Distribution Simulation Testing
There are numerous variables that medical packages and products will encounter when traveling from the point of manufacture to the sterilization facility, distribution center, health care facility, etc. A medical package falling from a fork lift, swaying around a truck during transit, or being stacked on top of other packages / containers in a storage warehouse are all examples of distribution occurrences.
Distribution Simulation is a systematic and repetitious way of testing shipping containers, using testing equipment which exposes these packaging systems to genuine, real-life hazards that may ensue within the forthcoming distribution environment. Distribution Simulation is a large and quintessential component that complies with the ISO 11607 standard.
It may also be necessary to expose the medical packages and products to atmospheric conditioning in order to simulate particular field conditions that a packaged product or component may encounter during its expected life cycle or testing cycle. The ASTM D4332 standard covers this.
Distribution Simulation Testing Types
Drop
Used to determine the rugged nature of medical packages and the effectiveness of its interior cushioning ability when the products/packages systems are exposed to impact during material handling operations.
Vibration
Used to determine the ability of medical packages and products to withstand shock and vibration encountered during the entire transit course.
Compression
Used to determine the maximum compression resistance and long-term stacking strength of both individual medical packages and their master shipping containers.
ISTA Procedure 1A – Testing Sequence and Types:
| Sequence | Test Type | Standard | Description |
| 1 | Vibration | ASTM D999 | Fixed Displacement, Rotary, Vertical Linear Motion |
| 2 | Drop | ASTM D5276 | Free Fall |
ISTA Procedure 2A – Testing Sequence and Types:
| Sequence | Test Type | Standard | Description |
| 1 | Atmospheric Preconditioning | ASTM E171 | Ambient Temperature and Humidity |
| 2 | Atmospheric Conditioning | ASTM D4332 | Controlled Temperature and Humidity |
| 3 | Compression | ASTM D642 | Machine Apply and Release |
| 4 | Vibration | ASTM D999 | Fixed Displacement |
| 5 | Shock | ASTM D5276 | Drop |
| 6 | Vibration | ASTM D999 | Fixed Displacement |
Related Topics
- ISO-11607
Packaging for Terminally Sterilized Medical Devices - ASTM - D Standards
- ASTM - F Standards
- ISTA Testing Standards
- Distribution Simulation Testing
- Package Validation Testing
- Real Time Aging
- Accelerated Aging
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