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DOC 29

HYGIENIC DESIGN OF PACKING SYSTEMS FOR SOLID FOODSTUFFS

December 2004

DOC 29©EHEDG 2 of 19

European Hygienic Engineering and Design Group

EHEDG Secretariat

Ms. Susanne Flenner

Lyoner Str. 18

60528 Frankfurt, Germany

Tel.: +49-69-66 03-12 17

Fax: +49-69-66 03-22 17

E-Mail: [email protected]

Website: www.ehedg.org

Developed with support from the European Commission and in co-operation with 3-A and NSF

International.

THE ENGLISH VERSION OF THIS EHEDG DOCUMENT IS THE OFFICIAL VERSION. THE EUROPEAN COMMISSINON SUPPORTS THE DEVELOPMENT OF THE EHEDG GUIDELINES. THE RESPONSIBILITY FOR THE PREPARATION, DEVELOPMENT AND ISSUANCE OF SUCH GUIDELINES LIES WITH EHEDG. DUE TO THE TECHNICAL AND GENERAL NATURE OF THE GUIDELINES, NEITHER THE EC NOR EHEDG MAY ASSUME ANY LIABILITY RESULTING FORM THE INTERPRETATION, APPLICATION OR USE OF SUCH GUIDELINES.


Contents Page

Introduction.........................................................................................................................................................5 1 Objective and Scope .............................................................................................................................5 2 Normative references............................................................................................................................5 3 Definitions ..............................................................................................................................................5 4 Product and process description ........................................................................................................6 4.1 Food products .......................................................................................................................................6 4.2 Packaging process................................................................................................................................6 5 Hygiene measures...............................................................................................................................10 5.1 Hygienic requirements of the packing department and the packing process..............................10 5.2 Performance of the gas supply to the packing machine.................................................................11 5.3 Packing machine requirements .........................................................................................................11 5.4 Conveyors with product contact .......................................................................................................14 6 Cleaning and decontamination ..........................................................................................................14 7 Monitoring and control .......................................................................................................................15 8 References ...........................................................................................................................................15 Appendix A........................................................................................................................................................16 Appendix B........................................................................................................................................................17 Appendix C........................................................................................................................................................18 Appendix D........................................................................................................................................................19


HYGIENIC DESIGN OF PACKING SYSTEMS FOR SOLID FOODSTUFFS *

©EHEDG

C. de Koning (1), P. Golz (2), L.A.M.J. Jetten (3), M.A. Mostert (4), E.J.C. Paardekooper (5)**, T. Slomp (6),

* Report prepared by the Subgroup Packing Machines of the European Hygienic Engineering & Design

Group (EHEDG), December 2004

** Chairman

(1) Convenience Food Systems, PO Box 1, 5750 AA Bakel , Netherlands

(2) VDMA, Lyonerstrasse 18, 60528 Frankfurth am Main, Germany

(3) TNO Chemistry, PO Box 342, 7300 AH Apeldoorn, Netherlands

(4) Unilever R&D Vlaardingen, PO Box 114, 3130 AC Vlaardingen, Netherlands

(5) Eikenlaan 8, 5271 RS St. Michielsgestel, Netherlands

(6) Multivac, Bahnhofstrasse 4, 87787 Wolfertschwenden, Germany

The production of EHEDG guidelines is supported by the European Commission under the Quality of Life Programme, project HYFOMA (QLK1-CT-2000-01359)


Introduction

Previous guidelines describe how packing machines should be designed to comply with hygienic and aseptic design criteria and thereby with the requirements specified in Annex 1 of the Machinery Directive 98/37/EC (Section 9. Ref.1). Guidelines on hygienic packaging of food products (Ref. 2), aseptic packaging of food products (Ref. 3) and challenge testing of machines for liquid and semi liquid products (Ref. 4) have been published.

This guideline discusses how to meet the general criteria for packing machines for solid foods. Initially criteria will be determined for the whole packing process, which includes: the packing machine, the accessories such as conveyors, the deposit and filler systems, the gas medium, the environment of the packing process, cleaning, and the operators in charge of handling ingredients and food products.

