FAQ
FAQ
What does "cold chain" mean, and why is it important?
Cold chain refers to the ongoing management of temperature-sensitive shipments from production to the final consumer. This involves understanding shipping conditions, packaging design, duration of transport, and identifying crucial control points throughout the process.
What steps should I take to properly package a temperature-sensitive product?
For FDA-regulated items, like pharmaceuticals, it's best to consult with one of our knowledgeable team members. If your product is food, please refer to our packaging guidelines for assistance.
How is the cold chain sector regulated in the United States?
In the U.S., the transportation of temperature-sensitive items is overseen by the Food and Drug Administration (FDA) (https://www.fda.gov). As per the Code of Federal Regulations (CFR) Title 21, Section 211.94 (b), "Container closure systems must ensure sufficient protection against foreseeable external factors that could lead to the degradation or contamination of the drug product during storage and use."
For the transport of diagnostic specimens and infectious substances, the Department of Transportation (DOT) regulates these under Section 49 CFR parts 173.199 and 173.196, which mandates that "Special packaging (triple packaging, consisting of a primary receptacle, secondary packaging, and outer packaging) is required for shipping a diagnostic specimen."
Are there industry standards and guidelines in the U.S. that focus on cold chain?
Yes, several organizations provide guidelines related to cold chain management, including:
● The International Safe Transit Association (ISTA), which offers programs and services to support the distribution of packaged products.
● The American Society for Testing and Materials (ASTM), known for developing international standards for materials, products, systems, and services.
● The Parenteral Drug Association (PDA) and its subgroup, the Pharmaceutical Cold Chain Discussion Group (PCCDG). This group serves as an information exchange forum, educating its members on global shipping and distribution of temperature-sensitive medications through various trade and regulatory organizations. They also create guidelines and propose standards for validating shipping and distribution processes.
● The U.S. Pharmacopeia <1079> assists manufacturers, distributors, and transporters in handling pharmaceutical products, providing information on storage and shipping practices to maintain product integrity from the manufacturer to the end-user.
ISTA Guide 7D: Thermal Control Transport Packaging for Parcel Delivery System Shipment, which includes a development test to assess the effects of external temperature on packaged products shipped via parcel delivery systems.
ASTM D-3103, Standard Test Method for Thermal Insulation Quality of Packages, which evaluates the thermal insulation quality of a package based on temperature differences between the packaged item and its external environment.
● PDA’s Technical Report No. 39: Cold Chain Guidance for Medicinal Products provides guidance for the pharmaceutical industry and regulators on essential principles and practices for shipping products requiring controlled temperatures during transit, along with design approaches for developing specialized packages and systems to protect temperature-sensitive products.
How can I assess transit duration and temperature cycles?
Transit duration refers to the total time a shipment is in transit. External temperature profiles indicate the ambient temperatures experienced by the shipping container during transit. There are several reliable methods for determining these temperature profiles, including analyzing summer highs and winter lows. Our engineering and technical teams possess extensive experience in helping clients map and assess these external temperatures using historical data, real-time data collection during transport, and specialized programs designed to analyze specific routes.
What do the R-value and K-value signify, and how do they assist me in selecting the optimal insulation for my packaging requirements?
The R-value indicates thermal resistance, reflecting a material's effectiveness in minimizing heat loss. A higher R-value signifies a superior capacity to reduce heat loss. Conversely, the K-value represents thermal conductivity, calculated by dividing the thickness of the insulation by its R-value. Generally, a high R-value results in a low K-value.
As insulation costs rise with increasing R-values, conducting a cost-benefit analysis is essential to identify the most suitable insulation for a specific purpose. Below is a summary of R-values categorized by insulation type. These values serve as general guidelines for one-inch thick insulation.
What are the consequences of failing to maintain proper temperature zones?
Failure to maintain temperature zones can result in:
● Product damage: For example, vaccines may lose potency at high temperatures, while drugs may crystallize irreversibly at low temperatures.
● Financial loss: Entire shipments may be discarded due to temperature deviations, leading to significant financial impact.
● Public health risks: Ineffective vaccines or drugs may compromise patient safety and harm reputations.
Which QY Refrigerants are best suited for the following shipping situations?
Tightly fitting packaging configurations – Opt for QY Foam Bricks, as they maintain their shape consistently whether frozen or thawed.
Long-lasting and economical maintenance of refrigerated products – Select other QY Gel Packs, available in various pouch materials and gel structures.
Wrap-around protection – Choose QY Saddle Bags (saddlebags, mats) for form-fitting protection of temperature-sensitive items.
Rough environments or reuse – Go for QY Gel Bottles, which are made from tough, puncture-resistant blow-molded high-density plastic.
Long-lasting and economical maintenance of frozen products – For a safe dry ice alternative, choose QY Gel Packs (500-ST Series).
Why is it crucial to maintain different temperature zones in cold chain transportation?
Maintaining temperature zones is critical in cold chain transportation because different biopharmaceutical products have unique temperature requirements. For instance, vaccines must stay between 2°C and 8°C, while plasma may require temperatures below -20°C. Accurate temperature control ensures:
● Product safety and efficacy, preventing failures or spoilage due to temperature fluctuations.
● Compliance with regulations and certifications, avoiding rejection or returns.
How does QIYAO help clients achieve precise control across multiple temperature zones?
QIYAO provides the following solutions to ensure precise control across multiple temperature zones:
● High-performance packaging materials: VIP insulation panels and EPP materials maintain stable temperature zones.
● Real-time temperature monitoring: Intelligent monitoring systems enable 24/7 tracking and alerts.
● Customized designs: Tailored transportation solutions meet diverse temperature requirements efficiently and reliably.