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Expiration

How Bluefin handles lot expiration and shelf life.

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Written by Mark Lopez
Updated over a week ago

Drug product expiration is a critical factor in supply and distribution forecasting.

Shelf Life

Shelf life is used in the lot recommendation algorithm when recommending lot manufacturing runs. The shelf life (in months) is used to calculate the expected lot expiration date in the recommended lots.

For convenience, the stability value is saved on each part, and then applied automatically to new lots that are created. The value can be over-ridden at a lot level.

Value

Description

Effective Date

The date that a new shelf life applies. A "Default Shelf Life" applies when no later effective date applies.
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Effective dates are useful when shelf life extensions are expected after shelf stability data is obtained.

Shelf Life

The number of months that a drug product many exist after manufacturing (the "Available On" date) before being considered destroyed.
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Bluefin considers a "shelf life month" to be 30.44 days, rounded down to the nearest whole day.

Consider using Do Not Ship, Do Not Count, and Do Not Dispense constraints to modify how Bluefin recommends lots.

Expires Date

Within Bluefin, each lot has an expiration date, the "Expires At" field. During forecasting, Bluefin considers the drug product usable until 23:59:59 on the day of expiration. After expiration, Bluefin will attempt to replace any drug products that have been expired and not dispensed with another lot, e.g., if the drug products were included in a seeding shipment at a site or was used in buffers at a depot. Drug product that was reserved in depot overages is not replaced.

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