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Trends in Food Science & Technology 12 (2001) 296–301

EHEDG Update

General hygienic
design criteria for  the eventuality of disassembly/accessibility for
cleaning and inspection

the safe processing  the moisture content of the product


 safety aspects including the formation of dust
and exposure to it
of dry particulate
Properties of dry materials relevant to handling
materials Dry materials or particulates in powder, agglomerate
or granulate form can be characterized in many ways.
Generally powders are defined as consisting of indivi-
dual particles, and sub-structures which have a diameter
smaller than 150 mm. Larger particulates are often
composed of many smaller particles and sub-structures
This article is an extended summary of the report pre- achieved spontaneously by the natural phenomena of
pared by: The Subgroup on Dry Materials Handling of the adhesion and electrostatic forces. With regard to micro-
European Hygienic Equipment Design Group (EHEDG). It is bial stability of dry products, when the water activity is
the xth in the series of EHEDG summaries published in below 60%, little to no microbial growth will occur.
TIFS. Copies of the full report (EHEDG Doc. 22 pre- Dry materials can be characterized by both their sin-
pared in March 2001) by J.L. Duffey, G. Hauser, H. gle particle and their bulk characteristics. Typical single
Hutten, K. Mager (Chairman) R.R. Maller, K. Masters, particle characteristics include: density, hardness,
G.M.H. Meesters, W. Rumpf and G. Schleining are moisture content, porosity, shape, size, softening point,
available from CCFRA at (pubs@campden.co.uk). Infor- and stickiness. Relevant bulk characteristics include:
mation about EHEDG can be found on the website at degree of aeration, resistance to attrition, bulk density,
www.ehedg.org # 2002 Published by Elsevier Science Ltd. dustiness, dust explosion class, flowability, glass transi-
tion temperature, moisture/volatile content, size dis-
Introduction tribution, solubility, electrostatic properties and
This is the first EHEDG document in which essential wettability. It should be emphasized that the bulk char-
requirements for powder handling processes are high- acteristics of industrial dry materials are at least as
lighted. The design of equipment, and methods to important as their single particle characteristics, and for
ensure the hygienic and safe processing of dry food each material and that the most important character-
materials are covered. Liquid to dry solid processes (like istics influencing materials handling will vary.
spray drying, fluid bed coating and agglomeration), and Flowability is an important characteristic for dry
wet solid to dry solid processes (like fluid bed drying material retention in equipment, and generally improves
and mixing) are included, but de-watering systems (e.g. with an increase in particle size and particle sphericity,
centrifuges, decanters and filters), which produce slur- and a decrease of moisture content, fines content, sur-
ries and wet cakes, are not. face stickiness and in neutralisation of surface energy/
Typical aspects of hygienic equipment design includ- charge.
ing cleaning of equipment, prevention of contamina-
tion, and microbial growth are considered. If wet Cleaning
cleaning is applied, the design criteria described in other The criteria for hygienic design of equipment and
documents also apply (EHEDG, 1993a, 1993c, 1996). If plants for dry materials handling depends upon the
dry cleaning is needed the procedures are described in moisture content of the dry material and the method of
this document. cleaning. The choice of cleaning procedure depends
The design criteria for handling dry materials must upon whether the plants or equipment to be cleaned is a
consider: designated dry or wet processing area or zone.
0924–2244/01/$ - see front matter # 2002 Published by Elsevier Science Ltd.
PII: S 0 92 4 - 2 24 4 ( 0 2 )0 0 00 3 - 1
EHEDG Update / Trends in Food Science & Technology 12 (2001) 296–301 297

