Instant Validation Autoclave
To have a validation carried out, please fill in the checklist for your device and send it to support@certoclav.com.
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Frequently Asked Questions
Instant Validation Autoclave – key questions answered clearly.
What does the validation of an autoclave mean?
Validation is a formal test that proves your autoclave and the entire reprocessing process meet the applicable requirements and sterilize reliably. It is carried out on site with your instruments as the load and is documented. Afterwards you receive a validation report.
What is Steri24's instant validation?
Instant validation is our accelerated validation service for your device. You fill in the checklist that matches your device and send it to our support team, after which we promptly arrange an on-site appointment. This way you quickly and efficiently obtain the standard-compliant validation of your autoclave.
How do I start the instant validation?
Please fill in the checklist for your device and send it to support@certoclav.com. We will then review your details and arrange an appointment with you for the on-site validation.
Is validation mandatory?
In Germany, validation is mandatory for everyone who reprocesses medical instruments used on humans, such as medical practices, clinics, podiatry, beauty/cosmetics, as well as tattoo and piercing studios. Anyone who does not reprocess critical instruments that come into contact with blood is generally not required to do so. If in doubt, we are happy to advise you on your field of application.
What legal basis underlies the validation requirement?
According to the requirements for operators of medical devices, the reprocessing of instruments that are used in a low-germ or sterile condition must be carried out with suitable, validated procedures in such a way that success is verifiably ensured. The KRINKO/BfArM recommendation specifies these requirements in more detail. We carry out validation in line with the current state of science and technology.
How does validation proceed and what is done during it?
During validation, the autoclave and the reprocessing process are assessed on site: using sensors, this includes a vacuum test, an empty-chamber profile and several sterilization runs with your instruments. Afterwards you receive a validation report.
What is on-site initial validation and what is done during it?
During initial validation, an approved validator uses measurement sensors to check whether your autoclave meets all requirements at the place of use, including a vacuum test, empty-chamber profile and several sterilization runs with your instruments. You then receive a validation report.
Who carries out the validation and can I do it myself?
Validation must be carried out by an approved validator and is practically impossible to do yourself, as high-quality measurement technology is required. Steri24 handles the entire process on site. In principle, it can also be carried out by another approved provider.
Does validation always have to take place on site?
Yes, validation must always take place on site with your instruments as the load, because it tests the actual conditions at the place of use. Sending the device to the factory for this is not possible. A device sent in can be serviced, but it can only be validated on site.
How often must the autoclave be validated?
Revalidation is generally due every 2 years; with the smooth operation of a Klasse B autoclave, this interval can usually be fully used. Larger devices or a high number of cycles may require earlier revalidation. We will remind you in good time of the due date.
At what interval must revalidation take place?
Revalidation is generally due every 2 years or after a certain number of cycles and is carried out on site. We agree the exact interval based on your device and your usage.
When must initial validation take place after purchase?
Initial validation should take place promptly after commissioning and is carried out in a separate appointment on site. You can already use the device after delivery; initial validation can also be done shortly afterwards.
Is my autoclave ready for use before validation?
Yes. Initial validation is a process validation and can also be done after commissioning; the autoclave is therefore generally ready for use after delivery and setup. Please nevertheless observe the requirements applicable to your field of application.
Can you also validate a device that was not purchased from you?
We can validate many devices from other providers, even if we do not service them. The prerequisite is that the prescribed maintenance has previously been carried out by the manufacturer or an authorized partner, as this is a basic requirement for revalidation. Send us the device data and we will prepare a quote.
Do you also validate devices from other manufacturers?
Yes, we can generally validate devices from established expensive manufacturers, even without servicing them ourselves. It is important that the manufacturer's maintenance is up to date. Let us know the model and manufacturer and we will assess the individual case.
Is validation mandatory for a foot care or podiatry practice?
As soon as you reprocess instruments that come into contact with blood, validation is also mandatory in podiatry and foot care. In pure foot care without critical instruments it is often omitted, but it can be done at any time later.
Does the autoclave have to be validated in the veterinary field?
In the purely veterinary field, validation is not legally required, as the obligation applies to the reprocessing of instruments used on humans. Voluntary validation is of course possible and can be worthwhile.
Does the autoclave have to be validated if no critical instruments are reprocessed?
If no critical instruments that come into contact with blood are reprocessed, there is generally no validation requirement. However, as soon as critical instruments used on humans are reprocessed, validation is required. We are happy to advise you on the classification of your instruments.
Is validation absolutely necessary for a new device?
If the new device is used to reprocess critical instruments used on humans, validation is required. It is carried out on site with or after commissioning. Whether it is mandatory in your case depends on the field of application.
Can I buy an autoclave without validation?
Yes, you can also order the autoclave without validation and commission it yourself according to the manual. Whether validation is mandatory depends on your field of application. It can be booked later at any time.
Can I order the initial validation directly together with the autoclave?
Yes, you can order the initial validation directly with the autoclave or commission it separately at any time afterwards. We arrange the appointment individually with you.
Can I have the validation done later?
Yes. Initial validation is a process validation and can also be done after commissioning; the autoclave is ready for use immediately after delivery. Validation can be commissioned at a later date at any time.
How quickly is an appointment for validation available?
The waiting time is usually in the range of a few weeks, often shorter in larger cities. With instant validation we speed up the process. We arrange the exact appointment individually with you.
