D)Time between use & cleaning: Cleaning procedures stipulate the maximum delay allowable between use of equipment & cleaning.
A worst case where the delay was more than the stipulated time has been carried out.
Managing allergen changeover in food production facilities can be exceptionally challenging, especially when different allergens are handled on the same line or piece of equipment.
Every cleaning procedure was reviewed for parameter such as unambiguous definition of cleaning location & equipment,instructions to disassemble & reassemble,ancilliary item cleaning,concentration of cleaning agent,no.
of consecutive lots mfd without cleaning,maximim time between equipment use & cleaning,definition of Key parameters such as water quality,temperature,duration, Temperature,no of rinse cycles(Min & Max), Drying(if required)etc The references of the relevant SOPs are already addressed in Table ----(above) 8.
The operators have been traine din the cleaning operations and records are maintained in---------- 14.
Analytical Test Methods: The Analytical Test Methods have been validated and are detailed in --------.
More than one can be chosen If detergent or cleaning agent is used,residue studies shoul be conducted and should be used as an additional marker substance. Selection of Worst Case-Justification-Worst case contaminant(active)-----give name ---Because it is slightly soluble in water -Worst case recipient product---------Because of its lowest batch size Worst case Equipment----------Mfg vessel,filling pump(FBD bags are product dedicated(for tabs) hence such parts are not critical while validating a cleaning procedure and acceptance criteria for such parts will be “ visually clean,dry & colourless” 11.
Sampling Methods: The following methods have been used: a)Visual inspection b)Direct Surface Swabbing c)Rinse solution analysis The first one is a must.
Equipment List: Following is a list of the Equipments covered under this exercise: GIVE TABLE----(See sample Document at the end of this post).
The relevant shadings to be given for each product manufacture along with key at the end of the table 7.
E0Cleaning only after campaigns: In the cleanong procedure the max no.
of batches comprising a campaign & maximum delay allowable comprising a campaign & cleaning operations is defined.
Hence the Wash Rinse Duration & Volume/Flow rates which are below the procedural rates have been studied.