Methods of producing and determining cleanability of parts for bioprocessing systems

An additively manufactured part for use in a bioprocessing system, wherein the additively manufactured part comprises a surface intended to be wetted in use, wherein the surface has one or more of the following areal roughness parameter values measured in accordance with ISO 25178-2:2022, wherein the one or more areal roughness parameter values are measured for the surface after filtering the surface to remove surface features having wavelengths below 2.5 pm and surface features having wavelengths above 11 pm:

• a mean dale area, Sda, of between 50 and 600 pm2;
• a mean hill area, Sha, of between 50 and 500 pm2;
• a density of peaks, Spd, of between 3000 mm−2 and 10000 mm−2;
• and a kurtosis, Sku, of between 6 and 20.

A method (230) of determining cleanability of a surface of a part for use in a bioprocessing system, the method comprising:

• manufacturing (210) the part,
• wherein the part comprises a surface that is intended to be wetted in use;
• and one or more of:
• measuring a mean dale area, Sda, of the surface after filtering the surface to remove surface features having wavelengths below 2.5 pm and surface features having wavelengths above 11 pm, and
• determining that the surface is cleanable if the mean dale area, Sda, of the surface is between 50 pm2 and 600 pm2;
• measuring a mean hill area, Sha, of the surface after filtering the surface to remove surface features having wavelengths below 2.5 pm and surface features having wavelengths above 11 pm, and
• determining that the surface is cleanable if the mean dale area, Sda, of the surface is between 50 pm2 and 500 pm2;
• measuring a density of peaks, Spd, of the surface after filtering the surface to remove surface features having wavelengths below 2.5 pm and surface features having wavelengths above 11 pm, and
• determining that the surface is cleanable if the density of peaks, Spd, of the surface is between 3000 mm′2 and 10000 mm′2;
• and measuring a kurtosis, Sku, of the surface after filtering the surface to remove surface features having wavelengths below 2.5 pm and surface features having wavelengths above 11 pm, and determining that the surface is cleanable if the kurtosis, Sku, of the surface is between 6 and 20.