Everything you need to know about compulsory autoclave checks
Guidelines of mandatory controls related to the use of an autoclave in 2023
Do you use an autoclave to sterilise food or pharmaceutical products? It’s imperative that you have your equipment inspected to avoid the risk of infection or sterilisation failure. Compulsory autoclave checks are a safeguard for your operators and maintenance staff.
An overview of your equipment is not enough. Using an autoclave that hasn’t been properly inspected increases the risk of explosion, gas, steam or water leaks. They also ensure quality sterilisation processes. Review our mandatory inspection guidelines to assist you in the use of an autoclave.
Autoclaves periodic testing: re-qualification, inspection and monitoring
The ESP regulations are the reference framework for mandatory autoclave inspections. In France, the decree of November 20, 2017, and the Environmental Code require periodic monitoring by inspection and re-qualification. These requirements do not exclude regular maintenance of your entire sterilisation system.
In the USA, ESPs must comply with the Boiler and Pressure Vessel Code (ASME BPVC). These standards vary from country to country; you must check the specific standards that apply before installing ESP.
What is a periodic inspection of an autoclave?
The periodic inspection of sterilisation equipment includes a documentary check. It takes into account the operating file and the associated documents (declaration of conformity, maintenance and intervention register, etc.). In technical terms, the periodic inspection includes:
- external inspection of the autoclave and inspection of the inner casing;
- inspection of its safety devices;
- inspection of pressure accessories.
The frequency of inspections varies depending on whether or not an inspection plan exists:
| With inspection plan | Without inspection plan | |
| Frequency: maximum every 6 years for autoclaves | Frequency: as often as possible, but no more frequently than 2 years after the initial start-up of steam generators, equipment with movable covers and quick-closing devices | |
| For piping systems, the interval between two inspections is left to the voluntary decision of the operator | Frequency: every 4 years for all other devices |
Periodic autoclave re-qualification: a more thorough inspection
Pressure equipment is also subject to periodic re-qualification. This comprehensive inspection is also known as a ten-year inspection. Periodicity varies depending on the type and use of the autoclave. The following table summarizes the situation:
| With inspection plan | Without inspection plan | |
| Periodic re-qualification every 12 to 14 years for steam generators and other vessels and piping systems | Periodic re-qualification every 10 years or less for steam generators, other vessels, and piping systems | |
| Re-qualification involves verification of the inspection operations specified in the inspection plan | Periodic re-qualification of piping systems: frequency to be defined in the approved guide |
On the administrative side, re-qualification involves reviewing the operation file. On the technical side, it involves:
- internal and external inspection of the autoclave;
- inspection of pressure accessories;
- inspection of safety equipment;
- inspection of control and safety devices;
- a hydraulic test of the sterilizer.
In addition, regulations require periodic re-qualification any time an autoclave is repaired or modified. Re-qualification is also required when there is a change of owner or operator.
Regular technical monitoring of autoclave equipment
Article L557-29 of the French Environmental Code states that the operator is responsible for maintenance. It is therefore in your interest to sign a maintenance contract. It provides the autoclave with the high level of safety required by the Environmental Code by means of the following operations:
- proper maintenance of equipment and fittings;
- verifying the presence of safety equipment (pressure relief devices, temperature controls);
- maintain a safety log;
- keep autoclave operating instructions handy.
The following table summarizes the key aspects of an autoclave maintenance contract:
| Key elements of an autoclave maintenance contract | Control operations on the autoclave | Equipment maintenance | Sterilisation tests | |||
| The goal of an autoclave maintenance contract is to ensure the safety and quality of sterilisation cycles | Control of operating elements | Preventive replacement of wear parts | After inspection and replacement, the company performs sterilisation cycle testing | |||
| Recommended: at least one visit per year, more depending on the number of sterilisation cycles | Control safety devices | Preventive replacement of specific parts that show signs of wear and tear | ||||
| The service contract includes inspection maintenance, and sterilisation testing | Inspection of electrical, air, gas and water circuits | Replacement parts according to the manufacturer’s specifications |
Mandatory post-procedure inspections
In addition to periodic testing, autoclaves are also subject to mandatory post-intervention testing. These are the conformity check and the post-intervention check.
Conformity checks are mandatory after any major intervention. It requires the organization to verify that the autoclave meets the essential safety requirements for the following items:
- performances;
- design;
- composition;
- manufacturing.
The post-intervention inspection is carried out after any significant intervention. Its purpose is to verify that the autoclave still meets the safety requirements defined by the Environmental Code (arts. R557-9-4 and R557-10-4).
The 2017 decree (arts. 26 to 30) defines the concepts of important, notable and non-notable interventions.
Which autoclaves are concerned by the controls?
According to the Environmental Code and the Decree of November 20, 2017, inspections apply to all equipment with a pressure greater than 0.5 bars. They concern, for example:
- single pressure vessels;
- steam pressure, water spray, immersion and bi-process autoclaves;
- small autoclaves;
- CMP, serial tower, CHP and CHS continuous-flow sterilizers.
In general, in-service monitoring applies to all pressure equipment and associated components (flanges, taps, fittings). It also applies to steam generators that use a fluid above 110° (steam, superheated water, gas, heat transfer fluid).
Who can perform compulsory autoclave checks?
In France, compulsory autoclave checks must be performed by an authorized body. It carries out the following inspections:
- autoclave commissioning;
- periodic re-qualification;
- periodic inspection;
- checks after interventions and/or repairs on the autoclave and its additional equipment.
However, the 2017 decree (arts. 17 and 23) introduces some nuances. It states that periodic inspection may be carried out by a competent person under the responsibility of the operator. It states that periodic re-qualification is carried out under the responsibility of an authorized body.
What are the risks of lack of control?
If an autoclave has not been inspected or subjected to the required conformity assessment, it must be taken out of service. In addition, failure to comply with compulsory autoclave checks may result in administrative sanctions by the Direction régionale de l’Environnement, de l’Aménagement et du Logement (DREAL).
On the other hand, omitting compulsory autoclave checks can increase risk in the following areas:
- explosion of the autoclave tank;
- gas, steam or pressurized water leaks.
These accidents throw up debris that can cause burns, suffocation, poisoning or inflammation.
In short, a company that performs inspections guarantees the safety of its agents and the quality of its products. Don’t have the time to do it yourself? Steritech can help you with all your compulsory autoclave checks. Don’t hesitate to contact our experts.