Testing & Certification - FAQ
- Both open and closed equipment used in food processing environments can be certified. EHEDG maintains a list of all equipment that has been certified.
- Although there are no limitations on the complexity of the piece of equipment, typically only small, individual components are certified rather than large, complex machines or processing systems.
- For certification of open equipment, ALL equipment surfaces are evaluated as product contact surfaces and must meet all hygienic design criteria in relevant EHEDG guidelines.
- Currently, only closed equipment with pipe connections between 25 mm (1 in) O.D. and 75 mm (3 in) O.D. can be tested due to limitations of CIP testing.
In general, all sizes of the same piece of equipment must be evaluated with a design review and CIP tested prior to certification. However, in a few instances where equipment designs are considered completely scaleable by an EHEDG AEO, testing of only one size can be used for certification of the entire range. In most instances, equipment is NOT completely scaleable. Currently, the only alternative to testing each size is to perform computational fluid dynamics modelling (CFD) of the different designs to select the size for testing that may be the most difficult to clean based on wall shear stresses and fluid exchange in critical areas. If the selected size passes CIP testing, the sizes with higher wall shear stresses and fluid exchange in critical areas may also be considered for certification and listed on the same certificate.
All closed pieces of equipment which are installed in a pipeline, e.g. pumps, valves, and inline sensors, must be tested according to the method of EHEDG Doc. 2. This test is a screening test for hygienic design and identifies areas that may contain a crevice which can trap soil and microorganisms or are not easily cleaned due to the flow dynamics.
Closed equipment which fully comply with the hygienic design requirements can be certified without testing. Examples are pipe lines or pressure sensors without elastomeric seals.
These terms are interchangeable and refer to "a method of assessing the in-place cleanability of food processing equipment" described in EHEDG Document 2 published by EHEDG. The test method is used as a basic screening test for hygienic design. It is used to determine if areas (or features) within a piece of equipment are “easily cleanable” by comparing the test results to that of a standard reference pipe soiled and cleaned during the same test. Due to inherent variability in the cleaning of equipment, the test must be repeated successfully at least 3 times for equipment to be eligible for certification. This test is required for equipment to be certified as Type EL Class I and EL Aseptic Class I.
EL Class I is only for closed equipment, intended to be cleaned-in-place (CIP) with liquids, and can be CIP tested using the method of Doc. 2. EL Class I AUX is for certification of auxiliary open equipment which is intended to be cleaned-in-place with liquids but not tested. EL Class II is for equipment which is intended to be cleaned with liquids but must be disassembled or dismantled prior to cleaning.
No. Since open equipment cannot currently be tested to ensure cleanability, open equipment intended to be cleaned with liquids can only be certified as EL Class I AUX or EL Class II. Open equipment intended to be dry cleaned only can be certified as ED Class I or Class II.
- The annual prolongation process provides EHEDG assurance by the certificate holder that the equipment design has not been changed in the past year.
- The 5-year renewal process allows EHEDG to ensure that certified equipment meets the latest criteria for certification due to changes in the EHEDG guidelines, certification criteria, or test procedures. This process is established in 2015.
Different elastomers may have different material properties. Experience has shown that different materials in the same mechanical design may affect the equipment cleanability. Since 2009 the certificate lists the elastomers that were CIP tested. The equipment is only certified when used with the elastomers listed on the certificate. Each elastomer listed on the certificate must be CIP tested using the method of Doc. 2.
Yes. For example Type EL Class I for cleanability and Type EL Aseptic Class I for sterile applications.
Yes, individual certification files will be issued. The evaluation report of the certificate will refer to the original equipment (test report or evaluation report).
EHEDG, in conjunction with the nominated AEO, will issue a revised certificate with the new name on it as a revision. The 5-year renewal anniversary date will not be reset. However, if there have been any changes to the EHEDG Hygienic Design Criteria or Test Methods a new certification procedure is required.
For closed equipment components intended to be cleaned in-place (CIP) with liquids (EL CLASS I certified), only the internal, wetted surfaces/parts are evaluated and certified to meet the hygienic design criteria according to EHEDG guidelines. This means that for pumps, valves and in-line sensors; the motor, drive, actuator or frame (if present) are NOT evaluated and certified for cleanability according to EHEDG guidelines. Only the internal, product contact surfaces are evaluated and certified according to EHEDG guidelines and, if necessary, tested for easy cleanability according to Doc. 2.
The date on the EHEDG certificate and Certified Logo indicate the month and year that the equipment was last reviewed and certified. As new guidelines have been created, existing ones updated and test methods improved, more recently certified equipment has to meet more detailed guideline criteria and/or pass more specific testing criteria. Equipment with certificates issued prior to 2009 were only reviewed according to EHEDG Doc. 8 while more recently issued certificates now take into account all EHEDG documents relevant to that piece of equipment. Equipment holding certificates with the most recent dates must meet the latest EHEDG guideline criteria and test methods. For the reasons described above, beginning in 2015, all certificates will be required to be renewed every 5 years to ensure the equipment meets the latest guideline and test method criteria.
If the multiple items are categorized according to the same Certification Class, e.g. TYPE EL CLASS I, and the designs are similar and covered by the same group of applicable EHEDG Guidelines then they can be listed on the same Certificate provided that they are certified in the same Month and Year, see FAQ above. This means that a manufacturer can maintain one Certificate for groups of similar equipment such as electromagnetic flow meters, coriolis flow meters, rotary lobe pumps, centrifugal pumps, diaphragm type sensors, etc. The design evaluation report will include references to all the individual cleanability test reports, if necessary.
EHEDG only allows metal to metal joints for equipment subject to certification under Type EL Class II and Type ED Class I and II. As they may harbor soil or liquids and could corrode, EHEDG does not recommend any direct metal to metal joints other than welding.
If the test programme was conducted after 1st January 2008 the report may still be valid for re-certification purposes if the design and materials have not been changed. Consult an AEO for review.
Certificates in the EHEDG database of valid EHEDG certificates might be highlighted with a "Renewal Pending" flag if a certificate is subject to renewal but the renewal process hasn't been completed yet. The raising of the flag is linked to the fulfillment of the following prerequisites:
- The certificate has already expired
- An application for renewal was handed in in time
- The component has already passed successfully the phase of HD-Evaluation
- The component is subject to being tested
Thus, testing and/or formal issuing of the certificate haven't been completed yet. The component might still fail the test. In this case the "Renewal Pending" flag will be withdrawn and the certificate will be removed from the database.