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Hygienic regulations for the food and pharma industry

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A definition of hygiene

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•Old concept related to medicine to reduce the incident of diseases•Means practices that prevent spread of desease-causing organisms•In the food, pharma and consmetics industry a product shall comply with microbial specifications appropriate to its use

(as per Wikipedia and WHO site )

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What is food?

Food is "any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans".

Cosmetics, medicines and tobacco products are not food.

(as per Chapter I, Article 2 of Regulation (EC) No 178/2002 of the European Parliament)

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What are pharmaceuticals?

A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment or prevention of disease. [1]

[1] US Federal Food, Drug and Cosmetic Act

Pharmaceutical products – more commonly known as medicines or drugs – are a fundamental component of both modern and traditional medicine. It is essential that such products are safe, effective, and of good quality, and are prescribed and used rationally [2]

[2] (as per WHO website)

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Why is hygiene a concern?

• By its nature food and pharmaceuticalscan spoil, posing a risk to humans in the form of contamination.

• Contamination can be chemical, biological or physical, but for weighing technology, (micro)biological contamination from bacteria or viruses is key.

• Food and Pharmaceuticals can be contaminated with bacteria during production

(as per Chapter I, Article 2 of Regulation (EC) No 852/2004 of the European Parliament)

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Why is hygiene a concern?

• Bacteria and viruses multiply very quickly under certain conditions and part of their food comes from the contents of the food or medicine.

• In doing so they release substances that make the food inedible.

• Bacteria can also cause direct harm to the human organism.

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Protection of consumers

• Different regulations have been put into force with the aim of protecting consumers from contamination.

• These laws and regulations require food and pharma manufacturers to undertake specific measures that ensure that their products have been produced under hygienic conditions.

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Safety in food and pharmaceutical production

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WHO decides the standards?

2002Food Safety Strategy

1968Good Manufacturing 

Practice for pharmaceuticals

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Product safety in the food industry

Guidelines:• Use of uncontaminated ingredients

• Prevent contaminating food with pathogens

• Separate raw and cooked foods

• Cook foods for the appropriate length of time and at the appropriate temperature

• Store food at the proper temperature.

• Use safe water and raw materials

(Codexalimentarius CAC/RCP 1-1969)

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Production equipment in the food industry

Guidelines:

•Designed to ensure adequate cleaning, disinfection and maintenance

•Manufactured from non-toxic materials

•Capable of being disassembled to allow for maintenance, cleaning, disinfection,

•Located for adequate maintenance and cleaning

•function in accordance with its intended use;

•facilitates good hygiene practices, including monitoring(Codexalimentarius CAC/RCP 1-1969)

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Industrial Weighing

Hygienic aspects of weighing technology

• Platform scales can have direct contact with food (contact with product).

• The components of vessel scales do not normally have contact with food (no contact with product).

• Technical weighing components can be sources of microbiological contamination whether they have contact with the product or not.

• The manufacturer of the weighing technology must ensure that the risk of contamination in the process is minimised.

• The scale operator must ensure that contamination in the process is minimised e.g. by cleaning the equipment.

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Does your kitchen look like this?

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Cleaning in the dairy industry

Acid/Alcalic/Chlorite agents

Rinse with process water

High pressure steam

High pressure water jet

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Cleaning in the chocolate industry

Wipe with a moist cloth, max. 60°C

Chemical cleaning agent

Compressed air

Floor cleaning machine

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Cleaning in the baking industry

Vacuum

Sweep/brushWipe with a dry cloth

Wipe with a moist cloth

Scrape

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How is hygiene managed in the pharmaceutical industry?

Pharmacuetical hygiene guidelines are to ensure

•The safety of patients•The Integrity of the product•The safety of the manufacturing staff

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Product Safety in the pharmaceutical production

Guidelines:• Use of uncontaminated ingredients

• Prevent contaminating Pharmaceuticals with pathogens spreading from people, pets, environment

• and pests.

• Store at the proper temperature.

• Use safe water and raw materials

• Protection of the Employee from Harmful effects of API materials

http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/

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Production equipment in the pharmaceutical industry

Equipment should be designed and constructed so as to:

• be suitable for its intended use;

• facilitate thorough cleaning;

• minimize the risk of contamination of products and containers during production;

• facilitate efficient and, if applicable, validated and reliable operation.

