The Life Sciences Industry

 

In this section, we offer a summary of the life sciences and biomedical industry sector.

This industry is based on the application of knowledge for the development of innovative products intended to use for the prevention and treatment of health conditions.  It is an interdisciplinary industry where we find the interaction and application of different branches of sciences such as Biology, Medicine, Chemistry, Biochemistry, Molecular Biology, Microbiology, and Pharmacology among other disciplines.

Science and Engineering knowledge is integrated for the development and innovation of products. Multinational companies are engaged in research, development, manufacturing, marketing and selling of products for the prevention and treatment of health conditions.

The biomedical industry is driven by education, research, innovation and entrepreneurship. It is divided into several segments.

 

Life Sciences Sectors 

The sector includes research facilities, universities, hospitals, medical education, biomedical researchers, pharmaceutical and medical device manufacturers, biotechnology companies, testing laboratories and other interested in the search of knowledge and its application.

Research is continually conducted to find and develop new products and technologies that can be used to cure, treat, protect and improve health.

The sector is widely distributed in the United States and around the world. It is a global market. The biomedical industry has an important role as an economic engine in many states and countries.

Those working in this sector have the satisfaction of being able to support and contribute to global health and well-being. Manufactured products are distributed to different parts of the world. Even the services provided can be global. Each employee can have an impact on the life, health and well-being of people around the world.

 

Devices and medical products  

One sector within this industry is the medical devices, technologies and medical products.

 

What are medical devices?

They are a series of equipment, instruments or objects used for therapeutic purposes.  According to the Food and Drug Administration (FDA), medical devices include instruments, apparatus, implants, in vitro reagents, and components or accessories intended for use in diagnosing diseases or other conditions, or in the cure, mitigation, treatment or prevention of diseases (www.fda.gov).  It has a physical or mechanical effect in the body.

According to ISO 13485 “Medical Devices–Quality Management Systems–Requirements for Regulatory Purposes” a medical device is any device, equipment, machine, implant, software with a function that can alleviate pain, to give a treatment, using physical or mechanical means and not chemical action.

The purpose of these products is to diagnose, prevent, monitor, treat, alleviate conditions, diagnose, monitor, wound treatment, and joint replacement.  They can even support and sustain life as for example pacemakers.  This Industry design and manufactures diverse products ranging from dental floss to pacemakers.

It can range from surgical instruments, heart valves, hospital beds, catheters, serum, serum bags, pacemakers, neuro stimulators, orthopedic process screws, spine support, diagnostic kits, glucose monitoring, intraocular lenses, orthopedic implants, prostheses and defibrillators, among many other products.

It has a variety of products and therefore varies in the complexity and types of regulatory controls.  There are three classifications according to the product, complexity and regulatory controls. Class 1 is the less complex, Class 2 (intermediate) and Class 3 are the ones that sustain life. If you go to a company and they tell you that they manufacture medical devices Class 3, means that are products that sustain the life and will have greater regulatory controls.

In the United States, the industry is highly regulated by the Food and Drug Administration, known as the FDA.  Each country has its own regulatory agencies that conduct inspections to ensure that product manufacturing is carried out following good manufacturing practices and the highest quality standards.

Medical devices products are intended to affect the structure or function of the body. Their main mode of action is not by a chemical reaction in the body, unlike the pharmaceutical industry that its mode of action is based on chemical intervention.

 

Pharmaceutical

Other important sector that is widely recognized is the pharmaceutical industry.  This industry is responsible for the development and manufacture of medicines. It is characterized by research and development activities to produce new drugs, therapeutic products, vaccines, biological, diagnostic substances and dermatological products. Its mode of action is by chemical mediation in the body. Pharmaceuticals are highly regulated in the United States by the FDA through the 21 CFR 211 “Current Good Manufacturing Practices for Finished Pharmaceuticals”. Each country will have the applicable regulatory agency.

 

Laboratory and Research 

Research, medical and testing laboratories are another area within the life sciences sector. It Includes research centers, tests and clinical labs. This segment is dedicated to biomedical and clinical research, biotechnology and medical testing among other areas.

 

Distribution  

The distribution sector is related to the distribution of medical, biomedical, biotechnology, and pharmaceutical materials and products. It includes companies that coordinate the delivery of  pharmaceuticals, medical devices and biological products from the manufacturing facility to distribution centers and to the final user or client.

