Rapid Sterility Testing Solutions

The need for a rapid sterility testing solution is greater than ever before. More importantly, the need for a complete RMM validation solution to reduce the time between purchase and routine use is more critical than ever. Learn how Celsis® for sterility, a modular solution, enables you to validate a system in less time with our new validation and implementation support packages.

REDEFINE RMM WITH CELSIS

Sterility testing solutions using rapid microbiology for testing pharmaceutical products in accordance with USP 71, FDA, and Ph. Eur 2.6.1 methods

With the Celsis® detection platform for rapid sterility, we’ve created an unprecedented set of solutions, features, and options in a package that's designed for simplicity, not complexity. Instead of just providing an instrument with reagents and leaving the rest up to you, we’ve done the upfront work by partnering with other industry leaders to create a solution that makes perfect sense.

Use the tabs below to navigate through our complete solution for rapid sterility testing: including instruments, reagents, optimized sterility testing consumables, and RMM validation solutions.

Celsis® Rapid Sterility Testing Instruments

the Celsis Advance II systemThe Celsis Advance II™ system provides the high capacity and high efficiency required for final product sterility testing samples for pharmaceutical  manufacturing. Capable of performing 120 assays per hour, the Celsis Advance II instrument provides a rapid detection solution for sterility testing, as well as bioburden and microbial limits test methods – all in the same instrument. 

The Celsis Accel® system reduces the footprint and throughput, but preserves the features found in the higher capacity Celsis Advance II™. Capable of performing 30 assays per hour, this system is ideal for companies interested in a rapid microbial method, such as makers of advanced medicinal therapeutic products (ATMPs), small batches of products with a short shelf life, or radiopharmaceutical products with a short half-life.

All Celsis® instruments share the same impressive features, fluid ease-of-use, and regulatory-ready software design. With so many features in common, there’s no need to compromise when adopting a rapid sterility test.

Benefits of Celsis® Instruments

Easy integration into your current sterility test protocols, leaving standard preparation methods intact. Adapts to current validated test methods for sterility via membrane filtration or direct inoculation.

Efficient – Eliminates days of incubation, replacing the standard 14-day traditional sterility test with a 6-day rapid sterility test.

Data-driven objective results, replacing the visual turbidity check with automated, instrument-based analysis.

Secure data integrity and control through on-board, regulatory-compliant software with automated reporting and multi-user management.


brochure cover

Are You Considering a Rapid Sterility Test?

Choosing a rapid method takes more time, energy, and money than ever before. And that's even before you consider what you'll need to implement it and ensure it works with your products and methods. Learn how Charles River, in collaboration with Sartorius® and Hardy Diagnostics, has created an unprecedented solution for rapid sterility testing.

Download the Brochure


Celsis® Rapid Microbial Detection Instruments

Product Code
Celsis Advance II™ System 7456004
Celsis Accel® System 7460288

 

Celsis AMPiScreen® Pharma ATP Bioluminescence Test Kits for Rapid Sterility

the Celsis AmpiScreen Pharma Reagent line

Adenosine triphosphate (ATP) bioluminescence provides an effective method for rapid sterility testing, but is solely dependent upon microbial growth to achieve sufficient levels of ATP for detection.

The Celsis AMPiScreen® Pharma ATP bioluminescence test kit can rapidly detect the presence of ultra-low levels of microbiological contamination up to 50% faster than standard ATP bioluminescence test kits, and 75% faster than the traditional sterility test.

When performing sterility testing, the ability to detect the presence of low level contaminations, as well as injured and stressed microorganisms, is a critical concern for pharmaceutical manufacturers. Even the smallest concentrations of stressed organisms can be detected, including problematic species such as Propionibacterium acnes, Staphylococcus epidermidis, and Micrococcus luteus, as demonstrated in the Celsis Equivalency Report for Membrane Filtration Sterility Testing.

The inherent subjectivity of visual growth confirmation is removed with a confident “Yes/No” answer, providing the same result as the compendial sterility test and critical information whether to release or hold a product.

Download the Product Sheet

 

Benefits of Celsis AMPiScreen® Pharma Reagents

Faster than traditional methods by up to 75%
Objectively confirms the absence of microbial contamination for raw materials, in-process bioburden, microbial limits, final sterility testing
Simple and efficient  reagent preparation, storage, and packaging
Compatible with both the Celsis Accel® and Celsis Advance II™

brochure cover

Are You Considering a Rapid Sterility Test?

