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Large Vaccine Production Facility QuicklyResumes Operations After Shutdown Period
was looking to introduce more rigorous control measures to ensure
a high level of bio-decontamination in its facility.
Situation
A leading industrial biotechnology company in Denmark that produces vaccines used in the biodefence market, was in need of a large-scale bio-decontamination program.
The business required a service that could enhance the contamination control regimes already in place in their facility. With GMP procedures incumbent within production operations, there was no contamination incidence to deal with but the company understood the negative impact an excursion could create and sought to help further secure their operations. High-risk periods of preventive maintenance and annual shutdowns were selected as focal points to introduce more rigorous control measures. The vaccine manufacturer had two core challenges for any service provider to meet:
Efficacy: The bio-decontamination service needed to achieve a 6-log sporicidal kill with minimal production downtime. For the company, the purchase of capital equipment was not an option.
Documentation: It was crucial that the process was fully documented for auditing and regulatory inspections.
Solution
After reviewing the bio-decontamination options on the market, the Bioquell RBDS service was commissioned to undertake the work. It was employed to establish a high bioburden reduction within the facility on a scheduled/ routine basis.
The hydrogen peroxide vapor technology offered by Bioquell RBDS achieves a 6-log sporicidal kill on every exposed surface and is validated against Geobacillus stearothermophilus Biological Indicators (BIs), which are considered to be the industry standard validation tool for determining hydrogen peroxide vapor bio-decontamination efficacy.
Full documentation was provided via a final report outlining all areas bio-decontaminated including locations of biological indicators with incubation results displaying validated efficacy.
Entire 4,500m3site
decontaminated using Bioquell™ Hydrogen Peroxide Vapor generators positioned at 36 locations
100% of biological indicators
placed in 150 locations achieved
6-log bio-decontamination
Completed on schedule in a tight
2-Day
time frame with detailed reporting
*Client Supplied Data
Deployment
Firstly, a complete site survey to discuss customer expectations, plus ascertain best management of on-site operations, was undertaken by an experienced Bioquell project manager before the arrival of the Bioquell RBDS engineers and equipment.
The enclosure was a vaccine production facility of approximately 4,500m3 with varying European Union Good Manufacturing Practice (EU GMP) grades including grade A (inside the filling equipment), B, C and D. Bioquell’s hydrogen peroxide vapor generators were positioned at 36 locations to optimize dispersion of the decontaminant. Sensors were also placed in seven different areas to record pertinent cycle parameters.
Bioquell’s 6-log Geobacillus stearothermophilus BIs were used to demonstrate the efficacy of the process. The BIs were placed at 150 locations throughout the entire production suite. During the bio-decontamination phase, a single external point of control ensured safe management of the process. Using low level hydrogen peroxide vapor sensors, regular monitoring of the zone perimeter for vapor leakage was carried out.
Following cycle completion, Bioquell aeration units were activated to break down the hydrogen peroxide vapor within the zone. The aeration units catalytically convert hydrogen peroxide vapor into oxygen and water vapor and were used in conjunction with the facility’s HVAC system.
Timeline
Day 1:
- 10:00 AM: Bioquell team arrive on site to transfer RBDS equipment into clean facility.
- 2:00 PM: RBDS equipment installed and tested.
- 3:00 PM: BIs and CIs placed in pre-agreed locations.
- 4:00 PM: HVAC and fire detection systems shut down, area evacuated and sealed off.
- 5:00 PM: Gassing cycle initiated after working hours.
- 7:00 PM: Gassing cycle complete. Overnight aeration begins.
Day 2:
- 8:00 AM: Bioquell team return to site to confirm area is safe for re-entry, collect equipment and BIs/CIs.
- 10:00 AM: Bioquell leaves site and incubates BIs.
Day 3: Preliminary BI results available — client can resume operations.
Day 9: Final BI results available.
Results
As injectable vaccines were manufactured within this facility, reestablishment of all EU GMP grades was paramount. Efficacy ofthe operation was judged with reference to incubation results of the BIs.
Upon completion of the decontamination process, the BIs were collected in conjunction with the removal of Bioquell RBDS equipment. After a standard seven-day incubation period, no growth was observed in 100% of the 150 BIs retrieved from the site, demonstrating that a 6-log sporicidal kill had been achieved in all areas within the scope.
Additionally, no equipment exposed to the hydrogen peroxide vapor bio-decontamination was affected, demonstrating the excellent materials compatibility of utilizing Bioquell technology.
The aim of biologically deactivating areas situated throughout the production facility within the required two-day time frame was achieved, rendering the entire area completely bio-decontaminated. Due to the success of this initial program, the company engages the Bioquell RBDS team to annually bio-decontaminate the entire site.
“Due to the success of this initial program, the company engages the Bioquell RBDS team to annually bio-decontaminate the entire site every year.”
“Due to the success of this initial program, the company engages the Bioquell RBDS team to annually bio-decontaminate the entire site every year.”
– Bioquell RBDS Manager
Bioquell Rapid Bio-decontamination Services (RBDS)
RBDS is an all-inclusive service that helps you manage bio-decontamination in your research lab, production facility or hospital.