Written by: Kristina Lackey, Catie Vaccaro, Dahila Lopez, Steph Clark, Dr. Garrett Hellinghausen, Dr. Adam Garland
Disruption Labs is excited to introduce our new Preservative Efficacy Screening (PES). Designed as a rapid, customizable solution compared to the standard USP <51> method, our PES leverages our extensive experience in formulation to provide tailored insights. With our specialized testing, you gain detailed information to help address your specific product concerns and challenges effectively.
What are PET and PES Studies?
A PET study is designed to determine the overall antimicrobial efficacy of a food or beverage formulation. One example of an industry-standard PET study is the USP <51> preservative efficacy test method. The USP <51> test method is an antimicrobial efficacy test that involves spiking a product with a panel of challenge microorganisms and determining the log reduction of organisms at prescribed time intervals over 28 days [1]. The identities and amounts of each microorganism are fixed and defined according to the method itself. It evaluates the effectiveness of added preservatives in preventing microbial growth.
A PES study is a faster and more customizable screen of antimicrobial efficacy. This type of study is often used prior to or in support of full USP <51> testing.
Why Choose Disruption Labs for PET and PES?
Working with Disruption Labs means you have the added benefit of integrating in-house product development in support of your PET or PES study. Our Product Development team’s expertise allows them to create prototype formulations with a range of natural and synthetic preservatives to suit each client’s unique needs. The Product Development team’s proficiency with advanced formulation techniques, such as high shear mixing and microfluidization, allows for the evaluation of both water-soluble and oil-soluble preservatives without compromising product stability. Clients will receive and choose lead candidate formulations to move into the PES studies based on their evaluation, feedback, and approval. You won’t find formulation support at your typical testing laboratory!
In addition to offering standard USP <51> PET testing, Disruption Labs also offers a more rapid and customizable PES study.
Our PES studies have key differences from the standard USP <51> PET method. Standard PES studies evaluate preservative efficacy with the same microorganisms as USP <51> but within a condensed 9-day period. This allows for our customers to obtain critical information on the antimicrobial efficacy of their formulations with a much faster turnaround time. In addition, our standard PES study can be customized to include microorganisms that are of specific interest to your formulation, which are not part of the standard USP <51> set. This allows you to evaluate efficacy against as many potential concerns as possible and leave nothing to chance.
Conducting a PES Study
Our ISO-accredited microbiology department ensures rigorous testing standards. Their process involves:
1. Sample Preparation: Client-approved samples are prepared with common synthetic preservatives (e.g. sodium benzoate, potassium sorbate), natural preservatives, and a control without preservatives.
2. Microbial Testing: Following USP <51> guidelines, samples are spiked with five types of microorganisms (S. aureus, E. coli, P. aeruginosa, C. albicans, and A. brasiliensis) at high concentrations. Customization, based on customer input for microorganisms to be added or removed, is optional.
3. Incubation and Monitoring: Samples are incubated on YMR and TC plates and stored under standard conditions to promote microbial growth. Measurements are typically taken at Day 0, Day 2, and Day 7, but this can be customized to the client’s needs.
4. Data Analysis: Results are compiled into a comprehensive report, offering detailed insights into the effectiveness of the tested preservatives.
Time Kill Studies
In addition to PES, we offer time-kill studies for clients needing faster results. These studies, which follow ASTM guidelines, test antimicrobial agents over a shorter period of time (minutes to hours). Our 3-day method assesses how quickly an antimicrobial can kill microbes, providing valuable data so our clients can make more informed decisions.
This offering is further supported by our Product Development team and analytical testing capabilities to evaluate other impacts to the formulation based on pasteurization, including the degradation of any formulation components by the pasteurization process and any disturbance of the physical stability of the formulation.
Comprehensive Solutions from Disruption Labs
Disruption Labs offers more than just smarter, faster preservative efficacy screening. Our comprehensive services include:
· Product Development: Customized formulation services to meet specific client needs, with expertise in encapsulated and liposomal solutions.
· Prototyping and Technical Transfer: We support the entire new product development or product revamp process from concept to production.
· Manufacturing: Our UL CGMP-certified facility ensures top-quality production of custom ingredient solutions.
Disruption Labs’ PET and PES testing are a testament to our commitment to providing high-value processes and trusted partnerships. By choosing Disruption Labs, you gain access to a one-stop solution for quality products, including formulation and preservative efficacy screening, enabling you to make critical stability decisions confidently.
Let us help you ensure the safety and efficacy of your products with our expert testing and development services. For more information on customizing your formulation services with us, please reach out to hello@disruption-labs.com.
1. USP 51 - United States Pharmacopeia (2024). General Chapter, 〈51〉 Antimicrobial Effectiveness Testing. USP-NF. Rockville, MD: United States Pharmacopeia.