Spotlight Archives

Electronic management of EM results in the microbiology lab; Critical considerations and financial justification - September 1, 2010, EM Series #1

An appropriate microbiological environmental monitoring (EM) program should be established and used in production and laboratory facilities for both sterile and non-sterile products. The most stringent application of these procedures is for sterile products manufactured by aseptic processing.
“In aseptic processing, one of the most important laboratory controls is the EM program. This program provides meaningful information on the quality of the aseptic processing environment” (FDA Guidance for industry).
Typical pharmaceutical and biotech facilities may have several hundred or thousand environmental samples collected and processed on a daily basis. Most microbial EM programs generate a voluminous amount of data and require a large amount of time from the microbiology control labs. Due to the large amount of data that must be maintained, reviewed, and reported on, companies may consider acquiring data storage and management systems. This Spotlight will address the critical points to look at when considering the implementation of a paperless EM data management solution.

Microbial IDentification: Evaluation library databases for microbial ID: critical spects and recommendations - July 14, 2010, Microbial ID Series #3

The key focus of this review is to present questions to ask manufacturers and contract laboratory services about their microbial identification libraries and analytical tools used for microbial identifications. Accuracy, reproducibility and cost are all directly impacted by the method of data analysis and the library database used for determining a reliable identity. The article discusses the attributes and limitations of different methodologies in analyzing results to determine an identification. Equally important in a highly regulated industry, cGMP, compliance and validation strategies for library database entries and maintenance are explored. The focus of many system providers is in vitro diagnostics, therefore, recommendations for “Fitness For Use” in aseptic and sterile environments is very critical component in an evaluation.

Microbial IDentification: Overview of commonly used microbial ID methods - June 10, 2010. Microbial ID Series #2

In this paper, we present the most commonly used methods in the Quality Control laboratories. All microbiological identification methods have their inherent strengths and limitations. This is a well-understood fact. The challenge for the microbiology team working in the QC lab is to determine which method(s) work best in their specific situations. Contact us to get the printable version.

Rapid Microbiological Methods: What technologies and equipment are available today? (Part 2) - April 10, 2010. RMM Series #3

We continue to present RMM technologies and suppliers. This issue provides information about non growth-based methods and focuses on Nucleic Acid Amplification Technologies (NAAT). Contact us to get the printable version.

Bacterial Endotoxin Testing: What Tests and Equipment are available? - March 10, 2010. BET Series #2

In this issue we provide more detailed information about the existing technologies, with the associated commercial test reagents, and the equipment needed.

Microbial IDentification: What taxonomic level is needed? - February 1, 2010. Microbial ID Series #1

In a previous Spotlight article, the need for establishing a microbiology function was discussed. Whether a company decides they have a need for an in-house microbiology laboratory or utilizing an outside laboratory, the next step is to decide what information regarding identification is needed. Thoughts must be given to what detail or level of taxonomic information is useful and necessary.

Rapid Microbiological Methods: What technologies and equipment are available today? (Part 1) - January 2, 2010. RMM Series #2

Several instruments are available on the market and the selection of the system depends on the type(s) of testing you plan to perform. A review of the main existing and used technologies and suppliers is presented, starting with the growth-based methods.

Why do we have a Microbiology Laboratory here anyway? - Dec. 7, 2009.

Holiday parties, fun times and the New Year - what a great season! Imagine you are at a gal event and someone asks you the "what do you do?" question. Can you simply answer that question in layman's terms?

Bacterial Endotoxin Testing: An analytical challenge - Dec. 1, 2009. BET Series #1

Endotoxins may show toxic activity even at low concentration, causing severe reactions in humans. Detection is critical for BioPharmaceutical companies to ensure manufacturing of quality products, free of Endotoxin contaminations. Choosing and setting up effective endotoxin testing is a real challenge. Both test method and sample need to be considered as well as the test validation toward interfering factors.

Rapid Microbiological Methods: What considerations to review when looking at implementing a RMM? - Nov. 9, 2009. RMM Series #1

Sets of information need to be considered. You need to address some questions: What do you want to do with the system? What benefits will the system deliver? What do you need to know to submit the Capital Expense Request? What about the site infrastructure to install the system? What do you need to know about the vendor?