What is temperature mapping & what will it accomplish?
The FDA, Health Canada and other regulators are increasingly putting the pressure on drug manufacturers to be in compliance with GMP requirements for controlled temperature storage. This pressure is compounded by the need to eliminate financial risk or loss in addressing related equipment failures within a storage or logistics operation. When consumer safety, product quality, and compliance are all at stake, companies are forced to balance the ROI of these elements with packaging, environmental monitoring programs, and staffing.
Inadequately controlled environments can lead to ineffective medicines, spoiled product, damaged materials and frequent critical equipment failures. This all ads up to wasted dollars. Fortunately the cost of monitoring large warehouses and transportation environments has dropped significantly over the years.
The purpose of temperature (or thermal) mapping is to ensure that all areas of the process equipment or storage area achieve the required temperature. The outcome of the temperature map is to understand the temperature distribution in a storage area, and to define hot or cold spots of the process equipment or storage area. This takes into account the temperature and density of humidity of warehouses for the storage of environmentally sensitive products.
How is temperature mapping performed?
Infitrak performs the following process for temperature mapping:
- Create a validation plan and protocol, with logical and scientific justifications for each
- Identify areas at risk and develop protocol information to determine where the sensors can be fixed to eliminate the risk of products being out-of-range
- Select the right technology for the right job
- Set up mapping equipment and conduct a tests in extreme conditions
- Develop a full report describing the test’s findings and summarize the action to take
What will a properly designed temperature mapping study tell you?* For warehouses, refrigeration equipment or any storage area, it can help to determine:
- Fluctuations in temperature: Frequent changes in temperature in one location can be caused by direct exposure to internal cooling systems or outside air sources:
- Doors that are habitually left open
- Open dock doors in transit area
- Hallways to non-conditioned locations
- Air vents from HVAC systems
- Hot and cold spots: Hot and cold spots are frequently caused by three different factors
- Inadequately sized fans that are unable to circulate air
- Air coming out of the HVAC system
- Walls or shelving that block airflow
- HVAC Efficiency: Inability to maintain target warehouse temperature. If the overall warehouse temperature can not be maintained, an expert evaluation of the HVAC system is in order.
Test before you invest
Before investing in new or larger fans, removing unnecessary walls, setting new policy, curtains, or purchasing upgraded HVAC equipment, a study can tell you if it is lower cost to simply rearrange shelves to promote airflow or updating procedures to ensure refrigeration equipment doors are kept closed. Keeping better control of your temperature distribution storage area also can have the affect of reducing your utility costs.
For an evaluation of your temperature controlled transport or storage area, please contact us.
*You should also note that in order to be fully compliant with regulations, refrigeration equipment should also be qualified in addition to mapping.
Ryan Sanders – Vice President of Sales
Ryan Sanders is the Vice President of Sales and a co-founder of Infitrak. With more than 12 years of experience in sales and marketing in the pharmaceutical, food and life science industries. Ryan’s activities are focused on developing new marketing strategies and initiatives to support direct and in-direct channel sales across all core verticals. Ryan’s portfolio also includes managing infitrak’s current channel partners and maintaining customer and reseller relationships. Ryan’s extensive background in the supply chain and technology sectors allows him to provide our customers with comprehensive solutions that are tailored to their unique requirements.
Karl Giamov – Vice President, Technology
Karl Giamov is the Vice President of Technology and a co-founder of Infitrak. As the head of the technology department, Karl is responsible for the design and development of Infitrak software products and the integration of all hardware components into the Infitrak platform. With more than 12 years experience in the design and development of web-enabled systems and the integration of state-of-the-art hardware, including RFID devices, IR tracking systems, WiFi, Bluetooth and other transmission frequencies, Karl has been instrumental in delivering reliable, cutting edge solutions to our customers.
Jean Bédard – President and Chief Executive Officer
Jean Bédard, MBA, is the President and Chief Executive Officer for Infitrak Inc. Mr. Bédard has more than 16 years of experience in developing and managing companies in the highly-regulated pharmaceutical, life science and food sectors. He has acted as the Vice-President, Business Development for a world class company specializing in regulatory compliance, validation and process engineering for the Pharmaceutical and Biotechnological sectors. Mr. Bédard has also acted as the CEO of a large Cold Chain company, responsible for managing over 1,000 individual projects. In addition to Mr. Bédard’s extensive work experience, he also holds an MBA in Bio-industries Management from the UQAM in Canada, and has had extensive training in management, regulatory compliance, validation and regulatory engineering.
