Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Chemical Agents for Microbial Control01:27

Chemical Agents for Microbial Control

148
Chemicals play important roles in controlling microbial growth by targeting microbial structures and functions as sanitizers, antiseptics, disinfectants, and sterilants.Alcohols are commonly used sanitizers, effectively disrupting lipid membranes, which compromises cell integrity. They are also used as antiseptics and disinfectants due to their rapid action and versatility.Phenols and their derivatives phenolics , known for denaturing proteins and disrupting cell membranes, are particularly...
148
Steps in Outbreak Investigation01:18

Steps in Outbreak Investigation

156
In the ever-evolving field of public health, statistical analysis serves as a cornerstone for understanding and managing disease outbreaks. By leveraging various statistical tools, health professionals can predict potential outbreaks, analyze ongoing situations, and devise effective responses to mitigate impact. For that to happen, there are a few possible stages of the analysis:
156
Key Techniques in Microbiology01:29

Key Techniques in Microbiology

162
Aseptic techniques prevent contamination, ensure experimental accuracy, and protect researchers and microbial cultures. These techniques are essential in clinical, industrial, and research settings where sterility is required.Maintaining Sterility in Laboratory PracticesScientists maintain sterility by sterilizing tools with heat or chemicals, disinfecting work surfaces, and handling cultures in controlled environments. Working near an open flame or within a laminar flow hood reduces the risk...
162
Standard Precaution01:26

Standard Precaution

2.0K
Standard precautions are the minimum infection control safeguards used while caring for all patients, irrespective of their disease condition. They help prevent the spread of common infectious microorganisms to healthcare workers, patients, and visitors in all healthcare settings.
Hand hygiene is the most crucial means to prevent the transmission of disease. Employers are legally required to provide their workers with personal protective equipment (PPE) to minimize exposure or contact with...
2.0K
Methods for Controlling Microbial Growth01:29

Methods for Controlling Microbial Growth

190
Microbial growth control refers to various methods employed to inhibit, reduce, or eliminate microorganisms to ensure safety and hygiene across different settings. These methods are categorized based on the target environment and the level of microbial control required.Biocides are versatile agents designed to control microorganisms by either inhibiting their growth or outright killing them. These agents work through various physical, chemical, mechanical, or biological mechanisms. The...
190

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Considerations in Qualifying Critical Suppliers.

International journal of pharmaceutical compounding·2023
Same author

Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control.

International journal of pharmaceutical compounding·2023
Same author

Sterile Basics of Compounding: Contamination Control Strategies, Part 2.

International journal of pharmaceutical compounding·2022
Same author

Sterile Basics of Compounding: Contamination Control Strategies, Part 1.

International journal of pharmaceutical compounding·2022
Same author

Sterile Basics of Compounding: How to Implement a Robust Visual-inspection Program.

International journal of pharmaceutical compounding·2022
Same author

Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2.

International journal of pharmaceutical compounding·2021

Related Experiment Video

Updated: Aug 4, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

3.5K

Advanced Compounding; How to Investigate Microbiological Excursions at a Sterile Compounding Facility.

Amy Summers1

  • 1Restore Health Consulting LLC, Laguna Beach, California. info@restorehealthconsulting.com.

International Journal of Pharmaceutical Compounding
|March 31, 2023
PubMed
Summary

Investigating microbiological excursions in cleanrooms is crucial per USP <797> guidelines. This article details root cause analysis using Ishikawa diagrams and other key investigation elements for sterile compounding facilities.

More Related Videos

Investigation of Microbial Cooperation via Imaging Mass Spectrometry Analysis of Bacterial Colonies Grown on Agar and in Tissue During Infection
09:49

Investigation of Microbial Cooperation via Imaging Mass Spectrometry Analysis of Bacterial Colonies Grown on Agar and in Tissue During Infection

Published on: November 18, 2022

2.2K
Tracking Microbial Contamination in Retail Environments Using Fluorescent Powder - A Retail Delicatessen Environment Example
05:49

Tracking Microbial Contamination in Retail Environments Using Fluorescent Powder - A Retail Delicatessen Environment Example

Published on: March 5, 2014

11.2K

Related Experiment Videos

Last Updated: Aug 4, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

3.5K
Investigation of Microbial Cooperation via Imaging Mass Spectrometry Analysis of Bacterial Colonies Grown on Agar and in Tissue During Infection
09:49

Investigation of Microbial Cooperation via Imaging Mass Spectrometry Analysis of Bacterial Colonies Grown on Agar and in Tissue During Infection

Published on: November 18, 2022

2.2K
Tracking Microbial Contamination in Retail Environments Using Fluorescent Powder - A Retail Delicatessen Environment Example
05:49

Tracking Microbial Contamination in Retail Environments Using Fluorescent Powder - A Retail Delicatessen Environment Example

Published on: March 5, 2014

11.2K

Area of Science:

  • Pharmaceutical Compounding
  • Microbiology
  • Quality Assurance

Background:

  • United States Pharmacopeia (USP) Chapter <797> mandates thorough investigation of non-conforming cleanroom conditions.
  • Effective November 1, 2023, timely investigation of microbiological excursions is required.
  • Sterile compounding facilities face regulatory scrutiny regarding environmental monitoring.

Purpose of the Study:

  • To outline essential elements for investigating microbiological excursions in sterile compounding.
  • To demonstrate the application of Ishikawa diagrams for root cause analysis.
  • To discuss critical concepts including product impact, CAPA effectiveness, and trend analysis.

Main Methods:

  • Root cause analysis utilizing an Ishikawa (fishbone) diagram.
  • Product impact assessment to determine risk to compounded sterile preparations.
  • Corrective and Preventive Action (CAPA) effectiveness verification.
  • Trend analysis of environmental monitoring data.
  • Identification of common investigational pitfalls.

Main Results:

  • A structured approach to investigating microbiological excursions is presented.
  • The use of Ishikawa diagrams facilitates comprehensive root cause identification.
  • Key components for effective investigations, including CAPA and trend analysis, are highlighted.

Conclusions:

  • Adherence to USP <797> requires robust investigation protocols for microbiological excursions.
  • The outlined methodology provides a framework for ensuring sterile compounding quality and safety.
  • The principles discussed are applicable to various environmental monitoring excursions beyond microbiological contamination.