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operator interactions/interventions, allowing microbiologists to focus on interpreting the data and reacting with rapid microbiological tools when control cannot be maintained.
particle counts as an indicator of viable contamination will no longer be necessary. The real-time detection of viable particles in liquids will be common place.
TR:
Today, the global regulatory expectation is very clear regarding classifying and monitoring of pharmaceutical cleanrooms for non-viable particles during aseptic processing. Current guidance as to when to monitor for airborne microbiological particles is not so clear, there is no distinction between
classification and monitoring. Culture-based methods
will continue to compliment rapid methods although the guidance surrounding microbiological monitoring will be enhanced, such as an expectation to monitor continuously during critical aseptic processing.
The variability associated with microbial measurements will be openly accepted as new techniques are compared to the current compendial approach.
A first step has been taken with the revision of USP 1116
recommending a transition from fixed low count limits to number of occurrences. This is an excellent platform for discussion regarding the significance of low microbial counts associated with the highly variable compendial method.
It is almost impossible to purchase a non-viable particle counter today and
not other. have them correlate with each Conversely, it is almost impossible to
purchase an active air sampler from different manufacturers and obtain comparable results. It is inevitable that this situation will improve through the update of the relevant ISO standards and their association to the GMPs.
particularly sequence-based (including next-generation sequencing) methods will have all the advantages of the methods that are present today. Such technologies are well-positioned to address hurdles such as accuracy, fast turnaround time, strain typing and addressing mixed culture samples.
PB:
Regulatory agencies already identify genetic methods for identification of microbes as the preferred method. With the increasing adoption rate of RMMs, we are gradually seeing a shift in the way QC microbiology is being conducted.
microbiology vendors in the coming years. They will continue to address today’s unmet needs and reduce non value-added tasks in the lab. If Pharmaceutical companies reinforce upstream collaborations with vendors it will allow key innovations to diffuse more rapidly such as Mass Spectrometry Identification or Automated Cytometry for example. Also, giving more flexibility to pharmaceutical
RJ:
More and more alternative methods will be made available from
I see more shifts to molecular methods. Molecular methods,
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In less than 15 years, real-time fluorescence based airborne viable particle detectors will be commonly used. Non-viable airborne
companies to implement in process alternative methods would certainly help to leverage these technologies more quickly. Today’s expectations for validating any given alternative method are so high that I doubt many of the traditional and accepted methods used daily would pass such criteria. Simplifying the implementation for in-process tests while sticking to the compendial methods for release would allow for improved product quality and cost savings, all while keeping the reference framework of the traditional methods.
References 1.
2. 3. 4. 5. 6.
http://www.cdc.gov/hai/outbreaks/meningitis.html
Jimenez, L. 2007. Microbial diversity in pharmaceutical product recalls and environments. PDA Journal of Pharmaceutical Science and Technology 61:383-399.
Sutton, S.W., and L. Jimenez. 2012. A Review of Reported Recalls Involving Microbiological Control 2004-2011 with Emphasis on FDA Considerations of “Objectionable Organisms”. American Pharmaceutical Review 15, January/February: 42-57.
Torbeck, L., D. Racassi, D.E. Guilfoyle, R.L. Friedman, and
D.Hussong. 2011. Burkholderia cepacia, the decision is overdue. PDA Journal of Pharmaceutical Sciences and Technology 65:535-543.
Kou-San Ju, and R.E. Parales. 2010. Nitro aromatic compounds from synthesis to
biodegradation. Applied and Environmental Microbiology 74:250-274. Lessie, T.G., W. Hendrickson, B.D. Manning, and R. Devereux.
Genomic complexity and plasticity of Burkholderia cepacia. FEMS Microbiology Letters 144:117-128.
UNDERSTANDING, ACCELERATED *Patents: 5,701,012; 5,895,922; 6,831,279
www.americanpharmaceuticalreview.com |
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