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Controlling Bioburden Levels in API Production

Removing organic contaminants at every stage of processing can only improve product quality. Filters are an obvious technology choice for contaminant removal. You can read more information below on choosing what level of filtration is appropriate for any process step, or go to the product selection table at the bottom of this page for filter options.

In some cases, simple clarification filtration is all that is required to allow optimal process performance. However, in many other cases, reducing the number of microorganisms in the fluid, also called bioburden reduction, will improve process performance and enhance product quality.

Bioburden Reduction

Reducing the bioburden is not the same as removing all bacteria. In fact, removing all bacteria, otherwise known as sterilizing filtration, is defined by a different set of performance measures and is usually only performed as the last filtration step before final product packaging.

Reducing the number of organisms, the "bioburden" is done by using filters similar to those used for sterilizing filtration, but the performance requirements are not as stringent. That does not mean that bioburden control is a secondary consideration. Reducing the bioburden in a system keeps the system operating more efficiently and, most important, protects the expensive sterilizing filters from excessive loading which would shorten their life and increase costs.

Sources of Bioburden

While bacteria and other microorganisms may enter any system with ingredients from outside sources, the most likely source is the environment in and around the facility. Molds, yeasts and bacteria that are endemic to the plant location are more likely to enter the processes. They may be carried by plant personnel or simply come in with the air.

The type of organisms will depend on the type of environment. A warm moist environment may have numberous molds and bacteria. Dry or cooler environments may also have these, but perhaps in lower numbers, making control somewhat less complex.

Filters in API Production

The figure shows the possible locations of several bioburden reduction filters. Reducing the possible bioburden that might be in product components is seen on the left. These filters are not specifically protecting downstream filters, but assuring the quality of the product components. They protect process integrity.

Protecting final product quality requires that the containers are clean and bacteria-free. The wash systems to the right in the figure clean and rinse the containers so that the final product is pure. The highlighted bioburden reduction filters are there to protect the more expensive and critical sterilizing filters used for wash solution and rinse water.

The most critical of the bioburden reduction filters is in the center of the figure. It is protecting the final, product sterilizing filters. The filter combination is designed as a single functioning unit that removes all bacteria. The design is based on the expected bacterial load and the organisms that make up that load.

Custom systems are designed for new applications and to solve challenges in existing processes. Critical Process Filtration will work with you to design, build and install a cost-effective system that delivers the results you need. Contact us or visit our custom filtration systems page for more information.

Choosing the Right Filter

The choice of filter to use for bioburden reduction is based on the organisms likely to be found in the process. In general, as mentioned above, organisms endemic to the location of the facility (molds, airborne bacteria, yeasts, etc) will be the likely targets of bioburden control filtration. Depending on the size of the organisms, membrane filters with 0.65μm, 0.45μm or 0.22μm ratings may be used. In some cases, operators may choose the bioburden reduction filter based on its ability to remove all of the bacteria that are likely to be found. The sterilizing filter, in those cases, is purely an insurance policy against system upset.


Application Summaries

Critical Process Filtration has multiple filter options for removing bacteria and other microorganisms. To read more about these filters and bioburden reduction and control in API production, click on one of the links below. Critical Process Filtration has created short explanations of how reducing bioburden is one step in assuring product quality and safety.

The table below shows filter technology options for bioburden control from Critical Process Filtration with links to more detailed data on the filters. Click on the in the appropriate location to download a data sheet for the filter media and configuration that fits your needs.

Media Code Filter Media Filter Grade Cartridge Data Sheet Capsule Data Sheet Disc Filter Data Sheet Pore Sizes Available (µm) Features
BPS Asymmetric Polyethersulfone (PES) Membrane Biopharmaceutical
0.03, 0.1, 0.22, 0.45, 0.65, 1.8, 1.0, 1.2 Highly asymmetric, hydrophilic PES membrane in single-layer configurations for high efficiency, high flow rates and low product absorption
PPS Double-Layered Asymmetric Polyethersulfone (PES) Membrane Pharmaceutical
0.03, 0.1, 0.22, 0.45, 0.65, 1.8, 1.0, 1.2 Symmetric, hydrophilic PES membrane for high efficiency filtration of water.
BNM Nylon 6,6 Membrane Biophamaceutical
0.1, 0.22, 0.45, 0.65 For bioburden reduction in water and feedstocks.
PNM Nylon 6,6 Membrane Pharmaceutical
0.1, 0.22, 0.45, 0.65 For bacteria removal in pharmaceutical processing. For bioburden reduction and sterilizing filtration.
BCWPS High Capacity Polyethesulfone (PES) Membrane Biopharmaceutical
0.2, 0.5 and 1.0 single layer; 0.5/0.2 and 1.0/0.5 dual layer High capacity membrane with single or dual layer configurations for bacteria and particulate reduction, low product adsorption and protection of final filters
BPVWL High capacity, Hydrophilic Polyvinlyidene fluoride (PVDF) Membrane Biopharmaceutical
0.22, 0.45, 0.65, 1.2 High void volume membrane with high holding capacity for systems that may have high particulate loads

To estimate the number of filters you will need for your application, use our unique sizing tools.

Critical Process Filtration will provide Validation assistance. Click here to download a brochure outlining those services.