Basics of sterile compounding

bubble point testing.

Laura Thoma

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)54-57
Number of pages4
JournalInternational Journal of Pharmaceutical Compounding
Volume18
Issue number1
StatePublished - 2014
Externally publishedYes

Fingerprint

Membranes
Testing
Pyrogens
Water
Pharmacies
Pressure drop
Hot Temperature
Flow rate
Hydraulics
Pressure

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science
  • Pharmacology (medical)
  • Pharmacology (nursing)
  • Pharmacy

Cite this

Basics of sterile compounding : bubble point testing. / Thoma, Laura.

In: International Journal of Pharmaceutical Compounding, Vol. 18, No. 1, 2014, p. 54-57.

Research output: Contribution to journalArticle

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