scholarly journals Application of Design of Experiments (DOE) to the Development and Validation of a Swab Sampling Method for Cleaning Validation

2017 ◽  
Vol 2 (1) ◽  
pp. 16
Author(s):  
Pilar Rodríguez-Loaiza ◽  
Salvador Namur ◽  
Mario González-de la Parra
Keyword(s):  
Factorial Design ◽  
Sampling Method ◽  
Sampling Methods ◽  
Active Pharmaceutical Ingredient ◽  
Fractional Factorial ◽  
Surface Sampling ◽  
Cleaning Validation ◽  
The Subject ◽  
Development And Validation ◽  
Full Factorial

Cleaning validation is one of the key elements of the validation program of an active pharmaceutical ingredient (API) manufacturer. One of the most important aspects of cleaning validation is the sampling methods. Swabbing or surface sampling is the subject of this article. The application of sequential experimental designs for the efficient development of a swab sampling method, based on a fractional factorial design followed by full factorial design, is illustrated in this article.

Characterization of a Solid Oxide Fuel Cell Gas Turbine Hybrid System Based on a Factorial Design of Experiments Using Hardware Simulation

2011 ◽  
Author(s):  
Bernardo Restrepo ◽  
Larry E. Banta ◽  
David Tucker
Keyword(s):  
Fuel Cell ◽  
Design Of Experiments ◽  
Solid Oxide Fuel Cell ◽  
Factorial Design ◽  
Gas Turbine ◽  
Fractional Factorial Design ◽  
Solid Oxide ◽  
Fractional Factorial ◽  
Oxide Fuel ◽  
Full Factorial

A full factorial experimental design and a replicated fractional factorial design were carried out using the Hybrid Performance (HyPer) project facility installed at the National Energy Technology Laboratory (NETL), U.S. Department of Energy to simulate gasifer/fuel cell/turbine hybrid power systems. The HyPer facility uses hardware in the loop (HIL) technology that couples a modified recuperated gas turbine cycle with hardware driven by a solid oxide fuel cell model. A 34 full factorial design (FFD) was selected to study the effects of four factors: cold-air, hot-air, bleed-air bypass valves, and the electric load on different parameters such as cathode and turbine inlet temperatures, pressure and mass flow. The results obtained, compared with former results where the experiments were made using one-factor-at-a-time (OFAT), show that no strong interactions between the factors are present in the different parameters of the system. This work also presents a fractional factorial design (ffd) 34-2 in order to analyze replication of the experiments. In addition, a new envelope is described based on the results of the design of experiments (DoE), compared with OFAT experiments, and analyzed in an off-design integrated fuel cell/gas turbine framework. This paper describes the methodology, strategy, and results of these experiments that bring new knowledge concerning the operating state space for this kind of power generation system.

Application of the Taguchi method to the design of a robot sensor

Robotica ◽  
1995 ◽  
Vol 13 (6) ◽  
pp. 607-617 ◽  
Author(s):  
H. Rowlands ◽  
D. T. Pham
Keyword(s):  
Experimental Design ◽  
Taguchi Method ◽  
Factorial Design ◽  
Optimum Design ◽  
Fractional Factorial ◽  
Experimental Techniques ◽  
Factorial Designs ◽  
Design Technique ◽  
Systematic Method ◽  
Full Factorial

SummaryThis paper considers the use of the Taguchi method as a means to identify the optimum design of a robot sensor. The sensor is modelled by a complex set of equations which makes optimisation using traditional calculusbased methods difficult. The Taguchi method is employed as a systematic method to understand the performance of the sensor whilst using a limited number of model evaluations. The Taguchi method is based on the experimental design technique and the results of using a full factorial design, 1/2 and 1/4 fractional factorial designs are compared. The advantage of using the Taguchi method over traditional experimental techniques is also discussed.

scholarly journals Assessment of Fractional Factorial Design for the Selection andScreening of Appropriate Components of a Self-nanoemulsifyingDrug Delivery System Formulation