• See speakers notes for full definition and rules

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Global Harmonisation of Standards

• The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.

• ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner

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ICH Guidelines

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Guidelines for ICH Standards

• Hygiene for production equipment

• Covered under: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

www.ich.org/products/guidelines/quality/article/quality-guidelines.html

• as an example of local implementation of the same standard

www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129098.pdf

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Pharmaceutical Hygiene Regulations

• Following the ICH Guidelines Q7A for production equipment

• Each Country Organisation implements the harmonised standards and quidelines which are being more and more widely accepted be everyone

• The country organisations can be found listed

http://www.pharmweb.net/pwmirror/pwk/pharmwebk.html

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•Asia-Pacific Economic Cooperation (APEC),•The Association of the Southeast Asian Nations(ASEAN)•The Gulf Cooperation Council (GCC)•The Pan American Network for Drug Regulatory Harmonisation (PANDRH)•The Southern African Development Community (SADC).

•These and wider organisations and regulatory affairs bodies worldwide see the ICH standards as best practice and many are adapting them to their own regulatory requirements.

Wider ICH Cooperation

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National pharma regulations

Regional regulations for equipment

Global food management 

systems 

Regional audit systems

How are the standards implemented?

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Which area follows which standards?

USA

Europe

China

India & Asia

Japan

Don‘t move forward!Please click on the Hyperlinks!

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Hygiene Regulations in the USA

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Good manufacturing practice according to FDA

HACCP for the food industry

BRC certification system for the food industry3A hygienic design for food and pharma

NSF standards for food

ISO 22000 Management System

EHEDG hygienic design for food equipment

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• ICH Q10 describes one comprehensive approach to an effective pharmaceutical quality system that is based on ISO concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”.

• ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current GMP requirements is optional

FDA

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ISO 22000

• Management system requirements for companies to control food safety hazards, applicable worldwide www.iso.org

Objectives

• Implementation of managment systems• Demonstration of compliance with regulations• Effective communication with customer and

suppliers• Includes HACCP system and ISO 9001 elements• Harmonization of different Food Safety

Management Systems

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HACCP

• HACCP (Hazard Analysis and Critical Control Points) is a system for controlling food safety hazards

• The system comprises seven principles

• A critical control point (CCP) is a point in the production chain at which product defects and health risks can be ruled out through monitoring

• The HACCP system requires the definition of thresholds, verifications and documentation

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HACCP has seven principles:

1) Identification of hazards: biological, chemical, toxic, physical (e.g. broken glass)

2) Specification of critical control points, e.g. formulation, baking, packaging

3) Specification of thresholds for the CCPs, e.g. temperature and time for baking

4) Procedure for monitoring CCPs (measurement technique)

5) Correctional measures for cases where a point has not passed controls, e.g. rejecting or reprocessing products when temperature fluctuations have occurred

6) Verification measures for testing the system7) Documentation for validating the system

HACCP

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Potential risks for process weighing technology:

• Dosing error during manual filling• Dosing error caused by incorrect formula entries during automatic filling• Dosing error caused by weighing equipment inaccuracies• Microbiological contamination of the product caused by

contaminated scalesManagement of risk through:• Automatic dosing solutions• Documentation of the dosing process• Hygienic design of the weighing equipment

HACCP

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European Hygienic Engineering & Design Group (EHEDG)

Consortium founded in 1989 by manufacturers of components, machines and devices and leading manufacturers in the food industry and research instituteswww.ehedg.orgwww.hygienic-design.comObjectives:- Exchange of knowledge- Publication of guidelines- Development of test procedures for identifying

weak hygienic points- Specification for standardisation- Certification of components

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Zone concept

as per EHEDG

: basic – Zone BPrevention of product contamination using GMP; no product in open spaces (e.g. warehouse, control room)

: medium – Zone MGuarantee that products are not contaminated in machinery(e.g. product output, production)

: high – Zone HPrevention of product contamination during open processes (such as product filling)

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Principles of "hygienic design"

Definition (as per EHEDG): Design of components and devices with special attention to cleanability.Objective: for equipment to be easy to clean

