Routine GxP Facility Maintenance
Active GxP facilities are exposed to viable and non-viable contaminants via on-going operations, personnel traffic, and material transfer
Robust decontamination and disinfection protocols are used to neutralize these contaminants and ensure operations continue safely without interruption.
Strong disinfection and sterility protocols ensure high levels of product integrity, regulatory compliance, and minimize facility downtime.
How we can help:
Our team of experts will support in the development, implementation, and execution of sustainable and compliant protocols that best suit your facility’s needs.
Maximize production output by leaving the cleaning to the experts.
Cleanroom Routine Maintenance
Routine cleans are carried out at a regular interval whether weekly, bi-weekly, monthly, bi-monthly etc., and can be carried out within your own time parameters or those established after consultation as being appropriate for your needs.
Regular cleans are designed to help maintain an already stable and fully functional facility. Regular clean is carried out in accordance with your own cleaning regime and methods and is designed to help maintain good practice within a cleanroom.
Cleaning can be carried out in accordance with your own gowning and transfer methodology and all our staff are highly trained to provide the best quality clean of your facility.
Critical Cleans
Decontamination clean can be applied during or after any cleanroom construction or renovation project, following a major spill or within any environment that requires in-depth and sustained attention; especially for soil removal and particulate build up.
It also applies to post-shutdown cleaning and any decontamination after planned and/or emergency maintenance, and is especially useful prior to inspection, audit or validation.
The Decontamination Clean is specifically designed to remove heavy bioburden and large amounts of particulate, and to rapidly increase the performance and cleanliness of the controlled environment.
Decontamination Fogging
iHP® Fogging is a patented two-step process that activates and ionizes a 7.8% Hydrogen Peroxide sole active ingredient based solution into a fine mist/fog known as ionized Hydrogen Peroxide (iHP™).
6-LOG REDUCTION
Application time: taking only 5 seconds per square foot to apply. Contact time to disinfect: 7-minute. Does not damage equipment so rooms do not need to be emptied. Even highly technical equipment can be left out. Does not leave any toxic residue. There is no need to wipe or rinse surfaces.
Documentation & Validation
Vibraclean provides a complete final report confirming a 6-log kill of the spaces or surfaces we’ve treated for you.
Each report includes the readings of our internally produced, high-quality biological and chemical indicators. Our biological indicators are made from Geobacillus stearothermophilus endospores to ensure reliable results in seeking to validate a 6-log reduction of bioburden from the decontamination process.
Key parts of your report also will cover detailed cycle parameters and graphs, pre- and post-vapourising environmental conditions recorded, incubation records of the biological indicators, maps showing the placement of all equipment and indicators, equipment calibration information, and certificates of analysis for all consumables used including the hydrogen peroxide.