2019 ◽  
Vol 9 (4) ◽  
pp. 609-618 ◽  
Author(s):  
Ilham Kuncahyo ◽  
Syaiful Choiri ◽  
Achmad Fudholi ◽  
Ronny Martien ◽  
Abdul Rohman
Keyword(s):  
Particle Size ◽  
Factorial Design ◽  
Delivery System ◽  
Tween 80 ◽  
Fractional Factorial ◽  
Drug Bioavailability ◽  
Main Effects ◽  
Full Factorial ◽  
Adequate Design ◽  
Selection Of

Purpose: Recently, a self-nanoemulsifying drug delivery system (SNEDDS) has showngreat improvement in the enhancement of drug bioavailability. The selection of appropriatecompositions in the SNEDDS formulation is the fundamental step towards developing asuccessful formulation. This study sought to evaluate the effectiveness of fractional factorialdesign (FFD) in the selection and screening of a SNEDDS composition. Furthermore, the mostefficient FFD approach would be applied to the selection of SNEDDS components.Methods: The types of oil, surfactant, co-surfactant, and their concentrations were selected asfactors. 26 full factorial design (FD) (64 runs), 26-1 FFD (32 runs), 26-2 FFD (16 runs), and 26-3 FFD(8 runs) were compared to the main effect contributions of each design. Ca-pitavastatin (Ca-PVT)was used as a drug model. Screening parameters, such as transmittance, emulsification time,and drug load, were selected as responses followed by particle size along with zeta potentialfor optimized formulation.Results: The results indicated that the patterns of 26 full FD and 26-1 for both main effects andinteractions were similar. 26-3 FFD lacked adequate precision when used for screening owing tothe limitation of design points. In addition, capryol, Tween 80, and transcutol P were selected tobe developed in a SNEDDS formulation with a particle size of 69.7 ± 5.3 nm along with a zetapotential of 33.4 ± 2.1 mV.Conclusion: Herein, 26-2 FFD was chosen as the most efficient and adequate design for theselection and screening of SNEDDS composition. The optimized formulation fulfilled therequirement of a quality target profile of a nanoemulsion.<br />

scholarly journals Full factorial design for optimization, development and validation of HPLC method to determine valsartan in nanoparticles

2015 ◽  
Vol 23 (5) ◽  
pp. 549-555 ◽  
Author(s):  
Lalit Kumar ◽  
M. Sreenivasa Reddy ◽  
Renuka S. Managuli ◽  
Girish Pai K.
Keyword(s):  
Factorial Design ◽  
Hplc Method ◽  
Full Factorial Design ◽  
Development And Validation ◽  
Full Factorial

scholarly journals DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF ARIPIPRAZOLE IN SWAB SAMPLES ON PHARMACEUTICAL MANUFACTURING EQUIPMENT SURFACES FOR CLEANING VALIDATION

2017 ◽  
Vol 9 (5) ◽  
pp. 141
Author(s):  
Sukhpreet Kaur ◽  
Indu Bala ◽  
Anjoo Kamboj
Keyword(s):  
Analytical Method ◽  
Sampling Method ◽  
Pharmaceutical Manufacturing ◽  
Manufacturing Equipment ◽  
Cleaning Procedure ◽  
Cleaning Validation ◽  
Production Area ◽  
Development And Validation ◽  
Validation Of Analytical Method

Objective: To validate simple analytical method and its application in the determination of residual aripiprazole in production area equipment and to confirm the efficiency of cleaning procedure.Methods: The swab sampling and UV method for residual estimation of aripiprazole in swab samples from equipment surfaces after manufacturing of three consecutive batches of aripiprazole 10 mg uncoated tablets were developed and validated.Results: The swab sampling method was developed and validated in order to obtain the suitable recovery (>90%). The swabs were saturated with acetonitrile. The UV method was developed using UV-Vis spectrophotometer at 255 nm. The calibration curve was linear (r2 =1.0000) over a concentration range of 1-30 µg/ml. The LOD and LOQ were 0.43 µg/ml and 1.32µg/ml, respectively. No interference from swab solution was observed and samples were stable for 24h. The determined concentration varying from 1.00-5.687µg/swab was well below the calculated limit of contamination i.e., 24.2µg/swab or 24.2 µg/25 cm2.Conclusion: The results obtained from cleaning procedure confirmed that the proposed procedure was able to remove aripiprazole from equipment surfaces below the value of 10 ppm criteria. So the proposed validated UV method with appropriate swab wipe procedure could be applicable for cleaning validation on residues of aripiprazole.

