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

Key Techniques in Microbiology01:29

Key Techniques in Microbiology

423
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...
423
Data Validation01:15

Data Validation

230
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
230
Physical Methods for Controlling Microbial Growth: Radiation and Filtration01:26

Physical Methods for Controlling Microbial Growth: Radiation and Filtration

215
Radiation and filtration are essential tools for microbial control, targeting microorganisms through distinct mechanisms. Radiation eliminates microbes by damaging their DNA, either killing them or inhibiting their growth. Based on wavelength, radiation is classified into two types: nonionizing and ionizing radiation.Non-ionizing radiation, such as UV radiation (200–400 nm), is absorbed by DNA, causing defects that effectively disinfect surfaces, air, and water, including safety cabinets.
215
Methods for Controlling Microbial Growth01:29

Methods for Controlling Microbial Growth

467
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...
467
Biological Methods for Microbial Control01:28

Biological Methods for Microbial Control

194
Biological agents offer an effective means of controlling microbial growth by leveraging natural processes like predation, competition, and the secretion of antimicrobial substances.Predatory bacteria such as Bdellovibrio species target and kill pathogens like Salmonella and E. coli. They are widely used in poultry farms to control infections. Myxococcus species help combat plant-pathogenic fungi. These naturally occurring predators serve as eco-friendly alternatives to chemical pesticides and...
194

You might also read

Related Articles

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

Sort by
Same author

Proteomic signatures of loss of glycemic control in youth-onset type 2 diabetes in the TODAY study.

The Journal of clinical endocrinology and metabolism·2026
Same author

Publisher Correction: A 98-qubit trapped-ion quantum computer with all-to-all connectivity.

Nature·2026
Same author

Stochastic Morphodynamics of the Human Aorta Across the Lifespan.

medRxiv : the preprint server for health sciences·2026
Same author

A 98-qubit trapped-ion quantum computer with all-to-all connectivity.

Nature·2026
Same author

Personalized modeling of stress and blood pressure reactivity using mobile health data.

Npj mental health research·2026
Same author

Mechanism-informed evaluation of particle formation in high-concentration monoclonal antibodies during fill-finish: Impact of pump materials, surface interactions, and system architecture.

Journal of pharmaceutical sciences·2026

Related Experiment Video

Updated: Sep 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

3.6K

A Quality by Design Approach to Microbial Retention Validation.

Annie Leahy1, Jennifer Juneau2, Kathleen Souza3

  • 1Process Solutions, MilliporeSigma, Bedford and Burlington, MA; and annie.leahy@milliporesigma.com.

PDA Journal of Pharmaceutical Science and Technology
|July 15, 2022
PubMed
Summary

Quality by Design (QbD) can reduce product-specific microbial retention testing for sterilizing filters in early-stage manufacturing. A risk assessment ensures early-stage products meet microbial retention requirements within a defined design space.

Keywords:
Final fillQuality by DesignSterilizing-grade filtersValidation

More Related Videos

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
05:45

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality

Published on: April 7, 2023

3.6K
Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
07:00

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

Published on: August 11, 2017

8.3K

Related Experiment Videos

Last Updated: Sep 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

3.6K
Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
05:45

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality

Published on: April 7, 2023

3.6K
Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
07:00

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

Published on: August 11, 2017

8.3K

Area of Science:

  • Pharmaceutical Manufacturing
  • Biotechnology
  • Filtration Technology

Background:

  • Current regulations mandate product-specific microbial retention testing for sterilizing filters.
  • Early-stage product development often lacks sufficient material for extensive testing.
  • This creates a bottleneck in the development and manufacturing of new therapeutics.

Purpose of the Study:

  • To explore the implementation of a Quality by Design (QbD) approach for sterilizing filtration.
  • To establish a paradigm that minimizes or eliminates the need for product-specific testing in early development.
  • To define a design space for microbial retention based on process and product parameters.

Main Methods:

  • Systematic variation of process and product parameters affecting microbial retention.
  • Establishment of a defined design space for sterilizing filter performance.
  • Development of a risk-based approach for early-stage (Phase 1) filter validation.

Main Results:

  • A QbD approach can define critical process and product parameters influencing microbial retention.
  • This allows for the establishment of a robust design space for sterilizing filters.
  • Risk assessment can confirm that early-stage manufacturing conditions fall within the validated design space.

Conclusions:

  • Implementing QbD for sterilizing filtration can obviate the need for extensive product-specific testing in early development.
  • A risk assessment strategy supports the use of an established design space for Phase 1 manufacturing.
  • Product-specific filter validation testing remains expected for later-stage development prior to marketing authorization.