The ability to clean equipment used in the processing  possible cross-contamination of dry material
of food material is essential to maintain standards of during a production change to another material
hygiene and dry material quality by: presents no problem to the quality of the dry
material subsequently produced
 preventing cross-contamination and/or co-min-  dry material remaining in the equipment does
gling of material during a production change to not present any risk of microbial growth occur-
another material ring due to the prevailing moisture content, tem-
 preventing degraded material arising from perature, and humidity conditions
deposits remaining in the equipment  dry material is non-hygroscopic, non-sticky
 preventing material remaining in the equipment
under conditions that would cause microbial
growth with possible contamination
Manual dry cleaning
Dry cleaning procedures should be focused on
What constitutes hygienically safe dry materials pro- removal of the main deposits and product-layers by a
cessing equipment depends upon the actual product and vacuum cleaner followed by brushing and/or scraping
equipment involved. Acceptable safety can range from the surfaces. Dust formation should be avoided as much
product contact surfaces being visibly free of any con- as possible. The deposits achieved by this method must
taminating source to surfaces requiring a high level of be carefully discharged or removed by a vacuum clea-
hygiene involving regular monitoring using appropriate ner. Cleaning with pressurized air should be avoided as
test methods. this creates dust clouds that can transfer contaminants
The frequency of cleaning depends upon the dry to other areas (and if used, the air should be of proces-
material and processing equipment involved. Equip- sing air quality and filtered).
ment should be cleaned at appropriate intervals to pre- Equipment suitable for manual dry cleaning must be
vent malfunction and dry material contamination that safely accessible. If equipment has to be dismantled to
would adversely affect both the quality of the dry gain access, dismantling must be possible without the
material produced and a safe equipment operation. use of special tools and lifting tackle.
Deposit formation increases the frequency of clean- The use of mechanical procedures (brushes, scrapers)
ing. results in the recovery of a secondary quality grade
material. Use of dense particles results in recovered mate-
Cleaning procedures rial mixed with the cleaning aid and therefore cannot be
Suitable cleaning procedures for dry food material used unless an economic and effective separation technique
processing plants include both dry and wet methods, is available or if the inert cleaning aid acts as an additive
and relate to the type of food material involved. For dry for the dry material mixture to have another end-use.
powders having a water-activity below 60%, microbial Hand-held cleaning equipment used on food material
growth possibilities can be rated as negligible, and dry contact surfaces:
cleaning methods are a possibility. For moist powders
microbial growth possibilities are high, especially in  must not be used for any other purpose or on
warm and humid conditions. Wet cleaning procedures any other material
are necessary and product contact surfaces of stainless  must be regularly cleaned and maintained
steel or equivalent are required. With oil and fat con-  must be clearly marked and stored in a clean and
taining (non-water related) sticky powders, possibilities dry location
exist for deposit formation on product contact surfaces
and dry material quality degradation through heat and/
or mechanical handling. Wet cleaning procedures are Damaged hand-held cleaning tools must not be used
necessary and product contact surfaces of stainless steel as there is a risk of broken parts remaining in the
or equivalent are required. equipment and passing to the dry material discharge area
during subsequent operation, with possibility of product
Dry cleaning contamination during the filling of bags or silos, etc.
Dry cleaning is applicable for dry food material con-
tact surfaces where: Semi-automatic dry cleaning
Acceptable procedures include the use of
 dry material remaining in the equipment as loose
layers or dust covering does not present any risk  in-place air jets and retractable nozzles that blow
of degrading the quality of the dry material sub- or sweep dry material off a contact surface into
sequently produced the product collecting area
298 EHEDG Update / Trends in Food Science & Technology 12 (2001) 296–301

 dense particles such as rice, crystal sugar and  brushes and containers of washing liquid (water/
plastic pellets conveyed as an abrasive medium detergent)
through ductwork handling dry material  water hoses
 vacuum cleaning

