Custom Search

Wednesday, May 9, 2012

Sterility testing biological products Adenosine Triphosphate bioluminescence

US FDA issues new rule for sterility test requirements for biological products, allows for using rapid tests for sterility testing.

On 5th May 2012 US FDA has issued amendment for rule for sterility test requirements for biological products, the new rule will be effective from 4 Jun 2012.

New rule will revise existing sterility requirements for biological products as per 21 CFR part 600 through 680. New rule will be considering and allowing use of new innovative test methods and scientific new advancements in assessing sterility of biological products.

Any sterile product is require to meet the standards for test for sterility which states that the product should be free from any viable microorganism, this would require each and every unit container of final product to be tested for sterility which is not feasible it is required to be destructed, therefore sterility of final product is assured by validation of aseptic processes and sterilization processes being used.
New rule on requirement for sterility allows manufactures to adapt novel sterility test methods which detect microbial contamination by Adenosine Triphosphate bioluminescence, chemiluminescence, and carbondioxide head space measurements, the new rule eliminates specified culture media formulations , and specified sterility test requirements for almost bulk material and so on you can read the law as provided in federal register link for which is provided below.

Adenosine Triphosphate (ATP) bioluminescence:
ATP , Adinosine Triphosphate is a source for energy storage for all microorganism , Triphosphate group is bound to adenine , and when phosphate to phosphate bonds in triphosphate breaks , it releases energy , which is used by microorganism as source of energy for all cellular biochemical reactions.
Thus presence of ATP can be used as marker for presence or contamination from microorganism.
Method which use detection of ATP is based on production of bioluminescence and its measurement with luciferin substrate and enzyme system luciferase , (obtained from Photinus pyralis)
In presence of ATP, luciferin is oxidized by enzyme luciferase , which produces bioluminescence. Optimum ph for this enzyme reaction is pH 7.75 . in presence of magnesium ions and cellular oxygen available in viable microbial contamination.This test requires less time as compared to routine sterility tests.

Here is the link for the new requirements

No comments:

How to successfuly 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 button

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 Check 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: Website:
Copyright © 2008-2020 all rights reserve