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| Stability Module |
| Stability and
Shelf-Life Analyses |
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Today’s challenge for many manufacturers is to meet both the FDA’s and the International Conference on Harmonization’s (ICH) guidelines. The intent of these guidelines is to clarify and raise basic testing standards. They are being incorporated by regulatory bodies around the world but especially in the US, Japan and Europe, and are helping to create a standardized regulatory environment worldwide. With this regulatory movement, the need for more, well-documented stability and shelf-life studies is paramount.
Stability and shelf-life testing ensures that products distributed to the public remain chemically and structurally unwavering once they are released. Stability protocols test:
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Potency of a product throughout its entire shelf-life to establish expiration dates |
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Effects of packaging material combinations |
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Effects of UV rays (products discoloration and etc.) |
Companies in regulated industries, including pharmaceutical, contract services, health & personal, and food and beverage, have long been involved with stability testing due to the requirements stipulated in 21 CFR 211.
In addition, new industry sectors are now being required to perform stability testing, which is creating analytical challenges not encountered before. Suppliers of bulk active pharmaceutical ingredients (API) and raw materials manufacturers now must have stability data for their products. Manufacturers of vitamins and supplements with botanical ingredients, while not yet required to meet the same regulatory requirements as drug manufacturers, are finding it beneficial to have dependable stability data to back up their label claims and expiration dates.
LabVantage’s Sapphire Stability Module enables customers to:
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Automate shelf-life testing to provide evidence of expiration dates |
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Automate the determination of product batch stability |
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Automate label creation ad hoc or based upon scheduled pull dates |
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Test raw materials, intermediate products and packaging components |
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Generate shelf-life samples automatically and establish the specified times and numbers for product pulls for each study |
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Create pull lists including partial sample pulls to remove test samples at defined protocol intervals |
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Provide considerations for the repetitive nature of study and sample selection |
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Maintain information about products, conditions (challenges) and custom protocols |
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Create reports for studies and protocols in a detailed or summary format |
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Manage inventory tracking by container or raw units |
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Delay or cancel individual conditions for each study |
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Require approval by alternate users for study/condition changes |
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Define the orientation of the container storage |
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Simply cut, copy and paste information in to a grid much like using Microsoft Excel |
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