Hand-held cleaning equipment used on food material


Semi-automatic procedures also require availability of contact surfaces:
access points, inspection ports, and manholes for visual
inspection of surfaces after cleaning.  must be cleaned immediately after use and must
Use of air jet cleaning methods will result in the not be used for any other purpose or on another
recovery of dry material within the quality specification material.
as long as the surfaces being cleaned are not fouled with  must be regularly inspected for damage and must
degraded material and the air used is of processing air be maintained. However, damaged brushes must
quality and filtered. not be used, as there is a risk of further damage
occurring during use and broken parts remaining
Wet cleaning in the equipment which can pass to the dry
Wet cleaning can be carried out on dry food material material discharge area during subsequent plant
contact surfaces where: operation and contaminate dry material in bags
and silos, etc.
 dry material remaining in the equipment as  must be clearly marked and stored in a clean and
deposits or as light powder layers represents a dry location
real risk of degrading the quality of the dry
material subsequently produced
 any cross-contamination of dry material during a Semi-automatic wet cleaning
production change to another material cannot be A semi-automatic cleaning procedure, sometimes
permitted referred to as washing-in-place (WIP) is a wet cleaning
 dry material remaining in the equipment repre- procedure of fully or partially assembled equipment
sents a real risk of microbial growth occurring specifically designed for this purpose where visual
due to prevailing moisture content, temperature, inspection and approval of cleanliness of a washed sur-
and humidity conditions face is required before equipment can be operated.
 dry material is hygroscopic and/or has a low Semi-automatic cleaning systems involve use of
softening point that gives rise to deposit forma- washing nozzles placed or lowered into ductwork and/
tion on contact surfaces. or silos or vessels that require cleaning. These nozzles
can be in the form of fixed spray balls, nozzles or jets, or
rotating spray devices (liquid turbine driven). Each
Wet cleaning can be conducted manually, semi-auto- nozzle or jet sprays water, detergent or cleaning fluid
matically or automatically but is always followed with a over a given contact surface area, and the nozzles or
rapid drying out procedure. jets are located so that the entire dirty contact surface
is subjected to direct impingement by the cleaning
Manual wet cleaning spray.
The cleaning procedure will normally start by the Safe dismantling equipment is necessary in order to
removal of the main deposits by a dry cleaning proce- install a semi-automatic cleaning washing device and
dure. The product contact surfaces are then pre-soaked also to give access for inspection.
either by hot or cold water with or without detergent. Cleaning liquids are normally collected from drainage
Finally, the equipment is cleaned by means of bru- ports on equipment and recirculated within the cleaning
shes, scrapers or waterhoses. After removal of as much piping system. Separate holding tanks are used for
water as possible by draining, the equipment has to be washing water, detergents or special liquids (with wet-
immediately and thoroughly dried out by passing warm ting agents, emulsifiers, acids and alkalis) as required by
air through the equipment before production of dry the food material processing operation.
material can recommence. Rinsing with clean water completes the washing
Equipment suitable for manual wet cleaning must be operation. The whole cleaning sequence can be auto-
properly designed, accessible and be safe to do so. If matically controlled (computerized). Dirty cleaning
equipment has to be dismantled to gain access, dis- water and washing liquids are treated according to local
mantling must be possible without the use of special liquid effluent requirements.
tools or lifting tackle. After cleaning, draining, and inspection, all equip-
Acceptable procedures include use of hand-held: ment has to be immediately and thoroughly dried out
EHEDG Update / Trends in Food Science & Technology 12 (2001) 296–301 299

by passing warm air through the equipment before handling systems must be non-toxic, cleanable, and not
production of dry material can recommence. impart contaminating smell to the dry material. Non-
metallic surfaces can create electrostatic charges on the
Automatic wet cleaning material, which can be problematic.
Automatic cleaning-in-place (CIP) is a fully auto-
mated cleaning procedure for equipment specifically Hygienic design criteria
designed for this purpose where there is no need to dis- Dry materials handling must take into account the
mantle any parts of the equipment to locate cleaning noz- possibility for material lump formation, creation of dust
zles or to inspect surfaces for cleanliness after washing. explosion conditions, high moisture deposit formation
Automatic cleaning systems feature fixed mounted in the presence of hot air, and material remaining in the
cleaning devices/nozzles in vessels, ducts, silos, etc., equipment after plant shutdown (even if a degree of self-
interconnected with piping to recirculation pumps and emptying is achieved).
the cleaning liquid storage tanks, one each to hold the
various cleaning media used, i.e. water, detergents, Product contact surfaces
alkalis, etc. Product contact surfaces should be smooth and resis-
All valves in the piping system are remote controlled. tant against dry material contact and also against liquid
The duration of the sequence of the cleaning cycle is chemicals used in wet cleaning. Product contact surfaces
automatically controlled (computerized) and the clean- therefore should be free of crevices, pitting, pinholes
ing program is selected according to the type of plant and any hairline cracking that can cause material pene-
operation and material processed. Automatic drying out tration and cleaning difficulties. A roughness standard
of the equipment is also part of the cleaning sequence of Ra < 0.8 mm is recommended where there is a risk of
and the equipment must remain closed after the clean- microbial growth associated with high moisture content
ing operation. in the dry material or wet cleaning.
After cleaning and draining all the equipment has to In order to carry out a dry cleaning operation, contact
be immediately and thoroughly dried out by passing surfaces should be fully accessible for safe manual
warm air through the plant before production of dry cleaning and inspection. For a hygienic wet cleaning
material can recommence. Frequency of periodic vali- operation, contact surfaces should not be horizontal,
dation of the cleaning procedure depends upon the dry but have a slight slope to facilitate drainage of cleaning
food material being processed. solutions. The possibility for product contact on sharp
internal corners (r< 6 mm) and recesses, etc., where dry
Construction materials material can accumulate, should be avoided. Windows
Construction materials for equipment coming in con- and inspection ports mounted in product contact sur-
tact with food (including associated adhesives) must be faces should be flush with the surrounding surfaces to
food grade (FDA-approved or national equivalent). minimise dry material build-up. When using non-
Selection of construction material depends upon the metallic materials as contact surfaces, the porosity of
dry materials, method of cleaning and cleaning agents the materials should be investigated with regard to ease
to be used. of cleanability.

