USP <1072> Disinfectants and Antiseptics - Use and Application of Sanitizers, Disinfectants and Sterilants

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>

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Microbiology plays a role throughout the manufacture of pharmaceutical products. Both non-sterile and sterile products are susceptible to the microorganisms they contact during the manufacturing process and may include the raw materials and in-process operation through final product. The environmental and utility systems must also be maintained as must the packaging components, manufacturing equipment, and personnel. To maintain this controlled process and environment, sanitizers, disinfectants and sterilants (sporicides) are essential.

To assist with maintaining this controlled environment also requires knowledge of the microorganisms present and their susceptibility to various sanitizers, disinfectants and sterilants. Whether the final product is non-sterile or sterile, the bioburden exists throughout the process and/or within the product's environment. A critical review of the overall microbiological process will determine whether the critical “in-process” points permit the final product to meet its acceptance criteria. USP<1072> Disinfectants and Antiseptics, a General Information Chapter, is a useful tool which assists the user in the maintenance of this controlled process.

The determination of the disinfectant to use is largely dependent upon the site of application and the type of microorganism present. For example, Gram positive cocci are very easy to kill, while spore forming rods and fungi are more resistant. Other elements that need to be considered include the biocidal activity, concentration of microorganisms, contact time, and secondary issues to include water hardness and organic materials. In addition, surface films may also interfere with the direct contact of the microorganism and the disinfecting agent. Any "objectionable" or "specified" microorganisms that may be encountered during the procurement of raw materials and the processing must be considered.

Whether you are auditing a raw material supplier, a testing laboratory, or your own facilities, you should be aware of the critical role the microorganisms play throughout. You should be aware of the various microbiological related documents, e.g., raw material sampling criteria, in-process, API, final product, environmental and utilities, to determine whether the SOPs, validations as well as government and other regulatory body documents are maintaining the control required to permit the final product to enter the marketplace as microbiologically safe.

The objective of this live training webinar is to explore the use of various sanitizers, disinfectants and sterilants within a controlled environment and learn which materials may be appropriate for your facilities’ operations and to assure that you are complying with your own SOPs, governmental and regulatory guidances and regulations. USP<1072> Disinfectants and Antiseptics, a General Information Chapter, is a useful tool which will assist the user in the maintenance of this controlled process.

Learning Benefits:
-The FDA’s view on disinfection. -The spectrum of disinfection. -The effectiveness of differing types of sanitizers, disinfectants and sterilants on a microbiological population as per USP<1072>.
-How Microbial Enumeration (USP<61>, <62>) impacts all microbiological issues.
-Microbiological identification and its application in choosing the correct disinfectant/sterilant.
-Testing requirements within a disinfection program.
-Microorganisms to include within a disinfection testing program.

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Several FDA related Disinfection Issues,
The Choosing of an Acceptable Sanitizer, Disinfectant or Sterilant (Sporicide),
Microbial Identification and the Choosing of the Proper Disinfectant,
Why a “Complete” Identification is not Always Required in Selecting a Disinfectant,
Proper Application of a Sanitizer, Disinfectant or Sterilant,
11:30 AM Break
11:40 AM Myths Surrounding Resistance to Disinfectants,
Why a “Complete” Identification is not Always Required in Selecting a Disinfectant,
Which Government Body Regulates Disinfectants,
Microorganisms to Include in Disinfection Testing,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>



Course Number: 216

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

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