- Materials (stainless steel, plastic)- Surface finish (smooth, even)- Self-draining (tilted surfaces)- Accessibility (cleaning, maintenance)- Avoidance of screws and gaps- Resistance to products andcleaning agents

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International Food Standard (IFS)

The objective is to ensure food safety Brought into force in 2003 by large European retailers The IFS is a standardised evaluation system for auditing all food

manufacturers which supply products for retailers Based on the ISO 9001:2008 quality management standard as well as

the "Good manufacturing practice" (GMP) and HACCP The recent IFS version 6 contains 10 knock-out criteria with which a

certificate would be denied. www.ifs-certification.com

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International Featured Standard (IFS) – Version 6

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Requirements to cleanability

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BRC

• BRC - Certification system for the food industry, established by the food industry, implemented in EU and USA, www.brcglobalstandards.com

Principles:

• Senior management commitment

• HACCP –Plan must be implemented

• A quality managment system must be established

• Pre-requisite programmes defining operational standards

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BRC

Reference to Hygienic Design:

•Appropriate materials for food processing

•Cleanability, maintainability

•Suitability, where food contact

No detailed requirements for hygienic design given

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3-A

• 3-A – Non-profit organisation for advancing hygienic equipment design in the food, beverage and pharma industry

• Established by regulatory sanitarians, equipment manufacturers and processing companies, implemented in the USA, www.3-a.org

Principles

• Development of design requirements for buildings and equipment

• Licences the 3-A logo• Harmonization with global standards

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3-A

Reference to Hygienic Design:

•Appropriate materials for food and pharma processing

•Cleaning-In-Place concept

Detailed requirements for materials and hygienic design given

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NSF

• National Sanitary Foundation – Non-profit organisation for consumer health for food, water and consumer goods

• Founded 1944 by the University of Michigan, implemented in the USA, 150 countries worldwide www.nsf.org

Principles

• Publishing standards for food, water and consumer goods

• Auditing and certification of manufacturers of equipment

• Sartorius Combics range is NSF approved according to NSF/ANSI 169

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US Hygienic Relationships

Hygienic Quality System

FDA & ICH implements the

WHO Good Manufacturing

Practices

ISO 2200Quality System

Accountability and Harmonization

HAACPSafety in each

aspect of food or drug production

BRCCertification that requirements are

met

EHEDG NSF A3Engineering

Standards for Manufaturing

Equipment and Materials

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Where „Hygienic Design“ is important?

“Hygienic Design” is important in all production processes, where there occurs a potential risk of product contamination by microorganisms.

Hygienic Design

Food Industry PharmaceuticalIndustry

Chemical Industry Biotech Industry

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Which are the benefits of „Hygienic Design“?

The use of components, which are optimised in hygienic aspects, helps to reduce costs for a clean production environment.

Higher productivity/Cost savings

Low risk ofcontamination

Low consumption of

detergents

Short cleaningcycles

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Essentials of „Hygienic Design“

Target:Easy

Cleanability

Surfacefinish

Self draining

Accessability

Avoidance ofscrews and

slots

Resistance to product

anddetergents

Industrial Weighing

08. November 2011 Seite 1

Signum Combics: Hygienic in every detail:

-smooth surfaces for easy cleaning-completely made from stainless steel-protection class IP65

-optimised surface finish RA < 0.4 m-stainless steel polished feet

Industrial Weighing

08. November 2011 Seite 2

IF series: Hygienic in every detail:

-smooth, clean shape-no welding on the top plate-protection class IP69k-high quality stainless steel AISI 304;AISI316Ti-optimised surface finish, e-polished -fully hermetically sealed

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Sample Application in Pharma Industry

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The Challenge

To make use of the essentials of „Hygienic Design“ by designing load cells and mounting kits.

The solutions must take into account the actual problems and given circumstances, but without limitation of functionality!

