A Contamination Control Strategy Gone Wrong

2021 ◽  
Vol 25 (5) ◽  
Author(s):  
Jeanne Moldenhauer

Warning letters and regulatory inspection observation reports (e.g., FDA 483) often provide useful information for assessing risks in your facility and preparing for upcoming inspections. Starting with the updates to the European Union’s Annex 1 for the Manufacture of Sterile Drugs there has been an increased focus on contamination control strategies in facilities. A contamination control strategy is an integral part of pharmaceutical manufacturing, whether sterile or non-sterile. For this article we are going to look at a series of observations for a vaccine production facility and how we might learn from these observations. Highlighted are some of the contamination control issues. The FDA 483 Report was published in redacted form.

Author(s):  
Carla Benea ◽  
Laura Rendon ◽  
Jesse Papenburg ◽  
Charles Frenette ◽  
Ahmed Imacoudene ◽  
...  

Abstract Objective: Evidence-based infection control strategies are needed for healthcare workers (HCWs) following high-risk exposure to severe acute respiratory coronavirus virus 2 (SARS-CoV-2). In this study, we evaluated the negative predictive value (NPV) of a home-based 7-day infection control strategy. Methods: HCWs advised by their infection control or occupational health officer to self-isolate due to a high-risk SARS-CoV-2 exposure were enrolled between May and October 2020. The strategy consisted of symptom-triggered nasopharyngeal SARS-CoV-2 RNA testing from day 0 to day 7 after exposure and standardized home-based nasopharyngeal swab and saliva testing on day 7. The NPV of this strategy was calculated for (1) clinical coronavirus disease 2019 (COVID-19) diagnosis from day 8–14 after exposure, and for (2) asymptomatic SARS-CoV-2 detected by standardized nasopharyngeal swab and saliva specimens collected at days 9, 10, and 14 after exposure. Interim results are reported in the context of a second wave threatening this essential workforce. Results: Among 30 HCWs enrolled, the mean age was 31 years (SD, ±9), and 24 (80%) were female. Moreover, 3 were diagnosed with COVID-19 by day 14 after exposure (secondary attack rate, 10.0%), and all cases were detected using the 7-day infection control strategy: the NPV for subsequent clinical COVID-19 or asymptomatic SARS-CoV-2 detection by day 14 was 100.0% (95% CI, 93.1%–100.0%). Conclusions: Among HCWs with high-risk exposure to SARS-CoV-2, a home-based 7-day infection control strategy may have a high NPV for subsequent COVID-19 and asymptomatic SARS-CoV-2 detection. Ongoing data collection and data sharing are needed to improve the precision of the estimated NPV, and here we report interim results to inform infection control strategies in light of a second wave threatening this essential workforce.


Author(s):  
Young Joo Shin ◽  
Peter H. Meckl

Benchmark problems have been used to evaluate the performance of a variety of robust control design methodologies by many control engineers over the past 2 decades. A benchmark is a simple but meaningful problem to highlight the advantages and disadvantages of different control strategies. This paper verifies the performance of a new control strategy, which is called combined feedforward and feedback control with shaped input (CFFS), through a benchmark problem applied to a two-mass-spring system. CFFS, which consists of feedback and feedforward controllers and shaped input, can achieve high performance with a simple controller design. This control strategy has several unique characteristics. First, the shaped input is designed to extract energy from the flexible modes, which means that a simpler feedback control design based on a rigid-body model can be used. In addition, only a single frequency must be attenuated to reduce residual vibration of both masses. Second, only the dynamics between control force and the first mass need to be considered in designing both feedback and feedforward controllers. The proposed control strategy is applied to a benchmark problem and its performance is compared with that obtained using two alternative control strategies.


2014 ◽  
Vol 525 ◽  
pp. 646-652
Author(s):  
Min Bian ◽  
Qing Yun Guo

The robust H2/<em>H</em>∞ control strategy for a class of linear continuous-time uncertain systems with randomly jumping parameters is investigated. The transition of the jumping parameters is decided by a finite-state Markov process. The uncertainties are supposed to be norm-bounded. It is desired to design a linear state feedback control strategies such that the closed-loop system satisfies H performance and minimizes the H2 norm of the system. A sufficient condition is first established on the existence of the robust H2/<em>H</em>∞controller bases on the bounded real lemma. Then the corresponding state-feedback law is given in terms of a set of linear matrix inequalities (LMIs). It is showed that this condition is equivalent to the feasible solutions problem of LMI. Furthermore, the control strategy design problem is converted into a convex optimization problem subject to LMI constraints, which can be easily solved by standard numerical software.


2014 ◽  
Vol 909 ◽  
pp. 317-322
Author(s):  
Huan Pao Huang ◽  
Ji An Yu ◽  
Qian Su ◽  
Lei Wang

2 × 660MW ultra-supercritical units of O'Brien Power Plant are single configuration of auxiliary pilot project, due to the higher its parameters and performance requirements, it need better control strategies to ensure safe and economical operation. Against traditional cascade PID main steam’s temperature control system delaying large, this article proposed control strategy based on Smith estimated. Main steam’s temperature controlled object inert zone mathematical model can be showed by multi-volume model, and use the improved system for large inertia Smith Predictor to make dynamic parameter control systems improvements. Simulation results of the simulation machine show that: Optimization emperor steam temperature control is in an adjustable range and the policy in separate auxiliary units is feasible.


