scholarly journals Resource Modelling for the QC Laboratory at XYZ Pharmaceuticals in Southern Africa

2021 ◽  
Author(s):  
Ngonidzashe Portia Munhuweyi ◽  
Zita Ekeocha ◽  
Stephen Robert Byrn ◽  
Kari L Clase

Quality control (QC) laboratories are critical components in drug manufacturing and running them efficiently contributes to better, consistent supply of cost-effective quality products, while also and preventing deaths due to untimely delivery or unavailability of medicines. Having a resource modelling tool to estimate resources needed to handle a particular demand in a given system is essential for efficient running of QC laboratory. This study was done to establish such a model at XYZ Pharmaceuticals. The list of all products manufactured by XYZ Pharmaceuticals Southern Africa was reviewed; and product families for all products were identified. Analysts’ hands on time (HOT) to process one sample of each of the product families was estimated. The number of analysts required to support the workload at XYZ Pharmaceuticals was calculated using the HOTs for the different product families and the Maslaton’s Calculation Model. A baseline resource model was established.

2014 ◽  
Vol 31 (7) ◽  
pp. 788-810 ◽  
Author(s):  
Claudia Paciarotti ◽  
Giovanni Mazzuto ◽  
Davide D’Ettorre

Purpose – The purpose of this paper is to propose a cost-effective, time-saving and easy-to-use failure modes and effects analysis (FMEA) system applied on the quality control of supplied products. The traditional FMEA has been modified and adapted to fit the quality control features and requirements. The paper introduces a new and revised FMEA approach, where the “failure concept” has been modified with “defect concept.” Design/methodology/approach – The typical FMEA parameters have been modified, and a non-linear scale has been introduced to better evaluate the FMEA parameters. In addition, two weight functions have been introduced in the risk priority number (RPN) calculus in order to consider different critical situations previously ignored and the RPN is assigned to several similar products in order to reduce the problem of complexity. Findings – A complete procedure is provided in order to assist managers in deciding on the critical suppliers, the creation of homogeneous families overcome the complexity of single product code approach, in RPN definition the relative importance of factors is evaluated. Originality/value – This different approach facilitates the quality control managers acting as a structured and “friendly” decision support system: the quality control manager can easily evaluate the critical situations and simulate different scenarios of corrective actions in order to choose the best one. This FMEA technique is a dynamic tool and the performed process is an iterative one. The method has been applied in a small medium enterprise producing hydro massage bathtub, shower, spas and that commercializes bathroom furniture. The firm application has been carried out involving a cross-functional and multidisciplinary team.


2021 ◽  
pp. 1-27
Author(s):  
Dominique J. Monlezun ◽  
Christopher Carr ◽  
Tianhua Niu ◽  
Francesco Nordio ◽  
Nicole DeValle ◽  
...  

Abstract Objective: We sought to produce the first meta-analysis (of medical trainee competency improvement in nutrition counseling) informing the first cohort study of patient diet improvement through medical trainees and providers counseling patients on nutrition. Design: (Part A) A systematic review and meta-analysis informing (Part B) the intervention analyzed in the world’s largest prospective multi-center cohort study on hands-on cooking and nutrition education for medical trainees, providers, and patients. Settings: (A) Medical educational institutions. (B) Teaching kitchens. Participants: (A) Medical trainees. (B) Trainees, providers, and patients. Results: (A) Of the 212 citations identified (N=1,698 trainees), 11 studies met inclusion criteria. The overall effect size was 9.80 (95%CI 7.15-12.456.87-13.85; p<0.001), comparable to the machine learning (ML)-augmented results. The number needed to treat for the top performing high quality study was 12. (B) The hands-on cooking and nutrition education curriculum from the top performing study was applied for medical trainees and providers who subsequently taught patients in the same curriculum (N=5,847). The intervention compared to standard medical care and education alone significantly increased the odds of superior diets (high/medium versus low Mediterranean diet adherence) for residents/fellows most (OR 10.79, 95%CI 4.94-23.58; p<0.001) followed by students (OR 9.62, 95%CI 5.92-15.63; p<0.001), providers (OR 5.19, 95%CI 3.23-8.32, p<0.001), and patients (OR 2.48, 95%CI 1.38-4.45; p=0.002), results consistent with those from ML. Conclusions: This study suggests that medical trainees and providers can improve patients’ diets with nutrition counseling in a manner that is clinically and cost effective and may simultaneously advance societal equity.


