Mail: info@sterilize.it  – Linkedin: sterilize.it


  • Member Area
  • Registration
  • About us
  • Processes
  • Applications
  • Bookstore
  • Useful Links
  • Contact us
  • About us
  • Processes
  • Applications
  • Bookstore
  • Useful Links
  • Contact us

Decontamination with hydrogen peroxide: use and technical developments

ABSTRACT

This article compares the concepts of sterilization, disinfection and decontamination with reference to the different scopes thereof. Decontamination by hydrogen peroxide vapor and its use for conditioning the Sterility Test Isolators are discussed. A technologically new method for the vaporization ofthe hydrogen peroxide and its dosage control is presented.

Keywords: Sterilization, sterile, disinfection, chemical bio-decontamination, hydrogen peroxide, autoclave,
sterilizer, sterility test isolator, washers.

STERILIZATION, DISINFECTION, AND DECONTAMINATION: A TERMINOLOGICAL REVIEW

For a long time, the word sterilization has been used to indicate those processes, in food and pharma-industry or in hospital care, targeting the complete inactivation of viable microbial species on the surface and/or in the bulk of an object, including bacterial spores. According to a widely accepted definition, an object is sterile when completely free of contamination due to viable organisms. Therefore, sterility could be seen as an absolute concept: an object is sterile, or it is nonsterile. However, if we move from the rather abstract field of definitions to every day practice, things grow more complex: how can we objectively state that an object is sterile?

A common feature of all the known methods for testing sterility condition is the destruction of the sterility, if any, of the object being tested, thus making it no longer usable for its intended scope: in other words, no sterility test methods are known for a given object, that completely respect the integrity of it, without affecting its properties and damaging, more or less, the condition, if any, of sterility. In the case of packaged sterile products, it is even possible to say that no non-destructive sterility tests exist. This paradox can be expressed by saying that sterilization is a special process, where the results of processes (efficacy of sterilization) cannot be verified by subsequent inspection and testing of the product (the items sterilized) (Publimed, US National Library of Medicine, PMID: 10402868).

Therefore, a statistical verification of a successful sterilization is the sole economically sustainable alternative which implies the necessity of attaining a very high probability that a batch of the sterilized product does not contain non-sterile items. For these reasons, the industrial sterilization is defined as ‘a process used to render a product free of viable organisms with a specified probability’ (PDA, TR#1 revised 2007).

[…]

 

 

  • author: Mascherpa Vittorio

The content you requested is only available for registered users. Please, register to download the file.
It's fast and free. Register here.
If you are a registered user enter your e-mail address and password to log in.

• Download
PDF File

0
0
0
0

related articles

  • A history of isolator and containment technology, Part 6: Development of the validation of isolators
  • A history of isolator and containment technology Part 2: Flexible film isolators
  • Practical issues on PFS sterilization: an analysis of critical aspects
  • Risk considerations for the installation of a new pharmaceutical facility autoclave
  • History of isolator and containment technology Part 1: Early containment leading to flexible film isolator

0 Commenti

Leave Reply Annulla risposta

Il tuo indirizzo email non sarà pubblicato. I campi obbligatori sono contrassegnati *

Search
  • Enter your keyword

  • Processes

  • Applications

  • Author

Recent articles
  • A History of Isolator and Containment Technology, Part 5: Development and use of sterilising agents with associated devices
  • A history of isolator and containment technology Part 4: Transfer devices
  • A history of isolator and containment technology Part 3: Non-flexible film isolators including RABS
  • A history of isolator and containment technology Part 2: Flexible film isolators
  • Importance of risk assessment for aseptic transfer in pharmaceutical compounding

Results after a chemical decontamination cycle performed with vaporized H2O2

Could hydrogen peroxide decontamination affect the results of a sterility test?

Scroll
Contact

Mail: info@sterilize.it
Linkedin: sterilize.it

Member Area
Accesso
Password persa
Process
  • Aseptic processing
  • Cleaning
  • Chemical bio-decontamination
  • Moist-heat sterilization
  • Sterilization
Application
  • Blood bags
  • Environmental Monitoring
  • Food
  • General
  • Hyaluronic Acid
  • Other applications
  • Package Integrity
  • Pharma – Liquids
  • Pharmaceutical compounding
  • Pre-filled syringes (PFSs)
  • Robotics
  • Sealed containers
  • Validation
Subscribe to newsletter

Subscribe to our newsletter to stay informed about our news and info.

Join here

© Copyright 2020 Sterilize.it. All rights reserved. Privacy Policy e Cookie

Fedegari Autoclavi SpA | Albuzzano - SS 235 Km 8, CAP. 27010 (PV) | REA: PV- 130961 | P.IVA IT00303010185 | PEC: amministrazione@pec.fedegari.com | Capitale Sociale Versato 5.000.000,00 € i.v.