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Chill Factor: The Top 5 Temperature-Sensitive Products Requiring Cold Chain Shipping

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Maintaining the quality and integrity of temperature-sensitive products demands meticulous attention to their specific temperature requirements. This task becomes especially daunting when these products traverse long distances, traverse diverse climate zones, and navigate through various seasons. However, meeting this challenge head-on is imperative to ensure that products reach their destination in pristine condition.

Shipping temperature-sensitive products entails thorough planning and seamless coordination at every stage of the process, spanning from initial packaging to final delivery. Furthermore, post-delivery, proper storage and handling procedures must be adhered to diligently to preserve the desired temperature. It’s paramount that everyone involved in the shipping process comprehends the criticality of handling temperature-sensitive products with utmost care. Only through collaborative efforts can we successfully tackle this challenge and ensure the safe and secure delivery of these products.

In this article, we’ll explore the top 5 temperature-sensitive products that necessitate cold chain shipping.

#1- Insulin

 Insulin, a hormone crucial for regulating blood sugar levels in patients, facilitates glucose metabolism by enabling cells to uptake sugar from the bloodstream for energy or storage. Manufactured to manage blood sugar in people with diabetes, insulin plays a pivotal role in their treatment.

With 415 million individuals worldwide living with diabetes, ensuring access to insulin is paramount. Being a temperature-sensitive product, insulin necessitates transportation within a reliable cold chain. This article aims to provide comprehensive guidance on shipping insulin to guarantee its effectiveness.

Key considerations for shipping insulin

Insulin, like many other temperature-sensitive products, can lose its efficacy or become unusable if not transported promptly and within the correct temperature range. Knowing the correct procedures for shipping insulin is essential to minimize the risk of spoilage and reduce unnecessary costs associated with replacing spoiled medication. Here are the key considerations for transporting insulin:

  • Packaging should accommodate both needle and pen forms of synthetic insulins, as they are typically injected.
  • Different forms of manufactured insulin have varying durations of effectiveness, ranging from rapid-acting insulin, which works within a few hours, to long-acting insulin, which lasts a whole day. Transporters must be mindful of the expiry dates of their shipments.
  • Insulin’s effectiveness diminishes when exposed to extreme temperatures. Prolonged exposure to extreme temperatures reduces its efficacy, leading to a loss of blood glucose control over time.
  • Insulin should be kept as cool as possible without freezing. Transporters must ensure that their shipments maintain the appropriate temperature and prevent insulin products from coming into direct contact with ice.
  • Changes in the color or clarity of insulin products can indicate viability. Clumps, solid white particles, or crystals in the bottle or pen are signs of spoilage, while viable insulin should remain clear and never appear cloudy.

Insulin Shipping Guidelines: A Comprehensive Approach

Ensuring the safe transportation of insulin is paramount, guided by international standards advocated by organizations like the WHO (World Health Organization). While these standards encompass various temperature-sensitive pharmaceuticals, they are particularly relevant to insulin shipment practices.

Temperature Tracking: Essential Protocol

Throughout the entire cold chain process, it’s imperative to employ a reliable temperature monitoring system such as the Smart Tag™. Upon receipt, recipients should meticulously examine the temperature tracker to verify the insulin’s integrity. Additionally, promptly sending the temperature log back to the manufacturer confirms the insulin’s transit at the designated temperature.

Maintaining Cold Chain Integrity

Thorough documentation of every shipping aspect, including temperature logs and handling procedures, is crucial. This comprehensive record serves as a valuable tool for evaluating cold chain efficiency and identifying potential areas for enhancement. Any breach in the cold chain mandates the disposal of the medication to ensure safety.

Refrigeration Practices

When not in use, insulin must be refrigerated. Refrigerators designated for insulin storage should undergo defrosting every 6–8 weeks unless they are self-defrosting. Moreover, these refrigerators should feature an integrated thermometer, calibrated at least annually for accuracy assurance.

Proper Storage Guidelines

Unopened insulin necessitates storage within the range of 36°F to 46°F. After opening, insulin can be stored at room temperature (59°F to 77°F) for up to a month, provided it remains in its original packaging, shielded from heat and light. However, irrespective of usage, insulin must be discarded one-month post-opening.

Adhering to Temperature Standards

The FDA (Food and Drug Administration) recommends storing insulin within the temperature range of approximately 36°F to 46°F to maintain potency until the package’s expiration date. Any alterations to the insulin, such as dilution or removal from the original vial, necessitate disposal within two weeks to ensure efficacy and safety.

insulin Packaging: Safeguarding Temperature Integrity

Efficient packaging is indispensable for preserving insulin’s temperature stability during transit. Various materials are commonly employed for this purpose:

Insulated Boxes: These provide a protective barrier against external temperature fluctuations, safeguarding insulin from heat or cold exposure.

