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Articles by James Agalloco
Aligning Environmental Monitoring Expectations with Scientific Realities
Introduction The global healthcare industry supplies parenteral products providing patient treatment. These products require rigorous control of contaminants.
From ‘Rogues’ to ?: Be Careful What You Wish For… …You Just Might Get it!
By: James Agalloco, Agalloco & Associates Introduction A recent blog post and discussion during a technical meeting centered around expectations for environmental monitoring approaching Grade A requirements in the assembly of non-product contact parts prior to ambient pressure H2O2 treatment of aseptic isolators.
Regulatory Pseudoscience – Myths, Opinions and Other Fantasies
By: James Agalloco, Agalloco & Associates Introduction We live in a society defined by laws of diverse types. There are laws established by governments to define taxation, human rights, immigration, contract management and traffic regulation. Relevant to the global healthcare industry are the regulations and guidelines established by regulators that define controls over production processes.
Salir del laboratorio para optimizar el control microbiano
MANUFACTURA James Agalloco Los expertos en microbiología deben emplear prácticas proactivas en el piso de fabricación, en lugar de depender de las pruebas. La presencia de microorganismos en productos farmacéuticos es un peligro potencial para la seguridad del paciente y la calidad del producto. En consecuencia, existen expectativas regulatorias de que las poblaciones microbianas sean controladas adecuadamente.
Descontaminación con peróxido de hidrógeno en fase de vapor en el mundo real
CALIDAD/REGULACIONES James Agalloco Los errores y las declaraciones erróneas del pasado han influido negativamente en las prácticas de descontaminación de la industria con peróxido de hidrógeno en fase de vapor y este artículo intenta aclarar el proceso. La introducción de la tecnología de aislamiento en la industria farmacéutica por la firma francesa La Calhene en la década de 1980 requirió un medio para la descontaminación microbiana confiable del interior del aislador.
Una evaluación revisada de riesgos asépticos y metodologías de mitigación
PROCESAMIENTO ASÉPTICO James P. Agalloco y James Akers El método revisado Aker-Agalloco incluye dos sub-métodos que pueden ser usados independientemente para evaluación de riesgos. Se entiende que el procesamiento aséptico se encuentra entre los procesos más complejos de la industria farmacéutica y uno cuya ejecución correcta es esencial para la seguridad del paciente.
No Estéril es No Estéril - Una verificación de la realidad sobre las expectativas del control microbiológico
CONTROL MICROBIOLÓGICO James Agalloco ¿Son irracionales las expectativas del control microbiológico? Las actividades de manufactura dentro de la industria farmacéutica están gobernadas por CGMPs que datan desde mediados de los 60’s y rara vez se cambian.
Logro del balance en la manufactura de productos estériles
INVESTIGACIÓN ARBITRADA James Agalloco y James Akers La validación de los procesos de manufactura estéril requiere del uso de indicadores biológicos para demostrar la letalidad de las técnicas de esterilización. Los organismos indicadores están ahí para simplemente medir el efecto del proceso de esterilización.
INVESTIGACIÓN ARBITRADA James P. Agalloco y James E. Akers El uso de peróxido de hidrógeno (H2O2) en la industria de salud global y otras industrias que requieren altos niveles de control de la contaminación ha crecido constantemente. Este crecimiento es atribuible a la capacidad de los químicos para matar esporas y esterilizar materiales, lo que se ha demostrado en una variedad de aplicaciones prácticas.
Pensamiento basado en el riesgo en la validación de procesos Encontrando el número apropiado de pruebas
James Agalloco El proyecto de guía para la validación de procesos de la Administración de Alimentos y Fármacos de EEUU cambia las expectativas regulatorias requiriendo que los fabricantes validen sus procesos realizando suficientes pruebas para alcanzar la significancia estadística. El autor describe porqué la significancia estadística, que la industria ha rechazado, impondría una carga irrazonable a los fabricantes y aportaría poco, si no es que ningún, beneficio.
James Agalloco y James Akers En un artículo anterior, los autores destacaron que las intervenciones del operador deberían evitarse porque llevan un riesgo inherente de contamina-ción del producto farmacéutico. El artículo definió dos categorías principales para las intervenciones y explicaron cómo deberían realizarse éstas.
09.09.21 -- Prefilled Syringes: Using X-Ray Analysis To Assess Container Closure Integrity
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd. The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials, due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays. By James E. Akers, Ph.D., James P. Agalloco, and Russell E.
09.02.21 -- Got Microorganisms? Determining Risk To Your Drug Product
By James Rolston, KPMG The FDA’s Office of Quality Surveillance launched a voluntary program to evaluate manufacturers’ quality management systems (QMSs) to inform decisions on the future development of an FDA rating system characterized as quality management maturity (QMM). This article explains the importance of QMM and what that looks like to the FDA. By James E. Akers, Ph.D., James P. Agalloco, and Russell E.
08.26.21 -- B. Cepacian: A Case Study On Objectionableness In Drug Manufacturing
Article | By Aurélie Mounier and George White, Cytiva With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs. Article | By Ania VanDyke, AbbVie The right CMO can expedite market launch, and an embedded CMO offers many advantages over other CMO models, including access to the extensive capabilities and know-how of the parent organization.
