Traning and Education

Certification Procedure

Evaluation

Every piece of equipment (open and closed) considered for certification must be evaluated by one of the EHEDG Authorised Evaluation Officers (AEOs). All evaluations will include a “Design Review”. For the design review, a new sample of the equipment is compared to official drawings provided by the manufacturer and to the appropriate EHEDG guidelines. For example, a pump will be reviewed for compliance with EHEDG Guidelines 8, 9, 10, 16, 17, 23, 25, 32 and 35. During the review, certain design features will also be measured and verified, e.g. surface roughness and internal radii. After the design review, the equipment may be recommended for re-design due to deviations from the EHEDG guidelines. Some deviations from the hygienic design criteria in the guidelines may be allowable if deemed "technically unavoidable" for the particular device to function as intended. After a successful design review, open equipment may be submitted directly for certification but most closed equipment will require testing for cleanability in-place (CIP) according to EHEDG Doc. 2. Only after successfully completing at least 3 CIP tests, will the closed equipment be eligible for certification.

Evaluation and cleanability testing for equipment cleaned with liquids (Type EL) proceed using the following steps, published in this Evaluation Procedure (PDF).

For Type ED, the procedure is based only on a design review using the following steps in this Evaluation Procedure (PDF).

Certification

Equipment which is considered to comply with the EHEDG guidelines following a design review by an AEO and CIP testing (if appropriate) by an EHEDG Authorised Test Laboratory (ATL) can be submitted for EHEDG certification. A certification file will be completed by one of the AEOs and reviewed by at least one other AEO before being accepted by EHEDG. Since open equipment and dry cleaned equipment cannot currently be tested, these certification files must be reviewed by all of the AEOs prior to certification. After successful review of a certification file and acceptance of the terms of the EHEDG contract for use of the logo, a "Certificate of Compliance" will be issued and the equipment will be included in the list of certified equipment on the EHEDG website. EHEDG has published a certification procedure for better understanding of the whole process. 

Certification Procedure Flowchart
Certificate of Compliance

The Certificate shows the name, type and sizes of the equipment, seal materials tested (see notes below), the supplying company, the EHEDG certification type with subcategory, unique reference number of the evaluation report, a date of issue and expiration date.

Certificate Example (PDF).

Note - materials used for seals: Based on testing experience and the concern for cleanability of different seal materials in hygienically designed equipment, EHEDG's EL Class I certificates include details of the materials that were successfully tested.

Note - different sizes of equipment: Testing is normally required for all sizes of one type of equipment unless it can be demonstrated (e.g. by flow modelling) that wall shear stress and fluid exchange are equivalent or greater for certification of sizes that were not tested.

Certification Contract and Use of the "EHEDG Certified Logo"

EHEDG Certification is based on a contract between EHEDG and the company requesting component certification. This contract describes all details about the use of the certification logo. Appendix 2 of the contract details the logo use conditions. The EHEDG Certified Logo will include the date (Month and Year) that the certification was issued. Equipment certification can only be performed by one of the AEOs.

Lifetime of Certification

In order to maintain certification, both annual prolongation and a 5-year renewal process are required as described here (PDF).

Annual Prolongation of the Certificate and Invoicing

The certificate must be renewed annually by the end of December. EHEDG will request confirmation from the certificate holder that the design of the certified equipment has not changed.

The initial fee for first issuance or renewal of a certificate is 350 EUR. The fee for annual prolongation of certificates is 150 EUR. For more information please see SCP 4-8 on Fees for Granting, Prolongation and Renewal of EHEDG Certificates.

If no changes have been made, the certificate is updated for the next period. If the certificate holder indicates that some changes have been made to the equipment in the past year, the AEO will request documentation of the changes and determine (optionally in collaboration with the WG Certification) whether these changes affect the validity of the certificate and require a new design review and/or CIP testing (which may require additional fees, determined by the reviewing AEO/ATL).

5-year Renewal of the Certification

Certification files must be renewed every 5 years based on the anniversary date of the initial certification. A new design review must be conducted, with re-testing if required, and the certification file re-issued with an updated logo. The renewal process will take into account any changes in the EHEDG Guidelines, Certification scheme, or test procedures within the previous 5 years. The fee for renewal will be set by the renewing AEO/ATL.

Flowchart Recertification (PDF).