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:
Post a Comment