Spotlight
Bacterial Endotoxin Testing Series - 3
Bacterial Endotoxins Test - Case Study
The bacterial endotoxins test (BET) and the limulus amebocyte lysate (LAL) test are mandatory quality control (QC) release tests for injectable drug products. Guidelines for the BET and monographs with endotoxin limits are included in major pharmacopeias.
Today, the US FDA recommends that Process Analytical Technology (PAT) be implemented as part of pharmaceutical manufacturing, which involves risk-based management at every step of the process. More companies are implementing in-line, on-line or at-line tools to provide them with real-time analysis on the manufacturing floor to build quality into process.
A Six Sigma analysis was conducted by an objective third party consultant to analyze LAL test efficiency at a biotech company. The study analyzed the sample process flow and turnaround time for two sets of in-process buffer samples.
General Topics Series
Microbial preservation of cosmetics, pharmaceutical and biotech products: Critical considerations
Protection of cosmetic, pharmaceutical or biotech products against microbial contamination is of major importance for related companies. This protection has two main objectives: first, the consumer health protection and second, the company image protection. To this end, the company responsibility is double: a/ to ensure that the product in its commercial form is free of microorganisms or in the limits accepted by the regulation according to the type of product, and b/ to ensure that the product will not be contaminated subsequently by the consumer, in a normal way of use, in such a way that it will jeopardize the consumer health or the product organoleptic properties. Each cosmetic, biopharma product is unique and the contamination risk requires each time a specific and accurate analysis, taking into account various criteria.
Rapid Microbiological Methods Series - 5
Validating your RMM technology - Understanding the process and developing your approach
If you have kept up with prior spotlights, you have gained a great understanding of the RMM solutions that are available and the various benefits of each approach. The next logical question may now be, “what does it take to validate these solutions”. Much like the different types of RMM approaches, the validation process can vary. Validation of the RMM solution requires understanding both internal and external requirements to appropriately validate the RMM solution. In addition, time and resource budgeting for validation is an important consideration.
Microbial ID Series - 6
Evaluating the Benefits of Outsourcing Microbial Identifications to a Contract Laboratory. What are the Criteria to Consider?
It has become routine practice for many pharmaceutical, medical device, nutraceutical and personal care companies to use external resources to facilitate their manufacturing processes. The reasons they seek external support is influenced by a number of factors, including: lack of sufficient internal resources, cost reduction, and process quality improvement by gaining technical expertise without accruing capital investment costs. Many organizations view outsourcing as a way to improve efficiency as witnessed by the growth trend in outsourcing operational activities and testing. In this article are presented six critical elements to evaluate a contract laboratory service for microbial identifications.
EM Series - 2
Active Microbiological Air Samplers
Critical considerations about sampling efficiency
An appropriate microbiological environmental monitoring program should be established and used in production and laboratory facilities for both sterile and non-sterile products. Monitoring airborne viable microorganisms is an important part of such a program. Sampling for those is a critical step and sampling efficiency impacts directly the results and related decisions and actions.
Microbial Identification Series - 5
Microbial ID - Survey Results
In combination with its Spotlight Series about Microbial IDentification, BioSciences Quality Testing Forum asked its readers to share their experience in this field. Over 60 microbiologists responded. Most of them were from pharmaceutical (50%), biotech (18%), and cosmetics (10%) companies, in and outside the US. Their responses are described.
The identification of microorganisms from the pharmaceutical and biotech production environment is an important objective. Microbial ID provides information about a potential contamination source and can help explain deviating results of microbiological analysis.
For example, the ID of S. epidermidis in a sample ...
Microbial Identification Series - 4
Phenotypic Identifications: Critical Considerations and Recommendations
All too frequently, assumptions are made concerning how to perform routine ID for microbiological control in the pharmaceutical industry. Objectivity is needed to interpret scientific publications and guidelines, just as it is needed for optimizing purchasing decisions when selecting methods for routine microbial ID. Laboratories must of course identify regulatory-related needs where objectivity is sometimes lacking. ...
Dave Pincus - Principal Scientist, Microbial Identification - R&D Microbiology, bioMérieux
Rapid Microbiological Methods Series - 4
Rapid Detection Systems - The importance of support: Critical steps for a successful implementation
Your impression of a brand, company or product is not formed because you had an outstanding sales rep or negotiated a great price. What really forms your long term impression is what support you get. The paper addresses the role of support and what makes support great! It also provides key considerations in each critical step of the process for a successful implementation.
EM Series - 1
Electronic management of EM results in the micro lab: Critical considerations & financial justification
An appropriate microbiological Environmental Monitoring program should be established and used in production and lab facilities for sterile and non-sterile products. “In aseptic processing, one of the most important lab controls is the EM program” (FDA Guidance for ind.). Typical biopharma facilities may have several hundred or thousand environmental samples collected, processed on a daily basis. Most microbial EM programs generate a voluminous amount of data and require a large amount of time from the QC labs. Companies may consider acquiring data storage & management systems. This Spotlight addresses the critical points to look at when considering implementing a paperless EM data management solution.
Microbial Identification Series - 3
Evaluating Library Databases for Microbial Identification
Critical Aspects and Recommendations
The key focus of this review is to present questions to ask manufacturers and contract lab services about their microbial ID libraries and analytical tools used for microbial ID. Accuracy, reproducibility and cost are all directly impacted by the method of data analysis and the library database used for determining a reliable id. 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 "Fitness for Use" in aseptic and sterile environments is also a critical component in an evaluation.
