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Packaging critical for in vitro diagnostics

Moisture, oxygen, and hydrocarbons can threaten the accuracy and consistency of in vitro diagnostic devices.


Analyzing urine, saliva, and blood samples are critical in determining patient care. That makes it critical for packaging to do its part to maintain the reliability of the in vitro diagnostics used for such samples.

In an October 2010 article for IVD Technology, Adrian T. Possumato writes, “IVDs are highly sensitive to changes in their packaging environment. Moisture is typically the biggest degradation threat to IVDs. The largest single contributor to moisture ingress is via imperfections in the seal of the packaging that is supposed to protect the IVD device.”

Oxygen and hydrocarbons are also a threat to IVD devices, he says. When moisture, oxygen, and/or hydrocarbons are inside the packaging they could result in “inaccurate and inconsistent test results,” says Possumato. “For example, a diabetic person using a compromised test strip to test his/her blood glucose levels could receive a false high or low blood glucose level reading, triggering an inaccurate administration of insulin.”

In the article, Possumato, Global Director, Healthcare Packaging at Multisorb Technologies, discusses sorbent options for IVDs and medical device packaging. The goal of packaging experts, he says, “is to select the right sorbent with the correct capacity to preserve the stability of the IVD, enhance its ability to deliver clinically acceptable specimens and results, and ensure a long-term shelf life.”

IVD Technology’s article concludes with Possumato discussing how IVD device advances are being developed regularly. “This on-going process puts new pressures on the packaging expert who will be required to understand the sensitivities of the new IVD devices, which will determine their packaging requirements.”

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