Tag Archive for QC microbiology

The Compendial Sterility Tests

Scott Sutton, Ph.D.
Microbiology Network, Inc.

Note:  The opinions expressed in this blog are those of the author and should not be interpreted as the positions or policies of USP or any other organization.

The compendial Sterility Test first appeared in recognizable form in the British Pharmacopeia in 1932 and then in the USP in 1935 as a direct response to a clear need for a recognized test to check for pharmaceutical product sterility.  Since this time, the design of the test has remained fundamentally unchanged although there has been refinements in the actual test design ending with its international harmonization in 2003. What we call the “Sterility Test” is more appropriate titled “Sterility Tests” in the compendia as the chapter includes two distinct types of testing, one utilizing membrane filtration and the second a direct transfer of the medicine into recovery media for recovery.  The concerns discussed below apply to both test designs. Read more

Alphabet Soup: Abbreviations and Acronyms of Interest

Scott Sutton, Ph.D.

 

One of the more challenging aspects of that first job, or starting a new job in a new company, is in learning the corporate culture.   The abbreviations and acronyms to which we all are addicted do not make this process any easier.    I often wondered why there wasn’t a standard listing of abbreviations issued to all new hires upon joining a company.

The Microbiology Network has prepared a list of commonly used abbreviations in pharma, biotech, personal care products and management jargon that might be of assistance.  Read more

The Compendial Draft Chapter on “Bioburden Control of Nonsterile Drug Substances and Products”

USP Chapter 1115 Pharm Forum 39(4) July/August 2013.

Scott Sutton, Ph.D.
Microbiology Network, Inc.

 

The long-awaited USP draft of a newly proposed chapter – <1115> Bioburden Control of Nonsterile Drug Substances and Products” has been released in Pharmacopeial Forum of July/August, 2013.   This chapter describes a risk-based approach to monitor and control of the manufacturing facility and process for non-sterile drugs. Read more