Protecting Ambient Products at a Reasonable Price
An introduction to ambient products
Ambient, or in some cases called ‘room temperature’, is a term used within the pharmaceutical, food and drink manufacturing industry related to either product types or storage. Unlike chilled products that require a chilled environment, or like frozen foods that require a frozen environment, ambient products require the surrounding environment to be at “room temperature”.
Ambient products are what form a good portion of a drug store or supermarket and can include (but are not limited to) soft drinks, aspirin, cold remedies, tea and coffee, cereals, canned meat, rice, and pasta. They will often have a very long shelf life and are at low risk or a low purchase price for the consumer.
Because the end-product is typically lower in cost, protecting these products requires a cost effective means to protect them from temperature excursions that may spoil them or shorten their shelf life. This requires a balance of packaging cost and product protection.
What influences ambient temperatures?
Ambient temperature is determined by a number of factors, including:
the weather outside
the quality of insulation in the room or transport vehicle
what or who is inside the room
the use of heating and cooling systems
For example, a data center with a lot of servers will be warm due to the heat generated by the computer systems. Body heat caused by people or even animals will also have an ffect. Ambient temperatures can also be affected by humidity.
Protecting products that are affected by ambient temperatures
Similar to frozen or refrigerated products, when qualifying your protective packaging, you need to first identify and document the requirements, including identifying product stability data, mode of transportation, and temperature sensitivity.
After you have your requirements, package design and testing can begin. Start with an understanding your product’s ambient temperature profile as defined by PDA Technical Report 39. What are the acceptable environmental conditions the product itself can be exposed to and how does it affect the products efficacy.
Three methods for creating an ambient temperature profile (and how to save money doing it)
There are three methods for creating a ambient temperature profile that can be used to design thermal packaging:
The first is for you to provide it (it may be a company standard or you can use data from a data logger).
The second is by using predetermined profile developed by a trusted 3rd party, who has mapped out 24, 48, and 72 hour profiles based on ISTA standards and tested them for the critical variables.
The third method, and likely the most effective, is to get the profiles from a company, like Infitrak, who has been performing studies long enough to have temperature profiles already available. This may include:
- Air pressure cycles and their effect on containers and venting,
- Compromised packaging due to security inspections, tampering, or radiation exposure
- Duration length and variability of shipment or storage time,
- Origins and destinations per geographical regions
- Physical stresses, like vibration effects on material being shipped, crushing / handling / dropping, leakage from/onto packages, package orientation, package placement,
- Seasonal differences in temperature and humidity (Summer, Spring/Fall and Winter),
- Transportation modes
This last method, getting the profiles from a 3rd party, is the most cost-effective when you either want to confirm your existing profiles or when you need to move quickly.
Once you determine and test the possible scenarios, you can integrate a means of protecting the products.
Cost effective options for protecting cold chain products during transportation
There are multiple directions to take in building a complete packaging system for ambient products. With the data you have collected during the profiling process you can now balance the amount of insulation, number and type of gel-packs, the size of payload box needed and develop an SOP on how to pack it.
You may also want to consider adding temperature indicators and data loggers to not only confirm your packaging is effective, but also to provide a bit of accountability. Knowing when or where an indicator activated or an excursion occurs allows you to assign accountability to the carrier, a location or an individual. Spending a couple dollars on each box to place an indicator and a bit more for a data logger on each shipment can provide evidence of temperature compliance. The number and cost of these measurement tools can be based on either the cost of the product, or the likelihood of exposure (crossing climate zones, length of transport, or breaking down shipments).
The lowest cost temperature indicator, a ShockWatch Temperature Indicator for example, may be as low as $1 and will take a snapshot of a temperature excursion and show the length of that exposure. Passive temperature data loggers, like the Logtag TREXI8 Temperature Data Logger can cost as little as $50 and store up to 8,000 readings.
