Controlled Environments
BSL-2/3 · HPAPI OEB 4–5 · Dual protection
BSL-2/3 biological containment and HPAPI handling with dual product and operator protection.
In detail
There are environments where protecting the product from its surroundings and protecting the surroundings from the product are the same problem. Our high containment rooms integrate primary containment equipment, secondary containment architecture and validatable documentation within a single project scope: BSL-2 and BSL-3 biological containment, HPAPI handling up to OEB 4–5, chemical intermediates that simultaneously demand 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 Laboratory Biosafety Manual, 4th ed. (2020), Directive 2000/54/EC, ISO 35001:2019+A1:2024. HPAPI containment documented to ISPE OEB classification and SMEPAC testing. Direct experience in ATEX projects for pharmaceutical applications with solvents.
Grade D to Grade A — every GMP class, every regulatory framework, one single project owner.
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Live pathogens. Pharmaceutical GMP. Both in the same facility — solved by a single engineering team.
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Since 2022, surgical antiseptics fall under pharmaceutical GMP — not biocides. The facility requirement changed without many manufacturers getting adequate notice.
See more →Sectores aplicables
Secondary containment for serious infectious disease research — designed for the failure consequences of the agent, not for a generic standard.
See more →Sectores aplicables
Grade D to Grade A — every GMP class, every regulatory framework, one single project owner.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — solved by a single engineering team.
See more →Sectores aplicables
Since 2022, surgical antiseptics fall under pharmaceutical GMP — not biocides. The facility requirement changed without many manufacturers getting adequate notice.
See more →Sectores aplicables
Secondary containment for serious infectious disease research — designed for the failure consequences of the agent, not for a generic standard.
See more →Sectores aplicables
Grade D to Grade A — every GMP class, every regulatory framework, one single project owner.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — solved by a single engineering team.
See more →Sectores aplicables
Since 2022, surgical antiseptics fall under pharmaceutical GMP — not biocides. The facility requirement changed without many manufacturers getting adequate notice.
See more →Sectores aplicables
Secondary containment for serious infectious disease research — designed for the failure consequences of the agent, not for a generic standard.
See more →Sectores aplicables