Barriers/Loose-fill: These fillers serve to cushion and secure insulin containers within the packaging, preventing movement and potential damage during transportation.

Cooling Elements: Ice or gel packs are frequently utilized to maintain the desired temperature inside the packaging. Prior to use, these packs can be pre-chilled in a refrigerator or freezer. However, it’s essential to ensure that insulin containers do not directly contact these cooling elements.

For enhanced temperature control, ice or gel packs are often combined with insulated packaging, maximizing the effectiveness of the cooling process.

Additionally, it’s imperative to clearly label insulin containers with prominent markings such as "Perishable" and "Keep Refrigerated" during shipment. This serves as a vital notification to both recipients and shipping personnel, highlighting the drug’s sensitivity to temperature fluctuations and the necessity for refrigeration. Such clear labeling helps ensure proper handling throughout the shipping process, maintaining insulin’s efficacy and safety.

Innovative Cold Chain Solutions: Advancing Insulin Transportation

Continuous advancements in technology and practices are revolutionizing the cold chain, particularly in supporting the transportation of temperature-sensitive products like insulin. Key solutions to be aware of include:

Refrigerated Transportation (Reefers): These specialized transport vehicles offer enhanced temperature control, ensuring the safe shipment of temperature-sensitive products such as insulin, even over long distances.

Energy-Efficient Cold Storage Warehouses: Modern cold storage facilities utilize energy-efficient technologies to maintain precise temperature ranges, catering to diverse product requirements simultaneously.

Integration of Robotics: Robotics has been integrated into cold chain processes, streamlining inventory management with heightened efficiency and reliability, reducing manual errors and enhancing speed.

#2- Vaccines

Ensuring Vaccine Viability: Guidelines for Transport and Redistribution

In the realm of vaccine distribution, the movement of vaccines can occur for planned redistribution or in response to urgent situations jeopardizing their effectiveness. However, such transport must adhere to strict protocols to maintain the viability of the vaccines. These guidelines, outlined in the CDC Vaccine Storage and Handling Toolkit, mandate the use of certified, calibrated digital data loggers (DDL) for temperature monitoring during transport, along with proper packing equipment.

The Vaccine/VFC Primary and Backup Coordinators play pivotal roles as experts in implementing vaccine storage for transport. Providers are urged to integrate detailed steps for vaccine movement into their Emergency Back-up Protocols and redistribution plans, where applicable.

Vaccine Transport According to CDC

In this section, transport refers to the swift and strategic movement of vaccines between providers or various locations within a short distance and timeframe. This method proves invaluable for emergencies, off-site clinics, or salvaging vaccines on the brink of expiration to prevent wastage.

Vaccine Transport: Understanding the Variations

When it comes to vaccine transport, distinct scenarios demand tailored approaches. Transporting vaccines to off-site or satellite facilities contrasts with both shipping and emergency transport. Shipping typically entails professional carriers and covers longer distances and time frames. Emergency transport, on the other hand, focuses on relocating vaccines swiftly to safeguard them when storage facilities are compromised, such as during power outages. While some transport protocols may overlap across scenarios, nuances exist, necessitating careful consideration.

Vaccine Transport

Vaccines from your supply should not be routinely transported. In instances where the transport of vaccine from your supply is necessary, take appropriate precautions to protect your supply. Vaccines should only be transported using appropriate packing materials that provide the maximum protection

A. Remarks:

B. The total time for transport alone or transport plus clinic workday should be a maximum of 8 hours (e.g.,if transport to an off-site clinic is 1 hour each way, the clinic may run for up to 6 hours), unless guidance from the manufacturer differs.

C. Use a transport temperature monitoring log to document temperatures and how long the vaccine is in the portable storage container.

D. Transport diluents with their corresponding vaccines to ensure there are always equal amounts of vaccines and diluents for reconstitution.

E. Your facility should have a sufficient supply of materials needed for vaccine transport of your largest annual inventory. Appropriate materials include:

• Portable vaccine refrigerator/freezer/ultra-cold freezer units (preferred option)

• Qualified containers and packouts

• Hard-sided insulated containers or Styrofoam™ (Use in conjunction with the Packing Vaccines for Transport during Emergencies‡ tool. This system is only to be used in an emergency.)

