FAQs for General Cold Chain Information
What is cold chain and why is it necessary?
Cold Chain refers to an uninterrupted flow of a temperature controlled shipment from manufacturing through delivery to end user. This requires knowledge and control of the shipping environment, package design, duration of the shipment(s) and critical control points throughout the process.
Cold chain is necessary to control product efficacy, product safety, and adhere to relevant regulatory requirements. Temperature-sensitive products that require cold chain solutions may include: pharmaceuticals, biological, diagnostic materials, lab samples, chemicals, and foods.
My product is temperature sensitive. What do I need to do to package it properly?
If the product is regulated by the FDA, such as a pharmaceutical article, please speak with one of our experienced staff members. If the product is a food item, please see our Simple Packout Guidelines.
How is the cold chain industry regulated in the U.S.?
In the U.S., shipment of temperature sensitive articles is regulated by the Food and Drug Administration (FDA) (www.fda.gov). According to Code of Federal Regulations (CFR) Title 21, Section 211.94 (b) "Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product."
Further regulations related to the shipment of cold chain items may be found in:
- US Pharmacopoeia (www.usp.org)
- ASTM D-3103-99 (www.astm.org)
- PDA, Technical Report #39, (www.pda.org).
- www.fda.gov
For diagnostic specimens and infectious substances, the DOT regulates this transport under provisions of Section 49 CFR part173.199 and 173.196, which states, "Special packaging (triple packaging, consisting of a primary receptacle, a secondary packaging, and an outer packaging) is required for shipping a diagnostic specimen."
Are there U.S. industry standards and/or guidelines that address cold chain?
There are several organizations that address cold chain guidelines, including the:
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International Safe Transit Associations (ISTA)
ISTA provides programs, services and activities that assist in packaged-product distribution.
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American Society for Testing and Materials (ASTM)
ASTM develops international technical standards for materials, products, systems, and services.
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Parenteral Drug Association (PDA) and its subgroup, the Pharmaceutical Cold Chain Discussion Group (PCCDG)
PCCDG is an informational exchange group that educates its members on global shipping and distribution of temperature-sensitive medicinal products through trade and regulatory organizations. This group also develops guidelines and proposes standards for validation of shipping and distribution of the products.
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U.S. Pharmacopeia <1079>
USP <1079> provides manufacturers, distributors, and transporters with assistance in handling pharmaceutical items. The document includes information on storage and shipping practices to ensure the integrity of the product from manufacturer to end user.
ISTA Guide 7D: Thermal Control Transport Packaging for Parcel Delivery System Shipment "Test procedure 7D is a development test to evaluate the effects of external temperature exposures of individual packaged products shipped through a parcel delivery system."
ASTM D-3103, Standard Test Method for Thermal Insulation Quality of Packages "This test method covers the determination of the thermal insulation quality of a package and its enclosed packaging from temperature differentials between the packaged item and the outside environment."
PDA's Technical Report No. 39: Cold Chain Guidance for Medicinal Products: Maintaining the Quality of PDA Temperature-Sensitive Medicinal Products Through the Transportation Environment "This technical report provides guidance to both the pharmaceutical industry and regulators on the essential principles and practices for shipment of products which require controlled temperatures during transit while providing a design approach to the development of specialized packages and systems which will protect temperature-sensitive products during transportation."
How do I determine transit duration/temperature cycles?
Transit duration is the amount of time that a shipment remains in transit. External temperature profiles refer to the ambient temperature that the shipping container witnesses during its transit process. There are a number of acceptable means by which the ambient profile can be determined (summer highs, winter lows). Our engineers at Cold Chain Laboratories have many of years of experience providing customers with both means of determining or mapping these external temperatures through existing temperature data, en route data collection, and programs specially aimed at mapping a specific set of routes.
What is pre-qualification and qualification testing? How do they differ?
Pre-qualification (PQ), or Design Evaluation (DE), is the initial development of a thermal package design based on the needs assessment of the user. A successful pre-qualification test generally provides assurance that a package design will pass a final qualification test.
The Final Qualification test, sometimes referred to as a Validation, provides reasonable assurance that the qualified product or process will produce similar results under stated conditions. Upon completion of an acceptable design, the Final Qualification is performed demonstrating reproducibility (often at n=3). Cold Chain Laboratories issues the Final Qualification Report, which includes all data, certifications, and proof of validated equipment necessary for the rigorous review of a full audit.