Methods of Rapid Microbiological Assay and Their Application to Pharmaceutical and Medical Device Fabrication

Abstract

There are several rapid microbiological methods becoming available that have useful applications in pharmaceutical and medical devices. They are ATP bioluminescence, fluorescent labeling, electrical resistance, and nucleic acid probes. In choosing to employ rapid methods, the microbiologist should examine their prospective performances against the specific requirements for that sector. Some methods may require expensive equipment and offer full automation, and others represent only a small investment. The regulatory view of these methods is changing and they still officially have not been approved in medical and pharmaceutical area, but it will still be up to the microbiologist to demonstrate that the method chosen is fit for the purpose intended.

Validation of constitutively expressed bioluminescent Pseudomonas aeruginosa as a rapid microbiological quantification tool

“…The lower limit of quantification was 10 3 CFU/mL, which is also reported in the validation document (PDA, 2000) and with studies using ATP bioluminescence (Kramer et al, 2008). According to a review of methods for rapid microbiological assay (Shintani et al, 2011), the sensitivity of the ATP bioluminescent method was quoted as greater than 10 2 -10 3 CFU/mL. However, a disadvantage of the ATP bioluminescent method was that there is a high rate of false positive results due to the fact that non-microbial ATP cannot be distinguished from microbial ATP and in particular microbial ATP from luciferase pathway (Kramer et al, 2008).…”

Rapid microbiological testing method

“…Three varieties of microbiological evolution conducted, one is for determination of presence of organism (presence-absence test) if any organism present then should determine how much is present (environmental test) and eventually identiication of organism which is present (identi ication test). (Shintani, 2014) 1. Presence-absence test 2.…”

Cosmetics Preservation: A Review on Present Strategies

“…The clumping of bacterial cells by some preservatives (chlorhexidine) is another problem which overestimates the viability. Thus, this technique is not applicable to Aspergillus and it is not suitable for processing complex formulations that cause problems in filtration of samples [ 116 ].…”

“…This reaction leads to the emission of photons and the intensity of the light produced is directly proportional to the rate of ATP [ 117 ]. However, this method is not applicable to the genus Aspergillus , and to creams or suspensions, since these latest could interfere with the detection of light emission [ 116 ].…”