MicroQuant™ Pseudomonas paraeruginosa, high CFU

9027-HQ-PACK ^™

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MicroQuant™ Pseudomonas paraeruginosa (high CFU) is a quantitated, best-in-class control developed to support USP General Chapter <51>. This ISO 17034 reference material is provided as a pack containing 5 vials of cryopreserved pellets (10⁷ to 10⁸ CFU per pellet) and 5 vials of rehydration buffer. This convenient, single-use format rehydrates immediately and is easy to use and store.

The estimated ship date for this item is November 25, 2024.

Product category: Bacteria
Classification: Bacteria, Pseudomonadota, Gammaproteobacteria, Pseudomonadales, Pseudomonadaceae, Pseudomonas, Pseudomonas aeruginosa group
Strain designation: R. Hugh 813
Type strain: Yes
Genome sequenced strain: Yes
Former name: Pseudomonas aeruginosa (Schroeter) Migula
Isolation source: Outer ear infection
Applications: Media testing

Quality control

Pharmaceutical testing

Water testing
Shelf Life: 2-8°C for 6 months
Shipping information: 5 vials of cryopreserved pellets and 5 vials of rehydration buffer
Storage conditions: 2°C to 8°C

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Price: $500.00 ea

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Documentation

Product sheet

Instructions for use

BSL 2

ATCC determines the biosafety level of a material based on our risk assessment as guided by the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL), U.S. Department of Health and Human Services. It is your responsibility to understand the hazards associated with the material per your organization’s policies and procedures as well as any other applicable regulations as enforced by your local or national agencies.

ATCC highly recommends that appropriate personal protective equipment is always used when handling vials. For cultures that require storage in liquid nitrogen, it is important to note that some vials may leak when submersed in liquid nitrogen and will slowly fill with liquid nitrogen. Upon thawing, the conversion of the liquid nitrogen back to its gas phase may result in the vial exploding or blowing off its cap with dangerous force creating flying debris. Unless necessary, ATCC recommends that these cultures be stored in the vapor phase of liquid nitrogen rather than submersed in liquid nitrogen.

General

Specific applications: MicroQuant™ products are available in both high and low CFU formats. Selection of low or high CFU MicroQuant™ products would be dictated by the guidelines for the microbial QC test being performed and the amount of material needed to execute such tests.
Growth promotion testing
Bioburden testing
Environmental monitoring
Microbial limit testing
Preservative efficacy testing
Antimicrobial effectiveness testing

Assay of antimicrobial preservatives

Efficacy testing

Media testing

Preparatory test control

Quality control strain

Sterility testing

Produces rhamnolipid surfactant

Pharmaceutical and Personal Care
Recommended as a test microorganism for EP 2.6.1 Sterility
Recommended as a test microorganism for EP 2.6.12 Microbial Examination of Non-Sterile Products: Microbial Enumeration Tests
Recommended as a test microorganism for EP 2.6.27 Microbiological Control of Cellular Products
Recommended as a test microorganism for EP 2.6.31 Microbiological Examination of Herbal Medicinal Products for Oral Use
Recommended as a test microorganism for EP 5.1.3 Efficacy of Antimicrobial Preservation
Recommended as a test microorganism for EP Monographs
Recommended as a test microorganism for JP 16 4.05 I Microbiological Examination of Non-sterile Products: Total Viable Aerobic Count
Recommended as a test microorganism for JP 16 4.05 II Microbiological Examination of Non-sterile Products: Tests for Specificed Micro-organisms
Recommended as a test microorganism for JP 16 4.06 Sterility Test
Recommended as a test microorganism for JP 16 G4 Microorganisms: Preservatives-Effectiveness Tests
Recommended as a test microorganism for JP 16 G8 Quality Control of Water for Pharmaceutical Use
Recommended as a test microorganism for USP <51> Antimicrobial Effectivness Testing
Recommended as a test microorganism for USP <60> Microbiological Examination of Nonsterile Products: Tests for Burkholderia cepacia Complex
Recommended as a test microorganism for USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
Recommended as a test microorganism for USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
Recommended as a test microorganism for USP <71> Sterility Tests
Recommended as a test microorganism for ASTM E2315: Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure
Recommended as a test microorganism for ASTM E640: Standard Test Method for Preservatives in Water-Containing Cosmetics
Recommended as a test microorganism for ISO 11930: Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
Preceptrol: No

Characteristics

Comments

The name of Pseudomonas aeruginosa strain R. Hugh 813 was changed to Pseudomonas paraeruginosa. This change is in response to phylogenomic and comparative genomic studies performed by Rudra et al. that identified two distinct clades of P. aeruginosa. Strains in Clade-2 were transferred to the novel species P. paraeruginosa with Pseudomonas aeruginosa strain R. Hugh 813 (ATCC 9027) designated as the type strain.

MicroQuant™ strains are best-in-class controls developed to support USP General Chapters. These precisely quantitated controls are provided in a single-use format that rehydrates immediately and is easy to use and convenient to store.

Handling information

Handling procedure

Remove the desired number of cryopreserved reference culture vials (gray crimp) and rehydration buffer vials (green crimp) from 2-8°C storage and place into a biosafety cabinet. One vial of rehydration buffer should be used for each vial of reference culture.
Uncap each vial. Add 1.0 mL of rehydration buffer to the reference culture vial. Recap the vial and allow the pellet to dissolve for 30 seconds.
Vortex on high for 30 seconds to ensure the suspension is well mixed. The suspension is now useable and contains 10⁷-10⁸ CFU per 1.0 mL.
If this product is used in alignment with USP <51>, add 100 µL of the above prepared suspension to 900 µL of the test sample.
Add 9.0 mL of the USP recommended diluent (not provided) to the 1.0 mL of sample prepared in step 5. Follow the procedure detailed in USP Chapter <51> for the challenge test.

