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April, 15 2024

iHP Integration into CDMO

Exploring SteraMist iHP Integration in CDMO

With cell and gene therapy, biopharmaceutical research and development spaces have grown in value and tighter quality control measures to ensure optimal environmental controls are in demand. Avid Bioservices – an active player in biopharmaceutical manufacturing for three decades – strictly adheres to cGMP regulations and guidelines in their state-of-the-art campuses. To continue delivering innovation, Avid has constructed a 53,000-square-foot facility dedicated to viral vector manufacturing. Having first been introduced to SteraMist and ionized Hydrogen Peroxide (iHP) technology through Interphex, Avid approached SteraMist to discuss environmental decontamination strategy for their upstream, downstream, and fill/finish suites – all of which were an ideal fit for iHP technology integration.

Avid Decon Control Panel

Scope of Work: Modular Cleanroom

Before implementing a new disinfection technology, Avid considered the traditional industry practice which included the manual set-up/removal of portable decontamination systems following the daily routine cleaning protocols for post-line clearance decontamination. While the manual decontamination process was the industry standard practice, Avid sought a new innovative approach for decontamination that would be “effective, reliable, and provide value above traditional practices,” which would be safe and cost-effective to operate vs the traditional practice. To accommodate their new viral vector campus, their new decontamination system would have to meet extremely strict prerequisites in several categories.

First and foremost, microbial neutralization must consistently reach a Geobacillus Stearothermophilus reduction threshold of 6-log or greater. Compliance with 21 CFR part 11 with respect to data integrity and security in addition to other GMPs. Additionally, the disinfection must not have an impact on other ongoing operations in other processing areas during the decontamination cycle of any one of the process areas, to ensure adherence to a dynamic facility schedule. Lastly, the installation had to consider and compliment their chosen method of modular laboratory construction. After thorough consideration, extensive risk assessments, and ROI analysis, SteraMist iHP was ultimately selected as their premier decontamination solution.

Meeting the Need of CDMO

Products Used:Custom Engineered System (CES)
Use Site:53,000 square foot Viral Vector Facility
Summary:Seeking a decontamination solution for their new, modular California facility, Avid Bioservices integrated SteraMist iHP technology

Requiring a balance of functionality and security, Avid’s new modular CDMO lab spaces with unidirectional flow was an ideal host for SteraMist. Custom Engineered Systems (CES) applicators and control panels were strategically placed to optimize every stage of the injection process. As a direct impact system subject to Quality Management systems, SteraMist’s integration with Avid’s BMS provides critical control over environmental monitoring and key area isolation, allowing Avid to schedule and execute cycles of iHP decontamination in specific areas while continuing production in non-treated spaces.

Cycles can be run and areas could re-open within the space of a manufacturing shift, allowing for a completely autonomous, passive decontamination experience with no need for prolonged shutdowns or evacuation. Additionally, SteraMist provides cycle recording, digital data export, printing, Active Directory integration, and password authentication with no risk of wireless tampering or falsification to conform to the electronic record keeping, validation, and data retention guidelines of 21 CFR Part 11. The installed system will also undergo a through system validation and qualification by both TOMI and Avid to ensure all critical performance parameters are successfully met. Speak to a SteraMist expert today to learn more!

I am confident that this integrated iHP system will set a new standard for large biotech and pharmaceutical facilities. I look forward to the installation of additional iHP systems in the future.

Rami Barghout, Director of Project Engineering, Avid Bioservices