• Coolant materials such as phase change materials (PCMs) or frozen water bottles that can be conditioned between 4° C and 5° C (39° F and 41° F)

• Insulating materials such as bubble wrap and corrugated cardboard—enough to form two layers per container

• TMDs for each container

Soft-sided containers specifically engineered for vaccine transport are acceptable. Do not use commercially available soft-sided food or beverage coolers because most are poorly insulated and likely to be affected by room or outdoor temperatures. The same shipping materials the vaccines were initially shipped in should rarely, if ever, be used as they are not meant for reuse. This could put the cold chain and, ultimately, the viability of the vaccine, at risk.

It is always safest to have vaccines delivered directly to a facility with a vaccine storage unit ready to receive the shipment, but this is not always possible. If necessary, vaccines may be transported using a portable vaccine refrigerator with a temperature monitoring device placed with the vaccines. If a portable vaccine refrigerator is not available, qualified containers and packouts with a TMD in each container can be used. For transport to an off-site clinic, bring only what is needed for the workday.

Transport Method Requirements: Emergency Versus Planned

NameEmergency TransportTransport for Off-Site Clinic, Satellite Facility, or Relocation of Stock
Portable Vaccine Refrigerator or FreezerYesYes
Qualified Container and PackoutYesYes
Conditioned Water Bottle Transport System*YesNo
Manufacturer’s Original Shipping ContainerYes (last resort only)No
Food/Beverage CoolersNoNo
*Conditioned Water Bottle Transport System is applicable only for emergency transport.


  • Portable Vaccine Storage Unit: A type of powered refrigerator, freezer or Ultra-Cold (UTC) freezer unit specifically designed for use during vaccine transport. These are passive units that require a power source to function. Some active units are “qualified” to maintain desired temperatures for a set amount of time in the event of a power loss. For proper use, follow directions stated in manufacturer instructions.
  • Qualified Container and Pack-out: A type of container and supplies specifically designed for use when packing vaccines for transport. They are passive containers that do not require a power source and are “qualified” through laboratory testing under controlled conditions to ensure they achieve and maintain desired temperatures for a set amount of time (i.e., Cool Cubes, TempArmour, etc.). For proper use, follow directions stated in manufacturer instructions.
  • Conditioned Water Bottle Transport Method: Method outlined according to CDC’s Packing for Emergency Transport. This is for emergency transport only; it should not be used for planned transport such as off-site clinics, transport to a satellite facility, or relocation of stock. If packed correctly, this method can maintain appropriate temperatures for up to 8 hours, but the container should not be opened or closed repeatedly.
  • Manufacturer’s Original Shipping Container: CDC and Pfizer have issued statements that the original shipping container can be used for transporting Pfizer’s Ultra-cold vaccine.

Coolants for Transport PCMs

between 4° C and 5° C (39° F and 41° F) can also be purchased to maintain proper temperatures. Follow the manufacturer’s instructions† for use to reduce the risk of freezing vaccines during transport.

Do not use frozen gel packs or coolant packs from original vaccine shipments to pack refrigerated vaccines. They can still freeze vaccines even if they are conditioned or appear to be “sweating.” In emergency situations, a system using conditioned water bottles can be used. Manufacturers’ original shipping containers may also be used as a last resort in an emergency situation.

Transport Planning and Preparation Improper packing for transport is as risky for vaccines as a failed storage unit.

Include vaccine packing and transport protocols in your routine and emergency storage and handling SOPs. At a minimum, include the following procedures and protocols:

For all staff-facilitated transport:

• Identify trained staff to pack vaccines as well as primary and backup vehicles and drivers for transport in advance.

• Consider renting a refrigerated truck if you have a large quantity of vaccines or need to transport vaccines an

extended distance.

• Take an inventory of your vaccines and record actions to protect the vaccines during transport.

• Open unit doors only when necessary and only after completing all preparation for packing and moving vaccines.

• If using a company or personal vehicle, only transport vaccines inside the passenger compartment (not in the trunk or bed of a truck, which may be too hot or too cold).

• Move transport containers directly to a vehicle that is already at a comfortable temperature, neither too hot nor too cold.

• Avoid leaving containers in areas where they are exposed to direct sunlight.

• Check vaccine temperature upon arrival at the alternative vaccine storage facility and store vaccines at

recommended temperatures immediately.

Transporting Opened Multidose Vials

If absolutely necessary, a partially used vial may be transported to or from an off-site/satellite facility operated by the same provider, as long as the cold chain is properly maintained. However, a partially used vial cannot be transferred from one provider to another or across state lines.

Transporting Diluents

Transport diluents with their corresponding vaccines so there are always equal amounts of vaccines and diluents for reconstitution. Follow the manufacturer’s guidance for specific temperature requirements.

If diluents stored at room temperature (20° C to 25° C [68° F to 77° F]) are going to be transported with refrigerated vaccines, they should be refrigerated in advance for as long as possible so they do not raise the container temperature when placed with refrigerated vaccines.

