Entornos Controlados
BSL-2/3 · HPAPI OEB 4–5 · Dual protection
Contención biológica BSL-2/3 y manipulación de HPAPI con protección dual de producto y operario.
En detalle
There are environments where protecting the product from the surroundings and protecting the surroundings from the product are the same problem. Our high-containment suites integrate primary containment equipment, secondary containment architecture and validatable documentation in a single project scope: biological containment BSL-2 and BSL-3, HPAPI handling up to OEB 4–5, chemical intermediates requiring simultaneous operator protection and product purity.
Engineering scope: directional HVAC, HEPA filtration on exhaust, differential pressure monitoring with alarms, effluent decontamination where the agent requires it. WHO Biosafety Manual 4th ed. (2020), Directive 2000/54/EC, ISO 35001:2019+A1:2024. HPAPI containment documented per ISPE OEB classification and SMEPAC testing. Direct experience in ATEX projects for pharmaceutical facilities with solvents.
Grado D a Grado A — todas las clases GMP, todos los marcos regulatorios, un único responsable de proyecto.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — resolved by a single engineering team.
See more →Sectores aplicables
Since 2022, surgical antiseptics are pharmaceutical GMP — not biocides. The facility requirement changed without adequate notice to many manufacturers.
See more →Sectores aplicables
Secondary containment for serious infectious disease research — designed for the consequences of agent failure, not a generic standard.
See more →Sectores aplicables
Grado D a Grado A — todas las clases GMP, todos los marcos regulatorios, un único responsable de proyecto.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — resolved by a single engineering team.
See more →Sectores aplicables
Since 2022, surgical antiseptics are pharmaceutical GMP — not biocides. The facility requirement changed without adequate notice to many manufacturers.
See more →Sectores aplicables
Secondary containment for serious infectious disease research — designed for the consequences of agent failure, not a generic standard.
See more →Sectores aplicables
Grado D a Grado A — todas las clases GMP, todos los marcos regulatorios, un único responsable de proyecto.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — resolved by a single engineering team.
See more →Sectores aplicables
Since 2022, surgical antiseptics are pharmaceutical GMP — not biocides. The facility requirement changed without adequate notice to many manufacturers.
See more →Sectores aplicables
Secondary containment for serious infectious disease research — designed for the consequences of agent failure, not a generic standard.
See more →Sectores aplicables
