ISO 17712 is an international standard that specifies requirements for the mechanical seals used on containers in order to provide tamper evidence and security for shipments. These seals are commonly used in various industries, including pharmaceuticals and high-value shipments. While ISO 17712 does provide general guidelines for testing and classifying these seals, it doesn’t specifically address the unique requirements of pharmaceutical or high-value shipments. However, there are certain considerations and best practices that can be applied when testing seals for such sensitive cargo.
Pharmaceutical and high-value shipments require a higher level of security due to the nature of their contents and the potential risks involved. Ensuring the integrity of the seals is crucial to prevent tampering, theft, and the introduction of counterfeit or harmful products into the supply chain.
Here are some guidelines that can be considered when testing seals for use in pharmaceutical or high-value shipments:
Seal Selection:
Choose seals that meet or exceed ISO 17712 requirements, focusing on the “High Security” category. These seals are designed to provide the highest level of tamper evidence and security.
Tamper Evidence:
Seals used in pharmaceutical and high-value shipments should provide clear and unmistakable evidence of tampering. Testing should focus on assessing the ease of tampering and the extent of visible evidence when tampering occurs.
Material Compatibility:
Consider the compatibility of the seal material with the contents of the shipment. Some pharmaceutical products or high-value items may be sensitive to certain materials, which could lead to contamination or damage.
Strength and Durability:
The seals must be able to withstand rigorous handling, transportation, and environmental conditions. Test the seals for their strength, resistance to cutting, and durability over time.
Locking Mechanism:
Evaluate the locking mechanism of the seals to ensure that they are not easily compromised. The locking mechanism should be secure and resistant to manipulation.
Unique Identification:
Seals should have unique identification numbers or codes to prevent unauthorized replacement. Testing should verify the readability and durability of these identifiers.
Tampering Techniques:
During testing, simulate various tampering techniques that potential criminals might employ, such as cutting, picking, freezing, or applying heat. Assess how effectively the seals resist these techniques and whether they provide clear evidence of tampering.
Independent Testing:
Consider involving third-party testing organizations or laboratories to conduct unbiased assessments of seal effectiveness. Independent testing adds credibility to the results and helps identify potential weaknesses.
Environmental Testing:
Perform tests under different environmental conditions, including temperature extremes, humidity, and exposure to chemicals. Ensure that the seals remain effective and tamper-evident in challenging environments.
Documentation and Reporting:
Keep detailed records of the testing procedures, methodologies, and results. Create comprehensive reports that outline the performance of the seals under various conditions and tampering attempts.
Continuous Improvement:
Regularly review and update seal testing procedures based on new security threats, advancements in tampering techniques, and feedback from real-world incidents.
Conclusion:
while ISO 17712 provides a framework for seal security, the unique requirements of pharmaceutical and high-value shipments necessitate additional considerations during testing. By selecting appropriate seals, conducting thorough and comprehensive testing, and continuously improving security measures, pharmaceutical and high-value shipments can maintain a higher level of security and safeguard their contents throughout the supply chain.