Never freeze diluents—not even during transport. Place an insulating barrier like bubble wrap between the diluents and conditioned water bottles or phase change materials.

Transporting Frozen Vaccines

If frozen vaccines must be transported, use a portable vaccine freezer unit or qualified container and packout that maintains temperatures between -50° C and -15° C (-58° F and +5° F) or -90° C and -60° C (-130° F and -76° F) for ultra-cold transport.

Follow these steps for transporting frozen vaccines:

• Place a TMD (preferably with a buffered probe) in the container as close as possible to the vaccines.

• Immediately upon arrival at the destination, unpack the vaccines and place them in a freezer at a temperature range between -50° C and -15° C (-58° F and +5° F) or -90° C and -60° C (-130° F and -76° F) for ultra-cold freezer storage. Any stand-alone freezer that maintains these temperatures is acceptable.

• Record the time that vaccines are removed from the storage unit and placed in the transport container, the temperature during transport, and the time at the end of transport when vaccines are placed in a stable storage unit.

Do not use dry ice, even for temporary storage† . Dry ice might expose the vaccines to temperatures colder than -50° C (-58° F).

Temperature Monitoring During Transport

Use a continuous TMD, preferably a DDL with the capability to measure minimum/maximum temperatures, for monitoring and recording temperatures while transporting vaccines:

• The TMD should have an accuracy of +/-0.5° C (+/-1° F).

• Place buffered probe material in a sealed vial directly with the vaccines.

• Keep the TMD display on top of vaccines so you can easily see the temperature.

• Record the time and minimum/maximum temperature at the beginning of transport.

Temperature Monitoring after Transport

Immediately upon arrival at the destination, vaccines should be stored in an appropriate storage unit with a TMD. Be sure to follow these guidelines for monitoring and recording storage unit temperature:

• If the device displays minimum/maximum temperatures, this information should be checked and recorded.

• If the device does not display minimum/maximum temperatures, then the current temperature should be checked and recorded a minimum of two times (at the start and end of the workday).

If vaccines cannot be stored in an on-site storage unit, they should be kept in the portable vaccine storage unit using the following guidance:

• If using a DDL that records minimum/maximum temperatures, only check and record temperatures each time the portable vaccine storage unit is opened. If the TMD measures current temperatures only, place the probe as close as possible to the vaccines, and check and record temperatures hourly.

• Keep the container closed as much as possible.

• For off-site clinic use, remove only one multidose vial or 10 doses at a time for preparation and administration by each person administering vaccines

#3- Blood & Blood Products

The following describes the proper conditions for packing and transporting blood and blood components for transfer or return.

Basic Standards

Specific guidance on packing on transport is meant, at a minimum, to preserve acceptable conditions for transfusable products. For example:

  • Red blood cells must maintain a temperature of 1 – 6º C during storage and 1 – 10º C while in transit.
  • Frozen products should not be thawed and refrozen.
  • No alterations should be made to the original container label.
  • The unit seal has not been broken or altered.
  • Hospitals must have a written policy in place to ensure proper handling of products during storage, as well as in transit.
  • Visual inspection is performed.
  • Only validated shipping containers are to be used for transport.

Blood Product Inspection

Prior to shipment of blood products, an inspection should be done to assure that the labels and appearances of the components are adequate for release and subsequent transfusion.

Additive Red Cells: To observe this component, adequate light is needed to observe the cell-plasma interface. The plasma should be observed for cloudiness and abnormal color especially near the interface. The segment interface is acceptable to observe.

Abnormal Appearance

AppearanceDescription
IctericDarker than normal pale yellow-tan
Pink to red plasmaMay be due to hemolysis or bacterial growth
LipemicNo harm to patient. Destroy lipemic plasma or platelets
Cloudy and pale greenMay be due to bacterial growth
Pale greenFemale donors may have pale green plasma due to birth control pills but it is not cloudy. These components are acceptable
ClotsComponents with visible clots will be quarantined for supervisory personnel


Fresh Frozen Plasma/Cryoprecipitate: Breakage of the component bag is to be observed and if broken, cannot be shipped. Other abnormal appearances are causes not to ship the component. Blood components that look abnormal must not be shipped. See Abnormal Appearance table above. Any components that are broken or have abnormal appearances that cause them not to be shipped will be discarded using the discard procedure.

Platelets: See abnormal appearance noted on the Abnormal Appearance table for causes not to ship the product.

  • Observe the bag for excessive air in the bag. Discard component if detected using discard procedure.
  • Observe the platelet for small clots or clumps. If there are any detected, consult supervisory personne
  • Observe the bag for grossly bloody (greater than 2% hematocrit) appearance. Discard if present using the discard procedure.

