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Functionality can encompass multiple areas, such as providing identified characteristics of the finished product (binders, thickeners, type of resin for plastic packaging, etc.), organoleptic characteristics (flavor, color, aroma, texture), product safety characteristics (to lower the p H or water activity), and preservatives (extension of shelf life, color, or flavor retention, etc.).Is there a raw material already in use that has the same or similar characteristics? Resource: List of existing approved materials and their specifications.Shortened onboard stability requires more user intervention to replace reagents and creates delays in work output. IVDs with multiple storage conditions, such as six months frozen or 24 hours thawed, require more user interaction, which could lead to errors when trying to establish the “after opening/thawing” expiration.• Preservative effectiveness for microbially controlled or sterile IVDs.Global regulations that apply to the control of adventitious agents in raw materials cover prions, viruses, mycoplasma, bacteria and molds/yeasts.

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Global regulations, current publications and current PDA technical reports aid in the development of this approach.

They can almost always hit first when a news story comes out that they can spin to attack their detested science.

On the other hand, it usually ensures that by the time I get home, have dinner, and settle down in front of the TV with my laptop to discusse the latest bit of science, there’s some tasty crankery to deconstruct.

Historically, research and development worked alone when selecting a new raw material.

But now a broad team of expertise is needed, due to increased access to unique and complex materials, global sourcing, handling methods, customer locations, and regulations.

Oddly enough, tonight appears not to be one of those times.

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