In developing a cost effective solution it is important to note that it is not just the cost of the insulating, temperature control and monitoring solutions themselves, but also the efficiency of your pack-out. For example, you may be able to optimize your pack-out for ambient systems by conditioning the gel packs differently or changing out your PCMs altogether in Winter versus Summer.
If all this is overwhelming or requires expertise beyond your in-house team, feel free to contact us for a no-obligation consultation.
Halloween, Vampires and Blood Safety
When you think about Halloween, you might think about candy, and kids dressing up, but have you also given some thought about your blood supply? Vampires do. Well, it seemed like a great opportunity to cater to our vampire clients and talk about blood safety and compliance in the blood supply chain.The ’30-minute rule’ typically mandated by regulatory agencies requires discarding red blood cells (RBCs) exposed to uncontrolled temperatures for more than 30 minutes to ensure safe RBC transfusion.
Why? What happens to red blood cells without proper temperature controls? To begin with, bacterial contamination is caused by increases in the metabolic processes that can cause damage to RBCs by preventing the release of cytokines and chemokines that may cause immunomodulation, a modification of the immune response or the functioning of the immune system. Exposed also shorten their shelf life and also decreases the oxygen carrying capacity of RBCs. Even five 30-min temperature exposures can induce significant bacterial growth by a psychrophilic strain.
Financial Costs of Blood Contamination
Failure to undertake blood bank temperature monitoring could not only cause serious health risks but also significant costs to your company. Data from a 2009 survey of Ontario and Quebec blood banks by the Canadian Blood Service found that of the 240 hospitals surveyed, 842 discarded units of blood cost the hospitals $294,000.
So what you do to help reduce financial loss and increase safety?
Start be assuring that good manufacturing practices for blood and blood components are observed. This includes adequate record keeping, a documented Standard Operating Procedures (SOPs), calibrated temperature regulating and monitoring equipment, and periodic audits of your blood distribution process. If you need support with any of these elements, consult with an Infitrak representative.
Infitrak Prequalifies Engel DeepBlue Temperature Controlled Coolers for Biologics
No other cooler on the market has a better reputation for durability and leak-proof protection than the Engel name. That’s why Infitrak chose Engel as the cooler-of-choice for same day delivery of blood, pharmaceuticals, tissue samples, and other biologics.
Designed from the ground up to re-define what a storage container could be, independent test results as well as validated testing from the Infitrak labs reveal how the DeepBlue cooler beats the competition in every way.
The Infitrak labs have qualified the Engel 13 quart cooler to maintain a consistent temperature at three different crucial temperature ranges: -20 to -10 C, 2 to 8 C, & 15 to 25C for up to 24 hours. This makes it ideal for blood banks, infusion clinics, labs and hospitals that require temperature consistency of their biologics, regardless of the season. The 80 quart product will maintain consistent temperatures for 28 hours with 34 openings or for 120 hours without openings and is ideal for same day delivery or long shipments.
Both a 13 quart and 80 quart offering are available now, are built to hold gel packs or PCM plates, andcan be shipped in any quantity. For pricing, please contact Infitrak directly.
PCMs match the temperature of the product while it is going through it’s phase change, making it ideal for temperature sensitive applications. Whether you know your packaging materials or are a newbie, this informative new paper from Infitrak will explain:
- How do PCMs work?
- Compare water-based PCMs vs other passive/hybrid materials
- Why not just always use water?
- Alternatives on the market today
- What type and how muchPCM is best for your application?
- What do you need to know to determine the type and how much PCMmaterial is needed?
When a supply chain disruption occurs, businesses need to have mitigation plans in place to prevent loss of market share to better prepared or less affected.
Infitrak has assisted companies in developing supply chain continuity plans for multiple modes of transport and the weather patterns that can affect them. Since weak spots in the system often aren’t apparent until after a disaster strikes, the plans should include qualified packaging, temperature mapping studies, redundancies and a cloud based global information system that links information about environmental conditions to logistics information around shipments.
Below are some of the top 10 things you can do to help build a supply chain contingency plan that helps you “weather the storm”:
- Know your regulations and make sure you are up to date with the latest changes. This not only makes the difference in product quality, but affects the cost of package, the types of carriers you should use, and the ability to distribute across borders.
