Custom Search

Friday, August 2, 2013

biological Indicator gives result of sterilization in two hours

New biological Indicator which gives result of sterilization in two hours developed.

With conventional sterilization indicators it takes minimum 24 hours for outcome of the results to know if a sterilization process is successful or not. Now with recombinant DNA technology a steam sterilization process can judged if it is successful or not in just two hours, with the use of novel biological indicator which can give result in just two hours, making the process very speedy in medical field where surgical instruments are required to be sterilized and used again in hospitals. It can also be used for sterile pharmaceuticals manufacturing.

US FDA have approved a new sterilization indicator  Verify Cronos Self Contained Biological Indicator (SCBI) (manufacturer Steris Corporation of Mentor, Ohio.), which make use of novel recombinant DNA technology. It consist of a genetically-engineered strain of gram-positive bacterium Geobacillus stearothermophilus, as biological indicator microorganism which is capable of surviving even in higher temparature. Hence if a steam sterilization process can destroy Geobacillus stearothermophilus organism the it can successfully destroy other microorganism as well, which means the sterilization process is effective.
.
The indicator The Verify Cronos Self Contained Biological Indicator (SCBI) is required to be placed along with instruments to be sterilized at appropriate level and position in an autoclave, and after completion of sterilization process , bacteria inoculated in the enrichment media. The strain contained in Verify Cronos Self Contained Biological Indicator (SCBI) is capable of producing an enzyme which fluoresce, which makes detection of microbial growth faster. If there is fluoresce then the sterilization process is successful and vice versa.

US FDA approved Cronos Self Contained Biological Indicator (SCBI) by “de novo classification” premarket review pathway, which facilitates speedy approval for novel drugs and devices which make use of novel technology and are in the favor of recipients or end users or patients awaiting treatments.


No comments:

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org