Quantitative QC Made Easy!

Quantitative QC Made Easy!

What is BioBall ®
BioBall is a small water soluble ball containing a precise number of micro-organisms delivering
unprecedented accuracy for Quantitative Microbiological Quality Control.
Over 25 individual strains are available in BioBall with application in the pharmaceutical,
food and water testing industries.
Pharmaceutical applications
The pharmaceutical industry is required to perform QC with inocula containing less than
100 cfu for several tests including growth promotion, sterility and method validation.
Two BioBall products are ideal for these QC applications:
Designed to provide 10 precise inoculations
• When re-hydrated into 1.1 mL of re-hydration
fl uid it provides 10 x 100 μL doses, each
containing 50 cfu
• 8 hour shelf life makes it ideal when several
controls are needed at the same time, or
within the same day
BioBall Quality
Designed for a single precise inoculation
• Provides a single inoculation of 30 cfu
• Ideal for any application that requires
a precise low cfu level inoculation
BioBall is produced to the world’s highest quality standards, achieving ISO Guide 34 accreditation.
ISO Guide 34 is a standard for reference material producers.
BTF as a Reference Materials producer is the fi rst company worldwide accredited for quantitative
microbiological reference standards, including BioBall.
ISO Guide 34 accreditation means that BioBall customers can have total confi dence
in the Certifi cates of Analysis and in the traceability of the strains used in BioBall.
ISO Guide 34 accreditation is issued by NATA, Australia’s Government endorsed provider
of accreditation for laboratories and similar testing facilities.

Designed to provide 10 precise inoculations
• Each BioBall ® has a batch mean between
500 and 600 cfu
• Standard Deviation is less than or equal to
10% of the batch mean
• When re-hydrated into 1.1 mL of re-hydration
fl uid, one BioBall provides 10 x 100 μL doses,
each containing 50 cfu
Growth Promotion Test using BioBall MultiShot 550
1. Tip the BioBall into BioBall
Re-Hydration Fluid, replace
the cap, wait 30 seconds
• 8 hour stability when re-hydrated with
BioBall Re-Hydration Fluid and
stored at 2 to 8 o C
• Ideal when several controls are needed
at the same time or within the same day
2. Vortex 5 seconds 3. Draw 100 μL aliquot
4. Pipette 100 μL onto plate 5. Spread, dry & incubate 6. Plate with 50 colonies
BioBall Advantages over other multi dose products
• Far less preparation time and fewer steps
• No quality issues with diffi cult micro-organisms
such as Pseudomonas aeruginosa
• Longer shelf life after re-hydration – 8 hours
• Greater precision with a known number of cfu
• Consistent number of cfu batch to batch
• Reduces risk of “failed QC” due
to variability of the inoculum

Number of colonies (cfu)
90
80
70
60
50
40
30
20
10
0
• Little or no preparation time
• Easy to use
• Precise known number of cfu
1
6
11
16
21
26
31
36
41
46
51
56
61
66
71
76
81
86
91
96
Designed for a single precise inoculation
• Each BioBall ® has a batch mean 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
Growth Promotion Test using BioBall SingleShot
1. Tip BioBall on the 2. Re-hydrate the BioBall 3. Spread, dry & incubate 4. Plate with 30 colonies
plate centre
BioBall Advantages over serial dilution
Serial dilution compared to BioBall
Days
From an Australian offi cial body involved in water testing:
• Consistent number of cfu batch to batch
• Reduces risk of “failed QC” due to variability
of the inoculum
101
106
111
116
121
126
131
136
141
146
Routine QC data of E. coli using the IDEXX Colilert ® / Quantitray ® test (January 05 to October 05).
Initially this laboratory was spiking 100 mL water samples with a spike dose prepared in their laboratory
by serially diluting a culture. They then switched to BioBall SingleShot.

