Preservative Efficacy (PET) Testing

ILS Limited Pharmaceutical Efficacy TestingILS can test a range of pharmaceutical preparations for preservative efficacy (PET), including parenteral, ophthalmic, oral liquid, ear preparations and topical preparations, performing methods of assessment to the EP, BP, USP and the JP.

Testing for Efficacy of Antimicrobial Preservation (PET) is performed to determine the type and minimum effective concentration of preservative required for satisfactory multi-dose pharmaceutical formulation.

The test consists of challenging the preparation with live organisms at a series of time points over an in use period of up to 28 days. At each time point analysis is performed to establish if organisms are present or not and therefore if the preservative is effective.

Depending on formulation type the pharmacopoeias propose different organism types as per the table below:

Organism

Oral Formulations

with test points at

0, 14 & 28 days

Topical Formulations 

with test points at 

0, 48hrs, 7, 14 & 28 days  

Injectable Formulations 

with test points at 

0, 6hrs, 24 hrs, 48hrs,

7, 14 & 28 days  

Candida Albicans

             X        

X

X

Aspergillus Brasiliensis

X

X

X

Pseudomonas Aeruginosa

X

X

X

Stapphlycoccus Aureus

X

X

X

Escherichia Coli

X

 

X

 

ILS test for all the above organisms plus additional ones such as Zygosaccharomyces rouxii depending on customers’ requirements.

 

We pride ourselves on customer service and value all of our customers please contact us to see if we can help you with your efficacy testing requirements.