What documents do I need for validation?
To get started we need the completed checklist for your device with the device and location data. Send this to support@certoclav.com, then we will review your details and get back to you to arrange an appointment.
What is in the checklist for validation?
The checklist captures the most important details about your device, the location and the planned use, so that we can prepare the validation in a targeted way. This allows the on-site process to be carried out efficiently and without delay.
Do you also handle the maintenance and validation of the device purchased from you?
Yes, we handle the maintenance and validation of devices purchased from us, including installation and initial validation on site, and on request as part of a maintenance contract.
Are maintenance and validation the same thing?
No, maintenance and validation are separate services and can be booked individually. It is sensible and usually cheaper to have both carried out as a package in one appointment.
Is the initial validation included when buying the autoclave?
Initial validation is not automatically included in the device price, as it must be carried out on site. You can order it directly with the autoclave or add it separately afterwards.
Does someone come on site for the validation?
Yes, validation is always carried out on site. In Germany, Austria and Switzerland the travel is free of charge, as we have trained technicians and service partners in the respective region.
Do you also offer validation in Austria and Switzerland?
Yes, we have trained technicians and service partners in Austria and Switzerland who come on site for installation, validation, maintenance and repair. The travel is free of charge. Please note that partly different requirements apply in Austria and Switzerland.
Can sealing devices also be validated?
Yes, our validatable sealing devices such as the CertoSeal can be validated in accordance with the requirements applicable at national and state level. Please contact us to arrange a delivery and validation appointment.
Can you also validate a thermal disinfector or washer-disinfector?
Yes, in addition to autoclaves we also validate washer-disinfectors (WD/thermal disinfector) within the framework of the applicable requirements. Let us know about your device and we will prepare a suitable quote.
Why is a new device alone not enough; why do I additionally need a validation?
A device can be technically flawless, but validation proves that the entire reprocessing process works safely under your specific conditions at the place of use, for example with your load and your water. Only then is the sterilization success verifiably demonstrated.
What happens if the validation is not passed?
If the validation shows deviations, we identify the cause and agree the necessary measures with you, such as maintenance, adjustment or adaptation of the load. The process is then checked again until the requirements are met.
Why does the validation need my own instruments as the load?
Validation tests the real reprocessing process. With your instruments as the so-called worst-case load, it is ensured that even parts that are difficult to sterilize are reliably covered. That is why validation takes place on site and not at the factory.
How long is a validation valid?
A validation is generally valid for around 2 years, after which revalidation is due. With heavy use or larger devices, a shorter interval can be advisable. We will inform you in good time before it expires.
What does validation cost?
The costs depend on the device and location and differ between Germany, Austria and Switzerland. The combination of maintenance and revalidation in one appointment is usually cheaper. We are happy to give you an individual quote on request.
Why is on-site initial validation comparatively involved?
Initial validation requires the travel of an approved validator, high-quality measurement technology and several documented test runs on site with your instruments. This prescribed test, including the report, explains the effort and the price.
Is the combination of maintenance and validation cheaper?
Yes, the combination of maintenance and revalidation in one appointment is generally cheaper than two separate appointments, as only one trip is required. We are happy to put together the right package for you.
Can I take out a maintenance and validation contract?
Yes, you can take out a maintenance and validation contract at any time after purchase; an immediate conclusion at the time of purchase is not necessary. This way the recurring appointments are arranged and you do not miss any deadlines.
Is the maintenance contract independent of the validation?
Yes, maintenance and validation are separate services and can be booked individually. However, it is sensible and usually cheaper to have both carried out as a package in one appointment.
Will you remind me of the due revalidation?
On request we will remind you in good time of the due revalidation, especially as part of a maintenance contract. This way your reprocessing process remains continuously documented in compliance with the standards.
What does the validation report contain?
The validation report documents the tests carried out and the measurement results, such as the vacuum test, empty-chamber profile and sterilization runs with your load. It serves as proof that your reprocessing process meets the requirements.
Who is allowed to carry out a validation as an approved validator?
Validation must be carried out by an approved, professionally qualified validator with suitable measurement technology. Our validators are accordingly trained and operate in Germany, Austria and Switzerland.
Does water quality play a role in validation?
Yes, water quality influences the sterilization result and the device condition and is therefore taken into account as part of the validation. For consistently good values we recommend treated water, for example via the AQUAdem water treatment.
Do you offer staff instruction during the validation?
Yes, an instruction is integrated during commissioning or initial validation on site. On request, we additionally offer training for your staff on sterilization and documentation.
How does SteriTrace support validation and documentation?
SteriTrace enables paperless documentation of your batches and thus facilitates the seamless, traceable record-keeping that is also required during validation. This way your reprocessing documentation remains audit-ready at all times.
What distinguishes your validation service from other providers?
Untypical for the price class, we offer a large, fast on-site service network in Germany, Austria and Switzerland with free travel. While other providers often have long distances or high costs, our instant validation ensures a swift, standard-compliant process.
Does the configurator help me choose the right device including validation?
Yes, in the autoclave configurator you select the device that suits your workflow and can already factor in services such as initial validation and maintenance. For questions about validation, we are also happy to advise you personally.
Who do I contact with questions about validation?
For questions about validation you can reach our team by email at support@certoclav.com. Feel free to send us the completed checklist for your device, then we will get back to you to arrange an appointment and answer any open questions.