US 12,367,256 B2
Methods for determining a limit of a tolerance interval, method for evaluating a production process and corresponding calculation device
Florian Knicker, Frankfurt am Main (DE); Christian Reuss, Frankfurt am Main (DE); Christian Weckbacher, Frankfurt am Main (DE); and Patric Ralph Stracke, Frankfurt am Main (DE)
Assigned to Sanofi, Paris (FR)
Appl. No. 17/612,319
Filed by Sanofi, Paris (FR)
PCT Filed May 25, 2020, PCT No. PCT/EP2020/064409
§ 371(c)(1), (2) Date Nov. 18, 2021,
PCT Pub. No. WO2020/239675, PCT Pub. Date Dec. 3, 2020.
Claims priority of application No. 19305653 (EP), filed on May 24, 2019.
Prior Publication US 2022/0244713 A1, Aug. 4, 2022
Int. Cl. G06F 17/18 (2006.01)
CPC G06F 17/18 (2013.01) [G05B 2219/32191 (2013.01)] 20 Claims
OG exemplary drawing
 
1. A method comprising:
providing a plurality of sample values, wherein the sample values fluctuate and define a sample value distribution, the sample values being values of a technical parameter related to sample items of a sample, wherein the sample items are parts of drug delivery devices, assemblies for drug delivery devices, or drug delivery devices, wherein the sample items are of the same construction, and wherein the technical parameter is limited by at least one technical limit value,
depending on the sample values, choosing a probability distribution function,
using the technical limit value to determine a cutoff value for the probability distribution function,
specifying a probability content for a tolerance interval, wherein a confidence level 1-α is used that specifies the probability that the tolerance interval that has to be estimated for the technical parameter will contain values of the technical parameters of at least a proportion of production items that is specified by the probability content,
wherein the value of 1-α is the confidence level, and
wherein α is the statistical significance, and
providing at least one limit of the tolerance interval for the technical parameter based on a transformed probability content, wherein said transformed probability content is based on the cutoff value and based on the specified probability content,
using the at least one limit of the tolerance interval to manufacture the drug delivery devices or the parts of drug delivery devices or the assemblies for drug delivery devices.