Turbidos. Design Verification. Contents

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1 Design Verification Turbidos Contents 1 adjustment Target value determination Stability Accelerated stress data Open vial stability Real Time Stability Result documentation Traceability... 9 Form: /9 valid of

2 1 adjustment The liquid raw material is tested by the quality control for the content of each individual parameter. If necessary, respective parameters are spiked or stripped to meet the specification for normal, elevated or pathological range. Imprecision 2 Target value determination The target value determination of HUMAN s control sera Turbidos is performed by own QC laboratories. The assigned target values for each parameter reflect the consensus value, obtained by statistical evaluation of the results of all participating laboratories. 3 Stability The shelf life of Turbidos has been confirmed by the results of real-time studies. Each lot of control serum is checked by temperature stress studies at the time of production. Retained samples of each batch are further tested at suitable intervals in order to monitor real-time stability during the assigned shelf life. Turbidos has an assigned shelf life of 2 years from the date of production. Data have been established during the design development and are secured by stress tests on each production batch. In parallel, each lot will be retested at the end of the expiration date to verify the stability. 3.1 Accelerated stress data Pilot batches have been subjected to accelerated stress studies. A typical data set is provided below. Turbidos Level 1 Level 2 fresh 5 41 C Dev. % fresh 5 41 C Dev. % Unit Albumin mg/dl Alpa-1-acid glycoprotein mg/dl antitrypsin mg/dl Alpha-2-macroglobulin mg/dl Antistreptolysin (ASO) IU/l Apolipoprotein A mg/dl Apolipoprotein B mg/dl Beta-2-microglobulin mg/l C3 Complement mg/dl C4 Complement mg/dl Ceruloplasmin mg/dl (CRP) mg/dl Haptoglobulin mg/dl IgA mg/dl IgE IU/ml IgG mg/dl IgM mg/dl Kappa Light Chain mg/dl Lambda Light Chain mg/dl Prealbumin mg/dl Rheumatoid Factors (RF) IU/ml Total Protein mg/dl Transferrin mg/dl Predicted product stability: From the above results of accelerated stress testing no degradation could be observed. Assuming an activation energy of 25,000 calories per mol, from the Arrhennius equation at least months stability at C can be predicted. Design Verification and Product Data for TURBIDOS 2/9

3 3.2 Open vial stability The stability after opening has been checked at storage conditions C. The data are summarised below (units and parameters follow the above scheme). Turbidos Level 1 Level 2 fresh C Dev. % fresh C Dev. % Unit Albumin mg/dl Alpa-1-acid glycoprotein mg/dl antitrypsin mg/dl Alpha-2-macroglobulin mg/dl Antistreptolysin (ASO) IU/l Antithrombin III mg/dl Apolipoprotein A mg/dl Apolipoprotein B mg/dl Beta-2-microglobulin mg/l C3 Complement mg/dl C4 Complement mg/dl Ceruloplasmin mg/dl (CRP) mg/dl Haptoglobulin mg/dl IgA mg/dl IgE IU/ml IgG mg/dl IgM mg/dl Kappa Light Chain mg/dl Lambda Light Chain mg/dl Prealbumin mg/dl Rheumatoid Factor (RF) IU/ml Total Protein mg/dl Transferrin mg/dl Conclusion: The claimed stability of 30 days after opening, stored at C, is confirmed Design Verification and Product Data for TURBIDOS 3/9

4 3.3 Real Time Stability The real time stability was confirmed with three independent lots. Lot IM0704 Level 1 Level 2 after after Acidglycoprotein mg/dl Antitrypsin mg/dl Alph-2-Macroglobulin mg/dl (ASO) IU/ml Antithrombin III (AT3) mg/dl Beta-2-Microglobulin mg/l Ceruloplasmin (CER) mg/dl Complement C3 (C3) mg/dl Complement C4 (C4) mg/dl mg/dl (hscrp) mg/dl Haptoglobin (HPT) mg/dl IgA mg/dl IgG mg/dl IgM mg/dl Kappa Light Chain mg/dl Lambda Light Chain mg/dl Prealbumin mg/dl Properdin Factor B (PFB) mg/dl <.0 Xxx Rhematoid Factor (RF) IU/ml Transferrin (TRF) mg/dl IgE IU/ml Albumin g/dl Total Protein g/dl Design Verification and Product Data for TURBIDOS 4/9

