Package Validation and Pre-Shipment Testing

Pre-shipment testing or distribution testing involves controlled and objective assessment of packaging and product performance in the Package Testing Laboratory. This testing evaluates the response of packaging and product to the hazards and rigors of the distribution and shipping environment.

Smithers Pira leads the world in applying its knowledge of product, packaging and testing to provide validation and transit testing solutions for packaging suppliers, manufacturers and brand owners. Smithers Pira's expertise in transit testing covers the range of market sectors including fast moving consumer products (FMCG) and consumer packaged goods (CPG); medical, pharmaceutical and healthcare products; and electronics products including personal and industrial electronics.

Example projects are shown below

Objectives for Pre-shipment Testing

Most transit testing projects involve one of the following objectives:

• Pre-shipment validation of a new product to ensure that the product itself is sufficiently robust to withstand the rigors of distribution and handling
• Validation of a new packaging component or system (or a modified pack) to ensure that the packaging is able to protect the product and reach the point of use in the right condition - this includes ensuring that the packaged product retains all its functionality and that innovative packaging or product features are not compromised
• Trouble shooting a real life shipment issue in order to reduce damage and losses occurring in the field - this might also be to reduce field repair service or recall costs for industrial goods
• To support regulatory compliance for medical and healthcare products where evidence is required as part of a regulatory submission (FDA, MRHA) - distribution validation testing is used to demonstrate that the packaged goods will reach the point of use in sterile or satisfactory condition.

Smithers Pira's Expertise in Package Testing

Smithers Pira's expertise covers the range of shipping environments, including: healthcare lanes and the cold chain shipping environment, parcel and courier delivery, LTL shipments, unit load and full pallet shipments, retailer distribution and mixed load shipment, and roll cage and mixed pallets. Our knowledge of the supply chain and distribution testing extends from point of manufacture, through the shipment process, to point of sale, and beyond to customer/consumer use, including:

• Vibration testing to simulate road, rail, air and sea shipment conditions
• Drop testing and horizontal impact testing to simulate mechanical handling (fork lift truck handling, electric pallet truck movements, container handling, automated pallet and case handling)
• Drop and shock testing to represent manual handling (at 3rd party, brand owner or retailer distribution centre)
• Drop and handling testing to simulate in-store operations (including trolley handling and shelf loading)
• Compression testing to simulate warehousing/storage of products (including creep testing analysis to evaluate the effects of elevated temperature or longer term storage)
• Climatic conditioning to represent ambient, chilled and frozen retail environments, and elevated temperature and sub-zero global shipping conditions)
• Reduced pressure (vacuum) testing representing the effects of high altitude or reduced pressure air-freight shipments.

Post-test Integrity Assessment Capability (ISO 11607)
For terminally sterile medical packaging there is a need to demonstrate that the manufacturing, transit and storage environments do not compromise the sterility of the pack. For sterile barrier packaging, laboratory transit testing is followed by an integrity assessment.

In the UK Smithers Pira has extensive Materials Testing and Primary Packaging Testing laboratories, offering a broad range of tests including those specified within ISO 11607.

In the US these post-test integrity testing services are provided through Smithers Pira's Huntington Beach laboratory, with focus on section '6.3 Packaging-system performance testing' and section '6.4 Stability testing' of Part 1 of ISO 11607. Testing capability includes gross leak detection (ASTM F2096), dye penetration testing (ASTM F1929), seal strength testing (ASTM F88), determination of leaks by bubble emission (ASTM D3078) and visual inspection (ASTM F1886).

Examples of Pre-shipment and Distribution Validation Projects

• Regular validation testing for global confectionary brand to ensure packaged products are able to withstand common hazards of distribution. These projects involve unit load testing considering road transit (vibration) and pallet stability and mechanical handling assessments (drop and side impact/stability tests); testing is based on ISTA protocols.
• Routine investigation of packaging fitness for new high value fragrance products for the European market (client test method developed by Smithers Pira)
• Stage-gate validations for range of innovative aerosol products in the health and personal care sector, based on ASTM D4169
• Standard ASTM D4169 testing for global medical device producer in support of FDA compliance
• Retail supply chain fitness assessments (covering unit load, mixed load and individual pack testing) for drinks products in aluminum cans, for leading global beverage brand, using mix of standard and Smithers Pira developed tests
• Standard validation testing of medical products using ISTA 3A for large international healthcare goods provider.