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Material selection for moulded medical parts
Sterilisation method and fluid contact narrow the material choice faster than mechanical requirements do.
Start from the sterilisation method. Gamma, ethylene oxide and steam each rule out different polymers, and a material that is mechanically ideal but degrades under the customer's sterilisation route is not a candidate at all.
Then consider fluid contact and duration. A part that touches a blood sample for thirty seconds and a part that holds a drug solution for two years are different problems, and the second one brings extractables and leachables questions that the first does not.
Mechanical requirements usually come last, because by the time the first two constraints are applied the field is narrow. Where a customer's preferred material fails one of the first two tests, we say so at quotation rather than moulding it and letting validation find out.
Specifications
| Constraint one | Sterilisation method |
|---|---|
| Constraint two | Fluid contact and duration |
| Constraint three | Mechanical requirements |
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