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

Cleaning, Sterilization, and Disinfection01:30

Cleaning, Sterilization, and Disinfection

11.6K
Cleaning, disinfection, and sterilization are the methods that help to break the infection chain and prevent disease.
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
11.6K
Scale-Up Processes01:14

Scale-Up Processes

105
The scale-up of microbial fermentation processes is essential in industrial biotechnology, allowing the transition from laboratory-scale experiments to commercial-scale production while aiming to maintain product yield and quality. This process requires meticulous adjustment of equipment design, process parameters, and contamination control strategies to accommodate increasing culture volumes.At the laboratory scale, cultures are typically maintained in 1 to 10-liter glass or autoclavable...
105
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

593
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
593
Methods for Controlling Microbial Growth01:29

Methods for Controlling Microbial Growth

2.7K
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...
2.7K
Upstream Processing01:27

Upstream Processing

97
Upstream processing represents a critical phase in biomanufacturing, wherein biological systems such as microorganisms, mammalian cells, or insect cells are cultivated to produce therapeutic proteins, vaccines, enzymes, or other biologically derived products. This phase encompasses all steps from the selection and genetic manipulation of the production organism to the cultivation of cells in bioreactors under tightly controlled environmental conditions.Host Selection and Genetic OptimizationThe...
97
Physical Methods for Controlling Microbial Growth: Radiation and Filtration01:26

Physical Methods for Controlling Microbial Growth: Radiation and Filtration

1.7K
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.
1.7K

You might also read

Related Articles

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

Sort by
Same author

Designing a CCS that Focuses on Materials Transfer into Cleanrooms, RABS, and Isolators: Poster Presented at PDA Microbiology Conference 2025.

PDA journal of pharmaceutical science and technology·2026
Same author

PAT Implementation - Managing the Transition from Traditional Environmental Monitoring to In-Process Control of Aseptically Filled Products.

PDA journal of pharmaceutical science and technology·2025
Same author

Considerations for the Validation of Non-CFU Based Bio-Fluorescent Particle Counting Technologies.

PDA journal of pharmaceutical science and technology·2025
Same author

Letter to the Editor.

PDA journal of pharmaceutical science and technology·2024
Same author

Sterility Testing for Hematopoietic Stem Cells.

Journal of clinical microbiology·2023
Same author

Risk Assessment Approach to Microbiological Controls of Cell Therapies.

PDA journal of pharmaceutical science and technology·2020
Same journal

A PAT-aligned framework for installing and operating particle counting systems to detect pre-limit particle-size distribution shifts in ISO-8 (non-sterile) controlled areas.

PDA journal of pharmaceutical science and technology·2026
Same journal

Using Positive Controls to Define the Defect Detection Range for CCIT Method Development and Validation.

PDA journal of pharmaceutical science and technology·2026
Same journal

Patient-Centric Drug Delivery: Establishing Injection Hold Time Limits for Large Volume Autoinjectors.

PDA journal of pharmaceutical science and technology·2026
Same journal

Gas flow through micro-capillaries â which flow law is most suitable to predict the flow rate through micro-capillaries?

PDA journal of pharmaceutical science and technology·2026
Same journal

Peer Review.

PDA journal of pharmaceutical science and technology·2026
Same journal

In-situ Verification of Disinfection Rotation for Contamination Control.

PDA journal of pharmaceutical science and technology·2026
See all related articles

Related Experiment Video

Updated: May 1, 2026

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

4.4K

Development, Validation, and Implementation of a Pharmaceutical Facility Disinfection Program.

James Polarine1, Matt Hofacre1, Tony Cundell2

  • 1STERIS Corporation, Mentor, OH.

PDA Journal of Pharmaceutical Science and Technology
|April 29, 2026
PubMed
Summary
This summary is machine-generated.

This review details cleaning and disinfection programs for pharmaceutical manufacturing, crucial for microbial control and Good Manufacturing Practices (GMP). It covers validation, regulatory compliance, and advanced techniques like Vaporized Hydrogen Peroxide (VHP) for contamination control.

Keywords:
Coupon StudyDisinfectantDisinfectant ApplicationDisinfectant RotationDisinfectant ValidationField TrialVaporized Hydrogen Peroxide

More Related Videos

The Portable Chemical Sterilizer PCS, D-FENS, and D-FEND ALL: Novel Chlorine Dioxide Decontamination Technologies for the Military
14:17

The Portable Chemical Sterilizer PCS, D-FENS, and D-FEND ALL: Novel Chlorine Dioxide Decontamination Technologies for the Military

Published on: June 29, 2014

14.0K
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

7.9K

Related Experiment Videos

Last Updated: May 1, 2026

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

4.4K
The Portable Chemical Sterilizer PCS, D-FENS, and D-FEND ALL: Novel Chlorine Dioxide Decontamination Technologies for the Military
14:17

The Portable Chemical Sterilizer PCS, D-FENS, and D-FEND ALL: Novel Chlorine Dioxide Decontamination Technologies for the Military

Published on: June 29, 2014

14.0K
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

7.9K

Area of Science:

  • Pharmaceutical Manufacturing
  • Microbial Control
  • Good Manufacturing Practices (GMP)

Background:

  • Maintaining microbial control is essential in pharmaceutical manufacturing to ensure product safety and comply with Good Manufacturing Practices (GMP).
  • Current regulatory landscapes, including U.S. FDA (21 CFR 211) and EU GMP Annex 1, mandate stringent environmental controls.
  • Industry guidelines (USP <1072>, PDA TR70, IEST RP 18.5) provide frameworks for cleaning and disinfection programs.

Purpose of the Study:

  • To provide a comprehensive overview of developing, validating, and implementing cleaning and disinfection programs for pharmaceutical facilities.
  • To integrate regulatory expectations and industry best practices for robust contamination control.
  • To highlight the importance of both laboratory and in situ efficacy studies for disinfectants and sporicidal agents.

Main Methods:

  • Review of regulatory requirements and industry guidance documents.
  • Emphasis on laboratory disinfectant efficacy studies and in situ field trials.
  • Discussion of validation methodologies for manual and automated disinfection technologies.

Main Results:

  • Outlines key considerations for disinfectant selection, rotation, and validation.
  • Details environmental monitoring strategies and the application of Vaporized Hydrogen Peroxide (VHP) for bio-decontamination.
  • Presents case studies and data-driven insights for effective contamination control, including equipment cleaning validation.

Conclusions:

  • A robust approach to validating cleaning and disinfection programs is critical for pharmaceutical manufacturing.
  • Integrating laboratory data with field trials ensures effective microbial control.
  • Adoption of advanced technologies like VHP and validated automated systems supports future contamination control strategies.