Improved ATP Bioluminescence Reagents for Cosmetics Contamination Testing
Cosmetic microbiological safety requires the most advanced contamination detection platforms. Celsis AMPiScreen® AP is an amplified ATP bioluminescence test specifically designed to the meet the cosmetic microbiology needs of large and small manufacturers of cosmetics, personal care, over the counter, and consumer care products. This contamination detection reagent test kit provides a comprehensive solution for all cosmetic, personal care, and consumer care manufacturers, especially those owning brands in the all-natural, organic, or botanical cosmetics markets.
Contamination Detection in Half the Time of Traditional QC Microbiology Methods
The amplified ATP bioluminescence reaction used in Celsis AMPiScreen® AP reduces high background signal by depleting non-microbial ATP while amplifying low levels of microbial ATP, generating faster quality control (QC) results in less than 24 hours. Contamination detection occurs days faster than traditional quality control methods for bioburden or microbial limits, which require up to five days of incubation. Moreover, the Celsis AMPiScreen® AP test is faster and easier to use than other on-the-market ATP bioluminescence test kits requiring more than 48 hours, product sample dilutions, or those that cannot differentiate non-microbial and microbial ATP signals.
Celsis AMPiScreen® AP Reagent Features
- Confidently obtain presence/absence contamination safety results in 24 hours
- Compatible with an even wider range of cosmetic and OTC products than Celsis AMPiScreen®
- Confirm the absence of microbial contamination in personal care, cosmetics, and consumer care products with high background ATP.
- Contains a new apyrase reagent to reduce background ATP
- Compatible with Celsis Advance II™ and Celsis Accel® instruments
Benefits of Celsis AMPiSCreen® AP for Cosmetic Microbiological Safety
A Solution for Evolving Consumer Demand for Natural Formulations
As the cosmetics and personal care industry shifts to utilizing natural and raw ingredients to meet the demands of consumers seeking organic and preservative-free formulations, so has Celsis® rapid detection for cosmetic microbiology. Over recent years, many popular natural ingredients have been introduced into product formulations produced by small to mid-size cosmetic manufacturers specializing in this niche market, or by large personal care and cosmetic manufacturers who have developed brands or product lines meeting shifting consumer preferences.
ATP Bioluminescence in the Presence of All-Natural Cosmetic Ingredients
Natural ingredients, preservative-free, or botanical formulations typically contain high levels of background ATP from all-natural ingredients and raw materials. The inherently high background ATP level creates interferences with the ATP signal generated by contamination from bacteria, yeast, and molds.
The most popular ingredients used today also add non-microbial ATP, such as coconut, aloe vera, quinoa, seaweed, honey, and vegetable butters, such cocoa and shea. Many of these all-natural ingredients have also led to product contamination issues when combined with preservative-free formulations.
Since ATP is present in all living cells, including plant-based natural ingredients, this has posed a significant challenge to makers of natural, organic, and botanical cosmetic products, which typically contain a high amount of ATP molecules from their ingredients. This has prohibited the use of rapid microbiological methods for this product category.
Celsis AMPiScreen® AP is the next evolution of our standard Celsis AMPiScreen® reagent kit, containing an additional reagent kit and injection step to deplete the non-microbial ATP caused by natural ingredients while leaving the microbial cells and their ATP intact.
Simplified Testing Platform for Multiple Product Lines and Multiple Sites
Process efficiency and global harmonization is even easier by adopting Celsis AMPiScreen® AP across the entire quality control system and across different locations. Since this ATP bioluminescence reagent kit can handle the widest variety of cosmetic microbiological safety test samples on the market, harmonized and standardized test methods can be used to test samples and products across multiple production lines and at each location. This provides cosmetic brands of all sizes the most efficient microbiological safety approach toward maximizing the total operational benefits of rapid microbiological methods.
Improved Cosmetics Contamination Testing
With the depletion of background ATP, cosmetic contamination detection performance has been improved in the Celsis AMPiScreen® AP assay. As formulation and raw materials can impart variation in background ATP from lot to lot, this reagent kit normalizes these differences and improves robustness, making the Celsis® assay even more resilient to typical production variation.