Re-Issue Inspection Requirements

Any blood or blood product that is returned to LifeServe Blood Center must be re-inspected before reissue. Products can only be reissued if the container:

  • Has not been penetrated
  • Temperature of the product has been monitored during transport and is acceptable.
  • Maintained at the proper storage temperature.
  • At least two segments must be attached to the packed cell.
  • Packed cell unit must be settled enough to allow re-inspection.

Secondary Packaging for Blood Tubes

 To facilitate processing, package all blood tubes from the same patient together.

  • Place absorbent material between the blood tubes and the first layer of secondary packaging. Use adequate absorbent material to absorb the entire contents of the blood tubes.
  • Separate each tube of blood collected from other tubes to prevent tube-to-tube contact. The first layer of secondary packaging must be secured with one continuous strip of evidence tape and initialed half on the tape and half on the first layer of secondary packaging by the person making the seal. For example, one of the ways to do this is.
  • Pack blood tubes in a gridded box lined with absorbent material. Seal the top half of the box to the bottom half with one continuous piece of evidence tape and write your initials half on the tape and half on the box.
  • Wrap and seal the first layer of secondary packaging (e.g., gridded box) with absorbent material.
  • Place the first layer of secondary packaging (e.g., gridded box) with absorbent material in the next layer of secondary packaging. An example of acceptable material is the Saf-T-Pak Disposable 2-Part Pressure Vessel system or its equivalent.
  • According to 49 CFR 173.199(b), if specimens are to be transported by air, either the primary receptacle or the secondary packaging used must be capable of withstanding, without leaking, an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi). Verify in advance that the manufacturer of either the blood tube or secondary packaging used in your facility is in compliance with the pressure differential requirement.

Outer Packaging for Blood Tubes

  • Use polystyrene foam-insulated, corrugated fiberboard shipper (may be available from your transfusion service or send-outs department).
  • For cushioning, place additional absorbent material in the bottom of the shipper.
  • Add a single layer of refrigerator packs on top of absorbent material.
  • Place the packaged specimens on top of the refrigerator packs.
  • Use additional cushioning material to minimize shifting while the shipper is in transit.
  • Place additional refrigerator packs on top of the secondary packaging to maintain a shipping temperature of 1 °C – 10 °C
  • Place blood shipping manifest in a sealable plastic bag on the top of the foam-insulated shipper lid, inside the cardboard outer container.
  • Keep chain-of-custody documents for your files.
  • Place your return address in the upper left-hand corner of the shipper top and put CDC’s receiving address in center.
  • Affix labels and markings adjacent to the shipper’s/consignee’s address that appears on the shipper.
  • Place the UN 3373 label and the words “Biological Substance, Category B” adjacent to the label on the front of the shipper.

Shipment

Blood specimen shipments may fall under regulations for infectious substances or diagnostic specimens depending on their known contents and intended analyses. Proper classification can be determined by referring to resources provided by the International Society for Biological and Environmental Repositories Best Practices (1) and the International Air Transport Association (12).

Temperature Conditions and Insulation Requirements

Blood specimens may experience temperature fluctuations during transit. Specific temperature conditions and insulation/refrigerant requirements vary depending on the intended analyses:

Ambient (+20°C to +30°C): Insulated packaging is required to protect specimens from extreme hot or cold ambient conditions.

Refrigerated (+2°C to +8°C): Gel packs designed for refrigerated temperatures are necessary.

Frozen (−20°C): Gel packs designed for frozen temperatures are needed.

Frozen (−70°C): Dry ice pellets or sheets are required.

Frozen (at or below −150°C): Liquid nitrogen dry shippers are necessary.

Temperature Monitoring Devices

Devices are available to monitor temperature trends during shipment. These devices either record temperatures at specific intervals or change color if temperatures exceed certain thresholds during transit.

#4- Pharmaceuticals

Shipping pharmaceuticals entails a complex and heavily regulated procedure, with numerous factors to consider such as temperature, humidity, and light exposure. Packaging and labeling must adhere to strict standards to ensure the potency and effectiveness of the products.

A variety of packaging options exist to maintain the appropriate temperature range for each product, necessitating careful selection. Additionally, humidity and light exposure are crucial factors to account for, as pharmaceuticals can be sensitive to these environmental conditions. Choosing packaging options that mitigate exposure to these elements is essential to safeguard the integrity of the products during shipping.

Essential Aspects of Pharmaceutical Transportation

Road shipment is the preferred method for transporting pharmaceuticals due to the specific storage requirements and the need for rapid delivery. Despite air travel being the fastest option, especially for long distances, its popularity has waned due to the lack of standardized practices and transparency.

