BIOBALL®

Delivering Confidence in Quantitative Microbiology

BIOBALL is a small water-soluble ball containing a precise number of microorganisms delivering unprecedented accuracy for quantitative microbiological quality control. BIOBALL is easy to use and requires no preparation or pre-incubation and is an accredited reference material under ISO Guide 34 standards.

BIOBALL is a small water-soluble ball containing a precise number of microorganisms delivering unprecedented accuracy for quantitative microbiological quality control. BIOBALL is easy to use and requires no preparation or pre-incubation and is an accredited reference material under ISO Guide 34 standards.

Applications include:

  • Media quality control
  • Positive controls for quantitative applications
  • Method validation
  • Accreditation compliance
  • Multi-laboratory standardization
  • Determining uncertainty of measurement
  • Proficiency Testing schemes 
  • Antimicrobial Effectiveness Testing
  • Disinfectant challenge testing

BIOBALL is available at four standard levels:

  • BIOBALL® SINGLESHOT – designed for a single inoculation with unprecedented precision
  • BIOBALL® MULTISHOT - 550 – designed for 10 inoculations with low variance
  • BIOBALL® HIGHDOSE - 10K – designed for a single precise inoculation at a higher CFU level
  • BIOBALL® MULTISHOT - 10E8 – designed for rehydration into 1.1mL of BIOBALL Re-Hydration

>> Download Available Strains brochure

BIOBALL FEATURES & SPECS

BIOBALL® SINGLESHOT:

  • Each BIOBALL has a batch mean of between 28 and 33 CFU.
  • Standard deviation less than 3 CFU.
  • BIOBALL SINGLESHOT is ideal when only one or a few inoculations are used within the day or if the highest level of precision is required.

BIOBALL® MULTISHOT - 550:

  • Each BIOBALL has a batch mean of between 500 and 600 CFU with a standard deviation <10% of the mean
  • When rehydrated with 1.1 ml of rehydration fluid, provides 10 x 100 uL doses, each containing 50 CFU.
  • Ideal when several controls are needed at the same time or within the same day.

BIOBALL® HIGHDOSE - 10K:

  • Each BIOBALL has a batch mean of between 8000 and 12000 CFU with a standard deviation of <15% of mean
  • Designed for single, precise inoculation at a higher cfu level
  • Ideal positive control where a higher inoculation level is required

BIOBALL® MULTISHOT - 10E8: 

  • Mean of between 0.7 and 1.5 x 10e8 cfu with a standard deviation of ≤ 20% of the mean.  
  • Designed for rehydration into 1.1 mL of BIOBALL Re-Hydration Fluid to provide 10 x 100 µL doses of 10e7.
  • Ideal for antimicrobial and preservative effectiveness testing

BIOBALL is an accredited reference material under ISO Guide 34 standard.

Visit www.bioball.com.

For BioFood:

BIOBALL is an ideal quantitative control for the food industry.

Applications:

  • Media quality control
  • Quantitative inoculant for the positive control
  • Method validation
  • Proficiency testing
  • Measurement of Uncertainty (MOU) determination
  • Determining limits of detection

BIOBALL needs no preparation prior to use and is water soluble. It can be taken directly from the freezer and added to a media plate, enrichment broth or food sample.

Pathogen Testing: BIOBALL SINGLESHOT

Food pathogens can be fatal at very low levels and food test methods need to detect pathogens at very low levels. BIOBALL SINGLESHOT is a perfect inoculant for the positive control in pathogen testing. BIOBALL can be added directly to enrichment broth or it can be added as a matrix spike to a sample of sterile matrix and enrichment broth (typically 25 g of sterile matrix and 225 ml of enrichment broth).

Non-Pathogen Testing: BIOBALL HIGHDOSE - 10K

Non-pathogen food contaminants such as yeast, mold and some bacteria, if present, are likely to be in large numbers. BIOBALL HIGHDOSE -10K is an ideal inoculant for the positive control in non-pathogen food testing. BIOBALL HIGHDOSE - 10K can be added as a matrix spike directly to a sample of sterile matrix and diluent (typically 10 g of sterile matrix and 90 mL of diluent) or it can be added directly to diluent (typically 100 mL).

For BioPharma

Growth Promotion Testing

The pharmaceutical industry is required to perform QC with controls in the range of 10 to 100 cfu for growth promotion and sterility testing. BIOBALL has three products that are ideal for these QC applications:

1. BIOBALL MULTISHOT - 550 used with BIOBALL Re-Hydration Fluid
Designed to provide 10 precise inoculations over an 8 hour period.

  • Each BIOBALL has a batch mean of between 500 and 600 cfu
  • When re-hydrated with 1.1mL of re-hydration fluid provides 10 x l00uL doses, each containing 50 cfu
  • 8 hour stability when re-hydrated with BIOBALL Re-Hydration Fluid and stored between 2°C to 8°C
  • Ideal when several controls are needed at the same time or within the same day

2. BIOBALL MULTISHOT - 550 used with BIOBALL 14 Day Re-Hydration Fluid
Designed for convenience and greater efficency where lower numbers of quantitative tests are performed daily.