Metals Welding
Hygienic dry materials handling is best conducted Welds must be accomplished in a way that avoids
with product contact surfaces of stainless steel. Suitable susceptibility to accumulation of dry material and loca-
grades are SS 304, 304L (EN 1.4301/1.4306) and SS 316, lised corrosion. It is important to ensure that the
316L (EN 1.4401/1.4404). Aluminum and aluminum metallurgical properties of the weld material are as close
alloys (coated and non-coated) might also be used as as possible to the parent metal. General criteria for
dry material contact surfaces where only dry cleaning is welding are described in the EHEDG Doc 9 (EHEDG,
applied. 1993b) ‘‘Welding stainless steel to meet hygienic
requirements’’. Intermittent (spot) welding of dry pro-
Non-metals duct contact surfaces is in principle not acceptable.
Plastics (e.g Polycarbonate, PEEK, PVDF, PA and Normally, the surface roughness of welds does not
PTFE) and elastomers (e.g. NBR, Viton, Silicon, FEP- meet the recommended figure of Ra  0.8 mm. The
silicon) may be used, but contact should be limited cleanability of these parts in relation to the actual dry
where the dry material is abrasive. These materials must material being handled should be validated.
retain their original surface condition when exposed to
the processing and cleaning conditions. Static seals (gaskets) for duct and flange connections
Fabrics and non-metallic filter materials used in con- Static seals should be of an elastic material, have a
nection with the cleaning of air involved in dry materials non-porous surface and be cleanable. Static seals should
300 EHEDG Update / Trends in Food Science & Technology 12 (2001) 296–301

be clean before assembly and the possibility for pene- design is selected according to whether it is under pres-
tration of dry material into the gasket or seal during surized, vacuum or atmospheric, conditions, and the
equipment operation should be avoided. PTFE can be degree of acceptable leakage.
used as a static seal in combination with an elastomer Since liquid flushed seals normally present opera-
(food grade, FDA-approved or national equivalent). tional problems in dry materials handling processes, air
The PTFE should be of high-density resilient quality. purge seals are recommended to prevent dust entering
Metal-to-metal contact duct assemblies and paper-type the seal. The air purges also act to maintain the seal dry
gaskets between flanges can be applied where a plant during operation and assist in drying out the seal after
operates at atmospheric pressure and requires no wet equipment wet washing. Filtered air or nitrogen should
cleaning. be used to prevent product contamination by ingress of
Inflatable seals, e.g. for valves (Fig. 1) or around dirty air.
access doors and operable inspection ports should be Shaft entries that are sealed require extra attention in
used to prevent dry material build-up around the equipment handling of dry material. In principle, all
mounting frames. dynamic seals can leak, but leakage is minimized by
frequent and proper inspection, maintenance, and
Flexible connections cleaning. Since seals and their housings generate local
Flexible connections between duct ends are always areas where material can collect causing microbial
liable to cause dry material build-up between the flexible growth opportunities and a source of product con-
material and metal duct surface. Telescopic connections tamination, there should be ready access to seals for
should be avoided because of gaps at the duct ends (Fig. cleaning and inspection.
2) causing hygienic and operational risks. A build up of
material between the ducts cannot be avoided, but must Bearings
be minimized. No bearing should be in contact with dry material. If
A flexible plastic material avoiding any crevices must unavoidable, bearings can be protected by seals. It
seal the duct ends. Ring clamps for mounting flexible should always be evaluated whether air purging of
connections should be placed close to or right at the bearings during operation is required.
duct end to minimize dead areas for dry material build-
up. Hinges
Flexible connections must be easy to disconnect. Hinges should not be in contact with dry material.
Therefore the distance between the duct ends must be They should be placed only on the outside of equipment
large enough to accomplish ease of flexible connection and be accessible for easy cleaning and maintenance.
assembly and disassembly, and inspection of internal Continuous style piano hinges are not recommended.
conditions of the ducts. Inflatable seals can be used
where disconnecting is often necessary (e.g. for dis- Fasteners (screws, bolts, nuts)
charge or filling systems). Fasteners in contact with dry materials should be
avoided as much as possible. If this cannot be avoided,
Dynamic seals for shafts metal to metal contact is allowed, but only where no wet
Unsealed shafts in equipment contacting product are conditions occur during operation and cleaning. As
not recommended. Both lipseals and mechanical seals equipment dismantling for cleaning, inspection, and
can be used in dry materials handling. The actual seal maintenance involves loosening of nuts and bolts, ease

