Healthcare Industries CRO
Managing viral and microbiological contamination
VirHealth supports the healthcare sector in validating the products and procedures essential for managing viral and microbiological contamination (environmental and process controls).
In order to meet regulatory market access requirements, your disinfection technologies (product and equipment) must demonstrate microbicidal efficacy according to standards and/or guidelines recognized by the authorities.
We provide gold-standard assays to assess the effectiveness of disinfectants in suspension, on hard surfaces, and for instrument disinfection through soaking/immersion processes.
Disinfectant - Microbiology
Validation studies must demonstrate the suitability and efficacy of disinfectants according to their specific conditions of use.
| Standard | Activity | Step | Strains |
|---|---|---|---|
| NF EN1276 | Bactericidal | 1 (solution) | E. hirae, E. coli, P. aeruginosa, S. aureus, E. faecium |
| NF EN1650 | Fungicidal | 1 (solution) | C. albicans, A. brasiliensis |
| NF EN1656 | Bactericidal | 1 (solution) | E. hirae, P. aeruginosa, S. aureus, P. hauseri |
| NF EN1657 | Fungicidal | 1 (solution) | C. albicans, A. brasiliensis |
| NF EN 13704 | Sporicidal | 1 (solution) | B. subtilis |
| NF EN13697 | Bactericidal | 2 (Surface) | E. hirae, E. coli, P. aeruginosa, S. aureus |
| NF EN13697 | Fungicidal | 2 (Surface) | C. albicans, A. brasiliensis |
| NF EN 14561 | Bactericidal | 2 (Instr.) | E. hirae, P. aeruginosa, S. aureus |
We offer a broad range of protocols adapted from industry standards, alongside an extensive selection of additional microorganism strains to meet your specific requirements.
Disinfectant - Virology
| Standard | Step | Strains |
|---|---|---|
| NF EN14476 | 1 (solution) | Adenovirus, Norovirus, Poliovirus, Vaccinia, Parvovirus |
| NF EN17914 | 1 (solution) | Adenovirus, Norovirus, Poliovirus, Vaccinia, Parvovirus |
| NF EN16777 | 2 (Surface) | Adenovirus, Norovirus, Vaccinia virus |
| NF EN17915 | 2 (Surface) | Adenovirus, Norovirus, Vaccinia, Parvovirus |
| NF EN17111 | 2 (Instr.) | Adenovirus, Norovirus, Vaccinia, Parvovirus |
| NF EN13610 | 1 (solution) | Lactococcus lactis P001 and P008 |
We offer a wide range of protocols adapted from industry standards and support you in defining test parameters. All testing can be performed in a BSL-3 laboratory on pathogenic viral strains.
Wipes
The use of pre-saturated wipes (either ready-to-use or manually saturated) has become a standard practice in the pharmaceutical industry, allowing for precise product dosage control, mechanical action on surfaces, and enhanced safety by minimizing the risk of chemical splashes on operators.
We evaluate the bactericidal, yeasticidal, and virucidal efficacy of RTU or manually saturated wipes according to the NF EN 16615 standard (4-field test) across a wide range of surfaces.
Efficacy testing can be performed on a wide range of strains (viruses, bacteria, yeasts, molds, and spores).
Experimental Innovation: We have developed an experimental procedure based on the NF EN 16615 standard to simulate the overlapping wiping method used on-site, incorporating 2 contamination zones and 8 recovery/analysis zones.
Surface spill simulation test
We have developed a reproducible procedure to simulate, in a laboratory setting, a surface spill of a contaminated liquid, its removal by wiping (cleaning), and the subsequent surface disinfection step using either an RTU or a pre-saturated wipe.
ALL PARAMETERS CAN BE ADJUSTED TO ALIGN WITH YOUR INTERNAL PROCEDURES AND SPECIFIC REQUIREMENTS.
Airborne room disinfection
automated process
Airborne Surface Disinfection (ASD) is a widely used automated terminal decontamination method in the pharmaceutical industry, particularly for Cleanrooms and Controlled Environments.
Leveraging our expertise in product and equipment validation according to the NF EN 17272 standard, we offer testing in 79m³ and 2m³ enclosures, taking into account your specific parameters (microorganisms, soiling, and environmental conditions) as well as your equipment.
Customized biological
indicators
We develop test procedures for the creation of customized biological indicators for on-site efficacy testing, including either the laboratory-scale production or the method transfer for in-house production.
QBI « Quantitative Biological Indicator »
Since 2020, VirHealth has developed a QBI (Quantitative Biological Indicator) strategy enabling worst-case quantitative evaluations of ASD cycle efficacy. Featuring stainless steel carriers inoculated with microorganisms (spores, bacteria, viruses, and mold spores) in the presence of interfering substances according to NF EN 17272, these QBI indicators are easily positionable within the areas, and residual microbial loads post-cycle are quantified in the laboratory.
