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.

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.

A random sample of every BioBall^™ batch is analysed and enumerated to set the mean and standard deviation of each batch. Please refer to the instructions for use document for each product.

All BioBall^™ products are catagorised as Risk Group 1 or Risk Group 2 organisms.

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.

BioBall needs to be stored frozen between -18^oC to -33^oC 
BioBall Re-Hydration Fluid needs to be stored between 18^oC to 25^oC
BioBall 14 Day Re-Hydration Fluid needs to be stored between 2^oC to 8^oC

 

Please refer to the instructions for use document for each BioBall^™ product

BioBall^™ products undergo both accelerated and real time stability trials.  Every batch of BioBall^™ is tested for stability when it is produced and on an ongoing basis.

As an ongoing service to our customers, batches that are approaching their expiry date are tested using accelerated stability trials. If a batch passes this testing then a new expiry date is issued.

What does this mean to you, our customers?

• The integrity of every BioBall^™ batch is constantly monitored.

• Customers should check the BTF website to determine whether a batch has been extended prior to discarding any BioBall^™ product.

• The certificate of analysis will be updated to display the extended expiry date and will be posted onto the BTF website. This update will replace the original certificate for that particular batch, but will still show the same batch number.

When using the BioBall^™ MultiShot 550 Re-Hydration Fluid and stored at 2-8^oC, 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 rehydration 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 rehydrated, and thus ensures stability over an extended period.

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

As the mixed kit contains numerous strains you will need to check each individual vial for the batch number and download each certificate for each batch that is within the kit.

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.

BioBall^™ is manufactured at the BTF head office in the Sydney Australia. All shipments (Excluding USA and some countries within Europe and Asia regions) are shipped directly from Sydney to the customer.

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 31st May 2011