Biotechnology Facility Design and Process Validation

2001 ◽  
pp. 739-767
Author(s):  
Michael G. Beatrice
1991 ◽  
Author(s):  
William C. Bullock ◽  
W. R. Pittman ◽  
Douglas C. Heinen

Author(s):  
Ellen Taylor ◽  
Sue Hignett

Thinking in patient safety has evolved over time from more simplistic accident causation models to more robust frameworks of work system design. Throughout this evolution, less consideration has been given to the role of the built environment in supporting safety. The aim of this paper is to theoretically explore how we think about harm as a systems problem by mitigating the risk of adverse events through proactive healthcare facility design. We review the evolution of thinking in safety as a safety science. Using falls as a case study topic, we use a previously published model (SCOPE: Safety as Complexity of the Organization, People, and Environment) to develop an expanded framework. The resulting theoretical model and matrix, DEEP SCOPE (DEsigning with Ergonomic Principles), provide a way to synthesize design interventions into a systems-based model for healthcare facility design using human factors/ergonomics (HF/E) design principles. The DEEP SCOPE matrix is proposed to highlight the design of safe healthcare facilities as an ergonomic problem of design that fits the environment to the user by understanding built environments that support the “human” factor.


Polymers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 650
Author(s):  
Jose Maria Alonso ◽  
Jon Andrade del Olmo ◽  
Raul Perez Gonzalez ◽  
Virginia Saez-Martinez

The transfer of some innovative technologies from the laboratory to industrial scale is many times not taken into account in the design and development of some functional materials such as hydrogels to be applied in the biomedical field. There is a lack of knowledge in the scientific field where many aspects of scaling to an industrial process are ignored, and products cannot reach the market. Injectable hydrogels are a good example that we have used in our research to show the different steps needed to follow to get a product in the market based on them. From synthesis and process validation to characterization techniques used and assays performed to ensure the safety and efficacy of the product, following regulation, several well-defined protocols must be adopted. Therefore, this paper summarized all these aspects due to the lack of knowledge that exists about the industrialization of injectable products with the great importance that it entails, and it is intended to serve as a guide on this area to non-initiated scientists. More concretely, in this work, the characteristics and requirements for the development of injectable hydrogels from the laboratory to industrial scale is presented in terms of (i) synthesis techniques employed to obtain injectable hydrogels with tunable desired properties, (ii) the most common characterization techniques to characterize hydrogels, and (iii) the necessary safety and efficacy assays and protocols to industrialize and commercialize injectable hydrogels from the regulatory point of view. Finally, this review also mentioned and explained a real example of the development of a natural hyaluronic acid hydrogel that reached the market as an injectable product.


Author(s):  
Ajay Babu Pazhayattil ◽  
Naheed Sayeed-Desta ◽  
Emilija Fredro-Kumbaradzi ◽  
Jordan Collins

1997 ◽  
Vol 21 (1) ◽  
pp. 71-99 ◽  
Author(s):  
Richard C. Morey ◽  
David A. Dittman

The “go/no-go” decision for a candidate property, i.e., whether or not to actually acquire the site, choose the brand (flag), build and operate the hotel, requires the explicit consideration of the interconnectedness of the many myriad elements affecting the property's potential profits. The many facility design decisions (number and mix of rooms, capacity for F&B operations etc.) as well as other strategic choices (e.g., size of marketing program, level of service aimed for) must recognize the site's competitive features and interactions with the above. Also, the particular design and operational features for a given property will affect its different revenue streams, fixed and variable costs, efficiency and profits. The authors consider developers contemplating acquiring a given site, choosing a brand, building and operating a new hotel. They offer a normative approach for this type of decision which arrives endogenously at possibly attractive options for the brand, design and strategic choices for the site. The final decision as to which option to actually use, if any, should be based on subjecting the above identified scenarios, as well as others, to traditional feasibility analyses where judgment and expert opinion are applied. The authors' implementable approach integrates a “best practices” benchmarking methodology with regression analysis to yield a mathematical programming optimization model. A key advantage of this approach lies in its contrast to conventional approaches for site selection which often ignore the more detailed design and strategic choices. The approach deals explicitly with the complex interfaces between marketing and operations management as the endogenous site and competitive environmental factors interact with the endogenous brand and facility design choices. By identifying attractive options to be further explored (that might otherwise be overlooked), several types of errors are avoided: i) an incorrect “go/no go” decision could be recommended for the site in question; ii) even if the right decision to proceed is made, the forecasted level of annualized profits could be in error, leading to an incorrect priority for the activity; iii) the incorrect brand and facility design choices could be made for the site. Other key advantages of the suggested approach are that 1) various substitution possibilities (between more or less capital, labor, materials etc.) are considered; 2) not only is the best brand and configuration identified, but also a ranking of other brands is available if the “best” brand is not available; 3) the “best practices” at other specific sites (which serve as the basis for the recommendations) are identified, thereby enabling management (possibly through site visits) to isolate the actual cultures, processes and procedures to be transported and emulated at the candidate site. This paper illustrates the approach for two different sites.


2011 ◽  
Vol 60 (2) ◽  
pp. 671-675 ◽  
Author(s):  
M. E. Sawan ◽  
A. M. Ibrahim ◽  
P. P. H. Wilson ◽  
E. P. Marriott ◽  
R. D. Stambaugh ◽  
...  

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