Final evaluation of the hygienic criteria for the whole packing line of solid foodstuffs is performed at the food processor’s site. In the food industry, the food manufacturer is responsible for meeting food safety and hygienic requirements of the product to be packed. The food processor must clearly specify these requirements for the whole packing line, the packing machine and accessories.

1 Objective and scope

This guideline is intended to provide recommendations, dealing with engineering, construction and installation aspects, for setting up packing systems for solid foodstuffs. The applicable food product categories are described and the unit operations used are explained. It identifies hygienic requirements of the packing department and the packing process, the performance of the gas supply to the packing machine, the packing machine itself and conveyors with product contact.

Not considered are the measures to be taken by the food processors themselves as these aspects are the responsibility of the processors and are strongly related to the specific demands determined by the type of foodstuff processed and packed.

2 Normative references

The following documents contain provisions that, through reference, constitute provisions of this guideline. At the time of publication, the editions listed below were valid. All documents are subject to revision, and parties are encouraged to investigate the possibility of applying the most recent editions of the documents mentioned.

EN 1672-2:1997 Food processing machinery – Basic concepts – Part 2: Hygienic Requirements

EN ISO 14159:2002 (E) Safety of machinery – Hygiene requirements for the design of machinery

EN ISO 12100-1:2003 Safety of machinery - Basic concepts, general principles for design - Part 1: Basic terminology, methodology (ISO 12100-1:2003)

EN ISO 12100-2:2003 Safety of machinery - Basic concepts, general principles for design - Part 2: Technical principles (ISO 12100-2:2003)

3 Definitions

The definitions in the EHEDG Glossary (see www.ehedg.org/glossary.pdf) apply to this guideline.


4 Product and process description

4.1 Food products

The products to be packed could be divided in four major groups: convenience products, ready meals, meal components and sliced products.

These products are the most critical solid foods and they are characterized by a water activity of more than 0.97, low acid, not pasteurised or sterilised after packaging, and distributed through the cool chain. Other relevant characteristics are pH, packaging conditions (modified atmosphere or vacuum), normal lifetime (shelf life from packaging to retail sales) and open shelf life (after opening the pack for consumption). Examples of products, which must be packed according to this guideline, are given in Table 1.

Table 1: Solid Food Products

Product# aw pH MA

fresh meat 0.98 – 1.00 5-6 vacuum, low O2

meat products 0.85 – 0.98 5-6 vacuum, low O2

sliced cheese 0.85 – 0.98 6-8 vacuum, low O2

fish 0.98 – 1.00 6-8 Mix of inert gasses

CO2, N2, CO

ready meals 0.98 – 1.00 5-8 CO2 and N2*

sandwiches >0.97 5-8 CO2 and N2*

salads 0.98 – 1.00 5-7 CO2 and N2*

cut vegetables 0.98 – 1.00 6-8 CO2 and N2*

fruit salads 0.98 – 1.00 6-8 CO2 and N2*

cheese 0.96 – 1.00 5-8 Vacuum or MAP

# All products must be transported, distributed and stored at cooled conditions. Depending on the product class the standard conditions are 0-3°C, 4°C or lower than 7°C.

* Sometimes CO or Argon are used.

4.2 Packaging process

The packaging process consists of the following steps:

a) Product positioning

The execution depends on the dimensions of the product and the need to orientate the product before loading. Very often guiding the product on a belt does this. For products that are more difficult to orientate a robot arm might be needed.

b) Product loading

Product loading can be executed in different ways and depends on the product to be loaded.


Option 1: Loading with conveyor

Figure 1: Loading with conveyor Option 2: Manual loading (see Appendix 1: Hygiene performance of operating staff).

Figure 2: Manual loading


Option 3: Loading by pick and place (using a robot)

Figure 3: Loading with robot

c) Tray and pouch feeding

Providing the tray or pouch (pre-made or formed in the machine)

d) Packaging

Option 1: Thermoforming and sealing

The trays are produced in the packaging machine by thermoforming of a film. The trays are supplied by a belt to a product assembly area for loading, followed by a sealing process.


