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Sterility Testing and Monitoring


These tests provide a simple, inexpensive, unambiguous,
USP <71>-compliant sterility evaluation of your CSPs within
your normal work-streaming demands.

We have developed a simple, economical, and pharmacy-friendly method of testing and monitoring the end-product sterility of CSPs. In accordance with USP 797, this type of testing provides a fast and effective means of evaluating the quality of CSPs as a reflection of compounding process integrity and efficacy. In order to produce meaningful results, the pharmacy testing mechanism needs to be familiar to the operative, easy to use, and provide no false positive results, which may skew the process evaluation, resulting in costly and unnecessary corrective actions.

SteriTEQ™, SteriMS™ and SteriQUOT™ (Patent Pending) incorporate a simple, direct-injection aerobic and facultative anaerobic microbial testing process using only a pharmacy-familiar vial and syringe without the need for extraneous or unfamiliar tubing, pumps, filters, spiking requirements, incubators, or unfamiliar manipulations. ThioTEQ™, ThioMS™ and ThioQUOT™ also incorporate a simple, direct-injection anaerobic and facultative aerobic microbial testing process without the need for pumps, filters, tubing, or unfamiliar manipulations. Using this elegant, fast, pharmacy-friendly system, the individual compounding the sterile product is responsible for performing the entire sterility testing or monitoring exercise within the scope of his or her uninterrupted daily compounding workflow. Any positive result is, therefore, attributable only to this individual within the unbroken continuum of his or her routine aseptic technique. This eliminates any false-positive result attributable to intervention by another person, unfamiliar or difficult testing processes, process interruption/intervention, or non-compounding-process equipment. SteriTEQ, SteriQUOT, ThioTEQ, and ThioQUOT are unique to the CSP evaluation process. These tests provide a simple, inexpensive, unambiguous USP <71>-compliant sterility evaluation of your CSPs within your normal work-streaming demands.

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USP <797>

 

Lab Safety has developed four simple, economical, pharmacy-friendly methods of testing and monitoring the end-product sterility of CSPs in accordance with USP <797>. This testing provides a fast and effective means of evaluating CSP end-product quality as an indicator of your CSP process integrity.

SteriTEQ (Patent Pending) incorporates a unique LVP product-additive rather than product-sampling procedure. SteriQUOT incorporates a product sampling procedure for SVPs. Both provide the USP <71>-compliant sterility test phase for aerobic microbiological contamination of compounded sterile LVPs and SVPs. Testing incorporates only a pharmacy-familiar vial, syringe, and needle with no extraneous or unfamiliar tubing, pumps, filters, spiking requirements, or incubators. Because the individual who compounds the sterile product is also responsible for performing the entire sterility testing exercise, any positive test result will be attributable only to this individual within the continuum of his or her aseptic technique. This factor eliminates any false-positive result attributable to intervention by other persons, unfamiliar or difficult testing manipulations, or equipment.

In the same pharmacy-friendly manner, ThioTEQ and ThioQUAT provide a product-sampled, USP <71>-compliant sterility test phase for anaerobic microbiological contamination of LVP and SVP end-products. ThioTEQ and ThioQUOT incorporate only a pharmacy-familiar syringe and needle, without the need for any extraneous or unfamiliar procedures or equipment. SteriTEQ, SteriQUOT, ThioTEQ, and ThioQUAT are unique to the CSP evaluation process providing a simple, inexpensive, and accurate sterility evaluation of CSPs within your normal work-streaming demands.