Sealing technology manual for the process industry - Hygienic design

HYGIENIC DESIGN In sterile technology, there is a rule that a seal must be in- stalled free of dead space and leaks. The groove must be 90% filled and the material must not have any swelling greater than 5%, otherwise gap extrusion will allow sea- ling material particles to contaminate the process medium. The resistance of the sealing materials, taking into account the production, CIP and SIP parameters and the require- ments of Hygienic Design, must be ensured. The elastomer materials that come into contact with the actual product must be sufficiently resistant to preclude their breakdown – in production or in cleaning and sterilization cycles – and the subsequent possibility of a deterioration of the product quality as a result of foreign matter stripped or dissolved from the interior of the plant. CLASS DETAIL PRODUCT OPERATING CONCENTRA- TION (%) TEMPERATURE EXPOSURE TIME (MIN.) CIP or circulation cleaners cont- aining nitric acid and surfactants Acidplus VA 35 0.5 – 2.0 +20 to +80 °C (+68 to +176 °F) Not specified CIP or circulation cleaners cont- aining formic acid and surfactants Beta VA 11 0.5 – 3.0 +10 to +70 °C (+50 to +158 °F) 30 – 60 CIP or circulation cleaners con- taining phosphoric acid and surfactants Divbrau VA 10 1.0 – 4.0 +10 to +70 °C (+50 to +158 °F) 20 – 60 Phosphoric acid-based foam cleaners Acifoam VF 10 3.0 – 10.0 +20 to +40 °C (+68 to +104 °F Not specified Alkaline, single-phase cleaners containing EDTA for circulation cleaning Solo VC 27 0.5 – 5.0 +40 to +80 °C (+104 to +176 °F) Not specified CIP or circulation cleaners cont- aining bases and surfactants Highstar VC 77 0.5 – 5.0 +40 to +80 °C (+104 to +176 °F) Not specified Alkali gel cleaners Powergel VG 1 2.0 – 10.0 +20 to +40 °C (+68 to +104 °F) Not specified Chlorinated alkali CIP or circulati- on cleaners Divo CIP VC 94 0.3 – 3.0 +20 to +60 °C (+68 to +140 °F) Not specified Hypochlorite-based disinfectants Divosan Hypochlorite VT 3 0.25 – 1.0 Room temperature Not specified Cleaning boosters containing surfactants, oxidants Divo Peroxy 0.2 – 0.5 +20 to +80 °C (+68 to +176 °F) Not specified Disinfectants containing peracetic acid Divosan forte VT 6 0.04 – 2.0 +20 to +60 °C (+68 to +140 °F) Not specified Amphoteric surfactant-based disinfectants TEGO 2000 VT 25 0.25 – 1.0 Room temperature > 20 APPENDIX PRODUCT PORTFOLIO MATERIALS RESISTANCE & PURITY ENGINEERING PLASTICS ELASTOMERIC MATERIALS TECHNICAL FUNDAMENTALS INTRODUCTION 63 Acidplus VA 350.5 – 2.0 Beta VA 110.5 – 3.0 Divbrau VA 101.0 – 4.0 Acifoam VF 103.0 – 10.0 Solo VC 270.5 – 5.0 Highstar VC 770.5 – 5.0 Alkali gel cleaners Powergel VG 12.0 – 10.0 Divo CIP VC 940.3 – 3.0 Divosan forte VT 60.04 – 2.0 TEGO 2000 VT 250.25 – 1.0 Room temperature > 20

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