Every piece of equipment (open and closed) considered for certification must be evaluated by one of the EHEDG Authorized Test Institutes. All evaluations will include a “Design Review” and most closed equipment will require cleanability testing according to EHEDG Doc. 2. For a 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 properly. After a successful design review, open equipment may be submitted directly for certification but most closed equipment will require testing for cleanability 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).
Equipment which is considered to comply with the EHEDG guidelines following a design review and CIP testing (if appropriate) by an EHEDG Authorized Test Institute can be submitted for EHEDG certification. A certification file will be completed by one of the EHEDG Authorized Test and Certification Institutes and reviewed by at least one other Authorized Institute 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 EHEDG Authorized Institutes 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.
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 and evaluating Test Institute, 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 tested during certification.
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.
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 EHEDG Authorized Test and Certification Institutes.
In order to maintain certification, both annual prolongation and a 5-year renewal process are required as described here (PDF).
The certificate must be renewed annually by the end of December. The EHEDG Authorized Institute that performed the certification will request confirmation from the certificate holder that the design of the certified equipment has not changed. The prolongation fee/license fee is 500 EUR per certificate. If no changes have been made, the certificate is updated for the next period. If the certificate holder indicates that some changes to the design have been made in the past year, the EHEDG Authorized Test Institute will request documentation of the changes and determine (in collaboration with other Test and Certification Institutes) whether the 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 Test Institute).
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 by an Authorized Institute. 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 Test Institute.
Flowchart Recertification (PDF).