Full citations and abstracts are provided below.
2014. Ragheb, S.M.; Jimenez, L. Polymerase Chain Reaction/Rapid Methods Are Gaining a Foothold in Developing Countries. PDA Journal of Pharmaceutical Science and Technology. 68(3): 239-255.
Detection of microbial contamination in pharmaceutical raw materials and finished products is a critical factor to guarantee their safety, stability, and potency. Rapid microbiological methods—such as polymerase chain reaction— have been widely applied to clinical and food quality control analysis. However, polymerase chain reaction applications to pharmaceutical quality control have been rather slow and sporadic. Successful implementation of these methods in pharmaceutical companies in developing countries requires important considerations to provide sensitive and robust assays that will comply with good manufacturing practice.
2014. Eaton, T.; Wardle, C.; Whyte, W. Use of a Real-Time Microbial Air Sampler for Operational Cleanroom Monitoring. PDA Journal of Pharmaceutical Science and Technology. 68(2): 172-184.
A sampler that detects and counts viable particles in the air of cleanrooms in real-time was studied. It was found that when the sampler was used to monitor airborne particles dispersed from a number of materials used in cleanrooms, including garments, gloves, and skin, the number of viable particles dispersed from these materials was greater than anticipated. It was concluded that a substantial proportion of these viables were of a non-microbiological origin. When the sampler was used to monitor a non-unidirectional airflow cleanroom occupied by personnel wearing cleanroom garments, it was found that the airborne viable concentrations were unrealistically high and variable in comparison to microbe-carrying particles simultaneously measured with efficient microbial air samplers. These results confirmed previously reported ones obtained from a different real-time sampler. When the real-time sampler was used in a workstation within the same cleanroom, the recorded viables gave results that suggest that the sampler may provide an effective airborne monitoring method, but more investigations are required.
2014. Gurramkonda, C.; Mupparapu, K.; Abouzeid, R.; Kostov, Y.; Rao, G. Fluorescence-Based Method and a Device for Rapid Detection of Microbial Contamination. PDA Journal of Pharmaceutical Science and Technology. 68(2): 164-171.
A method for rapid detection of microbial detection is presented. It uses the reduction of resazurin to resorufin as an indication of the presence of viable cells. The method is highly sensitive (limit of detection 1 CFU/mL) and rapid (detection time 180 s). A portable device that could allow the detection to be performed in the field is also described.
2014. Sandle, T.; Leavy, C.; Jindal, H.; Rhodes, R. Application of Rapid Microbiological Methods for the Risk Assessment of Controlled Biopharmaceutical Environments. Journal of Applied Microbiology. 116(6): 1495-1505.
To assess the different operational states within a biopharmaceutical grade clean room, using a rapid microbiological method. The method was a novel system, based on spectrometry, designed for sampling, discriminating, and enumerating airborne particles. Central to the study was the aim to determine the microbiological levels as a clean room went from standard use through maintenance and shutdown, disinfection, and then back to standard use. The objective was to evaluate whether a rapid method could replace conventional environmental monitoring using growth‐based media.