Figure 4: Thermoforming process

1. Packaging material for the base web (thermo formable film) is unwound from the reel

2. The film is heated in the forming die and formed into pockets

3. The formed pockets are loaded with product 4, manually or automatically

4. Product

5. The top web of packaging material (id film) covers the filled pockets

6. The air is evacuated from the sealing die and protective gas is added if required. Then the pack is sealed by the application of heat and pressure

7. The web of packs is cut across the machine direction initially

8. Production of the individual packs is completed after the longitudinal cutting operation.

Option 2: Tray sealing

In case of a tray sealing packing machine, the trays are supplied by a belt to a product assembly area for loading, followed by a sealing process.

Option 3: Flow wrapping

In case of a flow wrapping packing machine, the product is supplied on a belt to a film-shaping device, which covers the product and then applies sealing in longitudinal direction, creating a tube. Then the tube is sealed in transversal direction and the packs are separated.

Option 4: Form fill seal

In case of a vertical form fill sealing packing machine, the product is dropped into a pre-formed vertical tube that is created by sealing a web in longitudinal direction. After landing in the tube the pack is sealed and separated.


Figure 5: Form fill seal

5 Hygiene measures

The following issues are covered:

⎯ The hygienic requirements of the packing department and the packing process

⎯ Critical areas for hygienic design of the packing system

⎯ Performance of the gas supply to the packing machine

⎯ Packing machine requirements

⎯ Conveyors with product contact

5.1 Hygienic requirements of the packing department and the packing process

The packing machine should be installed in an environment appropriate for the handling of hygiene sensitive products. General aspects to be considered are:

⎯ The packing machine should be placed such that it is uncluttered and free access is available around the machine.

⎯ Unless mounted such that dust and other foreign matter cannot enter, overhead utilities (lighting, piping and ducts) should be avoided.

⎯ Clearance under the machine must allow for adequate cleaning and inspection to be carried out effectively.

⎯ Machines should not be positioned over drains if, in doing so, access for inspection and cleaning of the drains is restricted.


⎯ Equipment should be adequately located in position and mounting pads or feet suitably sealed to the floor.

⎯ Services such as air, water, and electricity shall be connected in a manner ensuring that proper hygiene of the equipment and area will be maintained.

⎯ The exterior of non-product contact surfaces should be arranged to prevent harbouring of contamination in, and on, the equipment itself, as well as in contact areas with other equipment, floors, walls or hanging supports.

EHEDG provides guidelines on these issues. Consult www.ehedg.org for more information.

5.2 Performance of the gas supply to the packing machine

⎯ The gas to be introduced for MAP packaging of the solid food should be of High Grade Food Quality or hospital grade.

⎯ The connections of the gas supply installation to the packing machine should be clean and disinfected.

⎯ All compressed air used for blowing on the product or contact surfaces is filtered to a minimum of a 0.3 micron level and dried to prevent the formation of moisture in the piping system.

5.3 Packing machine requirements

Hygienic food processing equipment should be easy to maintain to ensure it will perform as expected to prevent microbiological problems. Therefore, the equipment must be easy to clean and protect the products from contamination and must prevent the ingress of micro-organisms.

Issues:

⎯ Indirect product contact zone areas will be considered as product contact zone areas.

⎯ The equipment shall be installed such that it will not cause contamination of the ingredients, raw foods and end products.

⎯ Separation between product contact and non-product contact areas prevents cross contamination during operations. Indirect product contact zone areas are designed as if they were product contact zone areas.

⎯ Product contact surfaces are made to prevent build-up of product residue during operations.

⎯ Separation between product contact areas and non-product contact areas has to be determined by a risk analysis. See Fig. 6 for an example of determined product contact areas in a thermoforming machine.


Fig. 6: Product contact surface areas

Red: surfaces with product contact Yellow: surfaces with no product contact

⎯ All parts of the equipment should be installed at a distance of at least 1 meter from walls, ceilings and adjacent equipment to be accessible for transport systems for ingredients and packaging material and for easy access of operating staff (for inspection, cleaning and disinfecting, maintenance and to solve breakdowns).