When expedited delivery is necessary, pharmaceuticals can be transported by sea or rail in dedicated refrigerated containers. Many pharmaceutical companies opt for sea transport due to its well-established supply chain.

During pharmaceutical shipping, meticulous attention must be paid to controlling temperature and humidity levels. Ice packs should never directly contact medications, and products should be promptly retrieved from the factory or refrigerated warehouse. Comprehensive documentation of the entire journey, including timestamps and any fluctuations in container temperature, is essential. Leading transportation companies anticipate various scenarios, such as delays and malfunctions in cooling systems, to ensure the safe delivery of pharmaceuticals.

Pharmaceutical Transportation Regulations

Ensuring compliance with shipping regulations is paramount in the distribution of pharmaceuticals. These regulations guarantee the quality and safety standards for various medications and vaccines, from manufacturing facilities through the supply chain to retail shelves. Failure to adhere to these regulations can compromise the overall performance of the supply chain.

Standards Development and Updates

The Food and Drug Administration (FDA) and Current Good Manufacturing Practices (CGMP) have established stringent standards governing the manufacturing, holding, and distribution of pharmaceutical products. These standards were initially implemented in 1969 to regulate the manufacturing, holding, and distribution of food and pharmaceutical items. In 2015, these guidelines were revised to align with the requirements of the Food Safety Modernization Act (FSMA)

Comprehensive Information and Resources

Under Title 21 of the Code of Federal Regulations (CFR), the FDA provides comprehensive information regarding the handling and transportation of prescription medications. This resource serves as a valuable guide for pharmaceutical companies and stakeholders to ensure compliance with shipping regulations and maintain the integrity of pharmaceutical products throughout the transportation process.

Essential requirements for transporting pharmaceuticals

Vehicle Equipment

Ensure that pharmaceutical delivery vehicles are equipped with the necessary construction and amenities. Trailers, for instance, should be equipped with mandated temperature controls and safety measures.

Pharmaceutical Shipping Operations

To prevent cross-contamination, pharmaceutical shipping companies must thoroughly sanitize the cargo compartments of their trailers. Regular inspection and maintenance of temperature control and monitoring equipment are also imperative to ensure proper functionality.

Education and Training

All individuals involved in the distribution of pharmaceuticals must possess the required expertise. Documentation of this training is essential.

Labeling

Each container used for shipping pharmaceuticals must be clearly labeled and tagged.

Documentation

Accurate and up-to-date records pertaining to transportation and training must be maintained and securely stored.

Requirements for Transporting Pharmaceutical Products

Compliance with manufacturer and FDA standards regarding cold chain logistics is mandatory. Standardized vehicle equipment is crucial for pharmaceutical transportation. Trucks transporting pharmaceutical products must be equipped with temperature control and safety features. Trailer sanitation is necessary to prevent product contamination. Additionally, maintaining detailed records is essential. It is imperative to track the transportation and training records of all involved partners.

Packing Pharmaceuticals for Transportation

Careful and appropriate packaging is essential when shipping pharmaceutical products. Heat packs play a crucial role in shielding goods from various elements such as humidity, UV rays, and temperature fluctuations.

Approximately 7 out of 10 medications necessitate temperature-controlled shipping. Additionally, the transportation of natural products like tissues, regenerative agents, and hemoglobin requires specialized handling. Thermocontainers, capable of withstanding temperatures as low as -150 degrees Celsius, are commonly utilized for storing pharmaceutical products.

Some carriers utilize thermal pallets for shipping pharmaceutical items, providing an extra layer of protection. Thermally insulated pallet coverings can further safeguard pharmaceutical supplies from damage. Additionally, efficient storage of boxes and containers is essential, aiming to transport a large quantity of goods with minimal movement. Given the delicate nature of pharmaceuticals, there is a significant risk that products may become unusable or unsellable if their contents are compromised during transportation.

 Temperature-Controlled Transport

From the moment a pharmaceutical is manufactured, the countdown to its expiration date begins. Refrigerated transportation is vital to prevent spoilage of pharmaceutical products. Refrigerator trailers are equipped with a power source that enables them to operate independently of vehicles, ensuring continuous operation of their refrigeration systems. This feature ensures that pharmaceutical products maintain their required cooling conditions during transportation, whether by road or another method.

Follow the Refrigerant Flow

The principle of temperature-controlled transportation is not novel. The idea dates back to the 1840s when freezing temperatures and ice were employed to cold chain logistics by train.

Driver rules, confidentiality, safe cargo handling, incident reporting, cargo tracking, and mandated reaction times are just a few examples of the kinds of information that carriers may include in their instructions. When the transporter accepts a customer’s request to engage with them, they often sign contracts outlining these guidelines.

