Effective contamination control strategies facilitating axenic cultivation of Haematococcus pluvialis: Risks and Challenges

2021 ◽  
pp. 126289
Author(s):  
Byung Sun Yu ◽  
So Young Lee ◽  
Sang Jun Sim
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.


2007 ◽  
Vol 50 (2) ◽  
pp. 52-72 ◽  
Author(s):  
Chris Muller

Airborne molecular contamination (AMC) continues to grow as a major contamination control issue for microelectronics manufacturers. Because of this growth, chemical filter manufacturers are offering a large number of AMC control options from which the facility, process, and contamination control engineers must determine the best solution for their specific AMC control application(s). This paper will present information on the various types of chemical filters available, filter strengths and weaknesses, and the results of independent performance evaluations for a number of different chemical filter types. Several AMC control strategies employing chemical filtration will be discussed. Other topics include an introduction to gaseous contaminants and a definition of AMC; classifications of AMC; contaminants common to cleanroom applications, their sources, and effect; implementing AMC control—a three-step methodology for optimum control of AMC; gas-phase air filtration principles—adsorption, absorption, chemisorption, and factors affecting each; dry-scrubbing air filtration media—plain and chemically impregnated adsorbents; chemical filtration equipment designs—thin-bed and deep-bed systems; and AMC monitoring—passive and real-time reactivity monitors.


2021 ◽  
Vol 27 (3) ◽  
Author(s):  
Tim Sandle

Respiratory droplets are coronaviruses primary transmission mode and thus the majority of coronavirus risk mitigation strategies focus on the control of air. However, surface contact remains an alternative infection route. Hence, it remains a concern that the SARS CoV-2 virus can remain viable on surfaces for several hours.


2021 ◽  
Vol 27 (4) ◽  
Author(s):  
Tim Sandle

Respiratory droplets are coronaviruses primary transmission mode and thus the majority of coronavirus risk mitigation strategies focus on the control of air. However, surface contact remains an alternative infection route. Hence, it remains a concern that the SARS CoV-2 virus can remain viable on surfaces for several hours.


2017 ◽  
Author(s):  
Kelly N. Clark ◽  
Nicole B. Dorio ◽  
Michelle K. Demaray ◽  
Christine K. Malecki

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