Química y Especialidades
Since 2022, surgical antiseptics fall under pharmaceutical GMP — not biocides. The facility requirement changed without many manufacturers getting adequate notice.
The market in detail
The biocides market has a regulatory fork that directly determines which type of controlled environment is required. Regulation (EU) 528/2012 (BPR) governs antiseptics for intact skin and surface disinfectants in clinical settings. But since the AEMPS Resolution of 2 June 2021 (Note MUH 11/2021, in force June 2022), pre-operative surgical field and injection site antiseptics are medicinal products for human use in Spain — requiring GMP facilities and pharmaceutical laboratory authorisation under Royal Decree 824/2010. For the BPR segment: containment and ATEX zones. For the reclassified segment: full pharmaceutical GMP. One contractor capable of both.
Plant protection applications: European BPR, REACH and EFSA. SENASICA/ICA/SENASA for Latin American programmes. EPA FIFRA for facilities destined for the US market.
We design and build ISO 14644-1 cleanrooms (Class 1 to Class 9) as turnkey solutions.
See more →Entornos controlados aplicables
Dry rooms, inert atmosphere and ATEX zones where standard air is incompatible with the product.
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
Dry rooms, inert atmosphere and ATEX zones where standard air is incompatible with the product.
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
Dry rooms, inert atmosphere and ATEX zones where standard air is incompatible with the product.
See more →Entornos controlados aplicables