Choosing a rapid method takes more time, energy, and money than ever before. And that's even before you consider what you'll need to implement it and ensure it works with your products and methods. Learn how Charles River, in collaboration with Sartorius® and Hardy Diagnostics, has created an unprecedented solution for rapid sterility testing.

Download the Brochure

 

 


Celsis AMPiScreen® Pharma400 Assay Reagent Kit

Product RST400
400 Assay Kit Configuration Celsis LuminAMP™  8 x 8.6 mL vials
Celsis LuminEX®  8 x 8.6 mL vials
Celsis LuminATE®  8 x 50 assay vials
Celsis LuminATE® Buffer – 8 x 8.6 mL vials
Storage Conditions 2 – 8° C
Shelf Life Up to 12 months at 2 – 8° C

 

Celsis®-Qualified Hardy Diagnostics Rapid Sterility Test Media

vials of Hardy Diagnostics prepared fluid thioglycollate and trypticase soy broth sterility test

Most commercially available media is compatible with Celsis® technology, nor does it require the use of custom media and media containers, as do other rapid technologies. However, while any media can be used, not all media are optimized for rapid detection.

Charles River has partnered with Hardy Diagnostics, a leading manufacturer of more than 2,700 prepared culture media products, to provide rapid sterility test media pre-qualified for use with Celsis® rapid microbial detection instruments.

Now, customers can obtain verified FTM and TSB sterility test media, in alignment with United States and European pharmacopeia recommendations that is tested prior to release on Celsis® instruments. This ensures the important method variable of background ATP is controlled from lot to lot.
 

Trusted Industry Sterility Testing Media Provider

Manufactured in two US-based, ISO13485-certified facilities, Hardy Diagnostics products are currently used by over 9,000 microbiology laboratories throughout the world. All products manufactured by Hardy Diagnostics are tested to the highest standards for quality and performance.

Hardy Diagnostics tests each lot of commercially manufactured media using an industry-standard suite of quality control microorganisms and quality specifications, outlined on their certificates of analysis (CofA). The following organisms are routinely used for testing at Hardy Diagnostics, in accordance with USP <61> and <62>.

Download the Product Sheet

Benefits of Hardy Diagnostics Test Media for Celsis®

Optimized specifically for use with Celsis® instruments as part of a sterility application that achieves results in about half the time of the compendial method
Verified lot release with Celsis® instruments, ensuring controlled ATP background and process consistency for each batch of media
 
Consistent process and formulation from Hardy Diagnostics', ISO 13485 certification, and two manufacturing facilities, ensuring consistent product quality and availability

brochure cover

Are You Considering a Rapid Sterility Test?

Choosing a rapid method takes more time, energy, and money than ever before. And that's even before you consider what you'll need to implement it and ensure it works with your products and methods. Learn how Charles River, in collaboration with Sartorius® and Hardy Diagnostics, has created an unprecedented solution for rapid sterility testing.

Download the Brochure

 

 


Celsis® Qualified Hardy Diagnostics Sterility Test Media Configurations

Product Product Code Container & Volume
Celsis® Qualified Hardy Diagnostics Tryptic Soy Broth, USP CM101 100 mL Septum Top Glass Vial
Celsis® Qualified Hardy Diagnostics Fluid Thioglycollate Medium, USP CM1015 100 mL Septum Top Glass Vial

 

Celsis® Qualified Sterisart® NF Rapid Sterility Test Canisters

the Sterisart NF closed filtration system

With the Celsis® rapid sterility test, sample preparation methods are left nearly untouched, and do not require the addition of multiple, labor-intensive steps such as staining. Additionally, Celsis for rapid sterility does not require the use of Charles River testing consumables, such as the sterility test canisters.

While current on-market sterility test canisters have provided a viable solution for the traditional membrane filtration sterility test for over a decade, they are not all compatible with a rapid sterility test. Charles River has partnered with Sartorius, a leading international supplier of single-use solutions for the biopharmaceutical industry, to provide the Sterisart® NF closed filtration system qualified specifically for use with Celsis® instruments.

Labs can now take advantage of a complete RMM platform for rapid sterility testing that combines state-of-the-art sterility testing canisters used for years as prescribed through harmonized pharmacopeia chapters, with the process control that comes with ATP qualification, ensuring reproducible, rapid results, test-to-test and lot-to-lot.


Sterisart® Septum for Simple, Aseptic Sub-Sampling for Rapid Detection

The Sterisart® septum feature simplifies a critical step in the rapid sterility testing process, extracting samples for detection on Celsis® instruments. The port eliminates the need to pierce tubing or compromise the internal integrity of the test canister, reducing the risks of operator error and introducing false positives through external contamination.