Drivers are essential members of the supply chain. When carrying consequential commodities like medications driver’s attention to detail is crucial. By limiting the abundance of time the vehicle is left unattended and eliminating needless pauses, drivers can verify safety while transporting pharmaceutical products.

Training for drivers is also vital. Drivers need to acquire specialized training for the cold chain logistics process and be familiar with traffic laws. The driver has to be knowledgeable about refrigeration vehicles’ mechanics. The driver should always maintain the correct temperature in the conveyance.

The following recommendations can help drivers and medical companies reduce risks while carrying medications.

Theft Prevention

When transporting pharmaceutical products, it’s crucial to have effective theft protection measures in place. Given the high value of these items, they are prime targets for theft, which can lead to serious repercussions.

Responsibility for theft prevention measures is shared between the shipper and the carrier. Proper packaging is a key step that shippers can take to enhance security. Clear labeling indicating the contents of the package serves as a deterrent to potential thieves, as packaging without such identifiers may be less attractive to them.

Effective solutions to enhance security and reduce the risk of theft include:

  • Maintaining constant communication with the driver throughout the pharmaceutical transport process.
  • Implementing continuous GPS tracking to monitor the location of the shipment.
  • Employing a team of drivers to ensure constant supervision and security.
  • Utilizing chaperone services for added security during transit.
  • Opting for direct routes without any unnecessary detours.

Engaging in open communication with your pharmaceutical shipping partner is essential for implementing effective theft prevention strategies. By informing them about the nature of the goods being transported and the level of security required, your shipping partner can offer tailored solutions to meet your specific needs.

Understanding the Risks

Transporting pharmaceutical products comes with inherent risks, beyond just temperature fluctuations. These products are susceptible to various challenges during transit, including the threat of ending up on the black market due to cargo theft, which can fuel criminal activities and unethical practices. Despite secure warehouse facilities, many thefts occur while pharmaceutical products are in transit.

It’s crucial to consider the number of individuals involved in handling the shipment. Common sense dictates that the more people involved, the higher the likelihood of loss or theft during transit. When selecting a carrier for pharmaceutical shipping, opt for one that follows a direct, nonstop route. This minimizes the transit time and reduces the opportunities for potential mishaps.

#5- Food & Beverages

Whether you’re a small-scale farm dispatching fresh produce or meats, or a burgeoning frozen food enterprise seeking to expand your reach, the shipment of food products stands as a paramount concern in the food and beverage sector.

Guaranteeing the punctual and pristine arrival of each food consignment is pivotal. It can either solidify or shatter your rapport with preferred suppliers and wield a substantial influence on your financial standing.

How to Pack Food for Shipping

When preparing to ship non-refrigerated food items, it’s essential to prioritize food safety. Follow these steps to ensure your food arrives intact:

  1. Ensure proper sealing: Use tape to tightly seal plastic containers or wrap glass jars securely with an additional layer of plastic wrap or bubble wrap. This helps prevent leaks and breakage.
  2. Choose a sturdy packaging: Select a robust box and line its bottom with crumpled newspaper or packing peanuts to cushion the food and minimize the risk of damage.
  3. Thoughtfully arrange the items: Arrange the food snugly but not overly tightly packed inside the box to prevent shifting during transit.
  4. Seal the box securely: Close the box and seal it tightly with tape to provide extra protection during shipping.

For shipping perishable food, take these additional precautions:

  1. Insulate the food: Pack perishable items in an insulated container along with a cold pack or ice pack to maintain freshness during transit.
  2. Provide extra cushioning: Place the insulated container inside a larger box and fill any empty spaces with crumpled newspaper or packing peanuts for added protection.
  3. Clearly label the package: Label the box clearly as containing perishable items to ensure proper handling and timely delivery.

By following these guidelines, you can ship food safely and securely, whether it’s non-perishable or perishable.

Shipping Shelf-Stable Foods

 Even foods that are considered shelf-stable can be damaged by extreme temperatures or excessive movement. Shelf-stable simply means that a food can be safely stored at room temperature due to its contents and packaging.

Take care to package shelf-stable foods in sufficient padding, especially if they are contained in a thin cardboard box. Powders like cake mixes should be wrapped in plastic just in case damage occurs during transit. If an unknown powder is leaking from a box, the shipping company may delay the package to investigate.

Shipping Baked Goods

Baked goods may seem easy to send in the mail, but they are fragile and may go stale if they are not adequately packaged. Baked goods need airtight packaging in either bags or rigid plastic containers to stay fresh in transit. Although this adds to your overall cost, it’s important since it’s not always cost-effective to use the fastest shipping possible with baked goods.