It requires the implementation of specialized technologies for storage and highly regulated monitoring systems during distribution.  Distributors develop logistics competencies for the transport of therapeutic products, including biological products, devices, sensitive medical equipment, seeds and other biomedical products.

 

Life Sciences Workforce   

life sciences industry

This industry employs highly educated and trained workers. Personnel with different background and areas of expertise work in a teamwork environment to achieve common objectives, goals and metrics.

We find professionals with extensive experience, such as laboratory technicians, microbiologists, chemists, biotechnologists, scientists and engineers.  People with knowledge in Business Administration can explore opportunities in the area of Finance, Operations, and Supply Chain.

The average wage of employees working in the sector tends to be relatively higher than other industries due to the highly specialized training and skills required.  It is a complex industry in terms of product diversity, technologies, therapies, customers, requirements and regulations.  This industry is based on the development and use of biological, biomedical, and engineering knowledge, discoveries and scientific innovation.

Progress is made daily in the knowledge of biological processes and systems. Biomedical workforce is in an active search to understand how to use that knowledge and discoveries to create products that can improve health, develop new technologies and improve existing ones.

As any global company, they seek to be the first to introduce a product into the market, expand its scope, product portfolio, return of investment for its shareholders, and to improve health and quality of life. This is performed in compliance with the regulations and the highest quality standards.

This episode provides a summary of the life sciences and biomedical industry sector, which includes the pharmaceutical, devices and medical products, laboratory and research, and distribution.

This introduction is part of the course Understanding the Life Sciences Industry, created by Biobusiness Research.  You can access the course on http://www.biobusinessresearch.net

https://biobusiness.podbean.com/e/004-life-sciences-industry-overview/

 

 

Understanding the Life Sciences Industry (Online Course)

Understanding the Life Sciences Industry

Learn how it is to work in the medical products manufacturing industry.

This online, self-paced, introductory course is designed for those interested in a career in the life sciences and biomedical manufacturing industries such as the pharmaceutical, medical devices and biotechnology. The content focuses on individuals who want to understand what it is like to work in the industry.

It is useful for those who are interested to work in the industry, but do not know their organizational structure, or the dynamics of working in a highly regulated manufacturing environment, controlled by quality systems.

This program is designed for those who aspire to start a career or just want to know what it is like to work within a highly regulated industry such as the biomedical or life sciences industry.  We will provide a general overview of the industry, with emphasis on the manufacturing of pharmaceutical and medical products. Our goal is to help you understand the main roles and responsibilities and be better prepared for the job search. In general, we will present some of the important elements you need to understand about the industry.

At the end of this course you will learn about medical devices and pharmaceutical products. You will understand the rules that every employee who works in this highly regulated environment should follow. We will discuss some of the careers and functional areas that you can find in this industry. You will get the basic knowledge about quality, quality systems, audits, and non -conformities. In addition, you will have an overview of the business and regulatory aspects related to the sector. It is important that you recognize the international regulations and standards that each employee must follow to ensure that the product, processes and services meet quality standards and are safe to use.

The topics to be addressed include an introduction to the manufacturing industry, quality systems, international quality standards such as ISO, regulations, conformity and non-conformity, quality system audits, and Corrective and Preventive Actions, known as CAPA.  The CAPA system is related to investigating the cause of non-conformities and establishing the actions taken to correct the Non-conformity (corrective actions) and what actions are being implemented to prevent non- conformity (preventive actions) from occurring.  It is a highly regulated environment. Continually we are being audited by external agencies and internal auditors.

In addition to the regulatory side, there are other concepts that are part of the everyday vocabulary for those who work in this environment.  For example, production process controls, how to work in a controlled environment area, contamination control to guarantee the quality of the final product, environmental monitoring of production areas, microbiological quality controls, validations, equipment qualifications, project management, failures and non-conformity investigations, corrective and preventive actions (CAPA), and continuous improvement are just some of the areas of knowledge that are valued in the industry.

It is also important that you know what it is like to work in a clean room or controlled Environment area (CEA). These areas have controls in terms of cleanliness and contamination. The manufacturing environment is continuously monitored through microbiological tests, particle counts, temperature, humidity, differential pressure, and air changes, among others.

Several tests are carried out in the manufacturing areas to determine if complies with quality parameters and specifications. The area is controlled. It must meet the minimum requirements according to the quality standards. This is a little different scenario for those who have not been exposed to contamination controls in the working areas.

