In COVID era, the idea of total cleanliness could take you to establish a normal, daily question: how am I taking care of the dirty gown from my collaborators?
Are we, as a company, doing an outstanding washing process of our dirty clothes?
In order to define a risk-based decision guideline, maybe, we could considered the next concerns:
1-Is your company in charge of the laundry wash of the clothes that your collaborators are wearing?
If the answer is YES, you should considered the ISO 14698, where it describes how to validate the washing process under conditions of biocontamination. …
En un foro de profesionales de Microbiología Farmacéutica tuve la osadía de preguntar:
¿Saben si existe una norma (es decir, ISO, ASTM, etc.) que describa los puestos de trabajo en la industria farmacéutica o de dispositivos médicos?.
La finalidad de esta consulta, resultaba ser la necesidad de entender cuáles son las competencias mínimas que se requieren para trabajar en el creciente mercado laboral de la industria farmacéutica y de dispositivos.
Antes de compartir alguna de las respuesta, hay que entender la definición de competencia. Una competencia, según la norma ISO 17024, es la capacidad para aplicar los conocimientos y habilidades…
The original message is at the end.
I received this message this Father’s Day and I have been overly excited:
“Hello Professor (I had the habit of calling it that). Excuse me. Today I had a 15-hour schedule and then I had to drive for two hours to get home.
While driving I was meditating on what Father’s Day is .. And I made a mental list of the exemplary parents I know and it was at that moment that I remembered this anecdote about the first impression I have of you:
I was already a couple of years old…
The era of Bcc has become official at United States Pharmacopoeia in its chapter number 60. Since november, 2019, this chapter describes methodology and testing parameters for the detection of microorganisms of this complex.
Bcc is a gram-negative aerobic bacteria commonly found in soil and water. It is an opportunistic pathogen that has the ability to remain viable under harsh conditions as it is resistant to certain preservatives and antimicrobial agents. Pharmaceutical water systems are especially susceptible to contamination by these organisms.
Interchanging some short conversations with a great group of experts in this topic, such as Dr. Luis Jiménez…
One more time COVID is part of our agenda as it will be for next months, years?
But this time we are going to be focus on microbial security objectives that call the attention of the regulatory offices all around the world:
1-Bacterial Endotoxin Test (BET) can detect and quantify the amount of one of the most pyrogenic substances that can contaminated vaccines, injections, etc (sterile preparations and biomedical devices): the LAL from Gram negative bacteria.
2-The huge amount fo vaccines against SARS-Cov-2; those that will come in the soon future, will require, as always, to demonstrate that they are…
When I met Dra. Isabel Strong at the Universidad de Ciencias Médicas, School of Microbiology, we worked together by creating the program of a very new course for the first generation of microbiologists graduated from a private university: Microbiología de Industria Médica y Farmacéutica.
From those years working together, the idea of creating a community around the objective of sharing information in this field, found its opportunity grow up by the foundation of Microbiología Farmacéutica:
It was the very first time that spanish spoken countries had the change to share information in this field and of course, social media plays…
Think about the business owner who receives the first phone call of the day and is one of his collaborators announcing that he has been diagnosed positive. I think his face will look like:
But at the same time, he should make important decisions, in order to solve this unfortunately situation, and, in my opinion, he will be focus on two objectives: health security and business continuity.
Health security is certainly related with the cleaning process after a positive case in declared in your business, but also disinfection takes part in this process. Cleaning is related to remove from the…
Since I got involved in regulatory affairs of medications for Costa Rica social security market, I found such a a highly challenging world where patients and good quality medicines are the most important tasks.
Of course, regulatory affairs is influenced not only by the regulations already published in Latin America (LA), but also from different fields of knowledge and those fields have a important background that supports them.
Looking for that synergy, at www.mfeducativa.com we have been establishing cooperation agreements with different regulatory offices and professionals of the law. Just two examples:
1-https://www.gob.mx/cofepris/ has announced at the end of 2017…
When I asked Dr. Marcel Marcano (www.medicomicrobiologo.com.ve) to meet for a Facebook Live session in @microbiologiafarmaceuticacr to talk about pharmaceutical microbiology and real needs of the clinic, I was really surprised of how much we have in common, and I was really happy of finding such a very good microbiologist as Dr. Marcano is.
Topics such as microbial resistance to antibiotics and cleaning trends in facilities (hospitals, compounding, drug manufacturing) are just two of the reasons that called my attention at the 12th Annual PDA Pharmaceutical Microbiology Conference that I have just attended last october #PDAMicro and I had already…
I am just attending for my first time the Parental Drug Association (PDA) Global Congress in Pharmaceutical Microbiology (#PDAMicro 2017), in Bethesda, MD, USA and of course, the expectations were huge and right now in this moment, I feel that it has been the best way to use my time as a person who wants to promote educational skills in this very thrilling area of knowledge in pharmaceutical industry for spanish spoken countries, even Latin America (of course).
But trying to bring my feet to the ground, this morning I attended a session with United States people, specifically, with scientific…
Microbiología Farmacéutica Costa Rica. I help by solving problems and giving educational tools for pharmaceutical microbiologists facing regulatory challenges.