What Unseen Trouble Lies Within Your Processes?

Madison Hoal, senior global technical consultant, Ecolab Life Sciences

Hoal presented the audience with a question: What challenges do you encounter in your contamination-control processes? Robust cleaning, disinfection, and biodecontamination are all crucial to preventing microbial contamination related to manual manipulations throughout biopharmaceutical manufacturing. The EU Annex 1 for good manufacturing practice (GMP) requires contamination-control strategies to be documented for sterile manufacturing processes. Such strategies should be based on scientific justification and quality risk management (QRM) principles to mitigate the ingress of contamination into drug products. Contamination-control strategies must include detailed assessments of the design and controls of facilities, equipment, systems, and procedures.

“You don’t need to have a full document to identify contamination risks,” Hoal said. “Just [by] walking the manufacturing floor, you can see contamination risks.” Such risks can include failure to follow standard operating procedures (SOPs), poor facility design, and soiling or debris. Not all of those risks are visible, however, so contamination-control strategies must address both seen and unseen sources of contamination. Hoal said that addressing invisible concerns can be challenging for production of advanced-therapy medicinal products (ATMPs) because of the manufacturing scale and the nature of the therapies produced.

Many ATMPs are based on patient cells. ATMP manufacturing uses aseptic processing to prevent contamination and adverse impacts to patient health. That is a specific challenge in ATMP manufacturing, Hoal noted: “Every step is a step where contamination can enter the process, because every step is a step where humans are actively involved in the process itself.” She added, “Our very involvement is a risk to the product and to the patient.” ATMP processes can experience drastic changes when transitioning from research and development (R&D) to commercial manufacturing phase, in which GMP requirements increase significantly. Additionally, ATMP products are complex biologics that cannot be subjected to traditional means of sterilization. Sterility instead must be built into manufacturing steps through aseptic processing.

The Bioquell Qube isolator system from Ecolab is well-suited to ATMP manufacturing because of its affordability, compact design, and closed-processing capabilities. Because operators do not have direct contact with production materials within the system, the risk of microbial contamination from the surrounding environment and operators is reduced. The Bioquell Qube system also contains biodecontamination technology: It can disperse 35% hydrogen peroxide vapor (HPV) for residue-free, validated 6-log sporicidal cleaning. Before transfer into the Bioquell Qube unit, materials are manually disinfected. Once aseptic processing is complete, final products can be removed from the unit’s transfer hatch.

Change management can introduce contamination to biomanufacturing as well. When transferring processes and quality systems for GMP compliance, manufacturers often conduct complicated, challenging renovations. Expert guidance through the process of change management can be critical to generating robust, holistic contamination-control strategies.

Ecolab personnel can support life-science clients with manual cleaning and disinfection products, automated biodecontamination, and technical and regulatory expertise. Ecolab’s change-management program also can assist clients through evaluation of current cleaning, disinfection, and biodecontamination programs to identify noncompliance and other such insufficiencies. The Ecolab team also can recommend both manual and automated solutions. Once products are selected, Ecolab can support validation of disinfectants with its Validex program, which includes an extensive library of disinfectant efficacy data.

“ATMP manufacturing is a highly manual process that requires the human touch,” Hoal noted. “To solve complex challenges of ATMP manufacturing, the human element is just as important.”

Watch Online

See all presentations online from BPI Theater at BIO 2024.