Why Spore-formers Aren’t the Enemy in Biomanufacturing: Containment is Key

Date Posted

Biomanufacturing Lab-19

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 microorganisms 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. 

A bioprocess technologist monitors equipment at SRC's fermentation lab

Depending on the sensitivity of the project/products, our bioprocessing team may need to wear disposable gowns and booties in the fermentation plant. Such gowning procedures are put in 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.

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:

  • 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
    • 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.

IT’S CLEAN. RIGHT?

I’m a clean freak – you can ask my husband (and thank my mother). So the fact that I get to validate cleaning methods conducted during project change-over gets me pretty excited. Turns out, I’m also a nerd.

Environmental monitoring can vary depending on the project, but can include:

  • Surface testing using swabs or contact plates to validate cleaning activities on a solid surface, such as equipment, benchtops, floors and biosafety cabinets.
  • Air quality testing, where airborne microbial counts can be quantified and non-viable particulate counts can also be attained.

SPORES AREN'T BAD, JUST MISUNDERSTOOD

With trained staff, proven procedures and a solid validation program, our clients can rest easy knowing that cross-contamination can be avoided. We can achieve the expected level of safety and purity of products when working with spore-formers. This means that spores can continue to be a valuable research tool, without posing a threat.