Química y Especialidades
Since 2022, surgical antiseptics are pharmaceutical GMP — not biocides. The facility requirement changed without adequate notice to many manufacturers.
El mercado en detalle
The biocide market has a regulatory bifurcation that directly determines what type of controlled environment is required. BPR Regulation (EU) 528/2012 governs antiseptics for intact skin and surface disinfectants in clinical environments. However, since the AEMPS Resolution of 2 June 2021 (Nota MUH 11/2021, in force June 2022), pre-operative surgical field and injection-site antiseptics are human medicinal products in Spain — requiring GMP facilities and pharmaceutical laboratory authorisation under Real Decreto 824/2010. For the BPR segment: containment and ATEX zones. For the reclassified segment: full pharmaceutical GMP. One contractor with capability for both.
Agrochemical applications: EU BPR, REACH and EFSA. SENASICA/ICA/SENASA for Latin American programmes. EPA FIFRA for US-market facilities.
We design and build ISO 14644-1 cleanrooms (Class 1 to Class 9) as turnkey solutions.
See more →Entornos controlados aplicables
Salas secas, atmósfera inerte y zonas ATEX donde el aire estándar es incompatible con el producto.
See more →Entornos controlados aplicables
We design and build ISO 14644-1 cleanrooms (Class 1 to Class 9) as turnkey solutions.
See more →Entornos controlados aplicables
Salas secas, atmósfera inerte y zonas ATEX donde el aire estándar es incompatible con el producto.
See more →Entornos controlados aplicables
We design and build ISO 14644-1 cleanrooms (Class 1 to Class 9) as turnkey solutions.
See more →Entornos controlados aplicables
Salas secas, atmósfera inerte y zonas ATEX donde el aire estándar es incompatible con el producto.
See more →Entornos controlados aplicables