At the end of the course, you will have an overview of the role of quality control (QC) laboratories, which perform tests to ensure that the organization processes and products meet quality.  Laboratories, such as microbiology and chemistry, are usually part of the quality control function.

The regulatory and compliance area is critical in this type of industry.  We must follow the law, quality standards, and Good Manufacturing Practices (GMPs).  If we fully follow them, we are in compliance.  Compliance is a word that is part of the daily vocabulary in the industry. If we are not in compliance, quality events are generated, observations or audit findings are given, and the company has problems.  The quality role is to ensure that all elements of the Organization are in compliance.

Register now for the course in the following address:life sciences industry

https://www.biobusinessresearch.net/understanding-the-life-sciences-industry

 

 

 

 

Quality Assurance en la Industria

Taller: Quality Assurance in the Life Sciences Industry.

Conoce el rol del personal de QA en la Industria en el taller que ofrecerá Biobusiness Research el domingo, 27 de Octubre, en San Juan.

El personal de calidad es responsable de asegurar que los procesos y productos cumplan con los procedimientos, especificaciones y requisitos regulatorios en industrias como la farmacéutica, biotecnología, dispositivos médicos, alimentos, entre otras. Entre las funciones del profesional de Calidad incluye el Aseguramiento de Calidad (QA), Control de Calidad (QC) y Cumplimiento Regulatorio.

El taller está diseñado para introducir al estudiante, recién graduado y/o personal con poca experiencia al área de QA con énfasis en las industrias de manufactura.   El programa prepara a los estudiantes para entender la industria y prepararse para la búsqueda de empleo en este sector en y fuera de Puerto Rico.

El personal de calidad es responsable de asegurar que los procesos y productos cumplan con los procedimientos, especificaciones y requisitos regulatorios en industrias como la farmacéutica, biotecnología, dispositivos médicos, alimentos, entre otras. Entre las funciones del profesional de Calidad incluye el Aseguramiento de Calidad (QA), Control de Calidad (QC) y Cumplimiento Regulatorio.

El taller está diseñado para introducir al estudiante, recién graduado y/o personal con poca experiencia al área de QA con énfasis en las industrias de manufactura.   El programa prepara a los estudiantes para entender la industria y prepararse para la búsqueda de empleo en este sector en y fuera de Puerto Rico.

Entre los temas a discutir se encuentran:

  • Elementos de un Sistema de Calidad
  • Quality Assurance (QA) / Quality Control (QC)
  • Rol del Representante de Calidad
  • Buenas Prácticas de Manufactura (cGMP)
  • Estándar de Calidad ISO
  • Documentación, SOPs, Registros
  • Identificación y Traceabilidad de Producto
  • Control de Procesos
  • Laboratorios de Calidad
  • Liberación de Materiales, Servicio o Producto
  • Investigaciones y Acciones Correctivas / Preventivas (CAPA)
  • Adiestramientos
  • Auditorías
  • Control de Equipos
  • Mejoras de Procesos

Para información y registro puede acceder el siguiente enlace:

https://www.eventbrite.com/e/quality-assurance-qa-in-the-life-sciences-industry-san-juan-tickets-75969654281

Por otro lado, si no puede acceder el adiestramiento en San Juan, puede registrarse en la versión online en un formato autodirigido (self-paced) a través de la página www.biobusinessresearch.net.

La página del curso online es:  https://www.biobusinessresearch.net/quality-assurance-qa-el-rol-del-departamento-de-calidad-en-la-industriaQA

What is Biotechnology?

Biotechnology is an area of interest in the current years. It is a merge between biology and technology. It is like a “joint venture” between science and industry. Biotech is based on the biology, as it study microorganisms and living systems. These microorganisms have components that are molecules. The molecules include the DNA, RNA, proteins and carbohydrates.

Biotechnology is based on the application of biological knowledge to create products with a benefit to the population. Industries in this sector uses the biological molecules to develop products for a commercial purpose. Products may include food, health care products, pharmaceuticals, and vaccines. It is also used in agriculture to improve crop yields and prevent damage.

Biotech medicine is an area of commercial applications. They are based on components similar to proteins used by the body. These medicines are manufacture using living organisms or microorganisms that are genetically modified to produce the molecule of interest.

Usually biotech medicines are injected in the body because are large complex molecules that can be destroyed by the normal digestion process if ingested by mouth.

