FAQ

Q1 What microorganisms are available in the Bioball® format?

Click on the available strains link on the left hand side of this page for the list of reference strains currently available in the Bioball® format.

 

Q2 Can Bioball® be used on selective media?

Bioball® quality control is carried out using non-selective media (refer to Batch Certificate of Analysis for details of media). Bioball® can be used on selective media, however a comparison study is recommended to determine the % cfu recovery of a selective media.

 

Q3 How is quality control performed on Bioball®?

A random sample of every Bioball® batch is analyzed and enumerated to set the mean and standard deviation of each batch. Please refer to the instructions for use document for each product.

 

Q4 What risk group are Bioball® in?

All Bioball® products are categorized as Risk Group 1 or Risk Group 2 organisms.

 

Q5 How do I culture Bioball®?

Refer to the instructions for use document where details are given for use of Bioball® in solid and liquid media and also for method validation and daily batch controls.

 

Q6 What are the storage requirements for Bioball®?

Bioball® needs to be stored frozen between -18°C to -33°C
Bioball® Re-Hydration Fluid needs to be stored between 18°C to 25°C
Bioball® 14 Day Re-Hydration Fluid needs to be stored between 2°C to 8°C
Bioball® alt-RHF needs to be stored between 2°C to 8°C
Re-hydration Fluid should not be frozen

 

Q7 What re-hydration fluid is required for Bioball®?

Please refer to the instructions for use document for each Bioball® product

 

Q8 How does Bioball® MultiShot 550 stay stable for 8 hours after re-hydration?

When using the Bioball® MultiShot 550 Re-Hydration Fluid and stored at 2-8°C, our testing has shown that the number of CFU in each aliquot will remain virtually the same at time 8 hours, as at time zero.The reason that Bioball® products are able to be stable for such a long time after re-hydration when compared to other products and techniques, is due to the superior technology used to produce the product.For example, no other product in the world is able to specify an accurate range of CFU like Bioball® can.  This means that unlike other products, Bioball® contains a very accurate number of organisms to start with, which is very consistent from batch to batch, and from vial to vial.  This ensures that the numbers of organisms contained in each Bioball® are specified accurately, and will not vary greatly between samples.  It also means that we are able to specify a number of organisms accurately to be in the centre of the boundaries set by the various pharmacopeia (ie. 10-100 cfu) for spike controls, so that the number of organisms within each spike reliably falls within these boundaries.
Adding to the stability and life time of the product is the superior freeze-drying technique developed by BTF, and used to produce Bioball® products.  This superior freeze-drying technique ensures the physiology of organisms established within Bioball® are more consistent than when using other techniques.  This ensures more uniform behavior between organisms within each Bioball® when re-hydrated, and thus ensures stability over an extended period.

Q9 Where do I go to get the certificate of analysis and instructions for use documents?

All Bioball® documentation is available from the Bioball website. Click on “Instructions for Use” and “Certificates of Analysis” links either on the home page or in the left hand navigation bar

 

Q10 What is the permit requirements for my country?

Every country has different permit regulations to import Bioball®. You will need to check with your local government authorities to determine what permits you require.
Permits should be emailed to ML-AU-SYD-BTF-BIOBALL@biomerieux.com

 

Q11 Where is Bioball® manufactured?

Bioball® is manufactured at the Manufacturing Site in Sydney Australia.

 

Q12 Can I store Bioball® in a -70°C Ultra low temperature freezer?

The Bioball® storage conditions have been validated between -18°C and -33°C, therefore it is recommended to store Bioball® between these temperatures. It is not recommended to store Bioball® at lower temperatures unless the customer wishes to conduct their own validation for such storage temperatures.

 

 

 

 

FAQ list – last updated 29th of December 2016