MicroQuant™ Bacillus spizizenii, high CFU

6633-HQ-PACK ^™

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MicroQuant™ Bacillus spizizenii (high CFU) is a quantitated, best-in-class control. 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: Bacilli, Bacillales
Strain designation: NRS 231
Type strain: No
Genome sequenced strain: Yes
Former name: Bacillus subtilis subsp. spizizenii
Applications: Food testing

Media testing

Quality control

Pharmaceutical 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 1

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
Rabbit pyrogen testing
Bacterial endotoxin testing
Antibiotic assay
Potency testing

Produces restriction endonuclease Bsu6633I RefShibata T, et al. Site-specific deoxyribonucleases in Bacillus subtilis and other Bacillus strains. J. Bacteriol. 128: 473-476, 1976. PubMed: 824277 RefIkawa S, et al. Genetic studies on site-specific endodeoxyribonucleases in Bacillus subtilis: multiple modification and restriction systems in transformants of Bacillus subtilis 168. Mol. Gen. Genet. 177: 359-368, 1980. PubMed: 6246395 RefRoberts RJ. Restriction and modification enzymes and their recognition sequences. Nucleic Acids Res. 13: r165-r200, 1985. PubMed: 2987885

Quality control strain

Sporicidal test Ref Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal, sporicidal and fungicidal activity. London, UK:British Standards Institution;British Standard BS EN 12353:2006. Ref Chemical disinfectants --- Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and intitutional areas --- Test method and requirements (phase 2, step 1). London, UK:British Standards Institution;British Standard BS EN 13704:2002. Ref Chemical disinfectants and antiseptics --- Basic sporicidal activity --- Test method and requirements (phase 1, step 1). London, UK:British Standards Institution;British Standard BS EN 14347:2005. Ref Chemical disinfectants and antiseptics --- Application of European Standards for chemical disinfectants and antiseptics. London, UK:British Standards Institution;British Standard BS EN 14885:2006.

Biotechnology

Food testing

Pharmaceutical and Personal Care

Assay of streptomycin RefEuropean Pharmacopoeia Commission Microbiological assay of antibiotics. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.7.2, 1997 RefAOAC International Antibiotics in feeds, microbiological methods. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 957.23. RefFrerichs GN, Chandler MD. The identification and assay of antibiotics in live virus vaccines by electrophoresis in gel. J. Biol. Stand. 10: 205-211, 1982. PubMed: 6813333 RefSimon HJ, Yin EJ. Microbioassay of antimicrobial agents. Appl. Microbiol. 19: 573-579, 1970. PubMed: 4986725

Assay of streptonigrin RefPittillo RF, Woolley C. Biological assay of streptonigrin (NSC 45383) in body fluids and tissues of mice. Antimicrob. Agents Chemother. 5: 82-85, 1974. PubMed: 4209070

Assay of tobramycin RefBritish Pharmacopoeia Commission Biological assay of antibiotics. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XIV A, 2003 RefEuropean Pharmacopoeia Commission Microbiological assay of antibiotics. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.7.2, 1997 RefLightbown JW, Dixon H. The first international reference preparation of tobramycin. J. Biol. Stand. 10: 157-168, 1982. PubMed: 7096362

Assay of vancomycin RefEuropean Pharmacopoeia Commission Microbiological assay of antibiotics. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.7.2, 1997 RefU.S. Pharmacopeia General Chapters; <81> Antibiotics-Microbial Assays. Rockville, MD: U.S. Pharmacopeia; USP USP34-NF29, 2011

Control strain Ref Methodology for the Serum Bactericidal test: Approved Guideline. Wayne, PA. Clinical and Laboratory Standards Institute; CLSI M21-A. Ref Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved Guideline. Wayne, PA. Clinical and Laboratory Standards Institute; CLSI M26-A. Ref Medical microbiology; methods for the determination of susceptibility of pathogens (except mycobacteria) to antimicrobial agents: carrier of agents for agar diffusion test. Berlin, Germany:Deutsches Institut fur Normung;DIN DIN 58940-2. Ref Methods for the determination of susceptibility of pathogenic bacteria (without mycobacteria) to chemotherapeutic agents of discs for agar diffusion test example for getting the standard curve. Berlin, Germany:Deutsches Institut fur Normung;DIN DIN 58940-2 Beiblatt 1.