- Assign a “responsible person” establish and maintain GDP guidelines that allow you to oversee audits, maintain quality systems, ensure adequate records are maintained, create and maintain training of personnel, and build communications plans around recalls or other incidents
- Gain better control of your supply chain through improved visibility and traceability. That means knowing where your products are at all times and the condition of the product at each stage of the distribution process.
- It is important to minimize data loss by leveraging a SaaS-based model for 24-7 Internet data access to assure monitoring conditions are maintained and that records are archived.
- Demand visibility into all of the activities of your fleet, drivers and suppliers to assure that the chain of custody is always seamless.
- Prior to beginning a transport, plan for contingency events along route. Perform due diligence by looking at potential delays due to weather, customer intake, vehicle breakdowns, TCU malfunction, & temperature excursions.
- Evaluate how decision makers will know when a contingency event has occurred and what options are available for responding. This may mean implementing a live data capture system that alerts key personnel as needed.
- Minimize revenue loss by making a commitment to ensuring your supply chain processes are resilient and flexible through innovative technology products, allowing your business to react quickly and rebound from a disaster efficiently, with little revenue loss.
- Consider pre-coordinating with service locations along the route. Ensure a complete understanding of the service they offer and obtain contact information, particularly for after hours events to enable timely action. Communication and training are essential when high value products are at risk.
- Evaluate your distribution models and look for areas to improve. Consider carrier report cards, temperature mapping studies and a gap analysis. Often times these studies pay for themselves.
What strategies do you have in place for risk management? Let us know.
While there are many temperature monitoring products on the market today, they are not effective if they are not deployed properly. Door openings, hot and cold spots, shelf height, ventilation systems, and other elements can all affect how measurements are recorded and analyzed in the field. And, while, previous articles have talked about the risk associated with cold chain logistics and storage, temperature mapping is one of the more important methods for determining the cause of product quality issues.
Temperature mapping is based around three areas: compliance regulations, quality / safety issues, and energy efficiency.
What is temperature mapping?
The purpose of temperature (or thermal) mapping is to ensure all areas of the process equipment or storage area achieve the required temperature. The outcome of the temperature map is to understand the temperature distribution, and to define hot or cold spots of the process equipment or storage area. This takes into account the temperature & density of humidity of warehouses for the storage of environmentally sensitive products. You should note that regulations and guidelines state that thermal equipment needs to be qualified (IQ-OQ-PQ), storage areas and vehicles need to be temperature mapped, and both need to be monitored with temperature sensors installed at locations where worst case scenarios may appear (hot and cold spots).
Types of temperature mapping
1) Temperature Mapping for Warehouses
The purpose of a temperature warehouse mapping study is to evaluate storage conditions, analyze temperature and humidity distribution, and identify critical zones inside the warehouse. The resulting study will show:
- Variation of temperature at a single point or across an area
- The impact of interventions, such as door openings or power failures
- Identification of hot and cold spots within a defined area
- Length of time of any temperature excursions
- Ventilation and stock layout issues
All warehouses should be temperature mapped to determine the temperature distribution under extremes of external temperature. Mapping should be conducted in any new facility, facility expansion, or after any significant modification to the site, stock layout, or heating system.
2) Temperature Mapping / Qualification for Vehicle Validation
Qualification refers to checking that a product, service, equipment or system meets requirements and specifications and that it fulfills its intended purpose. It has always been the responsibility of the carrier to ensure the safety, quality and efficacy of the product during shipping operations. Temperature mapping documentation demonstrates that this quality status is continually maintained and further supports the company from a liability perspective. However, under today’s strict regulations and guidelines for transporting pharmaceutical product, maintaining current and ongoing documentation of storage area qualification is no longer optional. Current guidelines not only require temperature mapping, but they also require temperature monitoring with sensors installed where worst case scenarios may occur (doors, vents, etc).
A Qualification exercise for vehicles collects the following information:
- Summer and winter mapping data
- External ambient temperature
- Empty and loaded product data
- Cool down time verification
- Hot and cold spot identification
- Power failure tests
- Test results impact on product to incidents like door opens
- Shipment and packaging qualification tests
It is necessary that vehicle qualification be performed by a disinterested third party. Temperature mapping for vehicles includes validating transit-sized delivery vehicles to full size trailers.