👉 What is Packaging Validation?
The validation of packaging stems from the need to ensure the quality of products across the many steps in your distribution cycle: from shipping & storage to final user. It is a common requirement for many product categories, including a strong emphasis on the packaging quality requirements for the medical and pharmaceutical industries.
👉 What are the types of Packaging Validation?
Packaging Validation for medical devices & pharmaceutical goods is segmented into three categories.
✅ Environmental Conditioning
✅ Transport Simulation (or also known as Transit Testing)
✅ Integrity Testing (or also known as Sterile Barrier Integrity Testing)
👉 What is ISTA 2A?
The ISTA 2A Transport Simulation standard is designed to evaluate ready-to-ship packed items weighing up to 68kg.
ISTA 2A standard tests a packaging system's ability to withstand the physical stress of transportation throughout the product’s supply chain to the final users. The standard is issued by the International Safe Transport Association (ISTA), an organisation devoted to understanding the expectations of secure transport services.
👉 What is ISTA 2A’s test sequence?
ISTA 2A is composed of 4 testing types:
1️⃣ Atmospheric Conditioning
2️⃣ Compression Testing
3️⃣ Vibration Testing
4️⃣ Shock & Drop Testing
👉 What is Atmospheric Conditioning?
The protective features of a packaging may be reduced depending on the environmental conditions faced during transport. Both changing Humidity & Temperature levels may alter the packaging’s protecting abilities.
In ISTA 2A, the standard requires the first perform an atmospheric conditioning test sequence. In Atmospheric Conditioning Testing, the products are placed in an atmospheric conditioning chamber where they are faced with pre-defined specific changes in both humidity & temperature for a specific period of time.
ISTA 2A’s Atmospheric Conditioning follows the ATSM D4332 Standard.
📦 According to ISO 11607-1
ISO 11607-1 specifies the requirements related to the compliance of the packaging for sterilised medical devices, including materials, sterile barrier systems and packaging systems.
🎯 To learn more about our ISTA 2A Transport Simulation & Packaging Validation Services, visit on our website at www.medistri.swiss or directly contact our team at contact@medistri.swiss.
- The Medistri Team
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