ABSTRACT
Chikungunya virus (CHIKV) caused large epidemics throughout the Caribbean in 2014. We conducted nucleic acid amplification testing (NAAT) for CHIKV RNA (n = 29,695) and serologic testing for IgG against CHIKV (n = 1,232) in archived blood donor samples collected during and after an epidemic in Puerto Rico in 2014. NAAT yields peaked in October with 2.1% of donations positive for CHIKV RNA. A total of 14% of NAAT-reactive donations posed a high risk for virus transmission by transfusion because of high virus RNA copy numbers (10 (4) -10 (9) RNA copies/mL) and a lack of specific IgM and IgG responses. Testing of minipools of 16 donations would not have detected 62.5% of RNA-positive donations detectable by individual donor testing, including individual donations without IgM and IgG. Serosurveys before and after the epidemic demonstrated that nearly 25% of blood donors in Puerto Rico acquired CHIKV infections and seroconverted during the epidemic.
Subject(s)
Chikungunya Fever/epidemiology , Chikungunya Fever/virology , Chikungunya virus/isolation & purification , Viremia/epidemiology , Blood Donors , Epidemics , Humans , Incidence , Nucleic Acid Amplification Techniques , Puerto Rico , Serologic TestsABSTRACT
The vacuum integrity of freeze dryers is critical for attaining adequate process control and maintaining confidence in sterility assurance which is key for the manufacture of sterile pharmaceutical products. Although discussions on the topic have been published, there is no industry standard established that is based on empirical data or that has a justifiable scientific rationale. This article provides a review of the scientific literature in the public domain and most importantly, a perspective from 14 Pharmaceutical companies on the leak rate specifications commonly used in industry. Using this information we recommend a best practice for the lyophilizer leak rate test which includes detailing necessary preparation activities following Steam-In-Place (SIP) sterilization, defining a period of stabilization to eliminate pressure and temperature fluctuations and details of the test conditions and the test period. We conclude that for routine manufacturing practice the operational leak rate should not exceed 20 µbar L/s and we provide additional guidance for large volume and older lyophilisation equipment.
Subject(s)
Drug Packaging , Steam , Freeze Drying , Pharmaceutical Preparations , Quality Control , SterilizationABSTRACT
La investigación está orientada a indagar acerca de la identidad cultural del grupo juvenil que pertenece a las clases altas de la sociedad paceña y que popularmente es denominado como jailón. Este tema presenta muchas facetas interesantes y abre muchas interrogantes, partiendo desde el mismo denominativo popular jailón, respecto al cual resulta pertinente preguntarse cómo se originó, su evolución y el sentido vigente. Sin embargo, este trabajo pretende formular reflexiones en torno a las preguntas que emergen antes que darles una respuesta puntual.
ABSTRACT
La investigación propone una reflexión que aporta al actual debate académico sobre el perfil de la sociedad boliviana contemporánea. El trabajo está orientada a indagar la identidad cultural del grupo juvenil que pertenece a las clases altas de la sociedad paceña, para lo cual se pretende identificar quienes conforman dicho grupo y analizar los modelos, mitos, crencias y valores del mismo. No abarca temáticas como la sexualidad o el consumo de alcohol y drogas, pues la investigación se centra en los comportamientos visibles y directamente observables en los espacios abiertos y públicos definidos.