400 Assay Kit Configuration
Product Code AP4310 400 Assay Kit Configuration* Celsis LuminAMP™ 4 x 8.6 mL vials
Celsis LuminEX® x 8.6 mL vials
Celsis LuminATE®4 x 50 assay vials
Celsis LuminATE® Buffer 4 x 8.6 mL vials
Celsis LuminASE® 4 x 50 assay vials
Celsis LuminASE® Buffer 4 x 6.1 mL vials
Storage Conditions 2-8 °C Shelf Life Up to 12 months at 2-8 °C
Frequently Asked Questions about Celsis AMPiScreen® AP
What is cosmetic microbiology?
Cosmetic microbiology is the microbiological examination of cosmetic products to confirm the quality and safety of the product for consumers. This is commonly referred to as quality control microbiology in many adjacent industries, such as pharmaceutical and biopharma. This is to prevent the adulteration of cosmetic products from organisms which may cause harm to the consumer.
How are cosmetic products tested for microbiological contamination?
Cosmetic products are tested for microbial growth using a growth-based traditional method typically consisting of transferring a sample of the product into selective and non-selective growth media to allow for the growth of potential microbiological contaminations. The test can be performed using liquid growth media (enrichment broth) or agar media (for enumeration). This test is typically followed by a microbial identification assay to confirm the organism species or strain. Traditional or compendial cosmetic microbiology tests typically take 3-5 days to complete for enumeration to allow for microbial colonies to be visible to the human eye.
What regulatory guidance exists that covers testing cosmetics products for contamination?
Cosmetic microbial quality testing typically follows methodology outlined in a number of guidance documents provided for the industry through the United States Pharmacopeia and European Pharmacopoeia. These include the following:
- USP <61> Microbiological Examination Of Nonsterile Products: Microbial Enumeration Tests
- USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- Ph. Eur. 2.6.12 Microbiological Examination Of Nonsterile Products: Microbial Enumeration Tests
- Ph. Eur. 2.6.13 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- USP <1111> Microbiological Quality of Nonsterile Pharmaceutical Products
- Ph. Eur. 5.1.4 Microbiological Quality of Nonsterile Pharmaceutical Products
Additionally, the International Organization for Standardization (ISO) provides guidance through the following:
- ISO 21148 Cosmetics – Microbiology – General Instructions for Microbiological Examination
- ISO 21149 Cosmetics – Microbiology – Enumeration and Detection of Aerobic Mesophilic Bacteria
- ISO 18415 Cosmetics – Microbiology – Detection of Specified and Non-Specified Microorganisms
- ISO 16212 Cosmetics – Microbiology – Enumeration of Yeast and Mold
What is ATP Bioluminescence contamination detection?
ATP bioluminescence is based upon a naturally occurring reaction, where an enzyme (luciferase) converts the molecule luciferin into oxyluciferin in the presence of ATP. The molecule oxyluciferin will produce a photon of light, which is detected by a Celsis® luminometer. This reaction has been considered a gold standard for detecting the presence of bacteria, yeast, or mold in a product and has been cited in numerous studies dating back to the 1970s, since the bioluminescence reaction does not occur without the ATP molecules when ATP should not be present in a sample.
What’s the difference between Celsis AMPiScreen® and Celsis AMPiScreen® AP?
Celsis AMPiScreen® AP is the next evolution of our amplified ATP bioluminescence kit and expands the industry-leading product compatibility of Celsis AMPiScreen®.
How does Celsis AMPiScreen® AP reduce background ATP?
Celsis AMPiScreen® AP contains an additional apyrase reagent that depletes non-microbial background ATP. The additional injection of this reagent, which is completely controlled through automation within our Celsis® instruments, prepares samples by reducing the background ATP signal, allowing for better detection of microbial contaminant ATP.
Why use Celsis® over other ATP testing kits?
Many on-market ATP testing kits, such as handheld instruments, do not contain the additional necessary to discern product ATP from ATP introduced due to bacterial, yeast, and fungal contamination in cosmetic and personal care products. This can lead to an incorrect detection of contamination, called a “false positive”, which leads to unnecessary delays and follow-up testing. Additionally, generic ATP testing kits are problematic to integrate into recommended testing procedures outlined in USP <60>.
How do I use it with Celsis® instruments?
Celsis® instruments integrate with existing compendial testing methods, such as direct inoculation and membrane filtration; however, it can reduce the incubation time down to 24 hours. To learn how our Celsis® instruments function, including daily preparation and running assays using our automated testing platform and software, visit our Celsis Advance II™ Virtual Instrument Demonstration page to watch videos outlining the process.