The Journal of Validation Technology
Vol. 26, Issue 2, Apr 2020

Tim Sandle
The novel coronavirus SARS-CoV-2 (causative agent of the disease COVID-19) triggered a global pandemic in 2020, leading to a raft of government-imposed measures designed to slowdown the rate of infection, in order to reduce the pressure upon health services. While many parts of the economy shutdown, most pharmaceutical and healthcare facilities...
Paul L. Pluta
Handwashing, or hand hygiene, has become fundamental in modern life. Personnel working in regulated industries including pharmaceutical, medical device, food service, and others have been educated on the importance of handwashing for many years. Healthcare workers, especially with direct patient involvement, are also very well trained in...
Stacey L. Bruzzese
These past weeks have become a test in global resiliency, solidarity, creativity and good old fashioned grit. As the COVID-19 pandemic spread across the globe challenging community leaders to close, businesses, schools, shopping centers, restaurants and parks, citizens self-isolated in an effort to flatten the curve. Under stay at home orders many...
Ivan Soto
Companies in the biotechnology and sterile manufacturing business are required to validate their sterilization process for manufacturing equipment. In addition to initial validation these companies are required to re-qualify on a frequent basis the sterilization process for manufacturing equipment. The validation of sterilization processes...
Tim Sandle
The novel human coronavirus, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (1), and which emerged in Wuhan, China, in late 2019 and led to a global pandemic (2), presents a concern to all people and economic sectors, including pharmaceutical and healthcare facilities. Part of the concern relates to SARS-CoV-2 having the...
Daily Hernández, Amarilys González, Hasel Aragón, Marcos González, Milagros Ponce, Williams Ferro, Andrés Tamayo, Camilo Ayra-Pardo, Abel Hernández, Lianet Rodríguez-Cabrera, Rodolfo Valdés*
Bacillus thuringiensis is a Gram-positive bacterium that produces toxins (e.g. Vip3Aa) that are able to induce resistance to insect plagues (e.g. Spodoptera frugiperda) in commercial crops. However, the Vip3Aa quantification in different plant tissues and phenological stages using a validated quantification assays have not been reported yet....
Orlando Lopez
In drug manufacturing, quality is viewed as a required objective to be achieved through management of the production process. Data are the results from the production process, and the way this process is performed affects the data accuracy. This paper discusses the significance of data quality and how it must provide accurate, valid, consistent,...
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