14.2 Requirements for hygienic design
Cleaning efficiencyis determinedby the necessary operational timeand the
required personnel.In orderto reducethe losseson operationaltimedue to
cleaning, the equipment needsto be designedfor easyaccessibility and easy-to-
use cleaning methods. In case of cleaningby hand,the reliability of the cleaning
resultis determined by the skillsof the personnelin following the cleaning
procedures and the available meansand cleaning materials.The designof the
equipment is of majorimportanceto the end result.
In the caseof closedequipmentoftencleaning-in-place(CIP)methodsare
applied. For openequipmentthese are moredifficult to applyand a combination
of cleaning by handwithpartialdismantlingis oftenapplied.
14.3 Applicationof ISO 14159..
14.3.1 Step1: Definition of the limitsof the machine
Define the intended use of the equipmentby specifying the following:
∑ Functional requirements± (i) capacity,(ii) processing conditionsand (iii)
product to be produced by the equipment.
∑ Safetyrequirements± (i) foodsafety, specifically for the product producedby
the machinery, and (ii) operator safety,specificallyfor the type of equipment.
∑ Operational requirements± (i) installation,(ii) operation,(iii) cleaning and
(iv) maintenance.
14.3.2 Step2: Hazards
Basedon the conditionsas specified in step 1, an overview is madeof potential
microbiological, physical and chemical hazards that are apparent in the
packagingprocess.Table14.1shows a typicallist.
14.3.3 Step3: Riskanalysison identifiedhazards
A quantificationof the riskscan be madeby findinga risk prioritynumber. This
is the multiple of Frequency (F) x Exposure (E) x Severity(S) of the hazardas
definedin Tables14.2,14.3and 14.4. A limitneedsto be defined:an arbitrary
valueof 60 is chosen in Table14.5.This value needsto be validated in practice.
Withthe quantificationas statedabove,the workflowshown in Fig. 14.1can
be applied duringthe design process. In this way the designercan keeptrack of
the decision process,whichneedsto be documented for eachstep.The decisions
will be documented in the constructiondossier. In this way designdecisionson
occupationaland foodsafetyissues are recorded. It is particularlyuseful for
evaluating newapplicationson existingequipment.
Aftera design decision the risk priority number can be recalculated and
documented withthe identifiedhazard(Fig.14.2).
Improving the hygienicdesignof packagingequipment 229