Most of us are more familiar with the traditional chemical or drug-based medicines that are taken in solid or liquid form. Usually they are contained within a pill, tablet or capsule and are smaller molecules than proteins.

Several companies are investing in research and development in healthcare and agricultural applications to produce new and improve products. This is an interesting area to explore if you want to learn about the interaction of science, technology and industrial processes.

#biobusinessresearch #promotelearning #biotech #biotechnology

Measles Outbreak…What are Measles?

By: Eileen Ruiz, PhD

 

It is reported an outbreak of measles in the United States. What is measles? What are the symptoms? How people get infected? How can we prevent it?

This article is a brief summary of measles and provide answer to these questions.

 

Measles Outbreak

I was reading an article about an outbreak of measles in New York and what is perceived as the worst outbreak in decades (1).

According to the website of the New York State Department of Health, some areas of New York State are experiencing a measles outbreak, including the lower Hudson Valley and parts of New York City (2).

I get curious and start searching more information, as measles was a common condition decades ago, but today, it is preventable by vaccination. It is not a common illness in United States. Reports from the Centers for Disease Controls and Prevention (CDC) indicates that measles cases usually range from less than 100 to a couple hundred annually (5).

Then, I found that just in the first weeks of  2019, from January 1 to February 7, 2019, there have been 101 confirmed measles cases in ten states. The states that reported cases to CDC are California, Colorado, Connecticut, Georgia, Illinois, New Jersey, New York, Oregon, Texas, and Washington (3).

Let’s understand what measles is and how to prevent it.

 

What is measles?

Measles, also known as rubeola, is an infection caused by a virus. It is a serious respiratory disease characterized by an uncomfortable rash and high fever. It is associated mainly with childhood but can be found also in adults.

 

What are the symptoms?

Measles symptoms appear around 10 to 14 days after exposure to the virus.

When a person is in contact with the virus and get infected, there is an incubation time where the virus replicates in the body. The incubation period is around 10 to 14 days after infected.

Measles signs and symptoms typically begins as a mild illness with non-specific symptoms as fever, that can be accompanied by a persistent cough, runny nose, inflamed eyes or conjunctivitis, and sore throat. Fever may last 4 to 7 days.  Also, small white spots known as Koplik’s spots can be observed in the mouth, insides of cheeks, and throat.

Then, the acute illness and rash develops. The rash consists of small red spots, that can be slightly raised. Spots appears in clusters giving the skin a red appearance. The face breaks out first. On the next few days, the rash spreads down the arms and trunk, the thighs, lower legs and feet. Fever rises sharply (40◦C to 41◦C). Then, the rash gradually recedes, fading first from the face and last from the thighs and feet (4).

A person with measles can spread the virus to others for about eight days, starting four days before the rash appears and ends when the rash has been present for four days(4).  There is no specific treatment, as medicine does not kill the virus.

Diagnosis is based on signs and symptoms.  Blood test confirms the presence of the rubeola virus.

 

Occurrence

It is not a common condition as more children received the measles vaccine. It was reported in US an average of 60 cases per year from 2000 to 2010, but this increased up to 205 per year recently. Most of the cases occurs outside the country, while traveling, and in people who were unvaccinated. It is more associated to international travels.

It can be a severe or even fatal condition for babies and young children. Globally, the disease kills more than 100,000 people a year, mostly, children under the age of 5 (4).  From 2001-2013, 28% of children younger than 5 years old who had measles had to be treated in the hospital

 

How is obtained?

According to the CDC, Measles spreads when a person infected with the measles virus breathes, coughs, or sneezes. It is very contagious…a person can be infected just by being in a room where a person with measles has been, up to 2 hours after that person is gone. The virus can stay active on surfaces and in the air for up to 2 hours.

An individual can obtain measles from an infected person even before they have a measles rash. Measles is highly contagious from about four days before to four days after the rash breaks out. Almost everyone without the measles, mumps and rubella (MMR) vaccine will get measles if  exposed to the virus(5).

Once infected by the measles virus, the virus located and replicates in the nose and throat of the infected individual. When someone with measles coughs, sneezes or talks, infected droplets spray into the air. People can inhale them and get infected. Also, the infected droplets can locate on a surface, where remain active and contagious for several hours. A person can be infected by the virus by touching the surface, and then touching the mouth, nose, or eyes after touching the infected surface.

