Cell and gene therapy has made biopharmaceutical R&D spaces more valuable, increasing the demand for stricter quality control measures to maintain optimal environments.
Avid Bioservices has been heavily involved in biopharmaceutical manufacturing for 30 years and strictly conforms with cGMP regulations and guidelines in its modern facilities.
The company built a 53,000 ft2 space dedicated to viral vector manufacturing to continue providing innovation. Intephex introduced Avid to SteraMist and ionized Hydrogen Peroxide (iHP) technology.
Avid approached SteraMist to discuss environmental decontamination strategy for their upstream, downstream, and fill/finish suites, which are ideal for iHP technology integration.
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Scope of work
Before incorporating a new disinfection technology, Avid considered conventional industry practice. This included the manual set-up and removal of portable decontamination systems after the daily routine cleaning protocols for post-line clearance decontamination.
Although the manual decontamination process was the industry standard practice, Avid wanted an effective, reliable, and valuable new method for decontamination that would be safe and economical to use over the conventional approach.
Avid’s novel decontamination system would have to meet the strictest requirements in several categories to accommodate its new viral vector campus.
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
Microbial neutralization must constantly achieve a six-log reduction threshold of Geobacillus stearothermophilus and comply with 21 CFR part 11 for data integrity and security along with other GMPs.
Disinfection must not disrupt operations in other processing spaces during decontamination to ensure adherence to a dynamic facility schedule.
The installation had to consider and complement the selected approach of modular laboratory construction—SteraMist iHP was ultimately chosen as the premier decontamination solution following thorough consideration, extensive risk assessments, and ROI analysis.
Meeting the need
Necessitating security and functionality, Avid’s innovative modular CDMO lab spaces with unidirectional flow were the perfect host for SteraMist. Custom-engineered systems applicators and control panels were tactically positioned to improve the injection process at each step.
As a direct impact system dependent on quality management systems, SteraMist’s incorporation with Avid’s BMS offers critical control over key area isolation and environmental monitoring. It enables Avid to schedule and execute cycles of iHP decontamination in certain spaces while continuing production in non-treated spaces.
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Cycles can be completed, and areas can be re-opened within a single manufacturing shift, enabling a fully autonomous, passive decontamination experience without prolonged shutdowns or evacuation.
SteraMist also offers cycle recording, digital data export, printing, Active Directory integration, and password authentication without risk of wireless tampering or falsification to adhere to the electronic recordkeeping, validation, and data retention 21 CFR Part 11 guidelines.
TOMI and Avid will also perform a thorough system validation and qualification to successfully meet critical performance parameters.
Image Credit: SteraMist Disinfection and Decontamination Technology
About SteraMist Disinfection and Decontamination Technology
SteraMist is a global line of powerful disinfection and decontamination products and services that utilizes patented ionized Hydrogen Peroxide (iHP) technology.
Our scientific expertise, innovation, and dedication to creating a safer world through cutting-edge iHP technology allow SteraMist to serve our customers and industries with trusted products, leading to a smarter way to decontaminate and control infectious diseases.
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