This indicator illustrates the cleaning effect of dishwashers
for contaminated surgical instruments in the simplest possible form.
Mythentec acts as a system-supplier and can guarantee the complete batch traceability.
INITIAL SITUATION
As the customer wished to eliminate critical, design-related problems with standard indicators and to introduce its own improved product, they commissioned Mythentec to develop a functional indicator optimised in terms of its informative value. Prerequisite was the product’s compliance with the EN ISO 15883 standard for washer-disinfectors.
DEVELOPMENT
Work at Mythentec ranged from development of an optimised design right through to series production, resulting in a solution that achieves clear, unequivocal information on cleaning quality. Mythentec presented a complete concept in less than 60 development hours, which encompassed a technical specification, 3D design, material selection and prototypes. All other suppliers (e.g. for punched parts or packaging) were evaluated and commissioned by Mythentec.
INJECTION MOULDING
The transparent cover plate was manufactured in a 4-cavity mould using medical grade polycarbonate. The moulding has four snap fasteners and flights that define the four chamber heights of the indicator ranging from 0.75 to 2 mm. Regular component inspection is realised through IPC (in-process control), with the central master computer system continually archiving actual parameters.
FURTHER PROCESSING
Mythentec supplies the unit ready for sale and, because of the direct procurement
of all purchased parts, is the central contact for the customer. Each manufacturing step is carried out on the company’s site and must meet enhanced hygienic requirements. Sheep blood is applied to the carrier plates in a machine prior to the assembly of the plastic components. The finished indicators are individually packaged, sealed air-tight and placed in sales boxes. The exact batches involved in all packaging units can be traced accurately through the labels.
