Effective and Efficient CleaningOf Pharma Weighing Solutions

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Hygienically Designed Equipment

Prevent Cross-Contamination

Comply with Regulations

Improve Cleaning Efficiency

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Compliance MattersHow 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 pro-vide 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 Prac-tice (GMP) guidance, stating that equipment should be designed for its intended use, prevent contamination of the drug product and facilitate easy cleaning.

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GMP Cleaning ValidationGMP guidelines on cleaning validation, such as the Qualification and Validation Annex 15 of the European Commision, specify criteria for equipment cleaning as-sessment.

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 CertificationThe European Hygienic Engineering & Design Group (EHEDG) and the National Sanitation Foundation Inter-national (NSF) are the best-recognized international ex-perts in the area of good design practices for sanitary equipment applications.

METTLER TOLEDO provides weighing equipment that is designed according to sanitary standards and certified by EHEDG and NSF.

Good

M

anufacturing Practice

Consistent Quality

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No crevices and nichesInternal corners and angles should be rounded. Welds should be continuous, smooth and polished. Fasteners and open threads should be avoided to prevent accumulation of con-taminants.

Construction materialsThe construction materials must be corrosion resistant, non-toxic and non-absorbent. Surface roughness should be below 0.81 micrometer to prevent the accu-mulation of micro-organisms.

Open constructionThe construction should be open and easily accessible. Horizontal elements should be rounded and dead spaces and hollow areas avoided to prevent the accumula-tion of liquid and contaminants.

Sanitary StandardsNo-Risk DesignSanitary standards, as defined by EHEDG and NSF, include a wide range of equipment design aspects that have to be considered, such as select-ing the right construction materials, providing easy access for cleaning and preventing the accumulation of materials and liquids.

Hygienic risk Hygienic design Hygienic risk Hygienic design Hygienic risk Hygienic design

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Critical Design FeaturesOf Hygienic Weighing Equipment

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• Easy removal of weighing plat-form for cleaning access

• Open scale construction without dead space or horizontal sur-faces prevents materal accumu-lation

Hygienic foot design• Resist harsh environments and

cleaning procedures• Easily adjustable height without

open threads that could collect contaminants

Open design

Complete terminal protection (IP69k)

• Complete terminal protection (IP69k)• Double sealing of the terminal housing• High-tech pressure compensation vent• Protected sockets enable secure con-

nections• Seamless integration of screen and

keypad

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Easy cleaning access

• Pneumatic springs allow easy opening for cleaning

• Corrosion resistant and easy to clean

• All moving parts are sealed with gaskets to avoid corro-sion

Smooth surface• High-quality stainless steel (AISI

304 grade)• Smooth surface of up to 0.81

micrometer (electro-polished, blasted or grinded)

• Corrosion resistant and easy to clean

• Prevents accumulation of con-taminants and microorganisms

Open and rigid construction

• Open construction allows easy cleaning access to all parts

• Cross ribs provide stability and reduce size of potential con-tamination surface

Protected structure• Platform structure and supporting

elements (e.g. column, tubes) are closed and continuously welded

• Cables are hidden inside and cable glands are protected against dust and liquid ingress (IP69k)

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n Weighing EquipmentDesigned for Hygienic Environments

1 Bench Scales for Hygienic Environments

2 Floor Scales for Hygienic Environments

Model PBA430 PBK989

Key benefits Hygienically designedHighest sanitary standards

Heavy wash-down

Easy to cleanHigh-precision weighing

Robust construction

Certificates EHEDG, NSF, GMP certified GMP certified

IP rating IP68/IP69k IP67/IP68

Material Stainless steel AISI304 Stainless steel AISI304

Capacities 1.5 – 600 kilogram 3 – 300 kilogram

Approved resolution 1x3000e / 2x3000e Up to 300000e

More information www.mt.com/pba430 www.mt.com/PBK9

Model PFA779lift PUA579lift EZ-Clean™ VERTEX®

Key benefits Hygienically designedLiftable deck plate

for easy cleaning accessOpen cross-rib construction

Heavy wash-down

Hygienically designedLiftable platform for easy cleaning access

Heavy wash-downUltra-low profile for easy access

Easy to cleanStainless-steel pit sink

with drainageAutomatic opening of platform

for safe cleaning accessHeavy washdown

Certificates GMP certified EHEDG, GMP certified -

IP rating IP68 IP68 IP67/IP69k

Material Stainless steel AISI304 Stainless steel AISI304 Stainless steel AISI304

Capacities 300kg – 3000 kg 300kg – 1500 kg 600kg – 6000 kg

Approved resolution 3000e / 2x3000e 1x6000e / 2x3000e 3000e

More information www.mt.com/pfa779lift www.mt.com/pua579 www.mt.com/vertex

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2 Floor Scales for Hygienic Environments

3 Weighing Terminals for Hygienic Environment

Model ICS689 IND570 IND890

Key benefits Hygienically designedFast and accurate weighing thanks

to colorWeigh® Multi-functional manual weighing applications

Easy to cleanChemical resistance for harsh

cleaning agentsOptimized for blending, filling and

dosing operations

Easy to cleanLarge touch-screen supports

intutive handlingFree programming for customized

requirements

Certificates EHEDG, NSF, GMP certifiedGMP certified - GMP certified

IP rating IP68 IP68 IP67/IP69k

More information www.mt.com/ics689 www.mt.com/IND570 www.mt.com/IND890

The IP rating systemThe 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.

Level EHEDG, NSF, GMP certifiedGMP certified Level GMP certified

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 needMETTLER 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 Code 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.

www.mt.com/ind-pharma-regulationsFor more information

Subject to technical changes© 11/2015 Mettler-Toledo AGMarCom SwitzerlandMTSI ...

Mettler-Toledo AGCH-8606 GreifenseeSwitzerlandTel. + 41 44 944 22 11Fax + 41 44 944 30 60

Weighing applications in pharmaceutical production strongly influence final prod-uct 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 ComplianceWeighing in Pharma ManufacturingDownload the white paper

www.mt.com/ind-pharma-regulations Download the webinar

www.mt.com/ind-pharma-regulations-webinar

Regulatory Compliance Know-HowDownload Guidance