Frequently Asked Questions (FAQ)
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A crucial element of the technology is the monitoring of these changes in a reading zone found at the bottom of the test vial and separated from an incubation zone, thereby eliminating the masking of the optical pathway by the product and microbial turbidity. The signal is relatively constant until the numbers of microorganisms reach a threshold value; thereafter, there are accelerating changes in the color and fluorescence signals.
Although the system can detect as little as one cell per vial, organisms must first grow to a level exceeding a pre-determined, specific detection threshold. That threshold for bacteria is ≈100,000 cells/ml and the threshold for yeast/mold is ≈10,000 cells/ml. The time to detection depends on the initial concentration of organisms in the product sample. Therefore, highly contaminated samples rapidly detect, providing rapid warning of contamination.
- The software is validated to ensure accuracy, reliability, consistent performance, and the ability to generate accurate copies of the records.
- The records are protected to enable their accurate and ready retrieval throughout the records retention period.
- The software generates a user independent, secure, computer-generated, time stamped audit trail that cannot be altered by the operator.
- The access to the software is limited to authorized individuals
- Specificity (also called inclusivity and exclusivity),
- Limit of Detection,
- False Negative Rate,
- False Positive Rate,
- and Side-by-Side comparison.
As soon as a detection occurs in the system, the operator is alerted. The higher the contamination, the faster the result. This ensures rapid warning of poor quality raw material, in-process material, and finished product. Most completed (below specification) assay results are available either the same day or overnight. Yeast and Mold results can take up to 48 hours.
- Inoculate the vial with the sample, swab, or filter
- Place the vial in the BioLumix instrument
- Record the sample in the Windows®-based software
- The BioLumix instrument is capable of conducting 32 concurrent tests at a single temperature.
- Up to 32 instruments can be attached to one computer.
- There is random access to each vial location and various assays can be run in the same instrument.
- Each instrument has the shape of a drawer and each drawer of 32 tests has independent temperature control.
- All instruments can have a temperature test range of 18-60 ±0.2°C.
- The physical size of the BioLumix instrument is 16cm tall x 36cm wide x 65cm deep (6¼"t x 14½"w x 26¼"d) and weighs 15.8 kg (35 pounds).
Presence/absence endpoints may be applied if few organisms are expected (<10 CFU). In that case, calibration is not recommended. A more simple approach using the presence/absence endpoint is performed after the product has been diluted in appropriate detection medium.
Dilute-to-specification protocol requires diluting the sample to the specification limit required for product action or release. If there is growth, the sample fails; if there is no detection, the sample passes since the counts are below the specification limit.
Functional sterility includes the type of test where there is no allowable number of microorganisms and the product is not expected to contain any living cells. Therefore, in a functional sterility application, a pre-incubation time is incorporated into the protocol. The pre-incubation time is based on the target microflora. After pre-incubation, a sub-sample of the pre-incubation broth is transferred to vials containing the appropriate growth medium for testing.