Frequently Asked Questions
RFID is an acronym for Radio Frequency Identification which consists of a wireless system composed of tags and readers that rely on an internal power source and antenna.
Metals and liquid can interfere with the signal leaving unreliable results. While this isn’t as crucial with RFID inventory management, the outcome of an untracked temperature excursion would compromise a temperature-sensitive product leaving it unsafe for consumers. Varcode’s Smart Tag is an enhanced barcode label that provides real-time data down to the last mile that is easily integrated into current processes and extremely cost-effective.
We are currently working on a tag with the same functionality as our standard tags that will measure the time in which a product goes below a specific temperature. It is in the works and making great progress!
Time-temperature management is imperative in the cold chain. The FDA has established a “Danger Zone” in which a refrigerated food item’s temperature rises above 40°F for a specified period. A product’s journey encounters many stops along the way going between distribution centers before reaching its final destination. This is where temperature abuse most often occurs. Tracking the cumulative time that a product exceeds 40°F can be the difference between rejecting a product and deeming it acceptable for consumption. For example, during stops, a product may incur higher temperatures for a short period of time, 10 minutes here, 30 minutes there, which add up over time. If all those temperature fluctuations add up to over 4 hours cumulatively, the chances of bacteria growth significantly increase. With a color change indicator or data logger, it’s easy to take the temperature upon arrival and accept or reject the load based on those results. The cumulative time in which a temperature excursion occurs provides critical information about the quality and safety of the product.
While typical data loggers were a great addition to the cold chain when they first hit the market, they have not been able to keep up with the growing expectations of freshly delivered cold chain products. Some disadvantages of data loggers are as follows:
- Inability to track temperature from harvest to store – Data loggers only track segments of the journey usually from shipper to distribution center leaving gaps in the cold chain. Only tracking segments of the cold chain provides limited data and inaccurate results.
- Data is not in real time - When a data logger is tracking temperature for a pallet or entire truckload of product, a significant temperature excursion would cause the entire load to be rejected. Real time data would create the ability to take action during the product’s journey and drastically reduce food waste.
- Manually deciphering data leaves room for human error – Analyzing data can be a challenge when you must decipher so much code. Reading the data incorrectly could lead to increased product waste and loss of revenue.
- COST – Aside from the reactive approach of data loggers, they are expensive. The phrase “you get what you pay for” greatly applies here. A great commercial data logger can cost thousands of dollars per unit.
- Electronics – Data loggers require batteries which have requirements of their own to function properly and can easily malfunction.
Compliance with handling cold chain products = regulations that must be followed to ensure the safety and efficacy of the product.
The FDA’s Food Safety Modernization Act requires food processing and handling companies to create and implement a HACCP plan as a proactive approach to food safety. In order to comply, they must follow a strict set of guidelines in proper food handling, storage and transport of their cold chain products.
There are four key regulations that are directly related to cold chain requirements:
- 21 CFR 203.32 – Drug sample storage and handling requirements
- 21 CFR 203.36 – Fulfillment houses, shipping and mailing services, co-marketing agreements, and third-party record-keeping
- 21 CFR 211.150 – Distribution procedures
- Food Safety Modernization Act
Drug sample storage and handling requirements
This section highlights the need to handle and store drugs consistent with the manufacturer's instructions on the label required to keep the product in stable condition.
As stated on the Code of Federal Regulations website:
(a) Storage and handling conditions. Manufacturers, authorized distributors of record, and their representatives shall store and handle all drug samples under conditions that will maintain their stability, integrity, and effectiveness and ensure that the drug samples are free of contamination, deterioration, and adulteration.
(b) Compliance with compendial and labeling requirements. Manufacturers, authorized distributors of record, and their representatives can generally comply with this section by following the compendial and labeling requirements for storage and handling of a particular prescription drug in handling samples of that drug.
Fulfillment houses, shipping and mailing services, co-marketing agreements, and third-party record-keeping
This is clearly the documentation section and contains two parts. The first part lays out the responsibility of the manufacturer or third party to maintain the appropriate records as required under the Product Development & Management Association (PDMA) and the Parenteral Drug Association (PDA). The second part refers to the responsibility of the manufacturer or authorized distributor to produce any of the required records upon request within 2 business days.
As stated on the Code of Federal Regulations website:
“(a) Responsibility for creating and maintaining forms, reports, and records. Any manufacturer or authorized distributor of record that uses a fulfillment house, shipping or mailing service, or other third party, or engages in a comarketing agreement with another manufacturer or distributor to distribute drug samples or to meet any of the requirements of PDMA, PDA, or this part, remains responsible for creating and maintaining all requests, receipts, forms, reports, and records required under PDMA, PDA, and this part.
(b) Responsibility for producing requested forms, reports, or records. A manufacturer or authorized distributor of record that contracts with a third party to maintain some or all of its records shall produce requested forms, reports, records, or other required documents within 2 business days of a request by an authorized representative of FDA or another Federal, State, or local regulatory or law enforcement official.”
Distribution Procedures
Provides guidance on implementing written procedures that monitor expiration dates (supplying oldest first) and building an effective system in which drugs can be easily tracked in case of a recall.
As stated on the Federal Code of Regulations website:
“Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:
(a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.
(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.”
The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, to enhance the safety of our food throughout the supply chain. Stemming from the historical HACCP plan which required an implemented food safety plan for seafood, meat, poultry, and juice manufacturers and distributors, HARPC was created for all other food groups. Shifting focus from a reactive approach to a proactive approach, FSMA aims to protect public health by setting requirements to prevent foodborne illness outbreaks instead of responding to them after the fact.
FSMA is important to the cold chain because it enables the FDA to enforce control measures that will provide a safer food supply for consumers and decrease foodborne illness cases.
Cold chain monitoring is critical to identify any possible gaps in the cold chain that may affect the efficacy of the product. By using a temperature monitoring device such as an electronic data logger, color change indicator, temperature sensor, or Varcode’s Smart Tag™, a product’s temperature can be tracked throughout its journey to measure temperature excursions. To effectively monitor the temperature of a truck, pallet, box, or individual product, a device or label must be properly placed inside the designated container. This will allow the temperature to be tracked along the journey.
Temperature thresholds vary depending on the type of product.
For example, perishable food items must be kept below 40°F to avoid increasing the chance of bacterial growth. Typical refrigerated vaccinations must be stored between 36°F and 46°F and frozen vaccinations between -58°F and +5°F to maintain efficacy.
In a word – accessibility. No additional equipment or software is required to get started with the Varcode Smart Data Solution. Our easy-to-use, cost-effective tags allow for tracking of time over temperature on all product deliveries, not just a select few samples or a single temperature for a truckload. Secure a Varcode Smart Tag™ on each case or inside each consumer delivery. Use any smartphone or android scanner to scan the tags and have cold chain information delivered immediately.
Yes! Our tech team will work directly with your team for quick and easy integration of the Varcode app into your process.
Our system delivers exception-based alerts via email or text, reports, and analytics for information-based decisions on product safety and quality is delivered via our Smart Tag™ Management System and Dashboard. Or, download the data for impact into your business intelligence tool. Our easy-to-use web-based systems are password protected to secure your data.
You bet! Just call us at (312) 819-7003 and select 2 or click here to fill out a form .
