Microbiology is the field of science that focuses on the characteristics of microorganisms. This is the word used for small living things that cannot be seen by the naked eye. Examples of microorganisms include bacteria and fungi. Despite their small size, some of these microorganisms can be extremely dangerous to humans.
Within pharmaceutical and medical device manufacturing, it is essential that products are not exposed to harmful microorganisms. Microbiologists are often employed to test, monitor and report on the presence of harmful microorganisms within the manufacturing process.
There is a key role played by Microbiologists in the research and development (R&D) stages of pharmaceutical products. Microorganisms are used in development and testing of new drugs that treat or prevent the damage they cause (such as new antibiotics). Non-harmful microorganisms can also be useful within products.
Understanding and manipulating microorganisms can be extremely useful in the development of new therapies and microbiologists will play a big part in that. But for the remainder of this article, we’re going to focus on the role that Microbiologists play in the manufacturing process of pharmaceuticals and medical devices.
Contamination of a medical device or drug product could be extremely dangerous. As a result, Microbiologists are employed to carry out a number of duties throughout the manufacturing process.
This includes testing and monitoring of raw materials (e.g. water will be purified), the environment (e.g. air samples will be taken), equipment (e.g. samples from machines and tools will be routinely tested), and end products (e.g. each batch of the final product will be specifically tested for contamination).
There are strict regulations around the manufacture of pharmaceutical products and medical devices – Microbiologists working in this field will follow these closely. By following the industry manufacturing regulations, the risks posed by microorganisms can be minimized.
Within the manufacturing team, Microbiologists will typically operate within the Quality Department.
The role will depend greatly on what is being produced and how it is manufactured. Some products are manufactured in sterile environments – these products must remain free of all microorganisms (whether they are specifically harmful or not). Other products are manufactured in non-sterile environments – these products can contain some microorganisms, but only up to a strict pre-defined limit.
In general, the role will concentrate on an area such as:
- Ensuring that raw materials are free from microorganism contamination
- Careful observation of the number and types of microorganisms present in the manufacturing environment
- Making sure that finished products remain sterile and free from contamination (in sterile manufacturing) and within the previously agreed limits (for non-sterile manufacturing)
- Testing to see how the product would cope with contamination during “real world” use
The specific tasks involved with a job will depend on the manufacturing processes involved as well as the end product. As examples, tasks might include:
- Calibration and auditing of scientific equipment
- Designing and implementing strategies to assess and control contamination
- Running routine collection and testing of raw materials, samples from the manufacturing environment and/or the final product
- Growing, monitoring and identifying microorganisms within cultures
- Strict record keeping and storage of test result data
- Analysis and interpretation of test results
- Reporting issues of contamination following strict protocols
- Supervision of laboratory-based technicians
Microbiologists will be testing for things such as the presence of microorganisms, the number and type of microorganism present and how well microorganisms can grow when a product is exposed to “real-world” use.