BioBall ® strains for Pharmaceutical QC
Micro-organism
BioBall
Strain
Equivalent
ATCC Strain
Cell or
Spore
SingleShot
Product Code
MultiShot 550
Product Code
Aspergillus brasiliensis (niger) NCPF 2275 16404 Spore 56022 56011
Bacillus subtilis NCTC 10400 6633 Spore 56024 56012
Candida albicans NCPF 3179 10231 Cell 56026 56013
Clostridium sporogenes NCTC 12935 11437 Spore 56029 56014
Enterococcus faecalis NCTC 12697 29212 Cell 56031 56015
Escherichia coli NCTC 12923 8739 Cell 56034 56016
Pseudomonas aeruginosa NCTC 12924 9027 Cell 56040 56017
Salmonella abony ACM 5080 NCTC 6017 Cell 56042 56018
Staphylococcus aureus NCTC 10788 6538 Cell 56045 56019
Re-Hydration Fluid NA NA NA NA 56021
Strains sourced from NCTC, NCPF, IMVS, NCIMB & ACM | ATCC is a trade mark of American Type Culture Collection | ^BioBall will be shipped with a minimum of 6 months shelf life.
Packaging
BioBall is supplied in boxes of 20 vials, with one BioBall in each vial
BioBall SingleShot – 20 vials per box
BioBall MultiShot 550 – 20 vials per box
BioBall Re-Hydration Fluid – 20 x 1.1 mL tubes per box

Storage
BioBall ® needs to be stored frozen at ≤ -18 o C.
BioBall Re-Hydration Fluid needs to be stored between 18 to 25 o C.
Shipping
BioBall is shipped in polystyrene boxes with freezer bags. During long shipments BioBall may reach temperatures above
freezing. However, BioBall can be kept at 22 o C for up to 7 days without any impact on product performance. Shipping trials
have been undertaken to validate that BioBall will not exceed 22 o C during shipment.
Other bioMérieux products for the BioPharmaceutical Industry
Environmental Monitoring
bioMérieux develops and manufactures a wide range of solutions for the environmental monitoring of clean
rooms and isolators. From the Count-Tact 3P irradiated plates to the active air sampler airIDEAL ® 3P,
bioMérieux commercialises a range of products specially designed to fulfi l the specifi c requirements of the
BioPharmaceutical Industry.
Main products include: Irradiated and non-irradiated Count-Tact and settle plates.
bioMérieux also markets Quantiswab, a revolutionary swab allowing for safer and quicker surface monitoring.
Sterility Testing
bioMérieux provides a wide range of manual and automated products to determine whether aseptic conditions have been
maintained during aseptic processing, and that the fi nal product is sterile.
Main products include sterility testing culture media such as BTS or FTM broths for compendial methods
and BacT/ALERT ® system for rapid and in-process sterility testing.
Non Sterile Testing
For the control of non sterile products, bioMérieux culture media allow the detection and enumeration of specifi c
micro-organisms and total viable counts according to the requirements of the newly harmonized chapters of the European,
Japanese and US Pharmacopoeias.
Main products include non selective ready to use media, and media designed for the detection of specifi c
micro-organisms described in the Pharmacopoeias.
Further information
For further information on BioBall and the full range of bioMérieux products for the pharmaceutical industry, please contact
your local bioMérieux offi ce, bioMérieux distributor or visit www.biomerieux-industry.com, www.bioball.com

www.bioball.com

09-09 / 006GB99139C / This document is not legally binding, bioMérieux reserves the right to modify specifi cations without notice/ bioMérieux, the blue logo, airlDEAL ® 3P ® , Count-tacT 3P ® , Quantiswab ® , BacT/ALERT ® , BTF and BioBall are used, pending, and/or registered
trademarks belonging to bioMérieux SA, one of its subsidiaries or companies. ATCC is a trademark belonging to the American Type Culture Collection Corporation. BioBall ® does not contain organisms sourced from The American Type Culture Collection ® . NATA is a trademark
belonging to the National Association of Testing Authorities. Colilert is a trademark belonging to Acess Medical Systems Inc. Quantitray ® is a trademark belonging to IDEXX Laboratories Inc. Printed in Australia, bioMérieux RCS Lyon 673 620 399 - BTF ABN 22 086 488 084.
bioMérieux S.A.
69280 Marcy l´Etoile - France
Tel. 33 (0) 4 78 87 20 00
Fax. 33 (0) 4 78 87 20 90
www.biomerieux.com
www.biomerieux-industry.com

