bioMérieux’s BioBall mixed kits provide flexibility for the pharmaceutical industry

Mixed kits contain the most relevant pharmacopoeia strains required for quantitative microbiology

BioBall is easy to use and requires no preparation or pre-incubation

BioBall is a small water-soluble ball containing a precise number of micro-organisms delivering unprecedented accuracy for quantitative microbiological quality control.

More than 25 individual BioBall strains are available with applications in the pharmaceutical, food and water testing industries. BioBall offers three different products for pharmaceutical QC: BioBall SingleShot, BioBall MultiShot 550 and BioBall MultiShot 10E8.

For greater convenience and flexiblity for pharmaceutical laboratories who perform a small number of samples per day, BioBall is also available in 10 pack mixed kit configurations. BioBall mixed kits contain the most relevant pharmacopoeia strains required for quantitative microbiology.

BioBall SingleShot mixed kit ref. 410683 and BioBall MultiShot 550 mixed kit ref. 410682 contain:

  • 2 vials of A. brasiliensis
  • 2 vials of B. subtilis
  • 1 vial of C. albicans
  • 1 vial of E. coli
  • 2 vials of P. aeruginosa
  • 2 vials of S. aureus

BioBall MultiShot 10E8 mixed kit ref. 56150 contains:

  • 2 vials of A. brasiliensis
  • 2 vials of C. albicans
  • 2 vials of E. coli
  • 2 vials of P. aeruginosa
  • 2 vials of S. aureus

BioBall is easy to use and requires no preparation or pre-incubation. It can be added directly to media or matrix samples. BioBall is an accredited reference material under ISO Guide 34 standard.

BioBall is available in four standard levels:

BioBall SingleShot - mean of between 28 and 33 cfu with a standard deviation of 3 cfu or less (unless otherwise stated). Designed for a precise single inoculation. Ideal positive control for media QC, positive control for pathogen testing in the food industry and as a positive control for water and waste water testing.

BioBall MultiShot 550 - mean of between 500 and 600 cfu with a standard deviation of ≤ 10% of the mean. Designed for re-hydration into 1.1 mL of MultiShot 550 Re-Hydration Fluid to provide 10 x 100μL doses of 50 cfu. Ideal for pharmaceutical microbiology QC where multiple positive controls in the 10 to 100 cfu range are needed.

BioBall HighDose 10K - mean of between 8,000 and 12,000 cfu with a standard deviation of ≤ 15% of the mean (unless otherwise stated). Designed for a single precise inoculation at a higher cfu level. Ideal positive control for food testing where a higher cfu inoculation is required.

BioBall MultiShot 10E – mean of between 0.7 and 1.5 x 108 cfu with a standard deviation of ≤ 20% of the mean. Designed for re-hydration into 1.1 mL of BioBall Re-Hydration Fluid to provide 10 x 100μL doses of 107. Pharmaceutical and cosmetic preparations often require antimicrobial activity to prevent microbial proliferation or to limit the effects of contamination. The Pharmacopoeias require testing these products for the efficacy of antimicrobial preservation (e.g. USP 51, EP 5.1.3, JP19). BioBall MultiShot 10E8 is ideal for this application and simplifies preparation and provides a precise inoculum.

NEW - BioBall Plant Isolates is a new service offering, allowing you to order custom BioBall products with the strain that you require. It will provide you with BioBall made from your strain isolated e.g. during environmental monitoring of your production plant. All BioBall Plant Isolate products are manufactured at BTF (a bioMérieux Company) in Sydney Australia and maintain 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*. The BioBall process will add two passages to your strain, i.e. a strain sent in the third passage will result in a BioBall product at passage five.

What will you get?

BTF will manufacture a single dose BioBall with a batch mean of 60 cfu +/- 20%.

Standard variation from BioBall to BioBall within the batch < 20% of the batch mean.

Minimum order quantity: 10 boxes with 20 vials each.

Stability: 1 year from date of manufacture.

BTF/bioMérieux will arrange shipping of the micro-organisms from your laboratory to BTF Australia using our nominated carrier.

Applications include:

  • Media quality control
  • Positive control for quantitative QC
  • Method validation
  • Accreditation compliance
  • Multi-laboratory standardization
  • Determining uncertainty of measurement
  • Proficiency schemes
  • Antimicrobial effectiveness testing

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