Monitoring Microbial Contaminants Services
Backgrounds Services Advantages FAQs Resources
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.
Background
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.
Services for Detection of Microbial Contamination
Testing Types
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In-process Monitoring
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Microbial limits and bacterial endotoxin monitoring of pharmaceutical ingredients and packaging components.
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Presterile filtration bioburden monitoring.
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Air and surface monitoring in aseptic processing areas.
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Finished Product Testing
The microbiological tests used for the inspection of finished products are sterility and bacterial endotoxin tests.
Methods
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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).
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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
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Samples
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Samples of cells or microorganisms at different stages of culture.
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Samples of cells or microorganisms at different stages of production.
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Samples from a drug production line.
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Any other samples you need to test for microbial contamination.
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Sampling Process
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.
If you are ready to submit your samples for testing, please fill out the Sample Submission Form.
Deliverables
Upon completion of the test, a final report will be issued.
Advantages of 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.
Frequently Asked Questions
What is microbiological monitoring?
Microbiological environmental monitoring is a means of demonstrating an acceptable microbiological quality in a controlled environment and detecting changes promptly. In pharmaceutical microbiology, there is a need and interest to screen for the presence of microorganisms that are objectionable to the process and products manufactured.
What is microbial contamination in the laboratory?
Contamination refers to the unwanted impurities, such as chemicals, microorganisms, or physical substances, that enter or enter the initial or intermediate cell culture during sampling, preservation, processing, storage, transfer, packaging, and transportation processes.
What methods can be used to control microbial contaminants in the laboratory?
All infectious materials and contaminated equipment or apparatus should be disinfected before cleaning, storage, or disposal. Sterilization, disinfection, and preservation are all forms of decontamination. Autoclave sterilization is the preferred method.
Resources
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.
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