For quantitation

Follow steps 1-3 listed above.
Add 100 µL of the prepared suspension to 900 µL dilution buffer.
Repeat the dilution 4 times to achieve a dilution factor of 1.0 x 10⁵.
From the final dilution, pipette 100 µL directly on to a non-selective media plate. Use a sterile plate spreader for optimal results.
Incubate plates in an incubator at the appropriate temperature and time. If following a specific pharmacopeial chapter, use the incubation conditions specified.
Following incubation, read the plate for CFU counts.

Handling notes

For applications outside of compendial assays, please refer to the product page for ATCC 9027 for standard growth conditions.

Quality control specifications

Specification range: 10⁷ to 10⁸ CFU per pellet
Volume: 1.0 mL (following rehydration)
Verification method: Whole-genome Sequencing
Quality accreditation: Manufactured under an ISO 17034 accredited process

History

Deposited as: Pseudomonas aeruginosa (Schroeter) Migula
Depositors: CP Hegarty

Legal disclaimers

Intended use

This product is intended for laboratory research use only. It is not intended for any animal or human therapeutic use, any human or animal consumption, or any diagnostic use.

Reference material produced under an ISO 17034 accredited process.

Warranty

The product is provided 'AS IS' and the viability of ATCC^® products is warranted for 30 days from the date of shipment, provided that the customer has stored and handled the product according to the information included on the product information sheet, website, and Certificate of Analysis. For living cultures, ATCC lists the media formulation and reagents that have been found to be effective for the product. While other unspecified media and reagents may also produce satisfactory results, a change in the ATCC and/or depositor-recommended protocols may affect the recovery, growth, and/or function of the product. If an alternative medium formulation or reagent is used, the ATCC warranty for viability is no longer valid. Except as expressly set forth herein, no other warranties of any kind are provided, express or implied, including, but not limited to, any implied warranties of merchantability, fitness for a particular purpose, manufacture according to cGMP standards, typicality, safety, accuracy, and/or noninfringement.

Disclaimers

This product is intended for laboratory research use only. It is not intended for any animal or human therapeutic use, any human or animal consumption, or any diagnostic use. Any proposed commercial use is prohibited without a license from ATCC.

While ATCC uses reasonable efforts to include accurate and up-to-date information on this product sheet, ATCC makes no warranties or representations as to its accuracy. Citations from scientific literature and patents are provided for informational purposes only. ATCC does not warrant that such information has been confirmed to be accurate or complete and the customer bears the sole responsibility of confirming the accuracy and completeness of any such information.

This product is sent on the condition that the customer is responsible for and assumes all risk and responsibility in connection with the receipt, handling, storage, disposal, and use of the ATCC product including without limitation taking all appropriate safety and handling precautions to minimize health or environmental risk. As a condition of receiving the material, the customer agrees that any activity undertaken with the ATCC product and any progeny or modifications will be conducted in compliance with all applicable laws, regulations, and guidelines. This product is provided 'AS IS' with no representations or warranties whatsoever except as expressly set forth herein and in no event shall ATCC, its parents, subsidiaries, directors, officers, agents, employees, assigns, successors, and affiliates be liable for indirect, special, incidental, or consequential damages of any kind in connection with or arising out of the customer's use of the product. While reasonable effort is made to ensure authenticity and reliability of materials on deposit, ATCC is not liable for damages arising from the misidentification or misrepresentation of such materials.

Please see the material transfer agreement (MTA) for further details regarding the use of this product. The MTA is available at www.atcc.org.

Permits & Restrictions

Import Permit for the State of Hawaii

If shipping to the U.S. state of Hawaii, you must provide either an import permit or documentation stating that an import permit is not required. We cannot ship this item until we receive this documentation. Contact the Hawaii Department of Agriculture (HDOA), Plant Industry Division, Plant Quarantine Branch to determine if an import permit is required.

Limited Label License for MicroQuant™

Use of ATCC’s MicroQuant™ products are subject to the ATCC Material Transfer Agreement. Notwithstanding, ATCC hereby grants you the further right to use this single-use consumable MicroQuant™ product as a reagent for a single quality control assay in your laboratory only, whether as a commercial service or internally.

ATCC’s MicroQuant™ products contain trade secrets and intellectual property of ATCC, and you may not reverse engineer, replicate, alter, or tamper with the products or authorize any third party to do any of the foregoing.

ATCC’s MicroQuant™ products shall not be used for any other use restricted by the ATCC Material Transfer Agreement, including any animal or human therapeutic use, any human or animal consumption, any diagnostic use, or use to manufacture any products.

For information on obtaining additional rights, please contact:
ATCC Licensing
Email: [email protected]

MORE INFORMATION ABOUT PERMITS AND RESTRICTIONS

References

Curated Citations

U.S. Pharmacopeia General Chapters: <61> Microbial Examination of Nonsterile Products: Microbial Enumeration Tests. Rockville, MD USP34-NF29, 2011

U.S. Pharmacopeia General Chapters:<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. Rockville, MD USP34-NF29, 2011

U.S. Pharmacopeia General Chapters: <60> Microbiological Examination of Nonsterile Products Tests for Burkholderia Cepacia Complex.

British Pharmacopoeia Commission Test for sterility. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XVI A, 2003

British Pharmacopoeia Commission Tests for microbial contamination. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XVI B, 2003

View All Curated Citations for this Product

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