Industrialisation of a health care oxygenator

Industrialisation of a health care oxygenator

In the biomedical market attentionto quality and research for competitiveness are equally important: these two aspects heve been the guidelines for the of 40 components of a oxygenator.

Target:  

  •  Industrialisation of 40 different components focused on most effective us of the available injection machines.
  •  Validate product and process by Meccanica Genarele.
  • Very short leadtime

Activity:

  • Product optimisation (mouldability, criticity elimination).
  • Analysis of alternative production scenarios.
  • Mould manufacturei.
  • Product ena process validation.

Product and process optimisation

The high precision in terms of geometry and dimensional stability is a key factor in such a delicate market as the health care one.

To manage in advance on the part geometry and to widen the processing window and teherefore make the process more reliable has been a key aspect for the project success.

The need of the costumer is to produce 400.000 oxygenators per year, each one composed by 40 different PC parts to be produced with injection machines ranging from 60 to 350 ton.

The MG group has analysed from a technical and economical point of view different alternative mould configurations (multi-cavity and stack moulds), finally choosing the one most suitable for the injection machines available.

After the decision about injection moulds configuration, the focus was addressed to quality of machining and mechanism.

 

Product and process validation

  •  Cp,Cpk required
  •  SPC dimensions
  •  validation according to GMP (IQ,OQ,PQ)
  • Mould test through the Factory Acceptance Test (FAT) :
  • functional test
  • parameters set-up starting from MoldFlow inputs
  • long run wide sampling for long term capability evaluation recording process data through cavity pressure sensors
  •  moulding window investigation defining three moulding parameters settings (A,B,C)

 

 

Accuracy and speed

Even with the highest attention paid on each single step of the project, the possibility for the costumer to have Meccanica Generale as a single partner allowed to finished the project in only 15 months from start to SOP.

 

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