Fig. 1. Example of an inflatable seal of a butterfly valve for dry products.


EHEDG Update / Trends in Food Science & Technology 12 (2001) 296–301 301

Wiring and cabling


A potential risk of cabling is the contamination
caused by the collection of dirt and dust as well as
microbial growth. The following hygienic design criteria
are required:

 Cables should be located wherever possible in


designated utility/servicing areas
 The wiring and cabling should be located in
plastic or stainless steel pipes and prepared so
that dust and moisture cannot enter the pipes,
thus preventing the possible risk of creating con-
tamination conditions
 If used, cable trays should be of grid design and
Fig. 2. Telescope-like moveable connection between duct ends be accessible and easy to clean. Only one layer of
causing hygienic risks. cables is recommended and there must be space
between the cables. Vertical cable trays are pre-
ferred.
of removal is essential. Any potential thread seizure
through over-tightening must be prevented and there-
fore selection of the nut and bolt material is important. Powder tightness of equipment
Rivets should not be used for joining surfaces. Manual dry materials handling will always be a pos-
Hygienic design criteria for fasteners on equipment sible source of dust emission and also, when opening up
used in liquid processing (EHEDG, 1993c) also apply to equipment containing dry material. Therefore any areas
dry materials handling, and especially when dry materi- of manual dry materials handling and equipment access
als handling involves a wet cleaning procedure. should be fitted with local air extraction systems.
To prevent possible egress of dry material to the
External surfaces and insulation atmosphere, equipment handling dry materials should
Hygienic design criteria for external surfaces of be powder tight during operation and wherever possible
equipment are given in the EHEDG (1996) Doc. 13, operate under slight vacuum, although this does create
‘‘Hygienic design of equipment for open processing’’. the possibility for inward leakage of atmospheric air
It is recommended to avoid use of, wherever possible, into the equipment.
insulation material in order to prevent the possibility of
microbial growth or dust build up within the material. If Acknowledgements
for process, safety and/or environmental reasons, insu- The authors gratefully acknowledge the contributions
lation is needed, air insulation is the first recommended of members of the 3A Steering Committee. The produc-
option. Visual inspection of insulated surfaces should tion of EHEDG guidelines is supported by the European
still be possible to access build-up of dirt. If this is not Commission under the Quality of Life Programme, Project
possible, insulation materials like mineral wool or HYFOMA (QLK1-CT-2000–01359).
expanded polystyrene should be used. However, these
materials should be used with a full welded protected
external surface/cladding since these materials must not References
be allowed to get moist or wet.
For insulating against cold surfaces, insulation mate- EHEDG, 1993a. Document 8: Hygienic equipment design criteria
rials must be fully enclosed to prevent ingress of moist- EHEDG, 1993b. Document 9: Welding stainless steel to meet hygie-
ure. In cases where condensation may take place on dry nic requirements
EHEDG, 1993c. Document 10: Hygienic design of closed equipment
product contact surfaces due to creation of cold spots, for the processing of liquid food
equipment and silos located outside or in cool proces- EHEDG, 1996. Document 13: Hygienic design of equipment for open
sing areas require insulation. processing

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