2013 ◽  
Vol 3 (4) ◽  
pp. 629-637 ◽  
Author(s):  
C. Furlong ◽  
J. Tippett

During previous research into drinking water quality in Peru, it was found that water was becoming contaminated in households, and there was a lack of understanding surrounding this contamination. It was felt that returning these findings to the community could build capacity, enabling people to make more informed choices about drinking water practices. Several participatory methods were explored. Ketso®, a hands-on kit for engagement, was thought to provide the most appropriate approach, and was used to deliver several workshops in the community. Thirty-five participants explored their understanding of drinking water and factors that caused contamination. The method allowed them to explore these factors in depth and to develop several practical and simple solutions. One solution capitalized on a novel finding; participants associated the taste of chlorine with clean water, but were unaware that household bleach could be used as a cost-effective water treatment. Feedback was excellent, with Ketso seen as giving participants space to better understand and question their practices, whilst building capacity for change. This co-production of knowledge also allowed the researcher to gain a better understanding of local knowledge and perceptions. Such innovative knowledge exchange has important implications for future implementation of new water technologies and engineering projects.


Author(s):  
Janmejay Pant ◽  
. Ripudhaman

Standardization in Ayurvedic formulations ensures the establishment of standards for the quality and purity of raw materials, quality control during the drug manufacturing process, production of a good quality finished product, storage and distribution to maintain the quality of the final product. It is an essential tool for establishing quality control methods for Ayurvedic drugs. In Ayurveda, standardization has been well defined and documented in the classical and contemporary texts. Still, these have been written with an individualistic intent and not for industrial or commercial purposes.  Careful contemplation of the classical literature of Ayurveda was done, the current guidelines of WHO on standardization of herbal drugs, latest researches on the same via the internet were explored and examined in the purview of the newest standardization procedures.  In this article, an attempt has been made to bring to light the classical references related to standardization, the milestones in this on-going pursuit have been exhibited, with the use of the latest scientific methods being incorporated for a standardized Ayurvedic drug. It can be concluded from the review that standardization in Ayurveda is an on-going process where one needs to be strictly vigilant about the new scientific methods to study the fine chemical procedures and the intermediate compounds formed, but at the same time be aware of the classical. Ayurvedic methods concepts of the procedure. Asava-arista's medicinal characteristics of Ayurvedic classical dosage forms, liquid dosage forms based on self-generated alcohol with faster absorption, long shelf life, and increased market conformity have led to a continuous rise in demand. New fermentation methods and packaging innovations tend to have been embraced by many Ayurvedic processing units. The importance of standardization of such goods is underlined by these advances in manufacturing, distribution and storage. Therefore, it is of concern to examine the latest manufacturing situation and the standardization of the dosage type regarding the procedure and the consistency and effectiveness of the finished product. In addition to the effort to include criteria of consistency and standardization, the study consists of an overview and deliberates on the importance of improvements made to the conventional preparation processes, ingredients and material used in the process and the potential impact on its efficacy.


Author(s):  
Ângela Sousa ◽  
Ana Margarida Almeida ◽  
Joana Valente ◽  
João Queiroz ◽  
Fani Sousa

2020 ◽  
Vol 8 (2) ◽  
pp. 104-108
Author(s):  
Rashmi Saxena Pal ◽  
Amrita Mishra

Background: Standardization of herbal formulation is mandatory for the quality check of drugs for assurance of their therapeutic value. According to the World Health Organization reports, about 80% of the world’s population relies on traditional medicine. Dhatryadi Ghrita, a polyherbal preparation containing eleven ingredients, has a sweet taste, cold potency and sweet post-digestive effects. Objective: In this research article, quality control for ghrita has been assessed for some of the ingredients of Dhatryadi Ghrita. Materials & Methods: Quality control assessment was done with the aid of the HPTLC method. Precoated silica gel GF 254 was used as the stationary phase and the developed method used benzene:ethyl alcohol (9:1v/v). Scanning and quantification of the plates were performed at 254 nm and 366 nm. Result: The study confirms the presence of different constituents of Ghrita. Conclusion: routine analysis of Ghrita was facilitated with simple, accurate and cost-effective HPTLC method. Data has been provided to demonstrate the present and future applicability of the methods of quality control assessment of Dhatryadi Ghrita.


