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EVERY STEP OF THE WAY

Hardy Diagnostics Test Media for Celsis® Sterility ApplicationsA robust, rapid microbial method in today’s industry means more than just an instrument performing its designed task.

It means all of the method’s components working together to provide an optimal rapid microbial detection platform.

These include variables that go beyond the supplier’s own instrument or consumables.

Charles River has partnered with Hardy Diagnostics, a leading manufacturer of over 2,700 prepared culture media

products, to provide sterility test media pre-qualified for use with Celsis® rapid microbial detection instruments.

While most commercially available media is compatible with Celsis® technology, not all media is optimized for

it. Now, customers can obtain verified sterility test media, already in compliance with US and EU 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.

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.

MICROBIAL SOLUTIONS

Benefits of Hardy Diagnostics Test Media for Celsis®:

• Specifically optimized for use with Celsis® instruments as part of a sterility application that achieves results in about half the time of the compendial method

• Lot verification with Celsis® instruments, ensuring controlled ATP background and process consistency

• Hardy Diagnostics’ USP compliant processes and formulations, ISO 13485 certification, and two manufacturing facilities ensure consistent product quality and availability

Hardy Diagnostics Test Media for Celsis® Sterility Applications

Tryptic Soy Broth, USPTryptic soy broth (TSB) is one of the two primary media

recommended for use in sterility testing for the detection

of contamination with low incidence fungi and aerobic

bacteria. It is a common media, used in many different types

of microbial testing. TSB, also known as Soybean-Casein

Digest, conforms to the formula given by the United States

Pharmacopeia (USP).

FormulaIngredients per liter of deionized water

Pancreatic Digest of Casein 17.0 gm

Sodium Chloride 5.0 gm

Papaic Digest of Soybean Meal 3.0 gm

Dextrose 2.5 gm

Dipotassium Phosphate 2.5 gm

Final pH 7.3 +/- 0.2 at 25 ºC.

Quality ControlHardy 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>:

Test OrganismInoculation

Method*

Incubation

ResultTime Temperature Atmosphere

Staphylococcus aureus ATCC® 6538 J 24 - 72 hrs 30 - 35 °C Aerobic Growth

Pseudomonas aeruginosa ATCC® 9027 J 24 - 72 hrs 30 - 35 °C Aerobic Growth

Bacillus subtilis ATCC® 6633 J 24 - 72 hrs 30 - 35 °C Aerobic Growth

Bacillus subtilis ATCC® 6633 J 24 - 72 hrs 20 - 25 °C Aerobic Growth

Candida albicans ATCC® 10231 J 3 - 5 Days 20 - 25 °C Aerobic Growth

Aspergillus brasiliensis ATCC® 16404 J 5 Days 20 - 25 °C Aerobic Growth

* Refer to the document “Inoculation Procedures for Media QC” for more information.

askcharlesriver@crl.com • www.criver.com

Fluid Thioglycollate Media, USPFluid thioglycollate media (FTM) is recommended for the

cultivation of aerobic, microaerophilic, and anaerobic

microorganisms in normally sterile materials. When

incubated, this liquid broth medium forms, from the

surface down, a strata of decreasing oxygen concentration

environments along its depth, facilitating the growth of

obligate and facultative anaerobic microorganisms, as

well as microaerophilic and aerotolerant organisms. Hardy

Diagnostics’ FTM composition confirms to the formula stated

in USP <71>.

FormulaIngredients per liter of deionized water

Pancreatic Digest of Casein 15.0 gm

Dextrose 5.5 gm

Yeast Extract 5.0 gm

Sodium Chloride 2.5 gm

Sodium Thioglycollate 0.5 gm

L-Cystine 0.5 gm

Agar 0.75 gm

Resazurin indicator 1.0 mg

Final pH 7.1 +/- 0.2 at 25 ºC.

Quality ControlHardy 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>:

Test OrganismInoculation

Method*

Incubation

ResultTime Temperature Atmosphere

Staphylococcus aureus ATCC® 6538 J 24 - 72 hrs 30 - 35 °C Aerobic Growth

Pseudomonas aeruginosa ATCC® 9027 J 24 - 72 hrs 30 - 35 °C Aerobic Growth

Clostridium sporogenes ATCC® 19404 J 24 - 72 hrs 30 - 35 °C Aerobic** Growth

* Refer to the document “Inoculation Procedures for Media QC”

for more information.

** Tubes, bottles, and jars are incubated in an aerobic incubator

with the caps screwed down tightly to create an atmosphere of low

oxygen tension within the tube.

askcharlesriver@crl.com • www.criver.com © 2019, Charles River Laboratories International, Inc.

Storage and Shelf Life Upon receipt, these media should be stored at 2-25 ºC and away from direct light. As common good lab practices dictate,

media should not be used if there are any signs of deterioration, discoloration, contamination, or if the expiration date has

passed.

The expiration dating on the product label applies to the product in its intact packaging when stored as directed. The product

may be used and tested up to the expiration date on the product label and incubated for the recommended quality control

incubation times.

User Quality Control According to pharmacopeia recommendations and good lab practices, customers should continue to perform QC testing.

Hardy Diagnostics recommends users check for signs of contamination and deterioration and, if dictated by laboratory

quality control procedures or regulation, perform quality control testing to demonstrate growth or a positive reaction and

to demonstrate inhibition or a negative reaction, if applicable. Hardy Diagnostics quality control testing is documented on

the Certificates of Analysis (CofA) available from Hardy Diagnostics’ Certificates of Analysis website. In addition, users

may refer to the document “Finished Product Quality Control Procedures,” on the Hardy Diagnostics Technical Document

website for more information.

Hardy Diagnostics Test Media for Celsis® Sterility ApplicationsProduct Quantity Code

Celsis® Qualified Hardy Diagnostics Tryptic Soy Broth, USP, 100 mL Septum Top Glass Vial

Pack of 20 CM1010

Celsis® Qualified Hardy Diagnostics Fluid Thioglycollate Medium, USP, 100 mL Septum Top Glass Vial

Pack of 20 CM1015