Measles is common in other parts of the world, including countries in Europe, Asia, the Pacific Islands, and Africa. Worldwide, about 20 million people get measles each year. When people with measles travel into the United States, they can spread the disease to unvaccinated people and to children too young to be vaccinated(5).

Outbreaks can be associated to people in the US that got the measles after being exposed to someone who got measles while in another country.

 

Brief history

Since the introduction of the measles vaccine, measles has virtually been eliminated. The rate of measles in the U.S. recently increased from an average of 60 cases a year to 205 cases annually, maybe because a drop in vaccination rates. There are publications that associated the drop in vaccination rates to a study published in 1998, where a possible association of autism to the measles, mumps and rubella (MMR) vaccine was found. This study was not confirmed and according to Center for Disease Controls, scientists in the United States and other countries have studied the MMR shot vaccine and no link has been found between autism and the vaccine (5).

 

How to prevent it?

It can be prevented by vaccination. Physicians recommends that all children get the MMR shot.

A first dose if given to infants usually between 12 and 15 months. A second dose is given typically between ages 4 to 6 years.

Also, if a person had measles, the body’s immune system has developed the defense to fight the infection, therefore, people are immune and are unlikely to get measles again.

In summary, it is a severe respiratory infection but can be prevented by vaccination. The increase in the cases can be associated to the decrease in vaccination rate.  Measles is a condition that continues to be present in other parts of the world. If traveling internationally, it is recommended to get the vaccine.  On the other hand, people traveling to the US and its territories with the disease (even if not known that has measles) can easily spread the virus, contaminate those unvaccinated and initiate an outbreak.

This is a brief summary of what is measles and how to prevent it. Hopefully, this will be controlled soon.

 

 

References:

  1. https://www.the-scientist.com/news-opinion/new-york-faces-worst-measles-outbreak-in-decades-65305
  2. https://www.health.ny.gov/publications/2170/
  3. https://www.cdc.gov/measles/cases-outbreaks.html
  4. https://www.mayoclinic.org/diseases-conditions/measles/symptoms-causes/syc-20374857
  5. https://www.cdc.gov/vaccines/parents/diseases/child/measles.html

 

*This article was written by Eileen Ruiz, PhD, Founder of Biobusiness Research, an organization that promotes learning in areas related to the biomedical, life sciences industries, business and entrepreneurship.

QC Microbiology

A new academic semester begins. Some students are close to completing their studies and others will begin the job search. It is important you be prepared if you are getting ready to be part of the workforce. Search for information on the roles and responsibilities for different career options.

In this article we focus on understanding the responsibilities for a microbiologist in an industry environment. If you are looking for a microbiology job in the industry, we recommend that you understand what the role of the microbiologist is, what types of tests are performed, why are performed, and how they are executed. In this way you can be better prepared for a job interview.

You may not have the experience performing the testing, but you will be in a better position if you can demonstrate that you know what it is about, you understand the concept, the theory, the technique, and the purpose of the testing.

When we begin to work in the industry, we could say that we start without experience. You cannot execute any procedure until going through the training provided by the company. The previous experiences maybe only help you to speed up the time to complete your training, since you know and understand the concepts, however, you start from the basics.

When you start working in an organization such as a pharmaceutical or medical device manufacturer, you have to go through a training in the microbiological test to be performed and in the standard procedure to execute the method. It is not expected that on your first day you start performing the test immediately.

You have to go through a training, understand the internal procedures of the company, and even observe a certified analyst execute the test several times before you are certified to perform the test.

The process of certifying yourself in a laboratory method requires that you be trained in the internal procedure of the company. Usually you first read and understand the procedure, and then you accompany a certified analyst, whom you observe performing the test. As you observe the execution, you are being trained (“on the job training”). Once you are ready, you will perform the testing with the trainer who will be observing, directing you, clarifying the questions and the execution technique. When you demonstrate proficiency to perform the procedure on your own, you get certified and can execute. The training time depends on your knowledge, the complexity of the method you are doing, and your skills.

In the industry, the microbiology area generally has a quality control function. A representative sample of the batch, product or environmental conditions is taken and subject to a microbiological testing. Based on the test results, conclusions are established related to the quality of the product or process.

Let’s see some of the roles of a microbiologist’s position.

The Microbiology group performs routine microbiology testing on raw materials, components, final product and controlled environments areas. The test methods are already predefined in the policies, internal procedures and the compendial methods like the United States Pharmacopeia (USP). These procedures have to be aligned with FDA regulations and guidelines.