scholarly journals Efficient Adaptive Sampling Methods Based on Deviation Analysis of Piecewise Cubic Spline Interpolation

2021 ◽  
Author(s):  
Xi Cheng ◽  
long zeng ◽  
Haoyu Jiang ◽  
Xueping Liu
Keyword(s):  
Adaptive Sampling ◽  
Sampling Method ◽  
Sampling Methods ◽  
Spline Interpolation ◽  
Sampling Strategy ◽  
Reconstruction Error ◽  
Maximum Deviation ◽  
Surface Sampling ◽  
Cubic Spline Interpolation ◽  
Deviation Analysis

Abstract The on-machine inspection technique requires a certain manufacturing time, so it is important for a sampling approach to achieve high precision for a fixed number of inspection points. This study designs an efficient adaptive sampling method for the non-uniform rational basis spline (NURBS) curves and surfaces based on deviation analysis. For the free-form curves, it is an iterative method that is used to remove points that are less significant to the reconstruction error from the dense points on the curve. That is, the points are ranked by their maximum deviation from the theoretical curves. Different from the existing methods, a closed-form is derived to approximate the maximum deviation by analyzing the curve reconstruction method, i.e., piecewise cubic spline interpolation. The proposed method is compared with recent curve sampling methods, and the comparison results have shown that, under the same number of inspection points, the reconstruction error of the proposed method is reduced by 82%. The proposed curve sampling algorithm is then further extended to surface sampling, where the global characteristics of a surface are extracted as a series of curves on the surface. Thus, surface sampling is simplified to curve sampling in two directions. The proposed surface sampling strategy is compared with classic surface sampling methods using three representative surfaces. The results show that by using the proposed surface sampling strategy, the reconstruction error is reduced significantly. By applying our sampling method to the on-machine inspection system, the inspection accuracy can be greatly improved.

Development and validation of LC-MS and NMR methods for the qualitative and quantitative determination of carotenoids in food and byproducts

2019 ◽  
Author(s):  
Θάλεια Τσιάκα
Keyword(s):  
Quantitative Determination ◽  
Factorial Design ◽  
2D Nmr ◽  
Full Factorial Design ◽  
Box Behnken Design ◽  
Qualitative And Quantitative ◽  
Nmr Methods ◽  
Development And Validation ◽  
Full Factorial

Τα τελευταία χρόνια, οι νέες καταναλωτικές συνήθειες έδωσαν ώθηση στην αγοράφυσικών προϊόντων με ευεργετικές ιδιότητες. Επιπρόσθετα, η αύξηση των φυσικώνπαραπροϊόντων καθιστά ως επιτακτική ανάγκη την αξιοποίησή τους μέσω τηςπαραλαβής βιοδραστικών ενώσεων από αυτά. Στην παρούσα διατριβή, μελετήθηκε ηανάκτηση καροτενοειδών από παραπροϊόντα φυτικής (βερίκοκα) ή ζωϊκής (κεφάλιγαρίδας) προέλευσης και από λιπιδικά τρόφιμα (κρόκος αυγών και σώμα γαρίδας)εφαρμόζοντας μια συνδυαστική αναλυτική προσέγγιση που περιλαμβάνει (α) εκχυλίσειςυψηλών ενεργειών με χρήση συμβατικών και καινοτόμων πράσινων διαλυτών (φυσικοίβαθιά ευτηκτικοί διαλύτες, NADES) και πειραματικού σχεδιασμού (DOΕ) (β)υγροχρωματογραφία συζευγμένη με φασματομετρία μάζας (LC-MS/MS) καιφασματοσκοπία πυρηνικού μαγνητικού συντονισμού (NMR) και (γ) μοντέλωνπολυμεταβλητής στατιστικής ανάλυσης. Πιο συγκεκριμένα, εφαρμόστηκε εκχύλιση μευπερήχους (UAE) και με μικροκύματα (ΜΑΕ) για την παραλάβη καροτενοειδών από ταμελετούμενα υποστρώματα. Οι συνθήκες εκχύλισης βελτιστοποιήθηκαν με δυοδιαφορετικά DOE μοντέλα (23 full factorial design, Box-Behnken design). Η LC-MS/MSποσοτικοποίηση των καροτενοειδών υπέδειξε την καταλληλότερη μεθόδο εκχύλισης γιακάθε υπόστρωμα. Τα φάσματα NMR (1D-, 2D-NMR) ανέδειξαν το μεταβολικόαποτύπωμα των εκχυλισμάτων παραπροϊόντων βερίκοκου συναρτήσει των τεχνικών καισυνθηκών εκχύλισης. Η ταυτοποίηση των συνεκχυλιζόμενων μεταβολιτών υπεύθυνωνγια την ταξινόμηση των εκχυλισμάτων και η αξιολόγηση της επίδραση των συνθηκώνεκχύλισης σε αυτούς πραγματοποιήθηκε μέσω μοντέλων πολυμεταβλητής στατιστικήςανάλυσης (PCA, OPLS-DA). Συνοψίζοντας, η μελλοντική πιλοτική εφαρμογή τηςπαρούσας αναλυτικής μεθοδολογίας μπορεί να οδηγήσει στην μετατροπή τωνπαραπροϊόντων σε προϊόντα υψηλής προστιθέμενης αξίας και στην εμπορικήαξιοποίησή τους σε διάφορους τομείς της βιομηχανίας (τρόφιμα, φάρμακα, καλλυντικά,τροφοφάρμακα)

