June 18th, 2009
The above statement is a great quote from Dick Winokur, Vice President, Clinical Investigational Products at Sanofi-Aventis. He said this at the 2009 Clinical Trial Supply West Coast Conference in San Francisco while leading a session titled “Implementing Technologies to Manage the Clinical Supply Chain”.
Cold chain management is not new. It has been around for quite some time. The tools however keep improving and what worked a few years ago, or even last year, may still be good but not necessarily optimal. As digital technology (hardware, software and data management) continues to infiltrate and dominate our business practices, there is a requirement to always look forward and try to see what is on the horizon.
Electronic data loggers help companies migrate from analog to digital cold chain management, and with these data loggers come choices for data management. Each solution has benefits and drawbacks as no one solution fits all requirements. The individual company needs to determine what will work best for them, certainly in the present and hopefully in the future. Of course, the future is not always that easy to predict.
Globally, regulatory agencies continue to increase their presence in an effort to look out for peoples well being. Whether that relates to efficacy or safety of vaccines and pharmaceuticals, or for food safety and HACCP compliance, these governing bodies set policy and procedure, not only for product handling, but also for record keeping. Whenever you implement or update your cold chain management solution, pay attention to where your industry is going and consider how you can most easily get there.
Posted in Cold Chain, General, Pharma, Traceability | No Comments »
May 14th, 2009
In recent weeks there has been increased interest in Cold Chain Management tools from our neighbors to the north. Canada is updating their Guide-0069: Guidelines for Temperature Control of Drug Products during Storage and Transportation.
Guide-0069 is a guidance document developed by Health Canada addressing temperature control of drug products during storage and transportation. The guideline, previously issued November 17, 2005, has been updated and is about to be released by Health Canada.
This revision includes temperature control requirements for products transported and stored at room/ambient temperatures. The previous version only addressed those products that are considered to be cold chain or high risk which are transported or stored either refrigerated or frozen. Including room/ambient temperature products in Guide-0069 is a precautionary step attributed to what is considered unpredictable environmental conditions. The guideline is intended not only for manufacturers, but for all persons and companies involved in the transportation and storage of drug products.
Other revisions in these guidelines relate to requirements for training records. Canada Health Inspectors will expect to see gradual implementation of the revised guideline and will continue to document deficiencies and quote regulations in Exit Notices.
It is impressive that Health Canada recognizes the need for monitoring all conditions as a way to ensure efficacy of drug products.Â
Posted in Cold Chain, Pharma | No Comments »
May 1st, 2009
Last week, I attended the United Fresh 2009 show. This was my first United Fresh event and I was very impressed, especially with the Produce Traceability Demo Center. This area inside the exhibition hall featured products related to the Produce Traceability Initiative (PTI), a co-sponsored initialtive from United Fresh Produce Association, PMA (Produce Marketing Association) and CPMA (Canadian Produce Marketing Association).
In recent months, there have been a few incidents of salmonella. With any outbreak, it becomes critical to remove all contaminated foods from the public as quickly as possible. The FDA is considering programs for better food safety, but more importantly, the produce industry is independently taking measures for quick identification and traceback of individual batches for both prepared and raw foods.
The Produce Traceability Demo Center featured various software products designed to record and report information related to produce production and distribution. There were also solutions designed for consumer traceback of product specific information and history. Data collection varied by product but could include all or some of the following parameters: soil treatment, planting, growing, harvesting, packing, storage, transport, product temperature history, and retail information.
Software products for traceability varied by vendor, some being full enterprise systems and others being more targeted at specific attributes. What was most impressive is the way the industry as a whole is coming together with a focus on not only food safety, but also food quality.
Tags: Food Safety, Produce traceability initiative, United Fresh 2009
Posted in Food Safety, General, Traceability | No Comments »
April 20th, 2009
Welcome to the DeltaTRAK blog.
Our newly redesigned website is up and running and we have added a blog to share information and news. We’ll bring you the latest product releases, links to relevant content and thoughts from industry events. Please check back regularly and feel free to leave feedback. If there is a topic you’d like to see addressed, let us know. Share your success or tell us how your DeltaTRAK products have helped your business. We look forward to your comments.
Are your trucks arriving half full or empty?
Temperature abuse during transport can be devastating to your products. Data loggers and strip chart recorders are great insurance for your payloads, but they can be used for other things too.
Temperature recording devices are a smart, compact, inexpensive investment to help protect your temperature sensitive commodities. Their primary duty is to prove or disprove temperature abuse during shipping and help the receiver make their accept/reject decisions. But these devices can also be used to temperature map your vehicles. They can expose hot spots or areas of poor circulation inside a temperature controlled vehicle. They can tell you if a truck is sitting open too long at a particular stop on the route. Once a problem is diagnosed, steps can be taken to make sure the entire truck is cooled and maintained at its optimum temperature for its contents. Strategically placing data loggers or strip chart recorders throughout a truck will help you gain control of your cold chain and make deliveries more efficient. Finding and correcting weaknesses in your cold chain can save you money and increase profits, something every business wants.
Use temperature monitoring devices and make sure your trucks arrive as full as when they left.
Posted in General | No Comments »