5 Lot IM0704 Level 3 after Acidglycoprotein mg/dl Antitrypsin mg/dl Alph-2-Macroglobulin mg/dl (ASO) IU/ml Antithrombin III (AT3) mg/dl Beta-2-Microglobulin mg/l Complement C3 (C3) mg/dl Complement C4 (C4) mg/dl Ceruloplasmin (CER) mg/dl mg/dl (hscrp) mg/dl Ferritin ng/ml Haptoglobin (HPT) mg/dl IgA mg/dl IgG mg/dl IgM mg/dl Kappa Light Chain mg/dl Lambda Light Chain mg/dl Prealbumin mg/dl Properdin Factor B (PFB) mg/dl Rhematoid Factor (RF) IU/ml Transferrin (TRF) mg/dl IgE IU/ml Albumin g/dl Total Protein g/dl Design Verification and Product Data for TURBIDOS 5/9

6 Lot IM0910 Level 1 Level 2 after after Acidglycoprotein mg/dl Antitrypsin mg/dl Alph-2-Macroglobulin mg/dl (ASO) IU/ml Antithrombin III (AT3) mg/dl Beta-2-Microglobulin mg/l Complement C3 (C3) mg/dl Complement C4 (C4) mg/dl Ceruloplasmin (CER) mg/dl mg/dl (hscrp) mg/dl Ferritin ng/ml Haptoglobin (HPT) mg/dl IgA mg/dl IgG mg/dl IgM mg/dl Kappa Light Chain mg/dl Lambda Light Chain mg/dl Prealbumin mg/dl Properdin Factor B (PFB) mg/dl Rhematoid Factor (RF) IU/ml Transferrin (TRF) mg/dl IgE IU/ml Albumin g/dl Total Protein g/dl Design Verification and Product Data for TURBIDOS 6/9

7 Lot IM0910 Level 3 after Acidglycoprotein mg/dl Antitrypsin mg/dl Alph-2-Macroglobulin mg/dl (ASO) IU/ml Antithrombin III (AT3) mg/dl Beta-2-Microglobulin mg/l Complement C3 (C3) mg/dl Complement C4 (C4) mg/dl Ceruloplasmin (CER) mg/dl mg/dl (hscrp) mg/dl Ferritin ng/ml Haptoglobin (HPT) mg/dl IgA mg/dl IgG mg/dl IgM mg/dl Kappa Light Chain mg/dl Lambda Light Chain mg/dl Prealbumin mg/dl Properdin Factor B (PFB) mg/dl Rhematoid Factor (RF) IU/ml Transferrin (TRF) mg/dl IgE IU/ml Albumin g/dl Total Protein g/dl Design Verification and Product Data for TURBIDOS 7/9

8 Lot IM0904 Level 1 Level 2 after after Acidglycoprotein mg/dl Antitrypsin mg/dl Alph-2-Macroglobulin mg/dl (ASO) IU/ml Antithrombin III (AT3) mg/dl Beta-2-Microglobulin mg/l Ceruloplasmin (CER) mg/dl Complement C3 (C3) mg/dl Complement C4 (C4) mg/dl mg/dl (hscrp) mg/dl Ferritin ng/ml Haptoglobin (HPT) mg/dl IgA mg/dl IgG mg/dl IgM mg/dl Kappa Light Chain mg/dl Lambda Light Chain mg/dl Prealbumin mg/dl Properdin Factor B (PFB) mg/dl Rhematoid Factor (RF) IU/ml Transferrin (TRF) mg/dl IgE IU/ml Albumin g/dl Total Protein g/dl Design Verification and Product Data for TURBIDOS 8/9

9 Lot IM0904 Level 3 after Acidglycoprotein mg/dl Antitrypsin mg/dl Alph-2-Macroglobulin mg/dl (ASO) IU/ml Antithrombin III (AT3) mg/dl Beta-2-Microglobulin mg/l Ceruloplasmin (CER) mg/dl Complement C3 (C3) mg/dl Complement C4 (C4) mg/dl mg/dl (hscrp) mg/dl Ferritin ng/ml Haptoglobin (HPT) mg/dl IgA mg/dl IgG mg/dl IgM mg/dl Kappa Light Chain mg/dl Lambda Light Chain mg/dl Prealbumin mg/dl Properdin Factor B (PFB) mg/dl Rhematoid Factor (RF) IU/ml Transferrin (TRF) mg/dl IgE IU/ml Albumin g/dl Total Protein g/dl Any value outside of above target ranges is acceptable provided it is within the linearity of the specified method and differs by more than 30% from the other levels. Conclusion: The data confirm a 2 year stability of Turbidos 4 Result documentation For each batch of Turbidos quality control sera a leaflet is created which contains information on handling, stability, target values and permitted ranges for all specified parameters. 5 Traceability The assigned target values of Turbidos quality control sera are traceable to reference methods (i.e. IFCC) or reference materials (i.e. NIST), if applicable. Design Verification and Product Data for TURBIDOS 9/9

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