Press
The use of Pressure Equipment (ESP) presents risks. Indeed, the energy accumulated by pressure can be very significant. Sterilisation manufacturers, who are regular users of this equipment, are directly affected. In addition, the operator’s responsibility covers not only operation but also installation. Therefore, it is essential to be familiar with and comply with the regulations governing pressure equipment. These include the 2017 ministerial decree, the Environment Code, and the European Conformity (CE), Food Drug Administration (FDA), American Society of Mechanical Engineers (ASME) and Good Automated Manufacturing Practices (GAMP) standards.
Definition of pressure equipment
An ESP contains water, gas or steam under pressure. During operation, the pressure inside the equipment is higher than atmospheric pressure (
- containers (such as autoclaves);
- pipes;
- accessoires sous pression ;
- pressurised accessories;
- steam generators.
The regulations distinguish between fixed ESPs and transportable ESPs (ESPTs). Sterilisation manufacturers are equipped with autoclave-type ESPs.
What is the rationale behind ESP regulation?
When in service, pressure equipment poses a risk. The most feared accidents are vessel ruptures. These cause explosions, loss of containment and fires. The consequences are human injury and damage to products and equipment located nearby. The purpose of the regulations is to reduce these risks.
Composition of ESP regulations
The regulation of pressure equipment has two main aspects. The first concerns the texts governing the manufacture and sale of pressure equipment. The second relates to the use of equipment in a professional context. This section covers commissioning, repair, periodic inspection and requalification.
Manufacture and sale of devices: what are the regulations?
In order to be placed on the market, ESPs must comply with the regulations in force. In Europe, a body of directives provides the legal framework. In France, this is supplemented by other binding texts. ASME regulations apply internationally, particularly in America.
European regulations
It consists of Directive 2014/29/EU on simple pressure vessels, Directives 2014/68/EU (ESP) and 2010/35/EU (ESPT). The latter two strengthen the safety of ESPs and guarantee their free movement within the European Union. They require manufacturers, authorised representatives, importers and distributors to comply with their requirements. The EN 13 445 standard completes the framework.
French rules
ESP are also subject to compliance with the Environmental Code. This states (Article L557-4) that ESP must comply with ‘essential safety requirements […] in terms of performance, design, composition, manufacture and operation’. The regulations are also based on the decree of 20/11/2017 (monitoring of pressure equipment and simple pressure vessels).
Le droit international
In the United States, ESPs must comply with the ASME BPVC (Boiler and Pressure Vessel Code). Section VIII covers the design and manufacture of traditional pressure vessels. ASME is equivalent to the European DESP regulation. As these standards differ from country to country, it is important to check the specific standards applicable before installing an ESP.
Operation and use of ESPs: what are the obligations?
The ministerial decree of 20/11/2017 requires monitoring of pressure equipment during operation. Periodic inspections and requalifications are mandatory steps. This regulation of pressure equipment primarily concerns its commissioning. It also governs the normal operation of the equipment.
Obligations related to commissioning
Before pressure equipment is used for the first time, a declaration of commissioning is required. The operator completes this online (LUNE application). The purpose of this declaration is to confirm that the pressure equipment meets the general conditions for ‘safe’ installation and operation. This commissioning check is carried out by:
- an authorised body for steam generators and pressure vessels;
- company operating personnel recognised as competent for vessels or piping.
Periodic checks and requalifications
The provisions of the Ministerial Order of 20 November 2017 make periodic verification and requalification mandatory. Periodic verification must follow an inspection plan or the requirements of the Ministerial Order. Its frequency varies depending on the ESP. It includes the following points:
- external inspection of equipment;
- verification of documentation;
- inspection of safety accessories.
Re-certification is a thorough inspection. It includes a hydraulic pressure test and must be carried out by an authorised body. The frequency also depends on the type of ESP.
Food and pharmaceutical regulations
Does your pressure equipment sterilise food products for export? The US authorities impose FDA standards. These are similar to European general product safety standards such as Directive 2001/95/EC. The aim of these provisions is to reduce health risks and ensure that products are safe.
Dans le secteur pharmaceutique, la réglementation des équipements sous pression comprend les normes GAMP. Cet acronyme désigne un organisme de contrôle et un ensemble de bonnes pratiques. Celles-ci concernent notamment les processus de stérilisation sous pression des produits pharmaceutiques.
Compliance with regulations protects manufacturers
In conclusion, all devices that operate using pressure must comply with French, European and international law. Regulations governing pressure equipment concern their manufacture and/or use. They reduce the risk of accidents during operation and limit the operator’s liability in the event of a problem.
Do you require a professional to use your ESPs in accordance with regulations? Are you looking for new pressure equipment or a retrofit? Steritech offers a wide range of solutions that strictly comply with current standards. If you have any questions, please call our experts.