2012 ◽  
Vol 512-515 ◽  
pp. 788-793
Author(s):  
Xiao Hua Zhou ◽  
Ming Qiang Wang ◽  
Wei Wei Zou

Traditional decoupling control strategy of doubly-fed induction generator (DFIG) wind turbine makes little contribution to system inertia and do not participate in the system frequency control, the synchronization of large-scale wind power requires wind turbine have the ability to participate in the regulation of power system frequency. This paper adds a frequency control segment to traditional DFIG wind turbine and considers the doubly-fed wind turbine operating on the state of the super-synchronous speed, by analysis the effect of inertia and proportional control strategies, a fuzzy control strategy which combines the advantages of the former two control strategies is proposed, simulation results show that this control strategy can more effectively improve the system frequency response.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Vikash Gurugubelli ◽  
Arnab Ghosh

Purpose The share of renewable energy sources (RESs) in the power system is increasing day by day. The RESs are intermittent, therefore maintaining the grid stability and power balance is very difficult. The purpose of this paper is to control the inverters in microgrid using different control strategies to maintain the system stability and power balance. Design/methodology/approach In this paper, different control strategies are implemented to the voltage source converter (VSC) to get the desired performance. The DQ control is a basic control strategy that is inherently present in the droop and virtual synchronous machine (VSM) control strategies. The droop and VSM control strategies are inspired by the conventional synchronous machine (SM). The main objective of this work is to design and implement the three aforementioned control strategies in microgrid. Findings The significant contributions of this work are: the detailed implementation of DQ control, droop control and VSM control strategies for VSC in both grid-connected mode and standalone mode is presented; the MATLAB/Simulink simulation results and comparative studies of the three aforementioned controllers are introduced first time in the proposed work; and the opal-RT digital real-time simulation results of the proposed VSM control show the superiority in transient response compared to the droop control strategy. Research limitations/implications In the power system, the power electronic-based power allowed by VSM is dominated by the conventional power which is generated from the traditional SM, and then the issues related to stability still need advance study. There are some differences between the SM and VSM characteristics, so the integration of VSM with the existing system still needs further study. Economical operation of VSM with hybrid storage is also one of the future scopes of this work. Originality/value The significant contributions of this work are: the detailed implementation of DQ control, droop control and VSM control strategies for VSC in both grid-connected mode and standalone mode is presented; the MATLAB/Simulink simulation results and comparative studies of the three aforementioned controllers are introduced first time in the proposed work; and the opal-RT digital real-time simulation results of the proposed VSM control show the superiority in transient response compared to the droop control strategy.


2018 ◽  
Vol 32 (34n36) ◽  
pp. 1840098
Author(s):  
Yuan Li ◽  
Huifang Shen ◽  
Chao Xiong ◽  
Yaofei Han ◽  
Guofeng He

In order to eliminate the effect on the grid current caused by the background harmonic voltage and the reference signal on the grid connected multi-inverter, this paper adopts the double closed-loop feed-forward control strategy. This strategy is based on the inductor voltage and the grid-connected current, and the integrated control strategy of quasi-proportional resonance loop parallel to a specific harmonic compensation loop. Based on the closed-loop model of multiple inverters, the change curves of the transfer function of the two control strategies are compared with the feed-forward control and the composite proportional resonance. The two corresponding control methods are used to analyze the current quality of the multi-inverter impact. Finally, the MATLAB/Simulink simulation model is set up to verify the proposed control strategies. The simulation results show that the proposed method can achieve better tracking of the sinusoidal command signal at the fundamental frequency, and enhance the anti-interference ability of the system at the 3rd, 5th, and 7th harmonic frequency.


Author(s):  
Kai Wang ◽  
Xinping Yan ◽  
Yupeng Yuan

Nowadays, with the higher voice of ship energy saving and emission reduction, the research on energy efficiency management is particularly necessary. Energy efficiency management and control of ships is an effective way to improve the ship energy efficiency. In this paper, according to the new clean propulsion system configurations of 5000 tons of bulk carrier, the energy efficiency management control strategy of the clean propulsion system is designed based on the model of advanced brushless doubly-fed shaft generator, propulsion system using LNG/diesel dual fuel engine and energy consumption of the main engine for reducing energy consumption. The simulation model of the entire propulsion system and the designed control strategy were designed. The influence of the engine speed on the ship energy efficiency was analyzed, and the feasibility of the energy efficiency management control strategies was verified by simulation using Matlab/Simulink. The results show that the designed strategies can ensure the power requirement of the whole ship under different conditions and improve the ship energy efficiency and reduce CO2 emissions.


Author(s):  
G Zheng ◽  
H Xu ◽  
X Wang ◽  
J Zou

This paper studies the operation of wind turbines in terms of three phases: start-up phase, power-generation phase, and shutdown phase. Relationships between the operational phase and control rules for the speed of rotation are derived for each of these phases. Taking into account the characteristics of the control strategies in the different operational phases, a global control strategy is designed to ensure the stable operation of the wind turbine in all phases. The results of simulations are presented that indicate that the proposed algorithm can control the individual phases when considered in isolation and also when they are considered in combination. Thus, a global control strategy for a wind turbine that is based on a single algorithm is presented which could have significant implications on the control and use of wind turbines.


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