⎯ Surfaces with direct and indirect product contact are cleanable as measured by <1 CFU per 25 square centimetres, <1 CFU per 10 ml when the item is rinsed, acceptable RLU (device specific) when measured by residual ATP, and/or negative for residual protein or carbohydrate when using swabs to detect residual protein or carbohydrate (measured post installation).

⎯ Materials of construction for packing machines (Ref. 6)

⎯ Product contact surfaces and coatings: Surfaces of the machine parts that come in direct contact with high-risk ingredients must be made from non toxic materials and must have finishes which are impervious, non absorbing, washable, smooth and crack free to resist microbial settlement and to be easily cleaned and disinfected. (Note: surface defects on machined components are not acceptable). For detailed information on surfaces and geometry and surface finish / surface roughness, see Ref. 6.

⎯ Cleanability to a microbial level

⎯ Accessibility for inspection, maintenance and cleaning

⎯ Design of maintenance enclosures

⎯ Design of utilities and auxiliary equipment

⎯ Vacuum systems are considered as indirect product contact areas

⎯ Avoid niches and hollow areas (see Fig. 7)

⎯ Avoid product or liquid collection (see Fig. 8)

⎯ Hygienic operational performance (see Fig. 9)


Previous, non-hygienic design versus hygienic design

Figure 7: No niches

The AMI design guideline might be used to make these issues more clear (see Appendix 4; Principle 7).

Figure 8:

Product or liquid collection versus No product /liquid collection

An inclined plane, out of one piece


Figure 9:

Unhygienic versus Hygienic operational performance

5.4 Conveyors with product contact

Conveyor belts must be made from non toxic materials and must have finishes which are impervious, non absorbing, washable, smooth, crack free in order to resist microbial settlement and facilitate cleaning and disinfection. The quality of the surface finish must be such that, under the conditions of the food packing process, formation of bio-film cannot occur or is reduced to a minimum whereby the film can be removed. For more detailed information see Appendix 3.

All belting should be easily removable or the belt tension reduced easily without tools so that the surfaces underneath can be cleaned. Belt tension should be adequate throughout operations to prevent water pooling on belts.

6 Cleaning and decontamination

For details about cleaning and decontamination see Section 8. Ref. 2.

Some remarks:

⎯ Equipment, which is difficult to clean, need more stringent procedures. Effective cleaning products must be used and more attention must be paid to the cleaning operation, including visual checks afterwards.

⎯ Dismantled equipment parts as well as cleaning tools should be cleaned in a room that meets the requirements for safe handling of raw materials, intermediate and end products.

⎯ Cleaning of the process environment: all raw materials, products and packaging materials must be removed from the washing area prior to wet cleaning of equipment and the surroundings. If this is practically impossible, watertight coverings have to be provided in the area.


7 Monitoring and control

Protocols for hygiene monitoring and control of packing systems can only be defined once the system design meets the requirements of this guideline.

8 References

(1) Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery (Machinery Directive)

(2) EHEDG Document*) No.11, 1993. Hygienic packing of food products. Also as an extended abstract in Trends in Food Science and Technology (1993), 4(12):406-411.

(3) EHEDG Document*) No.3, 1993. Microbiologically safe aseptic packing of food products. Also as an extended abstract in Trends in Food Science and Technology (1993), 4(1):21-25.

(4) EHEDG Document*) No.21, 2000. Challenge tests for the evaluation of the hygienic characteristics of packing machines for liquid and semi liquid products. Also as an extended abstract in Trends in Food Science and Technology, (2001) 12(7):244-248

(5) Lelieveld, H.L.M., Hygienic design of factories and equipment in ‘The Microbiological Safety and Quality of Food 2’, Ed. B. Lund, T. Baird-Parket and G. Gould, 2000, p.1656-1690 (ISBN 0-8342-1323-0)

(6) EHEDG Document*) No.8, Third edition, 2004. Hygienic equipment design criteria.