It helps to use eco-friendly packaging like biodegradable packing peanuts to give the baked goods sufficient cushion. Inflatable air pillows are also a good option for larger boxes.

Frosted baked goods are especially challenging to send in the mail because there is no guarantee they won’t end up upside-down. You may need to use a “this side up” sticker or pay extra for special handling. Check your preferred carrier’s rules for shipments that require manual processing to avoid turning the package over.

Shipping Chocolate and Candy

Chocolate, gummies and certain other types of candy may melt if exposed to high temperatures. Even candy that you’ve never had trouble with before may start to melt if it is left in a truck in the middle of summer.

It’s best to wrap chocolate and candy in waterproof packaging. If the candy melts and leaks, the shipper may have to pull the package entirely for inspection and quarantine, especially if the contents are not properly labeled on the outside.

Shipping Liquids

 Liquids and semi-solid foods like jams and jellies are prone to leakage, so they require special handling even if they are not perishable. Like with meat, they should have additional wrapping around them to stop any leaks and spills from contaminating other products. This includes liquid medications and other pharmaceuticals.Some liquids are especially prone to leaks if high temperatures cause the contents of the container to expand. In the winter months, freezing temperatures can cause ruptures in containers, as the frozen liquid expands after initially contracting.

Most carriers require you to declare any liquid items in the package and use appropriate shipping materials to prevent damage and leaks. If you are unsure whether or not the item you are shipping counts as a liquid, check with the carrier directly. Alcoholic beverages generally require a special permit for domestic and international shipping due to the age restrictions for the possession of alcohol.

Oils are of special concern if their flashpoint is below 200°F, making them a flammable material that requires a hazmat label and special handling. However, most cooking oils have a flashpoint well above 200°F so they will not require flammable liquid handling.

Shipping Food Internationally

 Customs restrictions for importing are the single biggest obstacle for how to ship food internationally. Many countries require detailed paperwork proving where the food was made or grown, especially produce or meat. Some types of food and produce may be subject to additional tariffs that can cause delays once the food arrives at customs.

It’s vital to do your customs-related research and logistical planning well in advance. Ensure the recipient is informed of their responsibilities regarding customs paperwork, as there may be situations where they have to pay additional duties or fees. In some cases, a freight forwarder or customs broker can help with this step, but this may add an additional cost.

If there is any chance of delays, foods that require refrigeration should be sent in a refrigerated cargo container or stored in a refrigerated warehouse immediately upon arrival. Frozen gel packs may work for short journeys over international borders, such as for shipments to Canada and Mexico, but these may be insufficient for longer journeys.

3 Mistakes to Avoid When Shipping Food and Beverage

When you’re shipping food and beverage products, there are a few things to keep in mind to ensure your products arrive fresh and intact.

Here are three mistakes to avoid when shipping food and beverages:

1. Not using the right packaging materials

If you’re not using the right packaging materials, your products could be damaged in transit. Make sure to use sturdy boxes and packing material that will protect your products from bumps and jostling.

2. Not packing properly

If you don’t pack your products properly, they could shift around in transit and become damaged. Be sure to pack your products securely so they don’t move around during shipping.

3. Not labeling clearly

If you don’t label your products clearly, the person receiving your shipment may not know what it is. Be sure to include a packing slip or invoice that lists the contents of your shipment

What are the Most Time-Sensitive Types of Food?

Fresh foods, such as fruits, vegetables, dairy, and meat products are the most time-sensitive types of foods that are regularly shipped across the country. These food-grade products often have a short shelf life, are easily damaged during transport, and need to be transported at specific temperatures.

Shipping frozen foods also requires the use of complicated food logistics services. Frozen foods must travel in a frozen freight truck. The truck’s internal temperature must be lowered to 20 degrees before loading and must maintain a temperature below 10 degrees consistently on the road.

This prevents any of the food products from having an internal temperature above 10 degrees. If a frozen product’s internal temperature is above 10 degrees when it arrives at a vendor marketplace, the grocer may not accept it.

A Few Tips for Successfully Shipping Refrigerated Items

Before we wrap up the article, here are a few tips to consider when shipping refrigerated and frozen foods.

First, if you’re using a styrofoam or cold box, choose one with the thickest walls possible. The thicker the walls the more insulation there will be, which means your food will stay cold longer. Ideally, the walls should be at least 1.5 inches thick.

When placing your perishable food in your box ensure it’s already cooled, otherwise, condensation will start to form inside.

You’ll also want to make sure the items are properly wrapped in a liner bag before putting them in the box for shipping.

Finally, let the recipient know ahead of time when and where they can pick up their package. That way, they can receive it as soon as possible which will decrease the chance of anything spoiling.

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