Hygienic Design Hygienically Designed Equipment Prevent Cross-Contamination Comply with Regulations Improve Cleaning Efficiency Effective and Efficient Cleaning Of Pharma Weighing Solutions
Hygienic Design Compliance Matters How to Prevent Cross-Contamination Cross-contamination in drug manufacturing impacts product quality and may even lead to product recalls. Hygienically designed weighing equipment helps prevent cross-contamination and ensures regulatory compliance. In pharmaceutical manufacturing, a range of regulations and industrial standards provide guidance to help ensure product safety and efficacy. With regard to equipment design and use in pharmaceutical manufacturing processes, the leading authorities, such as FDA, WHO, EMA or ICH are very consistent in their Good Manufacturing Practice (GMP) guidance, stating that equipment should be designed for its intended use, prevent contamination of the drug product and facilitate easy cleaning. Good Manufacturing Practice Consistent Quality GMP Cleaning Validation GMP guidelines on cleaning validation, such as the Qualification and Validation Annex 15 of the European Commission, specify criteria for equipment cleaning assessment. METTLER TOLEDO's weighing platforms designed for the use in pharmaceutical environment have been certified by an independent testing institute with regard to GMP guidelines and current practices in cleaning validation. Hygienic Design Certification The European Hygienic Engineering & Design Group (EHEDG) and the National Sanitation Foundation (NSF International) are the best-recognized international experts in the area of good design practices for sanitary equipment. METTLER TOLEDO provides weighing equipment that is designed according to sanitary standards and certified by EHEDG and NSF. 2
Sanitary Standards No-Risk Design Sanitary standards, as defined by EHEDG and NSF, include a wide range of equipment design aspects, such as selecting the right construction materials, providing easy access for cleaning and preventing the accumulation of materials and liquids. Construction materials The construction materials must be corrosion resistant, non-toxic and non-absorbent. Surface roughness should be below 0.81 micrometer to prevent the accumulation of micro-organisms. Open construction The construction should be open and easily accessible. Horizontal elements should be rounded and dead spaces and hollow areas avoided to prevent the accumulation of liquids and contaminants. No crevices and niches Internal corners and angles should be rounded. Welds should be continuous, smooth and polished. Fasteners and open threads should be avoided to prevent accumulation of contaminants. Hygienic risk Hygienic design Hygienic risk Hygienic design Hygienic risk Hygienic design 3
Hygienic Design Critical Design Features Of Hygienic Weighing Equipment Complete terminal protection (IP69k) Double sealing of the terminal housing High-tech pressure compensation vent Protected sockets enable secure connections Seamless integration of screen and keypad ICS685 PBA430 Open design Easy removal of weighing platform for cleaning access Open scale construction without dead space or horizontal surfaces prevents material accumulation Hygienic foot design Resist harsh environments and cleaning procedures Easily adjustable height without open threads that could collect contaminants 4
Smooth surface High-quality stainless steel (AISI 304 or 316 grade) Surface roughness below 1 micrometer (electro-polished) Corrosion resistant and easy to clean Prevents accumulation of contaminants and microorganisms Easy cleaning access Pneumatic springs allow easy opening for safe and effective cleaning All moving parts are sealed with gaskets to avoid corrosion and accumulation of contaminants No crevices and niches Platform structure and supporting elements are closed and continuously welded Cables are hidden inside and cable glands are protected against dust and liquid ingress (IP69k) PFA779lift Protected load cell Hermetically sealed, IP68 protected stainless steel load cells Floor scale with open load cell areas for easy cleaning access Open and rigid construction Open construction allows easy cleaning access to all parts Cross ribs provide stability and reduce size of potential contamination surface 5