(7) AMI, American Meat Institute, EDTF, January 2003, seminar 3; Design principles for the processing equipment (see also http://www.meatami.com )

(8) EHEDG Document*) No.13, Second edition, 2004. Hygienic design of open equipment for processing of food.

*) Order information for all EHEDG documents can be obtained from the website www.ehedg.org


Appendix A

HYGIENE PERFORMANCE OF OPERATING STAFF

Operators should be given instructions before commencing work. Such instructions should include the basics of personal hygiene, hygienic handling of foods, with emphasis on precautions necessary to prevent contamination of food.

Hands must be washed frequently and thoroughly using a suitable hand cleansing preparation and running, warm, potable water. Hands must be washed before entering a food handling area, immediately after using the toilet, and after handling any material which might be capable of transmitting disease. There must be adequate supervision to ensure that this is done.

The use of gloves for product safety purposes is of dubious benefit. Thorough and frequent hand washing has been shown to be just as effective provided that nails are well trimmed. In case of a cut or minor infection or any condition which might pose a threat to the product, effective covering of the hands is essential and gloves may be appropriate in these cases. It should be noted that the wearing of gloves does not reduce the need for frequent hand washing.

Operators should be supplied with a complete set of hygienically laundered protective coating or with disposable clothing for one-time use. This must be worn only for the intended purpose and must not be worn in other departments. Clothing must be changed at least daily. It is the company’s responsibility to provide clean clothing, which may be facilitated by using a laundry service. In the changing room there must be physical separation of work clothes and outdoor clothes. Every operator has to wear disposable hair and, if needed, beard protection.

There should be an area designed with suitable drainage for boot washing operations. CCFRA research* has shown that manual cleaning (preferably during the cleaning shift) and industrial washing machines are satisfactory boot washing methods.

Special items:

⎯ All entrances and exits are intrinsically hygienic with double door entries, including a system that does not allow two doors to be operated simultaneously.

⎯ Hand washbasins to service a single hand wash, must have automatic or knee/foot operated water supply. Water supplied should be at a suitable temperature and a waste extraction system piped directly to the drain.

⎯ Suitable hand drying equipment e.g. paper towel dispensers or hot air dryers and suitable towel disposal containers for paper towels must be provided.

⎯ Alcohol-based hand cleansing dispensers must be readily available in the high-risk packing area for use when contamination takes place or when gloves have to be changed.

* Taylor J.H. et al (2000), Hand and footwear hygiene: An investigation to define best practice, R&D Report No. 110, Campden & Chorleywood Food Research Association, UK


Appendix B

HEATING VENTILATION AND CONDITIONING

Requirements for room air are:

⎯ Complete air-conditioning (with room temperature at 12°C), operating at overpressure, with all air circulating through filters 5-25 Pascal, a complete volume change every hour. A pressure difference between high risk to lower care zones should be 5-15 Pascal or have an air velocity 1,5 m/sec or greater through openings. Supplied air should comply with the desired standard, typically final filtration F9 for room air and H11 for process equipment air.

⎯ During cleaning operations, the air used has to go directly to the exhaust and after cleaning operations ambient air has to be recycled to increase environmental drying as necessary. Air should have a Relative Humidity of 60-70 %.


Appendix C

BELTS

Belts in contact with food are used for conveying or inspection of product. Embedded reinforcements, as well as fabric backing materials, must be covered to avoid contact with the product (Figure 1). Cut edges of belts, which incorporate reinforcing materials, must be sealed to prevent penetration by wicking (capillary action) of liquids into the interior. The whole of the belt must be accessible for cleaning.

Figure 1: Reinforcement of belts. (1.1) Open edges of belts with reinforcement cause the hazards of crevices or

penetration (wicking) of liquids; (1.2) reinforcing materials must be covered at edges of belts.

The belt edges can be supported by removable and easily cleanable covers (see Figure 2).

Figure 2: Sides of conveyor belts. (2.1) Non removable bearing surfaces for belts and covers as well as hinges of pivoted covers cannot be cleaned easily; (2.2) a cover, which can be removed for cleaning, must be

preferred.


Appendix D

AMI CHECKLIST

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