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Sökning: WFRF:(Svensson Torgny)

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1.
  • Åsberg, Dennis, 1988-, et al. (författare)
  • A quality control method enhancement concept : Continual improvement of regulatory approved QC methods
  • 2016
  • Ingår i: Journal of Pharmaceutical and Biomedical Analysis. - : Elsevier. - 0731-7085 .- 1873-264X. ; 129, s. 273-281
  • Tidskriftsartikel (refereegranskat)abstract
    • Quality Control methods (QC-methods) play an important role in the overall control strategy for drug manufacturing. However, efficient life-cycle management and continual improvement are hindered due to a variety of post-approval variation legislations across territories and a lack of harmonization of the requirements. As a result, many QC-methods fall behind the technical development. Developing the QC-method in accordance with the Quality by Design guidelines gives the possibility to do continual improvements inside the original Method Operable Design Region (MODR). However, often it is necessary to do changes outside the MODR, e.g. to incorporate new technology that was not available at the time the original method was development. Here, we present a method enhancement concept which allows minor adjustments, within the same measuring principle, outside the original MODR without interaction with regulatory agencies. The feasibility of the concept is illustrated by a case study of a QC-method based on HPLC, assumed to be developed before the introduction of UHPLC, where the switch from HPLC to UHPLC is necessary as a continual improvement strategy. The concept relies on the assumption that the System Suitability Test (SST) and failure modes are relevant for other conditions outside the MODR as well when the same measuring principle is used. It follows that it should be possible to move outside the MODR as long as the SST has passed. All minor modifications of the original, approved QC-method must be re-validated according to a template given in the original submission and a statistical equivalence should be shown between the original and modified QC-methods. To summarize, revalidation is handled within the pharmaceutical quality control system according to internal change control procedures, but without interaction with regulating agencies.
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2.
  • Almgren, Torgny, 1962, et al. (författare)
  • Optimization of opportunistic replacement activities: A case study in the aircraft industry
  • 2007
  • Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
    • In the aircraft industry maximizing availability is essential. Maintenance schedules must therefore be opportunistic, incorporating preventive maintenance activities within the scheduled as well as the unplanned ones. At the same time, the maintenance contractor should utilize opportunistic maintenance to enable the minimization of the total expected cost to have a functional aircraft engine and thus to provide attractive service contracts. This paper provides an opportunistic maintenance optimization model which has been constructed and tested together with Volvo Aero Corporation in Trollhättan, Sweden for the maintenance of the RM12 engine. The model incorporates components with deterministic as well as with stochastic lives. The replacement model is shown to have favourable properties; in particular, when the maintenance occasions are fixed the remaining problem has the integrality property, the replacement polytope corresponding to the convex hull of feasible solutions is full-dimensional, and all the necessary constraints for its definition are facet-inducing. We present an empirical crack growth model that estimates the remaining life and also a case study that indicates that a non-stationary renewal process with Weibull distributed lives is a good model for the recurring maintenance occasions. Using one point of support for the distribution yields a deterministic replacement model; it is evaluated against classic maintenance policies from the literature through stochastic simulations. The deterministic model provides maintenance schedules over a finite time period that induce fewer maintenance occasions as well as fewer components replaced.
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  • Resultat 1-10 av 46
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