Hardy Diagnostics Test Media for Celsis® Sterility Applications

MICROBIAL SOLUTIONS

Benefits of Hardy Diagnostics A robust, rapid microbial method in today’s industry means more than just an instrument performing its designed task. Test Media for Celsis®: It means all of the method’s components working together to provide an optimal rapid microbial detection platform. • Specifically optimized for use These include variables that go beyond the supplier’s own instrument or consumables. with Celsis® instruments as Charles River has partnered with Hardy Diagnostics, a leading manufacturer of over 2,700 prepared culture media part of a sterility application ® that achieves results in products, to provide sterility test media pre-qualified for use with Celsis rapid microbial detection instruments. about half the time of the While most commercially available media is compatible with Celsis® technology, not all media is optimized for compendial method it. Now, customers can obtain verified sterility test media, already in compliance with US and EU pharmacopeia • Lot verification with Celsis® recommendations, that is tested prior to release on Celsis® instruments. This ensures the important method variable of instruments, ensuring background ATP is controlled from lot to lot. controlled ATP background and process consistency Manufactured in two US-based, ISO13485-certified facilities, Hardy Diagnostics products are currently used by over • Hardy Diagnostics’ USP 9,000 microbiology laboratories throughout the world. All products manufactured by Hardy Diagnostics are tested to compliant processes and the highest standards for quality and performance. formulations, ISO 13485 certification, and two manufacturing facilities ensure consistent product quality and availability

EVERY STEP OF THE WAY www.criver.com Tryptic Soy Broth, USP Formula Tryptic soy broth (TSB) is one of the two primary media Ingredients per liter of deionized water recommended for use in sterility testing for the detection Pancreatic Digest of Casein 17.0 gm of contamination with low incidence fungi and aerobic Sodium Chloride 5.0 gm bacteria. It is a common media, used in many different types Papaic Digest of Soybean Meal 3.0 gm of microbial testing. TSB, also known as Soybean-Casein Dextrose 2.5 gm Digest, conforms to the formula given by the United States Dipotassium Phosphate 2.5 gm Pharmacopeia (USP). Final pH 7.3 +/- 0.2 at 25 ºC.

Quality Control 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>:

Incubation Inoculation Test Organism Method* Time Temperature Atmosphere Result 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.

Hardy Diagnostics Test Media for Celsis® Sterility Applications Fluid Thioglycollate Media, USP Formula Fluid thioglycollate media (FTM) is recommended for the Ingredients per liter of deionized water cultivation of aerobic, microaerophilic, and anaerobic Pancreatic Digest of Casein 15.0 gm microorganisms in normally sterile materials. When Dextrose 5.5 gm incubated, this liquid broth medium forms, from the Yeast Extract 5.0 gm surface down, a strata of decreasing oxygen concentration Sodium Chloride 2.5 gm environments along its depth, facilitating the growth of Sodium Thioglycollate 0.5 gm obligate and facultative anaerobic microorganisms, as L-Cystine 0.5 gm well as microaerophilic and aerotolerant organisms. Hardy Agar 0.75 gm Diagnostics’ FTM composition confirms to the formula stated Resazurin indicator 1.0 mg in USP <71>. Final pH 7.1 +/- 0.2 at 25 ºC.

Incubation Inoculation Test Organism Method* Time Temperature Atmosphere Result 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” ** Tubes, bottles, and jars are incubated in an aerobic incubator for more information. with the caps screwed down tightly to create an atmosphere of low oxygen tension within the tube.

[email protected] • www.criver.com 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 Applications

Product Quantity Code Celsis® Qualified Hardy Diagnostics Tryptic Soy Broth, USP, Pack of 20 CM1010 100 mL Septum Top Glass Vial Celsis® Qualified Hardy Diagnostics Fluid Thioglycollate Medium, USP, Pack of 20 CM1015 100 mL Septum Top Glass Vial