  • Each BIOBALL has a batch mean of between 500 and 600 cfu
  • When re-hydrated with 1.1mL of re-hydration fluid provides 10 x 100uL doses, each containing 50 cfu
  • 14 day stability when re-hydrated with BIOBALL 14 Day Re-Hydration Fluid and stored at - 18°C
  • Ideal when several controls are needed at the same time or over a two week period

3. BIOBALL SINGLESHOT
Designed for a single inoculation with unprecedented precision.

  • Each BIOBALL has a batch mean of between 28 and 33 cfu
  • Standard deviation of 3 cfu or less (unless otherwise stated)
  • BIOBALL SINGLESHOT is ideal when only one or a few inoculations are used within the day, or the highest level of precision is required

Sterility Assurance Testing

Sterility testing is a critical requirement in the manufacture of sterile pharmaceuticals and medical devices. Sterility testing media must undergo growth promotion testing using prescribed microbial strains and sterility testing methods must be validated to assure their capacity to recover compendia! strains when present in very low numbers. Alternative or rapid microbiological methods also require validation to verify equivalency with traditional sterility testing methods. For these purposes, use of very reliable and consistent inocula is essential to eliminate variation attributable to factors other than the performance of the media, processes or systems being tested. BIOBALL® SINGLESHOT and MulitShot - 550 strains deliver the exceptional accuracy and precision required for growth promotion testing and validation studies.

Antimicrobial/Preservative Effectiveness Testing

Pharmaceutical and cosmetic preparations often require antimicrobial activity to prevent microbial proliferation or to limit the effects of contamination. Preparing consistent inocula for these tests can be laborious and is often unreliable, necessitating time consuming repeat assays.

BIOBALL® MULTISHOT - 10E8 is ideal for this application and simplifies preparation and provides a precise inoculum.

Designed to provide 10 precise inoculations over a 2 hour period

  • Each BIOBALL MULTISHOT - 10E8 has a batch mean between 0.7 and 1.5 x 108 cfu
  • Standard deviation is less than or equal to 20% of the batch mean
  • When re-hydrated with 1.1 ml of re-hydration fluid it provides 10 x 100µL doses of 107 cfu
  • 2 hour stability when re-hydrated with BIOBALL Re-Hydration Fluid and stored between 2°C to 8°C.
  • Each 100 µL aliquot can be used to inoculate for example 20 ml of product, resulting in the required final concentration of 105 -106 cfu/mL product

BIOBALL advantages over controls prepared by serial dilution:

  • Little or no preparation time
  • Easy to use
  • Precise known number of cfu
  • Consistent number of cfu batch to batch

BIOBALL advantages over other multi dose products:

  • Far less preparation time and steps
  • Greater precision
  • Consistent number of cfu batch to batch
  • Reduces risk of "Failed QC" due to variability of the control

BIOBALL PRODUCT DEMOS

BIOBALL® SINGLESHOT Demo

BIOBALL® MULTISHOT - 550 Demo

BIOBALL® MULTISHOT - 10E8 Demo

 

bioMérieux, Inc. can manufacture custom BIOBALL® products to suit your specific needs. We currently offer two services:

BIOBALL PLANT ISOLATE

BIOBALL PLANT ISOLATE is a service offering allowing you to order BIOBALL with the strain that you require. BIOBALL PLANT ISOLATE maintains the high level of quality you are accustomed to with standard BIOBALL products.

What strains can be used?

Any strains from your in-house collection can be used to manufacture a BIOBALL PLANT ISOLATE, whether they're environmental monitoring isolates, contaminants of products or raw materials or from any other source within your facility.

Available in two formats

  Single Dose (60) Multi Dose (550) Multi Dose (10E8)
Mean cfu 60 ± 20% 450 - 650 5 x 107 to 1.4 x 108
Coefficient of variation (CV) <= 20% <=20% <=20%
Minimum number of vials per strain 100 vials (100 tests) 100 vials (1,000 tests)

100 vials (1,000 tests)

Expiration from date of manufacture 12 Months 12 Months 12 Months
Rehydrated stability N/A Two hours if used with standard BIOBALL rehydration fluid Two hours if used with standard BIOBALL rehydration fluid

How long will it take?

A BIOBALL PLANT ISOLATE will take approximately 12 weeks from the strain arriving at our facility, for development, manufacturing, stability testing and shipment back to you in BIOBALL format. We will provide an estimated delivery date once the order is placed.

BIOBALL SELECT

bioMérieux, Inc. can manufacture BIOBALL with any strain selected from specified culture collections and at any CFU level required. BIOBALL SELECT can also be made using any of your in-house strains or any proprietary strain with commercial or analytical value.

How long will it take?

A BIOBALL PLANT ISOLATE will take approximately 12 weeks from the strain arriving at our facility, for development, manufacturing, stability testing and shipment back to you in BIOBALL format. We will provide an estimated delivery date once the order is placed.

Customer Service Charter

BIOBALL CUSTOM SERVICES is dedicated to providing your BIOBALL SELECT or PLANT ISOLATE order at the exceptional levels of precision and quality associated with the BIOBALL brand. We are dedicated to delivering superlative customer service, continually seeking to improve our service to you, and evolving our business to meet your changing needs. BIOBALL CUSTOM SERVICES takes pride in providing exceptional customer service and product performance.

 

When it comes to food safety, you can never be too accurate.

BIOBALL LUMINATE® is a small, water-soluble ball containing a precise number of microorganisms, with a much higher recovery rate and lower standard deviation compared to serial dilution. Each BIOBALL LUMINATE microorganism is tagged with a Green Fluorescent Protein {GFP) marker, making it easy to distinguish from external contaminants-whether using traditional or rapid testing methods.

High fluorescence helps unlock value in the laboratory:

  • Each microorganism is individually selected to maximize recovery rate
  • Easily distinguish between internal and external contaminants
  • Streamlined workflow reduces labor requirements
  • Test anytime - no preparation time required, use straight from the freezer

BIOBALL LUMINATE is intended to be used as a daily control QC reference material for traditional and rapid method pathogen testing for food safety testing laboratories.

>> Download BIOBALL LUMINATE Brochure

Pioneering Diagnostics