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ASTM D4169 − 23e1 and ASTM D7389-16​

  • For sterile packaging systems, not only the ISO standards 11607-1 and 11607-2 must be applied, but also the packaging system development process, including FMEA, should be documented accordingly.

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  • It should also be pointed out that these two standards could in principle be applied to other products - with one difference: The requirement to maintain sterility does not apply.

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  • In addition, various standards exist dealing with specific requirements such as primary packaging materials for medicinal products.

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Best case:

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  • You might say: It has always been fine so far - but due to a change in the ASTM standards, it will not be possible to pass the performance test in the future.Such a statement will not be accepted by those responsible in the QA department or by the regulatory authorities. (FDA, EMA, etc. and/or the Notified Body)

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What about a "robust rationale" that conclusively demonstrates why what should be tested and why the test setup is applicable and practical?

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Basically, there are only two options:

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1. Proof of the integrity of a packaging system with an associated sipping system and a defined shipping route; as a consequence, a statement on the integrity is possible for this case only. This type of setup can be useful if, as an example, a product (API) requires a dedicated setup for a shipment from manufacturing site “A” to site receiving  “B”.​

 

2. A generic approach that does not depend on the shipping lane, but covers a global shipping lane with a defined shipping system (corrugated board box (e.g. FEFCO 0201 or often called American box).

 

  • In both cases, evidence must be provided that the product's performance is guaranteed at the point of use, e.g. that it is still sterile and can be used for its intended purpose.

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It is clear: Option 2 would be a one-size-fits-all approach

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However, what is the worst-case scenario in Option 2?

Example:

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  • Let's presume the product is transported as a homogeneous - i.e. unmixed - shipping box from the production site to a picking center, where it is separated and then fed into an order-specific “pick and place” picking process. 

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Question:

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  • Is it really possible to refer to a performance report that only covers the transport from the production site to any picking center? After all, let's not fool ourselves here, it is highly unlikely that the picking center will use the boxes that the manufacturer has used. Action is needed because the manufacturer is responsible and must take appropriate steps in advance.

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Finally, let's take a look into the details:

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  • So it's worth taking a closer look at the distribution channels, e.g. are only Less Truck Load shipments sent and always on a load carrier, such as pallets, or are products also sent in single parcel shipments? These are huge variations!

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What safety factor (assurance level) should be applied: 

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  • What is the worst-case scenario for transport to the picking center and subsequent onward shipment to the customer, e.g. hospital, pharmacy?

 

  • The decision must be based on knowledge and not on “faith”, such as: "We don't want any risk, so the highest safety factor is applied!"

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  • Your QA should be aware of what is actually being tested in a performance simulation and what it means in reality.​

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  • It would mean for a BC- fluting box [400x600x50 mm] according to ASTM D4169-23e1, the box must be capable of withstanding approx: 10.2 [kN]!In this case, a solid wooden box is recommended.

 

  • Example to apply a risk based assessemt click here! It can be summarised for more than one shipping box.

 

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