Why spore-formers are not the enemy in biomanufacturing: Containment is key

Posted on July 12, 2016

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by Kim Baniulis

This article originally appeared on the Saskatchewan Research Council’s (SRC) blog From the Lab to the Loading Dock.

Spores are smart. They can survive without nutrients, can reproduce asexually and have resistance to extreme temperatures and chemical disinfectants. This means that spores can last a very long time, in some very harsh conditions – something all Saskatchewanians know about! Unfortunately, these unique survival characteristics give spores a bad rap with manufacturers. 

Spore-forming microorgansims can be an outstanding tool for research in microbiology and biotechnology, particularly for agricultural and environmental applications where they can help promote plant health. However, many biomanufacturers refuse to work with them at the risk of cross-contaminating other products and areas. That’s where we come in. To ensure the safety and quality of all products manufactured in our facility, microbes are kept under stringent control to avoid releasing spores.

KEEPING SPORES ON LOCK DOWN

Our fermentation plant, which is co-managed by SRC and the National Research Council of Canada, is equipped with the capabilities to operate an entire production run as a closed system. This means that from inoculation (when the microbe is introduced to the system) through fermentation, and during any down-stream and final product processing, there is no exchange of material with the surrounding environment.

The ventilation system within the fermentation facility provides seven air exchanges per hour of 100 per cent fresh air, and the air pressures and flows are designed to minimize the potential for cross-contamination from personnel, materials and air turbulence. Off gases from the fermenters, the chemical exhausts from the fume hood and the exhaust from the biosafety cabinets are filtered and hard-piped to the biovents and removed by a dedicated exhaust system.

The moral of this story? Microbes are on house arrest in closed systems, and if one manages to break out, the facility’s containment system ensures it won’t get far.

PEOPLE AND PROCEDURES

Employees complete training for safety, quality and task-specific procedures and are only authorized to work on client runs after they have established competency. Technologists have extensive experience working with a wide range of microorganisms and diverse fermentation systems.

While working on particularly sensitive products, in the fermentation plant, our bioprocessing team wears disposable gowns and booties. Gowning procedures are put into place to reduce the potential for personnel to carry the spore-former out of the manufacturing area. When required, specific lab supplies can be dedicated to a particular client, or the use of disposable supplies can be incorporated.

A bioprocess technologist monitors equipment at SRC's fermentation lab

CHANGE IS GOOD. CHANGE-OVER IS BETTER.

After a bioprocess run is complete, the facility undergoes project change-over, which addresses the risk of cross-contamination with future work. The extent of the change-over can vary depending on the size and nature of the project, but usually includes:

-Proper management of any resulting or leftover biological samples and/or project material
-Biological products are usually returned to the client; biological waste is destroyed according to biosafety standards and in-house Standard Operating Procedures (SOPs).
-Equipment cleaning and refurbishing
-Cleaning and decontamination is done according to equipment-specific SOPs
-Necessary consumables are replaced
-Facility cleaning and decontamination
-Complete facility cleaning is conducted using decontaminants known to be effective against the microorganism used (and its spores). Effective sporocides include accelerated hydrogen peroxide-based cleaners and buffered phenol-based cleaners.

Read the rest of this post on From the Lab to the Loading Dock.

 

Thank-you to SRC for letting us share their blog post.

Read the SRC Blog!

Kim Baniulis
Quality Coordinator, SRC Biotechnology Laboratories