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Electrical enclosures in the pharmaceutical sector: safety, challenges and certifications

11 December 2025
Electrical enclosures in the pharmaceutical sector: safety, challenges and certifications

The pharmaceutical sector requires high standards in terms of safety, reliability and regulatory compliance. Electrical enclosures, the heart of industrial systems, play a crucial role in ensuring:

  • the safety of operators and machines,
  • the continuous reliability of operational activities and
  • the hygiene and sterility of production lines.

The design, installation, and maintenance of these enclosures must comply with specific regulations and obtain the necessary certifications to operate in the sector.

In this article, we will look at the specific characteristics of the pharmaceutical industry, the certifications required for stainless steel electrical enclosures intended for the pharmaceutical industry, the regulations governing the sector, and why choosing a certified enclosure is strategic.

Regulations and certifications for controlled environments

In controlled contamination areas (clean rooms), sterility is an essential requirement: external contaminants must not be able to reach either the products or the internal components of the electrical enclosure.

For this reason, pharmaceutical electrical enclosures must be:

  • Made of AISI 304L or 316L stainless steel, resistant to corrosion and intensive chemical washing.
  • Equipped with smooth surfaces, without edges or crevices, to prevent the accumulation of dust and microorganisms.
  • Designed with Hygienic Design, to allow for easy and frequent cleaning.

 

DISCOVER THE HYGENIC LINE

 

Electrical enclosures in explosion-risk areas

During pharmaceutical production, the use of fine powders, solvents, and flammable gases can create potentially explosive atmospheres.

In these cases, the enclosures must be:

  • Hermetic, to prevent the accumulation of dust inside.
  • Designed with effective heat dissipation systems to prevent overheating and accidental ignition.
  • Certified according to the ATEX 2014/34/EU directive.

 

Mandatory certifications for pharmaceutical electrical enclosures

In order to be installed and marketed, stainless steel electrical enclosures intended for the pharmaceutical sector must comply with a series of mandatory certifications:

Optional but strategic certifications

In addition to mandatory certifications, there are additional certifications that increase the technical and commercial value of the enclosure and the company with which you collaborate:

  • ISO 9001 — ensures that the manufacturer operates with a certified quality management system. 
  • ISO 14001 – ensures that factors of its activities that interact with the environment are kept under control

Conclusions

Choosing a certified electrical enclosure designed for pharmaceutical environments not only means complying with the law, but also ensuring safety and hygiene.

Thanks to its range of products, a specialised partner such as Irinox Electrical Enclosures can assist companies in the Xion, design and validation of the most suitable enclosure for each application.

The IRINOX product range has:

  • CE/UKCA marking
  • UL certification (Type 1, 12, 4, 4X) and IP 66 (or higher) rating DGUV certification according to EN 1672-2
  • ATEX certification (for categories 2 and 3) /IECEx for explosion risk areas
  • 304L or 316L stainless steel material (for the most demanding environments)
  • Hygienic design with smooth surfaces and no edges or crevices where contaminants can accumulate
  • FDA-compliant blue interlocking silicone gaskets

Finally, the company is a member of EHEDG and is certified to ISO 9001, ISO 14001 and ISO 45001.

IRINOX products are fully customised to meet the specific needs of your plant, complying with the most stringent regulations and integrating perfectly into the most complex production contexts. Contact us to discuss your needs and find out how we can help you design electrical enclosures that meet the challenges of your industry.

IRINOX SERVICES FOR THE PHARMACEUTICAL SECTOR