Application of Taguchi's Design of Experiments to the Study of Biomechanical Systems

2004 ◽  
Vol 20 (3) ◽  
pp. 219-229 ◽  
Author(s):  
Nenzi Wang ◽  
Yen-Hsiu Liu
Keyword(s):  
Design Of Experiments ◽  
Factorial Design ◽  
Signal To Noise Ratio ◽  
Optimization Procedure ◽  
Full Factorial Design ◽  
Fractional Factorial ◽  
Efficient Global Optimization ◽  
Set Up ◽  
Taguchi’S Design Of Experiments ◽  
Full Factorial

An efficient global optimization procedure is presented by using Taguchi's design of experiments (TDE) as a means for undertaking biomechanical studies that rely on experimentations. The proposed TDE is a systematic method of fractional factorial designs for conducting experiments with many independent variables. The approach can provide a step-by-step means for predicting the results of a comparative full factorial design only with a small number of tests. In this study a three-level, four-variable heel-toe running model, and a two-level, seven-variable bicycle example were examined to show the capability and robustness of TDE. In the process of the analysis, the orthogonal array and signal-to-noise ratio analysis of TDE were used to set up the trial conditions and analyze the results. It is shown that in the heel-toe running analyses the TDE successfully predicted the optimum sets of variables with 89% fewer trials than the full factorial design. The reduction in number of trials in the bicycle example is 94%. As a result, the use of TDE analysis to replace a full factorial analysis can considerably reduce the number of trials and still provide a useful outcome in many multifactor biomechanical studies.

Earphone terminal quality improvement through sequential experimental design

2015 ◽  
Vol 32 (7) ◽  
pp. 693-702 ◽  
Author(s):  
Zhen He ◽  
Xu-tao Zhang ◽  
Gui-qing Xie ◽  
Min Zhang
Keyword(s):  
Factorial Design ◽  
Response Surface ◽  
Response Surface Model ◽  
Full Factorial Design ◽  
Fractional Factorial ◽  
Surface Model ◽  
Quality Performance ◽  
Content Type ◽  
Input Variables ◽  
Full Factorial

Purpose – The purpose of this paper is to improve the key quality performance of the terminal of earphone in an electronic company. Design/methodology/approach – Sequential experimental designs are employed. Significant input variables are found through a full factorial design. Then a response surface model is constructed considering curvature in the linear model. Findings – Optimized key input variables’ parameters are found using the response surface model. The key quality performance, coplanarity of the terminal of earphone has been improved. Research limitations/implications – Instead of running a full factorial design in the first stage, a fractional factorial may be used to reduce experimental runs. Practical implications – The paper presents a good solution for reducing defects caused by large coplanarity of a kind of earphone terminal. Originality/value – The methodology used in this case can be easily extended to similar cases.

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