Download the Product Sheet

Benefits of the Sterisart® NF System for Celsis® for Rapid Sterility Testing

Rapid sterility results in about half the time of the compendial test
Verified lot release with Celsis® instruments ensures controlled ATP background and process consistency for each lot of test canisters
Integrates seamlessly into current test method procedures, requiring no change to sample preparation processes when compared to the compendial test method
Extraction of samples via septum port feature ensures safe, sterile sample extraction for rapid detection
Compatible with a range of sample container types, peristatic pumps, and isolator configurations

brochure cover

Are You Considering a Rapid Sterility Test?

Choosing a rapid method takes more time, energy, and money than ever before. And that's even before you consider what you'll need to implement it and ensure it works with your products and methods. Learn how Charles River, in collaboration with Sartorius® and Hardy Diagnostics, has created an unprecedented solution for rapid sterility testing.

Download the Brochure

 

 


Celsis® Qualified Sterisart® NF Configurations

Product     Product Code Recommended Use
Celsis® Qualified Sterisart® NF Septum with 4 cm dual-needle 16466CR-GSD For closed, septum-topped sample containers
Celsis® Qualified Sterisart® NF Septum with 5.2 cm needle 16467CR-GSD For openable top sample containers such as ampoules, bottles, or bags
 

 

Celsis® Validation Support Packages for Rapid Sterility Testing

lab technician consults the Celsis equivalency validation report

Many labs have realized that the regulatory landscape has shifted when it comes to implementing rapid microbial methods (RMMs): organizations now have access to more guidance, resources, and support by regulatory agencies and thus no longer have to rely on their own internal staff to handle all aspects of a validation project. Typically, even an experienced validation team can spend 6-12 months proving the performance and functional equivalence of the alternative method without the presence of their product, after which they must also perform method suitability testing in presence of products.

Charles River can now provide customers a pathway to faster implementation by reducing validation time by 3–6 months through two innovative RMM validation support packages: Celsis® Complete and Celsis® Advantage. These provide two comprehensive options to suit the needs of organizations that would like to either outsource their validation testing or complete it themselves. Either way, both streamline the process and alleviate the majority of the validation process from QC personnel.

Both packages are built upon our complete, ready-for-regulatory submission Celsis® Equivalency Report that demonstrates method equivalency of the Celsis® rapid microbial detection method for sterility applications via membrane filtration after only 6 days’ incubation to the traditional sterility test method and 14 days' incubation. As part of the equivalency study, the limit of detection (LOD) and specificity were also demonstrated and are included in this 188-page validation report.

Download the Product Sheet

Benefits

Celsis® Complete Celsis® Advantage
Accelerates implementation time by eliminating the need to demonstrate method equivalency to the traditional sterility testing method

Compliant with methods described in USP <71>, Ph. Eur 2.6.1, and JP 4.06

Reduces the need to dedicate personnel, resources, and time to validation, improving lab efficiency by reducing disruption to day-to-day testing

Ready for regulatory submission dataset and report format for faster implementation of Celsis® rapid microbial detection for sterility

Eliminates the need for writing validation testing protocols, determining statistical analyses, and how to determine a regulatory-approved validation strategy

Outsources testing in presence of product for method suitability, equivalency, limit of detection, and specificity to Charles River  
 

 

brochure cover

Are You Considering a Rapid Sterility Test?

Choosing a rapid method takes more time, energy, and money than ever before. And that's even before you consider what you'll need to implement it and ensure it works with your products and methods. Learn how Charles River, in collaboration with Sartorius® and Hardy Diagnostics, has created an unprecedented solution for rapid sterility testing.

Download the Brochure

 


Celsis® Validation & Implementation Support Options

Product Celsis® Complete Validation & Reports
Product Code VAL6000MS
Includes
  • Method Validation documentation for Equivalency, Specificity, Robustness, Ruggedness, and Limit of Detection via the Celsis® Sterility Equivalency Validation Report.
     
  • cGMP Validation Testing in Presence of Product for Method Suitability, Equivalency, Limit of Detection, Specificity performed by Charles River Laboratories.
Product Celsis® Advantage Reports & Protocols
Product Code VAL6100MF
Includes
  • Method Validation documentation for Equivalency, Specificity, Robustness, Ruggedness, and Limit of Detection via the Celsis® Sterility Equivalency Validation Report.
     
  • Protocols for Testing in Presence of Product for Method Suitability, Equivalency, Limit of Detection, Specificity provided by Charles River Laboratories.