The strengthening of ATEX (Explosive Atmospheres) regulation brings of several companies to request an ATEX safety audit of their installations.

The ATEX regulation concerns all the sectors of activity. Indeed, not only the industries that use chemical products (petrochemical industry, grain silos, wood processing industry) are concerned, but also the boiler equipment (gas or fuel oil), sites where flammable liquids (solvents, paints) are stored, equipment that uses combustible liquids under certain conditions, the activities involving flammable gases such as ethylene oxide, acetylene, propane or hydrogen, battery charging operations, manipulations of polyethylene balls,…

This is an essential point that should not be taken lightly by the companies because the safety of their plant and personal depends on those precautions.

As expert in ethylene oxide sterilization, one of the services we use to propose is the ATEX safety Audit for pharmaceutical and medical device industries.

ATEX – control of the explosion risks

ATEX is the name commonly given to the two European Directives for controlling explosive atmospheres:

1. Directive 99/92/EC: Minimum requirements for improving the health and safety protection of workers potentially at risk from explosive atmospheres
2. Directive 2014/34/EU: covers equipment and protective systems intended for use in potentially explosive atmospheres. The Directive defines the essential health and safety requirements and conformity assessment procedures, to be applied before products are placed on the EU market.

This is an important aspect for installations having explosive risks. To fulfil those directives, it is primordial to ensure safe equipment and personal training, always using safety procedures.

ATEX analysis, performed by RSD

RSD proposes to carry out ATEX analysis for pharmaceutical and medical device industries, especially for those companies that use ethylene oxide chambers for low temperature sterilization process.

Then ATEX audits are executed to give confidence to our customers, in the way that their installation can sterilize their product under safe conditions, and complying the laws.

As expert, RSD is specialized in ethylene oxide sterilization equipment, installation and process. In addition, we are Ism-ATEX level 2 certified. For those reasons, we are able to offer this Atex Audit for an ethylene oxide sterilization plant.

This kind of audit requires a specific know-how in ethylene oxide process and of course, a special knowledge applied to the ATEX environment. 

We carry out a personalized evaluation of the classified areas, and bring you all our expertise in the matter.

What does an Audit include?

• The ATEX audit provides assessment to make the site compliant with the European directive, and identify technical aspects to consider in order to increase safety levels.
• Such an audit can cover additional aspects of EO sterilization installation, like:

1. Risk assessment,
2. Classification of zones, including layouts,
3. Components and instrumentation (mechanical and electrical) checking,
4. Application of appropriate technical and organizational measures,
5. Equipment certification,
6. Inspection,
7. Maintenance,
8. Documentation,
9. Personnel training.

• A full report is delivered at the end of the Audit to identify all the potential issues, and recommendations to solve them in order to fulfil the mandatory ATEX directives.
• The RSD® audit’s allows you to benefit from independent analysis by experts who can assist you in your regulatory compliance process.

RSD offers customized services, according to the customer needs.

Please do not hesitate to contact us if you need any ATEX audit for your ethylene oxide sterilization installation, or for any additional information.

EO sterilization & pharma engineering Customized Services