Biosecurity and biocontention
The infrastructures of the INIA-CISA and IRTA-CReSA nodes have internationally recognized architectural and functional characteristics for the achievement of biosecurity and the maintenance of a safe biocontainment status. The main purpose is to provide a high degree of tightness to prevent the release of any exotic or enzootic pathogen, emerging, re-emerging or transboundary both within the facilities and the environment.
The building that contains the laboratories of high biological security is based on hydrophobic reinforced concrete structures. The interior of the installations is plastered with epoxy paints of double or triple layer that allow to carry out operations of effective decontamination. The architectural design of the work areas is based on a “sandwich” model, designed to optimize its functionality. The work areas (laboratories, animal, entry and exit of personnel) are located in an intermediate plant. On the upper floor there is the entire High Efficiency air filtration system.
On the lower floor there are solid waste and effluent management processes. All the biocontained work area has a negative pressure with respect to the atmospheric in unidirectional continuous flow or cascade differential gradient, so that the air always circulates from less areas contaminated to more contaminated, from lower to higher biological risk. There is no recirculation of indoor air, but 100% is renewed by a filtration of single or double systems and serial HEPA filters H14 (High efficiency Particulate Air).
The control and treatment of the waste generated inside the nodules is carried out in the lower plants with a total sterilization system, since they can be biocontaminated.
Liquid waste: treated with chemical, physical or mixed methods, microbiologically validatable and established under parameters of pressure, concentration of sterilizing product and temperature that allows to inactivate any known biological agent.
Solid watse: are eliminated through various systems such as pyrolytic cremator ovens, alkaline hydrolysis systems, steam autoclaves and chemical biodecontamination systems (SAS or Air locks) based on gas injection or chemical shower.
The good functioning of the biocontainment areas culminates with a correct performance of the properly trained specialist staff.
The entrance to the biocontained areas or areas is strictly supervised and is controlled electronically and in person. Access to these areas presents a special risk and is only possible for specially trained and authorized personnel, complying with strict entry and exit requirements, so that an effective mandatory decontamination is guaranteed.
On the other hand, it is essential that personnel with authorized access complies with existing work procedures, especially those that refer to the mandatory use of personal protective equipment and its adequate maintenance when necessary, with the aim of minimizing the consequences derived from possible direct incidents in special risk situations.
Finally, every worker who accesses the containment zone is subject to special quarantines, understanding these as the period of time that elapses between the abandonment of the risk zone and any contact with sensitive animals.
The security measures implemented are in accordance with the requirements, regulations and national and European legislations. Within the national scope and in application of the obligatory document base, stand out,
- the Law 31/1995, of November 8 and subsequent modifications, the Royal Decree 486/1997, of April 14, by which the ” minimum safety and health provisions in workplaces “, and subsequent amendments, Spanish RD 664/97 of May 12,” Protection of workers against the risks related to exposure to biological agents during work “, and the Technical Guide developed for this purpose by INSHT.
- The national legislative provisions focused on specific aspects of prevention and biological safety for a Biocontainment Facility of level 3, and specifically Law 10/1998, of April 21, on Waste, the Royal Decree 833/1988, of July 20, approving the “Regulation for the execution of Law 20/1986, basic toxic and hazardous waste”,
- the minimum applicable criteria on p personal protection such as Royal Decree 773/1997, of May 30, on “Minimum health and safety provisions relating to the use by workers of personal protective equipment”, or that which refers to the management of biological samples such as Royal Decree 65/2006, of January 30, which establishes “requirements for the import and export of biological samples.”
Within the normative character, both Infrastructures contemplate the requirements included in the UNE-EN standard on “containment and measures of physical security in microbiology laboratories “and the UNE-EN standard on” containment measures for experimental animals”.
These conditions and national obligations are increased by the implementation of those established by international organizations and institutions such as those established by the World Health Organization (WHO) in its “Manual of bio-safety in the laboratory”, the International Animal Health Code “of the Office International des Epizooties (OIE), the Terrestrial Animal Health Code of the OIE Standards constructive United States Department of Agriculture Research, Education, and Economics. “ARS Facilities Design Standards” or the International Regulations (ICAO / IATA, IMO / MDG, TPF / RID and TPD / ADR) for the transport of dangerous goods and, in particular, of infectious substances and diagnostic samples, among others.