3 Design of Mixing Units - Herbst Planetary Mixer

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3.6 Design of the Machine 27Table 4:frequently used stainless steel qualitiesMaterial No. Shortname (EN 10088-2) ASTM / AISI BS1.4301 X 5 CrNi 18-10 304 304 S 151.4404 X 2 CrNiMo 17-12-2 316L 316 S 111.4541 X 6 CrNiTi 18-10 321 321 S 311.4571 X 6 CrNiMoTi 17-12-2 316TI 320 S 31AISI = American Iron and Steel Institute, ASTM = American Society for Testing and Materials,BS = British Standard3.6.2 Surface DesignAll parts in contact with the product are hand ground and polished. If necessary thesurface may also be electrical polished.For special applications a coating, i. e. with Teflon, is possible.3.6.3 Regulations and Guiding RulesAll Herbst mixers are projected and fabricated in line with the latest regulations andguiding rules. These are in accordance with the guide lines of the chemical industryand relate to GMP and FDA. Furthermore an authorization of the CE-stamping can beobtained.The Ex-zone is designed according to ATEX 94/9 and the mixing units have to undergoa single inspection by the technical surveyor (i. e. TÜV) if requested for zone 0 / 20.3.6.4 Safety StandardsHerbst mixers are fitted with the necessary safety equipment, such as guards, bowl controlby proximity switch and manually operating controls of the bowl and the level adjustmentof the mixer head.Mixing units located in ex-areas (zone 1/21) are fitted with additional safety measuressuch as internal bowl wall scraper elements made of conductive material and level controlof double jacketed bowls.3.6.5 Suitable design to allow ease of cleaningAll parts in contact with the product are designed in such a way that easy cleaning ispossible. The surface shape is also subject to easy cleaning. Gaps are being avoided orarranged in such a way that they do not represent problems when cleaning.
3.6.6 Qualification and Validation3.6 Design of the Machine 28A qualification, i. e. a functional test of the unit, has to be arranged (as preparation)prior to the unit validation.The qualification consists of the following partial steps:• Design Qualification DQ• Installation Qualification IQ• Operational Qualification OQ• Performance Qualification PQThe unit operator provides the specification requirements for the new mixing unit in theDesign Qualification (DQ). These requirements constitute the design and constructionbasis which are confirmed in the Installation Qualification (IQ). The specification designand installation as listed in the accompanying DQ & IQ Certificates are to be checked forcompletion and conformity.This check, if not otherwise specified, is carried out visually. The unit design drawings, theIQ check list, the control circuit diagram and the documentary files serve as examinationmaterial.To be checked:• Unit components• Feed and discharge connections• Materials and substances in contact with the product• Documents• DrawingsThe installation qualification (IQ) as well as the function qualification (OQ) can be carriedout by the manufacturer, whereby both steps occur in close contact with and in thepresence of the end user.The OQ test program is the documentary evidence that the unit operates, trouble freeand with repeatable results all in accordance with the customers approved design andspecification. For these mechanical functional tests drinking water is used as the testmedium.
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3 Design of Mixing Units - Herbst Planetary Mixer

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