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
Designed for a single precise inoculation
• When re-hydrated into 1.1 mL of re-hydration
fluid it provides 10 x 100 μL doses, each
containing 50 cfu
• Provides a single inoculation of 30 cfu
• Ideal for any application that requires
a precise low cfu level inoculation
• 8 hour shelf life makes it ideal when several
controls are needed at the same time, or
within the same day
BioBall Quality
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 first company worldwide accredited for quantitative
microbiological reference standards, including BioBall.
ISO Guide 34 accreditation means that BioBall customers can have total confidence
in the Certificates 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
fluid, one BioBall provides 10 x 100 μL doses,
each containing 50 cfu
• 8 hour stability when re-hydrated with
BioBall Re-Hydration Fluid and
stored at 2 to 8oC
• Ideal when several controls are needed
at the same time or within the same day
Growth Promotion Test using BioBall MultiShot 550
1. Tip the BioBall into BioBall
Re-Hydration Fluid, replace
the cap, wait 30 seconds
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
• Greater precision with a known number of cfu
• No quality issues with difficult micro-organisms
such as Pseudomonas aeruginosa
• Consistent number of cfu batch to batch
• Longer shelf life after re-hydration – 8 hours
• Reduces risk of “failed QC” due
to variability of the inoculum
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
plate centre
2. Re-hydrate the BioBall
3. Spread, dry & incubate
4. Plate with 30 colonies
BioBall Advantages over serial dilution
• Little or no preparation time
• Consistent number of cfu batch to batch
• Easy to use
• Reduces risk of “failed QC” due to variability
of the inoculum
• Precise known number of cfu
Serial dilution compared to BioBall
90
80
60
50
40
30
20
10
96
10
1
10
6
11
1
11
6
12
1
12
6
13
1
13
6
14
1
14
6
86
91
81
76
71
66
56
61
51
46
41
36
31
26
21
16
6
11
0
1
Number of colonies (cfu)
70
Days
From an Australian official body involved in water testing:
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 ≤ -18oC.
BioBall Re-Hydration Fluid needs to be stored between 18 to 25oC.
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 22oC for up to 7 days without any impact on product performance. Shipping trials
have been undertaken to validate that BioBall will not exceed 22oC 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 fulfil the specific 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 final 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 specific
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 specific
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 office, 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 specifications 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
2. Re-hydrate the BioBall™
1.Tip BioBall™ on the
1.
plate centre
3. Spread, dry & incubate
4. Plate with 30 colonies
80
Number of colonies (cfu)
70
60
50
40
30
20
10
10
6
11
1
11
6
12
1
12
6
13
1
13
6
14
1
14
6
96
10
1
86
91
76
81
66
71
56
61
46
51
41
31
36
21
26
16
6
11
0
1
02-08 / 006GB99143A/ This document is not legally binding, bioMérieux reserves the right to modify specifications 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.
90
Days
From an Australian official body involved in water testing:
Routine QC data of E.coli using the IDEXX Colilert® / Quantitray® test (January 05 to October 05).
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
A B I O M É R I E U X C O M PA N Y
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 efficacy
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 simplifies 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 fluid 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 final 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
BioBall® MultiShot 10E8 Advantages over serial dilution
• Far less preparation time and fewer steps
• No quality issues with difficult 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
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 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 office, 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