Media testing RefBritish Pharmacopoeia Commission Tests for microbial contamination. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XVI B, 2003 RefEuropean Pharmacopoeia Commission Microbial contamination of products not required to comply with the test for sterility (total viable aerobic count). Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.6.12, 1997 RefUS Food & Drug Administration. GENERAL BIOLOGICAL PRODUCTS STANDARDS; General Provisions; Sterility Code of Federal Regulations Title 21: 21CFR610.12, Subpart B, 2005 RefU.S. Pharmacopeia Dietary Supplement Chapters: <2021> Microbial Enumeration Tests-Nutritional and Dietary Supplements. Rockville, MD: U.S. Pharmacopeia; USP USP34-NF29, 2011 Ref Microbiology of food and animal feeding stuffs--Guidelines on preparation and production of culture media-- Part 2: Practical guidelines on performance testing of culture media.. Geneva (Switzerland):International Organization for Standardization/ANSI;ISO ISO 11133-2:2003. Ref Microbiology of food and animal feeding stuffs --- Guidelines on preparation and production of culture media --- Part 2: Practical guidelines on performance testing of culture media - Annex B: Recommended test microorganisms for commonly used culture media. London, UK:British Standards Institution;British Standard DD CEN ISO/TS 11133:2003.

Membrane filter testing Ref Standard Test Method for Confirming the Sterility of Membrane Filters. West Conshohocken, PA:ASTM International;ASTM Standard Test Method D 4196-05.

Assay of amoxicillin RefLode H, et al. Comparative clinical pharmacology of three ampicillins and amoxicillin administered orally. J. Infect. Dis. 129: S156-S168, 1974. PubMed: 4834960

Assay of bekanamycin aminodeoxykanamycin, kanamycin B, kanendomycin

Assay of capreomycin sulfate capreomycin, capromycin RefBritish Pharmacopoeia Commission Biological assay of antibiotics. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XIV A, 2003

Assay of colistimethate sodium RefU.S. Pharmacopeia General Chapters; <81> Antibiotics-Microbial Assays. Rockville, MD: U.S. Pharmacopeia; USP USP34-NF29, 2011

Assay of colistin colimycin RefU.S. Pharmacopeia General Chapters; <81> Antibiotics-Microbial Assays. Rockville, MD: U.S. Pharmacopeia; USP USP34-NF29, 2011

Assay of dactinomycin actinomycin, actinomycin D

Assay of dihydrostreptomycin sulfate dihydrostreptomycin RefEuropean Pharmacopoeia Commission Microbiological assay of antibiotics. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.7.2, 1997 RefU.S. Pharmacopeia General Chapters: <71> STERILITY TESTS. Rockville, MD:U.S. Pharmacopeia;USP USP34-NF29, 2011 RefU.S. Pharmacopeia General Chapters; <81> Antibiotics-Microbial Assays. Rockville, MD: U.S. Pharmacopeia; USP USP34-NF29, 2011

Assay of erythromycin RefEuropean Pharmacopoeia Commission Microbiological assay of antibiotics. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.7.2, 1997

Assay of framycetin RefEuropean Pharmacopoeia Commission Microbiological assay of antibiotics. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.7.2, 1997

Assay of gentamicins gentamicin RefFrerichs GN, Chandler MD. The identification and assay of antibiotics in live virus vaccines by electrophoresis in gel. J. Biol. Stand. 10: 205-211, 1982. PubMed: 6813333

Assay of hygromycin B RefAOAC International Antibiotics in feeds, microbiological methods. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 957.23.

Assay of kanamycin RefBritish Pharmacopoeia Commission Biological assay of antibiotics. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XIV A, 2003 RefEuropean Pharmacopoeia Commission Microbiological assay of antibiotics. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.7.2, 1997 RefFrerichs GN, Chandler MD. The identification and assay of antibiotics in live virus vaccines by electrophoresis in gel. J. Biol. Stand. 10: 205-211, 1982. PubMed: 6813333 RefSimon HJ, Yin EJ. Microbioassay of antimicrobial agents. Appl. Microbiol. 19: 573-579, 1970. PubMed: 4986725

Assay of lactam antibiotics beta-lactam antibiotics

Assay of lasalocid X-537A, lasalocid A

Assay of mitomycin mitomycin C

Assay of monensin RefAOAC International Monensin in feeds, microbiological method. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 972.56. RefAOAC International Antibiotics in feeds, microbiological methods. Gaithersburg, MD:AOAC International;AOAC "Official Methods of Analysis of the AOAC International" 957.23.