Re-Hydration Fluid and stored at 2 - 8°C

02-08 / 006GB99143A/ This document is not legally binding, bioMérieux reserves the right to modify specifi cations without notice/bioMérieux, the blue logo, airDEAL ® 3P, CounttacT 3P,
Quantiswab, BacT/ALERT ®, BTF and BioBall are used, pending, and or registered trademarks belonging to bioMérieux SA, one of its subsidiaries or companies ATCC is a trademark belonging
to the American Type Culture Collection Corporation. NATA is a trademark belonging to the National Association of Testing Authories.Colilert is a tradmark belonging to Acess Medical Systems Inc.
Quantitray ® is a trademark belonging to IDEXX Laboratories Inc. Printed in Australia, bioMérieux RCS Lyon 673 620 399 - BTF ABN 22 086 488 084.
1. 1.Tip BioBall on the
plate centre
Number of colonies (cfu)
90
80
70
60
50
40
30
20
10
0
1
6
11
16
21
26
31
36
41
46
51
56
61
From an Australian offi cial body involved in water testing:
A BIOMÉRIEUX COMPANY
2. Re-hydrate the BioBall 3. Spread, dry & incubate 4. Plate with 30 colonies
Days
66
71
76
81
86
91
96
Routine QC data of E.coli using the IDEXX Colilert ® / Quantitray ® test (January 05 to October 05).
101
106
111
116
121
126
131
136
141
146
Initially this laboratory was spiking 100mL water samples with a spike dose prepared in their laboratory by serially diluting a culture.
They then switched to BioBall SingleShot.
BioBall is supplied in boxes of 20 vials, with one BioBall in each vial. BioBall MutliShot 550 Re-Hydration Fluid – 20 x 1.1 mL tubes per box.
For further information on BioBall and the full range of bioMérieux products for the pharmaceutical industry, please contact your local bioMérieux office,
bioMérieux distributor or visit www.bioball.com

What is BioBall ®
BioBall® is a small water soluble ball containing a precise number of micro-organisms delivering
unprecedented accuracy for Quantitative Microbiological Quality Control.
Over 25 individual strains are available in BioBall® with application in the pharmaceutical, food and
water testing industries.
Pharmaceutical & Cosmetic applications
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 effi cacy
of antimicrobial preservation (e.g. USP 51, EP 5.1.3, JP19). 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 simplifi es preparation and provides a precise inoculum.
Designed to provide 10 precise inoculations
• 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 fl uid it provides 10 x 100μL doses of 107 cfu
• Each 100 μL aliquot can be used to inoculate for example 20 mL of product, resulting in the
required fi nal concentration of 105 – 106 cfu/mL product
3 easy steps to prepare BioBall ® MultiShot 10E8 for an Antimicrobial Effectiveness Test
1. Tip the BioBall ® into BioBall
Re-Hydration Fluid, replace the
cap, wait 30 seconds
2. Vortex 5 seconds
3. Draw 100 μL aliquot

04-09 / 006GB99166A / This document is not legally binding, bioMérieux reserves the right to modify specifications without notice/ bioMérieux, the blue logo, BTF and BioBall are used, pending,
and/or registered trademarks belonging to bioMérieux SA, or one of its subsidiaries. ATCC is a trademark belonging to the American Type Culture Collection Corporation. NATA is a trademark
belonging to the National Association of Testing Authorities. Printed in Australia, bioMérieux RCS Lyon 673 620 399 - BTF ABN 22 086 488 084.
BioBall ® MultiShot 10E8 Advantages over serial dilution
• Far less preparation time and fewer steps
• No quality issues with diffi cult micro-organisms such as Pseudomonas aeruginosa
• Greater precision and reliability with a known number of cfu
• Consistent number of cfu batch to batch
• Reduces risk of “failed QC” due to variability of the inoculum
BioBall Strains for Pharmaceutical QC
Organism BioBall ® Strain Equivalent ATCC
Strain
Cell or Spore Product Code
Candida albicans NCPF 3179 10231 Cell 56145
Escherichia coli NCTC 12923 8739 Cell 56146
Pseudomonas aeruginosa NCTC 12924 9027 Cell 56147
Staphylococcus aureus NCTC 10788 6538 Cell 56148
Re-Hydration Fluid NA NA NA 56021
Strains sourced from NCTC & NCPF. ATCC is a trade mark of American Type Culture Collection
Packaging
BioBall® MultiShot 10E8 is supplied in boxes of 10 vials, with one BioBall® in each vial.
BioBall® Re-Hydration Fluid – 20 x 1.1mL tubes per box.
Further Information
For further information on BioBall® and the full range of bioMérieux products for the pharmaceutical
industry, please contact your local bioMérieux offi ce, bioMérieux distributor or visit www.bioball.com
bioMérieux S.A.
69280 Marcy l´Etoile - France
Tel. 33 (0) 4 78 87 20 00
Fax. 33 (0) 4 78 87 20 90
www.biomerieux.com
www.biomerieux-industry.com