Hydrogen Peroxide Methods for Decontaminating N95 Filtering Facepiece Respirators
Background The novel SARS-CoV-2 virus that causes coronavirus disease 2019 (COVID-19) has led to a global shortage of N95 filtering facepiece respirators (FFRs). Whereas a new N95 FFR should be used with every new patient procedure, in this emergency, it may be necessary to reuse FFRs when severe supply shortages exist.
03.09.21 -- Optimizing A Cell Culture Media Filtration Process
By James Akers, James Agalloco, and Russell Madsen Our industry has, with not insignificant regulatory assistance, obstructed the implementation of a technology that has proven safe and effective and was an enormous improvement over the conventional cleanrooms universally in place in the mid-1980s.
01.23.21 -- Slow-Walking The Isolator - A Cautionary Tale
Our industry has, with not insignificant regulatory assistance, obstructed the implementation of a technology that has proven safe and effective and was an enormous improvement over the conventional cleanrooms universally in place in the mid-1980s.
Slow-walking The Isolator - A Cautionary Tale
By James Akers, James Agalloco, and Russell Madsen For the past 12 to 18 months, I have been part of a PDA committee constructing responses to two versions of the proposed revision to Annex 1 for Manufacture of Sterile Medicinal Products. Throughout that effort I faced a personal struggle with having to deal with requirements based upon manufacturing technologies dating back over 40 years.
Slow-walking The Isolator - A Cautionary Tale
By James Akers, James Agalloco, and Russell Madsen For the past 12 to 18 months, I have been part of a PDA committee constructing responses to two versions of the proposed revision to Annex 1 for Manufacture of Sterile Medicinal Products. Throughout that effort I faced a personal struggle with having to deal with requirements based upon manufacturing technologies dating back over 40 years.
Loaded Chamber Temperature Distribution Studies
Empty chamber studies are an adaptation of loaded chamber temperature distribution evaluations described in FDA’s draft Large Volume Parenteral (LVP) CGMP regulation from 1976.i Constraining the temperature range across the loaded chamber has the goal of assuring sterilization is attained across the load, without over-processing of the filled containers.
Empty Chamber Studies (aka Much Ado About Nothing)
Empty chamber studies have been a part of sterilization validation since its beginnings in the 1970’s. The first regulatory mention of temperature distribution studies in the United States can be found in FDA’s draft Large Volume Parenterals (LVP) CGMP regulation from 1976 (never made official and withdrawn in 1991).
Maximum and Minimum Loads in Steam Sterilization
Steam sterilization is a critical process in the manufacture of many pharmaceutical and medical device products. Because of its importance and wide usage it receives a great deal of attention from both practitioners and regulators. Despite this focus, there are aspects relating to load size that prove troublesome, and can cause difficulty during sterilization cycle development, and validation.
Objectionableness: How To Know If A Microorganism Poses A Risk In Your Drug Product
By James E. Akers, Ph.D, James P. Agalloco, and Russell E. Madsen It is important to consider at the beginning of an exploration of species “objectionableness” in microbiological analysis that this idea is unique to our specific corner of the world. If you search for a definition of objectionable organisms in a microbiology reference text, you are unlikely to find one.
Objectionableness: How To Know If A Microorganism Poses A Risk In Your Drug Product
By James E. Akers, Ph.D, James P. Agalloco, and Russell E. Madsen It is important to consider at the beginning of an exploration of species “objectionableness” in microbiological analysis that this idea is unique to our specific corner of the world. If you search for a definition of objectionable organisms in a microbiology reference text, you are unlikely to find one.
B. Cepacia: A Case Study For Determining Objectionableness In Drug Manufacturing
By James E. Akers, Ph.D, James P. Agalloco, and Russell E. Madsen After introducing the subject of colonization and opportunistic pathogenicity, we can now return to a discussion of B. cepacia. First, we should begin by discussing what B. cepacia is and what it isn’t. A critical place to start is the fact that B. cepacia sounds like a typical bacterial taxonomic construction consisting of a generic name “Burkholderia” and a species name “cepacia.” B. cepacia is a very different situation.
B. Cepacian: A Case Study For Determining Objectionableness In Drug Manufacturing
By James E. Akers, Ph.D, James P. Agalloco, and Russell E. Madsen After introducing the subject of colonization and opportunistic pathogenicity, we can now return to a discussion of B. cepacia. First, we should begin by discussing what B. cepacia is and what it isn’t. A critical place to start is the fact that B. cepacia sounds like a typical bacterial taxonomic construction consisting of a generic name “Burkholderia” and a species name “cepacia.” B. cepacia is a very different situation.
B. Cepacia: A Case Study For Determining Objectionableness In Drug Manufacturing
By James E. Akers, Ph.D, James P. Agalloco, and Russell E. Madsen After introducing the subject of colonization and opportunistic pathogenicity, we can now return to a discussion of B. cepacia. First, we should begin by discussing what B. cepacia is and what it isn’t. A critical place to start is the fact that B. cepacia sounds like a typical bacterial taxonomic construction consisting of a generic name “Burkholderia” and a species name “cepacia.” B. cepacia is a very different situation.
Paradise Lost
When isolators were introduced into the pharmaceutical industry they were properly viewed with some degree of skepticism. The early designs were relatively crude in appearance and certainly lacked sophistication. With a few years of technology development and successful operational experience it seemed that the isolator would change the way in which sterile products were made across the world.
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