Assay of neomycin RefEuropean Pharmacopoeia Commission Microbiological assay of antibiotics. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.7.2, 1997 RefFrerichs GN, Chandler MD. The identification and assay of antibiotics in live virus vaccines by electrophoresis in gel. J. Biol. Stand. 10: 205-211, 1982. PubMed: 6813333 RefSimon HJ, Yin EJ. Microbioassay of antimicrobial agents. Appl. Microbiol. 19: 573-579, 1970. PubMed: 4986725

Assay of penicillin RefFrerichs GN, Chandler MD. The identification and assay of antibiotics in live virus vaccines by electrophoresis in gel. J. Biol. Stand. 10: 205-211, 1982. PubMed: 6813333

Assay of polymyxin B RefU.S. Pharmacopeia General Chapters; <81> Antibiotics-Microbial Assays. Rockville, MD: U.S. Pharmacopeia; USP USP34-NF29, 2011

Assay of spiramycin RefBritish Pharmacopoeia Commission Biological assay of antibiotics. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XIV A, 2003 RefEuropean Pharmacopoeia Commission Microbiological assay of antibiotics. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.7.2, 1997

Sterility testing RefBritish Pharmacopoeia Commission Test for sterility. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XVI A, 2003 RefEuropean Pharmacopoeia Commission Sterility. Strasbourg, France:European Pharmacopoeia Commission;European Pharmacopoeia EP 2.6.1, 1997 RefU.S. Pharmacopeia General Chapters: <71> STERILITY TESTS. Rockville, MD:U.S. Pharmacopeia;USP USP34-NF29, 2011 RefBowman FW, et al. Collaborative study of aerobic media for sterility testing by membrane filtration. J. Pharm. Sci. 60: 1087-1088, 1971. PubMed: 5000479 Ref Supplemental assay method for testing for preservative interference with sterility tests. :US Department of Agriculture;USDA, Center for Veterinary Biologics STSAM0903.01, 1999 Ref Sterility test, Growth promotion test. Tokyo, Japan:Japanese Pharmacopoeia;JP JP14e.part I.54. Ref Cleanrooms and associated controlled environments--Biocontamination control--Part 1: General principles and methods. Geneva (Switzerland):International Organization for Standardization/ANSI;ISO ISO 14698-1:2003.

Susceptibility testing RefMedical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 2: Active substance carriers for the agar diffusion test; Carrier loads and values required for drawing a standard curve. Berlin, Germany: Deutsches Institut fur Normung; DIN 58940-2 Beiblatt 2: 2002

Testing Ref Microbial limit test. Tokyo, Japan:Japanese Pharmacopoeia;JP Jp14e.part I.35. Ref Microbial limit test for crude drugs. Tokyo, Japan:Japanese Pharmacopoeia;JP JP14e.part I.36.

Testing antibacterial activity Ref Chemical disinfectants and antiseptics --- Surgical hand disinfection --- Test method and requirement (phase 2/step 2). London, UK:British Standards Institution;British Standard BS EN 12791:2005.

Testing bactericides

Validation control Ref Cleanrooms and associated controlled environments --- Biocontamination control --- Part 1: General principles and methods. London, UK:British Standards Institution;British Standard BS EN ISO 14698:2003.
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 2.7.2 Microbiological Assays of Antibiotics
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 4.06 Sterility Test
Recommended as a test microorganism for JP 16 5.02 Microbial Limit Test for Crude Drugs
Recommended as a test microorganism for JP 16 Monographs
Recommended as a test microorganism for USP <2021> Microbial Enumeration Tests
Recommended as a test microorganism for USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
Recommended as a test microorganism for USP <71> Sterility Tests
Recommended as a test microorganism for USP <81> Antibiotics-Microbial Assays
Recommended as a test microorganism for AENOR UNE EN 1104: Paper and board intended to come into contact with foodstuffs - Determination of the transfer of antimicrobial constituents
Preceptrol: No

Characteristics

Comments

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.

CA Dunlap et al. reclassified Bacillus subtilis subsp. spizizenii into the new species Bacillus spizizenii. Some platforms and databases may still identify this species by its previous name.

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 6633 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: Bacillus subtilis (Ehrenberg) Cohn
Depositors: NR Smith

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: <71> STERILITY TESTS. Rockville, MD:U.S. Pharmacopeia;USP USP34-NF29, 2011

U.S. Pharmacopeia General Chapters; <81> Antibiotics-Microbial Assays. Rockville, MD: U.S. Pharmacopeia; USP USP34-NF29, 2011

U.S. Pharmacopeia Dietary Supplement Chapters: <2021> Microbial Enumeration Tests-Nutritional and Dietary Supplements. Rockville, MD: U.S. Pharmacopeia; USP USP34-NF29, 2011

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

British Pharmacopoeia Commission Biological assay of antibiotics. London, UK:British Pharmacopoeia Commission;British Pharmacopoeia Appendix XIV A, 2003

View All Curated Citations for this Product

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