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Bellows protect the strain gauges but attract dirt and dust and can be

damaged easily

any holes, slots and open threads attract dirt and bacteria and are hard

to reach for cleaning

all horizontal surfaces lead to build up of solids and liquids

Varnished surfaces do not withstand the aggressive cleaning

procedures

Weighingequipment

State of the Art

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- Standardised sizes from 100kg to 2t

- Accuracy class D1 and C3

- IP69k, load cell IP68

- EHEDG*-certified hygienic design for fast and efficient cleaning

- High-quality materials offer an excellentchemical resistance

Contego® - Hygienic Weighing Module

Weighing modules

*European Hygienic Engineering & Design Group

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Test Procedures

Weighing module during Weighing module during Weighing module during the

dust testing high-pressure testing EHEDG test

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- Preassembled kit including load cell saves installation time

- Integrated constrainer and lift-off protection ensure horizontal and vertical stability

- “Jack-up”-function to quickly lift the vessel without hydraulic lifters

- Lateral cable outlet with hygienic cable gland or cable outlet in the upper mounting plate

Contego® - Hygienic Weighing Module

Weighing modules

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Hygienic Design in Detail

- O-ring to seal the contact surfaces between weighing module / container leg and weighing module / foundation.

- The specially designed connection geometry between the Silicone cover and the connection plates ensures a reliable sealing of the dust and water resistant internal space. This has been tested and certified by an external institute.

- The weighing module can be installed directly on the foundation or in connection with the optional mounting plate. On coated floors the mounting plate can be mounded.

Weighing modules

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Hygienic Design in Detail

- O-ring to seal the contact surfaces between weighing module / container leg and weighing module / foundation.

- The specially designed connection geometry between the Silicone cover and the connection plates ensures a reliable sealing of the dust and water resistant internal space. This has been tested and certified by an external institute.

- The weighing module can be installed directly on the foundation or in connection with the optional adapter plate. On coated floors the adapter plate is recommended.

Weighing modules

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Compression type hygienic load cell

... first load cell designed according to the stringent standards of Hygienic Design according to EHEDG.

: Capacities 1t up to 50t: Full stainless steel AISI 316: accuracy class C1, 0,03%: rocker pin principle for best compensation of expansion: permissible eccentricity 10mm: Hermetically sealed IP68 and IP69K: Calibration without weights: Model PR6202

**coformity planned for end of 2013

Load cells

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- Optimised surface finish

- Smooth and clean shape

- Self draining design

- Avoiding of gaps

- EHEDG approved

Comparable model PR6201

Load cells

Compression type hygienic load cell

Industrial Weighing Hygienic mounting kit with constrainer

Inclining surfaces where possible

Self draining parts

Fully hygienically welded

25 kN constrainer in one piece

Round head nuts

Mounting kits

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Comparison of mounting kits

Mounting kits

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PR 6130 Cable Junction Box

- Electropolished stainless steel housing- Protection class IP68/IP69K- Intuitive wiring with consistent colour coding- Special board design for stable and reliable

signal transmission- Membrane for pressure compensation prevents humidity access- designed according to EHEDG requirements- Approved for Ex-applications

Video Cable junction box

Accessories

Industrial Weighing PR 5230 Transmitter in field housing

- Electropolished stainless steel housing for fast cleaning

- protection class IP 66 offers reliable protection against access of humidity

- The stainless steel quality 1.4404 offers highest chemical resistance for a long-term application- optional load cell connection board- LCD 6-digit graphic display, polycarbonate,

customizable- Configuration via Ethernet TCP/IP- RS232/RS485 standard- 3 digital inputs, 3 relay outputs standard - optional Profibus-DP

Electronic instruments

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Maxxis 5 – Process ControllerIEC 61131-3 Programming: Perhaps the only scale controller that is programmed in the international programming language of PLCs.

ON Board IO: Comes standard with 4 1A 24V DC relays and 4 12V-24V inputs. TCP/IP Ethernet, USB 2 master, SD card, RS232 and RS485

IP65 Washdown Protection: Regardless of your installation, water intrusion will not be an issue with the Maxxis 5.

Libraries of Software programs available: Many customers will not need custom software written. Sartorius offers Batching, IBC, and more complete solutions ready to load into your Maxxis 5 controller.

Communication: Maxxis 5 supports Modbus TCP and Serial as Master and/or Slave, Ethernet/IP, DeviceNet, ProfiBus, ProfiNet, OPC, Analog Out and Serial Out.

Panel Mount or Cabinet: The Maxxis 5 with the desk mount or wall mount is large enough to house IO cards and provide for a generous user interface. The panel mount version can be used with greatly expanded I/O.

Electronic instruments

Industrial Weighing

Thank you for your attention!