Author(s):  
Giovanni Ferrara ◽  
Luca Innocenti ◽  
Giacomo Migliorini ◽  
Bruno Facchini ◽  
Anthony J. Dean

The increasingly stringent emissions standards in recent years have mandated low gas turbine emissions and thus changed the approach to combustion chamber design. In particular, lean burners based on highly premixed fuel-air flows have become more important. These combustors, termed Dry Low NOx (DLN), can now achieve emissions of 25 ppm and below in commercial operation. This development together with the inlet turbine temperature increase has resulted in less cooling air for combustion chambers and turbine blade cooling systems. The designer now needs to optimise cooling air flows that control the wall temperature of the components that confine the hot gases. Moreover, much of the air coming from the compressor is used to premix the fuel and only a smaller fraction is now available for cooling processes. In annular combustor configurations the air available for cooling the combustion chamber walls sometimes also has to cool the first stage nozzle. So the pressure loss along the combustor cooling passages has to be limited in order to assure a suitable supply pressure for these downstream cooling passages. We analysed the cooling air flow around the liner of an annular combustion chamber and we investigated the thermal flux and friction losses. In this paper we show the development of a calculation model that allows the critical components heat transfer analysis of a typical annular combustion chamber. The code developed is based on the generalised 1–D flow treatment. We have used experimental correlations for convection, film cooling and impingement borrowed from works found in literature. The code is provided with a graphical interface that helps the user during the calculation. This code was used in practical application to optimize the PGT5B combustion chamber cooling.


Author(s):  
Kevin Venne ◽  
Laurent Mydlarski ◽  
Federico Torriano ◽  
Mathieu Kirouac ◽  
Jean-Philippe Charest-Fournier ◽  
...  

To ensure the proper operation of hydroelectric generators, their cooling must be well understood. However, the airflow within such machines is difficult to characterize, and although Computational Fluid Dynamics (CFD) can be a reliable engineering tool, its application to the field of hydroelectric generators is quite recent and has certain limitations which are, in part, due to geometrical and flow complexities, including the coexistence of moving (rotor) and stationary (stator) components. For this reason, experimental measurements are required to validate CFD simulations of such complex flows. Of particular interest is the quantification of the flow within the rotor rim ducts, since it is directly responsible for cooling the poles (one of the most critical components of a hydroelectric generator). Thus, to measure the flow therein, an anemometer was designed. The anemometer had to be accurate, durable, cost-effective, easy to install, and able to withstand the extreme conditions found in hydroelectric generators (temperatures of 45°C, centrifugal forces of 300 g, etc.). In this paper, a thermal mass flow meter and a method for validating its performance, using hot-wire anemometry and a static model of a rotor rim, are described. Preliminary tests demonstrate that the thermal mass flow meter is capable of i) measuring the mass flow rate in the rotor rim ducts with an accuracy of approximately 10%, ii) fitting inside small rectangular ducts (12.2 mm by 51 mm), and iii) resisting forces up to 300 g.


2019 ◽  
Vol 4 (3) ◽  
pp. 1-6
Author(s):  
Caitlin Jones-Bamman ◽  
Susan Niermeyer ◽  
Kelly McConnell ◽  
John F. Thomas ◽  
Christina Olson

Background: Helping Babies Breathe (HBB) is a neonatal resuscitation curriculum that teaches life-saving interventions utilized in the first minutes after birth, reducing morbidity and mortality. Traditionally, it requires in-person facilitators for didactic and hands-on training. Objectives: The aim of this study was to offer HBB to nurses and nursing students in Guatemala, with the lead facilitator presenting concepts via telehealth and in-person facilitators providing hands-on demonstration. Methods: Learners completed pre- and post-tests that included the standard HBB knowledge check, as well as an assessment of the course teaching model. Learners also completed the standard Objective Structured Clinical Evaluations (OSCEs). Results: Eighteen learners were included in the analysis. All but one learner (94%) passed the course, and the average percent improvement from the pre- to post-test was 12%. All learners achieved passing scores on the OSCEs. Learners responded positively to questions regarding the technology, connection with the instructor, and ability to ask questions. Ninety-four percent of the learners agreed with the statement “this lecture was as good via telehealth as in person.” A cost analysis demonstrated approximately USD 3,979.00 in savings using telehealth compared to a standard in-person course. Conclusions: The telehealth model was successful in delivering course material to the learners and was well received. This model represents a cost-effective way to improve access to HBB. This study may not be generalizable to other populations, and the ability to use telehealth requires reliable internet connectivity, which may not be available in all settings. Further study and expansion of this pilot are needed to assess success in other settings.


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