Genre: Instruction

Instructions for use To Open BioBall ® Aseptically remove stopper Agar Plate 1 . Tip BioBall into the centre of the plate . 2 . Rehydrate by pipetting 100 μL of sterile water or 0.9 % saline solution directly onto BioBall . 3 . Wait 30 seconds for BioBall to dissolve . 4 . Use a sterile plastic spreader to evenly spread the dissolved BioBall over the plate surface . 5 . Ensure plate is dry before inverting and incubating . Membrane Filtration 1 . Tip BioBall into liquid sample . 2 . Mix by repeatedly inverting sample 3 . Filter the sample using standard test method . 4 . Follow standard test method for incubation Pour Plate 1 . Pipette 1ml of sterile water or 0.9 % saline solution into pour plate . 2 . Tip BioBall into the sterile water / saline solution . 3 . Wait 30 seconds for BioBall to dissolve . 4 . Add molten agar and mix according to standard test method . 5 . Incubate as required . Petrifilm ® 1 . Tip BioBall onto the centre of Petrifilm ® 2 . Rehydrate by pipetting 100 μL of sterile water or 0.9 % saline solution directly onto BioBall . 3 . Follow standard test method . 4 . Incubate as required . Petrifilm ® is a registered trademark belonging to 3MTM Corporation . Adding to Samples / Broths 1 . Tip BioBall ® into sample / broth 2 . Mix 3 . Incubate as required Intended Use BioBall SingleShot is a microbiological reference material containing a precise number of viable bacterial cells . It is designed for use as a quantitative quality control sample . Description BioBall SingleShot is a freeze dried water soluble ball containing a precise number of micro-organisms . The ball is a white sphere approximately 3mm in diameter . Quality Control BioBall SingleShot delivers a level of precision previously unobtainable in microbiology . Each batch of BioBall SingleShot is quality controlled by testing a minimum of 10 % of the batch up to a maximum of 50 . Vials are selected at random from throughout the batch and plated onto non-selective agar plates and DRBC for Aspergillus species . The plates are incubated then counted . Each standard batch of BioBall meets the following criteria ( unless otherwise stated ) : Mean 28-33 cfu Standard Deviation 3 cfu or less Certificate of Analysis Certificates of Analysis can be downloaded from the BTF website : www.bioball.com . The certificate states the mean cfu and standard deviation of the batch . It also states the 95 % Prediction Interval . The standard deviation is a measure of variability within the batch , the mean is the average cfu count tested on nonselective agar and DRBC for Aspergillus species . The Prediction Interval is a statistical analysis of the quality data stating that 95 % of your expected results will fall within this range . Our team of technical experts can be contacted regarding the interpretation of results . The micro-organisms used in BioBall ® SingleShot are derived from known reference strains . Their identity is confirmed by genetic typing . ATCC is a trademark of the American Type Culture Collection . Limitations CFU count ( mean , CV and standard deviation ) stated in this document and BioBall promotional literature , and batch-specific Quantification Data reported on BioBall Certificates of Analysis , are determined on non-selective culture media ( unless otherwise stated ) . Selective media vary greatly in their inhibitory properties amongst different formulations and amongst brands with similar formulations . Recovery rates from BioBall may be reduced relative to the selectivity of the media . Users of BioBall with selective media are advised to establish their own expectations for recovery rate for each BioBall strain on selective media and to base their performance expectations on data derived from the specific formulations and brands of selective media used in their laboratories . Where recovery rates are reduced on very selective media , users should consider using a greater inoculum to meaningfully assess the limits of detection of their media . Accreditation BTF as a Reference Materials Producer is the first company worldwide accredited for quantitative microbiological reference standards , including BioBall . Technical Assistance BioBall SingleShot can be used for other applications . For technical assistance please contact your bioMerieux or BTF customer support team . Safety Precautions BioBall SingleShot contains viable and potentially pathogenic bacteria and should only be handled by experienced laboratory personnel trained in the safe handling of these micro-organisms . The number of micro-organisms contained within BioBall SingleShot is low . However , BioBall SingleShot should be handled as if potentially infectious . Refer to your national safety guidelines . After use , dispose of packaging in accordance with appropriate biohazard disposal practices . Do not use the product if the packaging is damaged . Do not use the product after the expiry date . The product should be used according to the procedure described in this instruction for use document . Any modifications may affect the results . Warranty BTF warrants to the original purchaser only that the products will conform to the quantity and contents stated on the product labels and quality certificate for the duration of the stated shelf life .