Some examples of tests in which it is convenient to have knowledge or experience include:

  • Water tests (Total Viable count, coliforms, TOC, conductivity)
  • Bioburden tests to product
  • Microbial limit test
  • Sterility test by membrane filtration or direct inoculation. USP <71> establishes basic requirements for the method.
  • Bacterial endotoxin test on water samples, raw material, components and final product. This test can be done using the clot method, kinetic, chromogenic and turbidimetric method
  • Lethality studies
  • Determination of biological indicators (BI) population
  • Qualification of Disinfectants
  • Identification of microorganisms or normal microbial flora
  • Environmental controls. This topic includes routine environmental monitoring of controlled and classified areas, for example, manufacturing areas and laboratories. Viable and non-viable particulate tests are performed. Some forms of monitoring include the use of contact plates, settling plates and air samplers.

This is just a summary of some of the basic tests. There are additional tests that we will be discussed in future publications.

On the other hand, it is not only to perform the test, but after it is completed and the results are obtained, they must be documented and analyzed. It is critical, in terms of regulatory and quality systems terms perspective, to evaluate and document the data to determine if the results are acceptable or if an alert, action or the specification limits established in the procedure are exceeded. If any of these limits is exceeded, the Laboratory investigations are carried out.

It is the responsibility of Microbiology to assist in investigations related to non-conformities, deviations, out of specification (OOS), out of trend (OOT), or out of limits in the results obtained from products and environmental monitoring test. The microbiology analyst is responsible for reporting any non-compliance, initiating and / or leading the investigation efforts until resolution.

The role of microbiology in the regulated industries, such as pharmaceutical or medical devices, is very broad and critical. Decisions on the quality of a product are made based on the results obtained from the microbiology tests. It is a highly controlled and continuously audited area to ensure compliance with procedures, guidelines, standards and regulations. We encourage you to know more about microbiology focused on the area of ​​quality control. It is a very different environment as compared to what you have seen in the academy, but at the same time, you will be in a continuous learning and you will contribute a lot to the organization with the experience you acquire.

 

 

Control de Calidad en Microbiología

Comienza un nuevo semestre académico. Algunos estudiantes están próximos a completar sus estudios y otros comienzan la búsqueda de empleo. Es importante conocer que está buscando el mercado laboral, de manera que puedas ir preparándote, e ir buscando información de los diferentes roles y responsabilidades.

En este artículo nos enfocamos en entender las responsabilidades o descripciones de puesto para un microbiólogo que labora en la industria. Si estás buscando una posición de microbiología en la industria es recomendable que entiendas cual es la función o el rol del microbiólogo, que tipos de pruebas realiza, por qué las realiza, y como se ejecutan de manera que te ayude a estar mejor preparado para una entrevista de empleo.

Tal vez no tengas la experiencia ejecutando la prueba, pero estarás en una mejor posición si puedes demostrar que sabes de que se trata, entiendes el concepto, la teoría, la técnica, y el propósito de la prueba.

Cuando uno empieza a trabajar en la industria, podríamos decir que se comienza sin experiencia. No puedes ejecutar ningún procedimiento hasta pasar por el adiestramiento de la compañía. Las experiencias previas tal vez solo te ayudan a agilizar el tiempo para completar tu adiestramiento ya que conoces y entiendes los conceptos, sin embargo, empiezas desde lo básico.

Cuando comienzas a laboral en una organización como, por ejemplo, farmacéutica o de dispositivos médicos, tienes que pasar por un adiestramiento en la prueba microbiológica a realizar y en el procedimiento estándar para ejecutar el método. No se espera que en tu primer día comiences a ejecutar la prueba inmediatamente.

Tienes que pasar por un adiestramiento, entender los procedimientos internos de la compañía, e incluso, observar a un analista certificado ejecutar la prueba varias veces antes de que seas certificado para realizar la prueba.

El proceso de certificarte en un método de laboratorio requiere que seas adiestrado en el procedimiento interno de la compañía. Usualmente primero lees el procedimiento, lo entiendes y luego acompañas a un analista certificado, a quien observas ejecutar la prueba. Según observas la ejecución, te vas adiestrando (“on the job training”). Una vez estás preparado, pasas a ejecutar la prueba con el adiestrador quien estará observando, dirigiéndote, clarificando las preguntas y la técnica de ejecución. Cuando demuestras dominio y seguridad para realizar el procedimiento por tu cuenta, te certificas y puedes ejecutar. El tiempo de adiestramiento depende de tu conocimiento, la complejidad del método que estás realizando, tus destrezas. Puede ser días o semanas antes de que puedas realizar la prueba.

