Design Qualification (DQ) Testing Services

Design qualification is an initial test to screen and develop confidence on whether a proposed shipping system is suitable for additional qualification and validation, such as Operational Qualification (OQ) and Performance Qualification (PQ), as required. DQ testing may evaluate several shipping systems in parallel. As DQ testing is considered preliminary testing, typically the DQ is performed without QA oversight since shipping systems may not meet requirements.

The DQ testing of a proposed shipping system typically comprises of two aspects: 

  • Distribution/Mechanical
  • Thermal 

    Our team is able to help many clients with various shipping requirements, such as different temperature ranges, transportation methods. Screening and testing shipping systems can be expedited through our relationships with shipping systems manufacturers and testing laboratories domestically and internationally. 

Distribution/Mechanical DQ Testing

Distribution DQ testing verifies that the proposed shipping system can protect the product payload from typical shipping hazards, such as random vibration and shock (drops)  encountered during transport.

Load

Test Replicates

Description

Minimum Load

1

Smallest quantity to be shipped in proposed shipper

Maximum Load

1

Largest quantity to be shipped in proposed shipper

The minimum and maximum load configurations in the shipping system are tested to bracket the range in quantity of products to be shipped in the shipping system. Factors to determine which distribution/mechanical standard to select are the following: 

  • Packaging type (small parcel, pallet, etc.)
  • Mode of Transport (air, sea, ground, etc.)

For example, small parcel shipping systems are typically tested against ISTA 3A or ASTM D4169, while pallets are tested against ISTA 3B/3E or ASTM D4169. The packaging configuration and expected transportation method determine which testing schedule is to be  selected for the distribution testing of the proposed shipping system.

    Thermal DQ Testing

    Thermal DQ testing will test the proposed shipping system against simulated thermal profiles that mimic the expected hottest and coldest shipping lanes (see Lane Assessment). Typical standard thermal profiles are the following: 

    • ISTA 7D
    • ISTA 7E
    • Customer-specific
    • Modified versions of standard profiles to replicate the supply chain process 

    Using an accepted industry standard profile like ISTA 7D and ISTA 7E is the most common approach for qualifying various shipping lanes for thermal testing. If a customer-specific thermal profile is required, the profile should have actual temperature data along the hottest and coldest shipping lanes. For this purpose, the hottest shipping lane would be the hottest temperatures at origin/packout and hottest temperatures at destination/receiving, and the coldest shipping lane would be the coldest temperatures at origin and packout environment and the coldest temperatures at destination and receiving environment. Since gathering temperature data can be a costly study, the industry standard profiles are often selected as a worst-case shipping profile with justification. Factors to determine which thermal profile standard to select are the following: 

    • Seasonal (if applicable)
    • Expected shipping duration
    • Specific shipping/Receiving environmental conditions
    LBX can develop, execute, and summarize the DQ testing for a customer’s review while being compliant with the current industry and regulatory standards. After successfully demonstrating the shipping system’s ability to protect product from physical damage and maintaining thermal shipping requirements, qualification of the shipping system then undergoes Operational Qualification (OQ) and Performance Qualification (PQ) testing.

    What to Ask a Shipping System Vendor?

    Why choose a pre-qualified shipping system? At some point when designing a supply chain, a system for transporting the product must be developed or selected from available shipping system vendors. The most straightforward and least time intensive option is selecting a...

    Comparing ASTM D4169-16 to ASTM D4169-22

    What is ASTM D4169 testing? ASTM International developed the standard ASTM D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems,” to test a shipping systems’ ability to withstand typical distribution hazards that occur in a supply...

    Supply Chain Considerations: ISTA Thermal Profiles for Shipper OQ

    The purpose of this article is to explain why you may choose an established ISTA profile in lieu of using a custom profile for OQ temperature validation studies. The established ISTA ambient profiles are industry tested and widely accepted globally, whereas custom...

    Whitepaper: Evaluation of Shipping System Qualification Data

    The Lean Process Learn and apply industry best practices within your qualification processes to evaluate qualification data provided by thermal shipping system manufacturers and vendors. Leveraging pre-existing qualification packages is a tremendous time and resource...

    Fast Tracked Gene Therapy Shipping Qualification for BLA

    A global biotechnology company working toward regulatory approval of a gene therapy treatment was required to perform shipping validation to support review and approval in the US market. As the primary indication was targeted for fatal neuromuscular genetic disease...

    Overcoming a Challenging In-Country Distribution Model

    A leading fortune 500 company headquartered in Cambridge, MA was planning to launch a number of biological products into new markets for the first time. Product specific shipping qualification was performed and qualified shipping containers were in use for domestic...

    CDMO Platform Shipping Strategy/Qualification

    A leading cell and gene therapy CDMO located in Cambridge, MA desired to qualify and implement platform shipping systems that could maintain their product requirements and regulatory compliance.   Challenges Aggressive timeline to complete qualification and...

    How can we help?