated with the Produce Safety rule will not begin until the spring of 2019 to allow time for more guidance, training, technical assistance, and planning.

Upcoming Compliance Dates:

For covered activities, other than those involving sprouts (which have additional requirements and earlier compliance dates):

  • January 26, 2018: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $500,000.
  • January 28, 2019: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $250,000 but not more than $500,000 (small businesses).
  • January 27, 2020: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $25,000 but no more than $250,000 (very small businesses).

content was taken from fda.gov follow URL to find more on key requirements, training or exemptions. 

 

 

R-452A is a next-generation, lower global warming potential (GWP) refrigerant.

R-452A units delivered by Thermo King units in North America.  4-month in-field tests in 6 year old existing units validates temperature control performance.

  • -15F to 65F set points
  • ranging from fresh, to frozen, to pharamceuticals,

USA: Transport refrigeration firm Thermo King has announced it is to offer trailers and trucks using lower GWP refrigerant R452A in North America.

The announcement, which is dependent upon the refrigerant’s approval by the US EPA under its SNAP programme, follows Thermo King’s adoption of the new refrigerant blend in Europe at the beginning of 2015.

Reference:

READ THE PRESS RELEASE

Thermo King to offer R452A in US

FSMA Update – FDA Launches New FSMA

In addition, FDA has also updated the Produce Safety Rule page with the most current information on the rule’s requirements, compliance dates, training, technical assistance, and other resources. Today marks the first major compliance date for large farms (other than sprout growers) under the Produce Safety Rule. However, in September 2017, FDA announced  that routine inspections under the rule would be postponed until Spring 2019 to allow time during this upcoming year for additional education, outreach, and training.

The Produce Safety Rule mandated by the FDA Food Safety Modernization Act (FSMA) establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption; marking a fundamental shift from reacting to food safety problems to preventing them before they occur.

These updates are part of FDA’s commitment to ensuring that farmers, and other food producers, have the information and resources they need to comply with the new FSMA standards. FDA will continue to make information available to help stakeholders comply with the various FSMA requirements. Those interested should subscribe to the CFSAN Constituent Update and Food Safety Modernization Act email lists for the most up-to-date information.

About 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.

FDA has finalized seven major rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food. The FSMA rules are designed to make clear specific actions that must be taken at each of these points to prevent contamination.

information on this post created to fda.gov

FSMA Regulation Update

The final rule’s compliance date is April 6, 2017 for large shippers and carriers while smaller operators have until 2018. Shippers, Carriers Race to Prepare for April Start of Federal Food Safety Modernization new Regulation, say’s a new article by American Trucking Associations Inc.

The FDA Food Safety Modernization Act (FSMA) establishes a framework that involves multiple layers of protection and recognizes the important role we all play in protecting consumers from unsafe food. At its core, however, FSMA makes it clear that the food industry has the primary responsibility for food safety. FDA’s role is to establish strong, risk-based food safety standards and to oversee industry to help ensure that it is meeting these standards. Independent of FDA’s oversight role, FSMA also puts an obligation on certain entities in the food industry to verify that their suppliers are meeting FDA food safety standards. The agency contemplates a role for reliable, third-party audits, whether they’re conducted by a government agency or a private concern.

See what’s new in 2017 with the FSMA at www.fda.gov

EPA Tier IV Final Emissions Regulations

On May 11, 2004, the Environmental Protection Agency (EPA) signed the final rule introducing Tier IV emission standards, which phased-in over the period of 2008-2015. The Tier IV standards requires that emissions of PM be reduced by approximately 90% and NOx by approximately 37%.

January 1, 2013 was the effective compliance date for the Tier IV Final emissions standard. To meet the new standard, transport refrigeration unit
(TRU) diesel engines required advanced emission-control technologies similar to those found on current truck and tractor engines.

EPA Regulations Chart

Food Safety Modernization Act

Best Practices for Transport Temperature Control

A full range of solutions for your business from the food safety experts. Thermo King is committed to helping you maintain the highest standards for food safety & quality.

As the leader in transport refrigeration, Thermo King is committed to delivering solutions that enable your business to maintain the highest food safety and quality standards. As you know, today there is an even greater focus on maintaining the safety and integrity of your food cargo.

You can trust the experts at Thermo King to help you develop a food safety plan that meets the needs of your particular business. Let us help you choose from a full range of food safety product and training options to tailor the right solution for you.

Food Safety Brochure
FSM