Monitoring Microbial Contaminants Services

Creative Biolabs is one of the leading providers of CRO services in the United States, providing flexible and professional live biotherapeutics discovery and development services to pharmaceutical companies, biosciences, and contract research organizations.

Overview

Bacterial contamination control is an important aspect in the field of drug production. The presence of microbial contaminants in non-sterile preparations has not only been found to cause the deterioration of many products but has also been shown to be potentially hazardous to the health of consumers. The extent of the hazard depends on the types and numbers of organisms present, the route of administration, and the resistance of the patient to infection. Therefore, non-sterile preparations must pass microbial bioload tests and tests for the absence of some specific indicator pathogens. Most contaminants in pharmaceutical products and raw materials are bacteria, yeasts, and filamentous fungi (molds). Some of these contaminants may be pathogenic while others grow as commensals even in the presence of preservatives and spoiled products. The contaminants may evolve from the raw materials, manufacturing machines, production atmosphere, the persons conducting the process, or from the container into which it is finally filled and sealed.

Detection of Microbial Contamination in Biological/ Sterile Products

Many tests can be used to detect microbial contamination of biological products.

• Specific Media for the Presence of Colonies

Differential media uses specific media for the detection of microbial contaminants. Certain media support the growth of virtually all microorganisms. For rich media, microbial contaminants are detected by the presence of colonies, whose morphology differs from that of biological products. The suspected colonies can be further evaluated, such as by Polymerase Chain Reaction (PCR).

• Immunofluorescence Assay

An immunofluorescence assay can be used to determine the presence of microbial contamination. This method is particularly useful in detecting relatively low levels of microbial contaminants when the type, species, and strain of microbial contaminants are known.

Sampling Processes

Routine microbial testing is an important part of analyzing any product where microorganisms can live and grow. One of the most important steps for this purpose is the sampling process. Sample collection is the primary phase of a process in which data on batch characteristics are collected for evaluation.

Services at Creative Biolabs

• In-process Monitoring
1. Microbial limits and bacterial endotoxin monitoring of pharmaceutical ingredients and packaging components.
2. Presterile filtration bioburden monitoring.
3. Air and surface monitoring in aseptic processing areas.
• Finished Product Testing

The microbiological tests used for the inspection of finished products are sterility and bacterial endotoxin tests.

Techniques

Adopting a quick approach can help companies save time and cost. For better and faster control of raw materials and final products, rapid microbial methods are essential. These rapid methodologies can also offer better reactivity throughout the manufacturing procedure. Due to the inexpensive and simplicity of the traditional techniques, they are still widely used in different microbiological experiments.

Creative Biolabs has enabled clients to succeed in the field of live biotherapeutics research and development by providing reliable, high-quality, and innovative technical support, as well as exceptional customer service. We look forward to continuing to grow our business and expand our products and services. If you are interested in our monitoring microbial contaminants service, please do not hesitate to contact us.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.