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Basics of Sterile Compounding: Bubble Point Testing

Author(s):  Thoma Laura

Issue:  Jan/Feb 2014 - Volume 18, Number 1
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Abstract:  Compounding pharmacies that compound sterile preparations must choose sterile filters that are approved for human use. They may rely on the filter manufacturer’s Certificate of Quality to ensure the sterile filter is pyrogen free and has been tested for bacterial retention. The Certificate of Quality from the filter manufacturer also contains other useful information about the filter such as: flow rate and maximum pressure drop, thermal and hydraulic stress, and membrane results of the initial integrity test performed on the filter membrane with water, if a hydrophilic membrane. This article discusses the integrity test, which is often called the water bubble point test.

Related Keywords: Laura Thoma, PharmD, compounded sterile preparations, sterile compounding, sterile filters, filtration sterilization, integrity test, bubble point testing

Related Categories: STERILE PREPARATIONS, SUPPORT, QUALITY CONTROL

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