Hygienic Design Weighing Equipment Designed for Hygienic Environments Bench Scales Model PBA430 PBK989 Key benefits Hygienically designed Highest sanitary standards Heavy wash-down Certificates EHEDG, NSF, GMP certified GMP certified IP rating IP68/IP69k IP67/IP68 Easy to clean High-precision weighing Robust construction Material Stainless steel AISI304 or AISI316 Stainless steel AISI304 or AISI316 Surface Electro-polished Electro-polished Capacities 1.5 600 kilogram 3 300 kilogram Approved resolution 1x3'000e / 2x3'000e Up to 30'0000e More information www.mt.com/pba430 www.mt.com/pbk9 Floor Scales Model PFA779lift PUA579lift EZ-Clean VERTEX Key benefits Hygienically designed Liftable deck plate for easy cleaning access Open cross-rib construction Heavy wash-down Hygienically designed Liftable platform for easy cleaning access Heavy wash-down Ultra-low profile for easy access Easy to clean Stainless-steel pit sink with drainage Automatic opening of platform for safe cleaning access Heavy washdown Certificates GMP certified EHEDG, GMP certified - IP rating IP68 IP68 IP67/IP69k Material Stainless steel AISI304 or AISI316 Stainless steel AISI304 or AISI316 Stainless steel AISI304 or AISI316 Surface Electro-polished or glass bead blasted Electro-polished or glass bead blasted Electro-polished or glass bead blasted Capacities 300kg 3'000 kg 300kg 1500 kg 600kg 6'000 kg Approved resolution 3'000e / 2x3'000e 1x6'000e / 2x3'000e 3'000e More information www.mt.com/pfa779lift www.mt.com/pua579 www.mt.com/vertex 6
Weighing Terminals Model ICS689 IND570 IND890 Key benefits Hygienically designed Fast and accurate weighing thanks to colorweight Multiple manual weighing applications Easy to clean Chemical resistance for harsh cleaning agents Optimized for blending, filling and dosing operations Easy to clean Large touch-screen supports intuitive handling Free programming for customized requirements Certificates EHEDG, NSF, GMP certified - GMP certified IP rating IP69k IP69k IP69k More information www.mt.com/ics689 www.mt.com/ind570 www.mt.com/ind890 The IP rating system The IP rating (International Protection Rating, also called Ingress Protection Rating) classifies the protection level of electrical enclosures. It consists of the letters IP followed by two digits and an optional letter. The first digit indicates protection against the intrusion of solid objects and the second digit indicates protection against liquids. The conditions are described in the table below. 1 st digit Level of protection against solid particles (e.g: 6 signifies dust tight) IP68 2 nd digit Level of protection against liquids (e.g: 8 signifies suitability for immersion beyond 1m) Level Object size protected against Level Protected against 0 No Protection 0 No Protection 1 >50 mm 1 Dripping water 2 >12.5 mm 2 Dripping water when tilted up to 15 3 >2.5 mm 3 Spraying water 4 >1 mm 4 Splashing of water 5 Dust protected 5 Water jets 6 Dust tight 6 Powerful water jets 6k Powerful water jets with increased pressure 7 Immersion up to 1 m 8 Immersion beyond 1 m 9k Powerful high temperature water jets The protection you need METTLER TOLEDO provides a range of weighing solutions designed for fast and effective cleaning with the ingress protection you need. For example, the PFA779lift floor scale has an IP level of IP68. It is dust-tight and can be immersed in water. The PBA430 bench scale is rated IP69k, which means it is dust-tight and can be cleaned with high pressure and temperature. Contact us to discuss the protection requirements suitable for your cleaning process. 7
Regulatory Compliance Know-How Download Guidance Weighing applications in pharmaceutical production strongly influence final product quality and efficacy. However, regulations related to weighing often are vague. METTLER TOLEDO has developed a white paper and an on-demand webinar that explain how to: Implement weighing-related regulations Select compliant weighing equipment Schedule routine tests and calibration intervals Regulatory Compliance Weighing in Pharma Manufacturing Download the white paper www.mt.com/ind-pharma-regulations Download the webinar www.mt.com/ind-pharma-regulations-webinar www.mt.com/ind-pharma-regulations For more information Mettler-Toledo AG CH-8606 Greifensee Switzerland Tel. + 41 44 944 22 11 Fax + 41 44 944 30 60 Subject to technical changes 12/2015 Mettler-Toledo AG MarCom Switzerland MTSI 30254038