En la industria, generalmente el área de microbiología tiene una función de control de calidad. Se toma una muestra representativa del lote, producto o condiciones ambientales para realizar una prueba microbiológica. En base al resultado de la prueba se llega a conclusiones relacionado a la calidad del producto o proceso. Veamos alguno de los roles de la posición de un microbiólogo.

Realiza pruebas de microbiología de rutina a la materia prima, componentes, producto final y áreas de ambientes controlados. Los métodos de realizar las pruebas ya están predefinidos en las políticas, procedimientos internos y los métodos compéndiales como el USP (United States Pharmacopeia). Estos procedimientos tienen que estar alineados con las regulaciones y guías de FDA.

Algunos ejemplos de pruebas en las que es conveniente tengas conocimiento o experiencia incluye:

  • Pruebas de agua (Conteo Viable Total, coliformes, TOC, conductividad)
  • Pruebas de Bioburden a producto
  • Prueba de límite microbiano (Microbial Limit)
  • Prueba de esterilidad mediante filtración de membrana o inoculación directa. El USP <71> establece requisitos básicos para el método.
  • Prueba de endotoxina bacteriana a muestras de agua, materia prima, componentes y producto final. Esta prueba puede ser realizada utilizando el método de coagulo (gel clot), método cinético, cromógenico y turbidimetrico
  • Estudios de letalidad (Lethality Studies)
  • Determinar la población de indicadores biológicos
  • Cualificación de Desinfectantes
  • Identificación de microorganismos o flora normal microbiana
  • Controles ambientales. En este tema se incluye el monitoreo ambiental rutinario de las áreas controladas y clasificadas, por ejemplo, áreas de manufactura y laboratorios. Se realizan pruebas de particulado viable y no viable. Algunas formas de realizar el monitoreo incluye el uso de placas de contacto (contact plates), settling plates y los air samplers.

Esto es solo un resumen de algunas de las pruebas básicas. Existen pruebas adicionales que estaremos discutiendo en futuras publicaciones.

Por otro lado, no es solo realizar la prueba, sino que luego de completada y se obtienen los resultados, estos tienen que ser documentados y analizados. Es crítico, en términos regulatorios y de sistemas de calidad, el evaluar y documentar la data para determinar si los resultados son aceptables o si se exceden los límites de alerta, acción o especificación establecidos en el procedimiento. Si alguno de estos límites se excede se procede a las investigaciones de Laboratorio.

Parte de la responsabilidad de Microbiología es asistir en investigaciones relacionado a no conformidades, desviaciones, fuera de especificación (OOS), fuera de tendencia (OOT), o fuera de límites en los resultados que se obtienen de las pruebas a productos y monitoreos ambientales. El analista de microbiología es responsable de reportar cualquier non-conformidad, iniciar y/o dirigir los esfuerzos de la investigación hasta la resolución.

El rol de microbiología en las industrias reguladas, como la farmacéutica o dispositivos médicos es bien amplio y crítico. En base a los resultados de las pruebas de microbiología se toman decisiones de la calidad de un producto. Es un área altamente controlada y auditada continuamente para asegurar que se cumple con los procedimientos, guías, estándares y regulaciones. Te exhortamos a que conozcas más de la microbiología enfocada al área de control de calidad. Es un ambiente bien diferente al que conoces en la academia, pero a la misma vez, estarás en continuo aprendizaje y aportaras mucho con la experiencia que adquieras a la organización en la que labores.

Biobusiness Research – Promote bioscience, business and biomedical industry knowledge and skills

Biobusiness Research is a knowledge sharing organization. Our mission is to promote bioscience, business and biomedical industry knowledge and skills to support individual and community competitiveness.

Our mission drive us to:

  • Establish a learning, casual, environment where people are free to learn and share best practices.
  • Support bio entrepreneurship, business and workforce development.
  • Improve individual and community competitiveness through the development of people (one by one).
  • Contribute to our community by developing our people’s talent and as a result, be competitive in the market.

Our core values: Growth | Learn | Development | Networking | Share knowledge

We offer valuable content through: Workshops Online Courses, Webinars and Publications.

Our goal is to help those individuals with a science and technology background to develop job related knowledge and skills that are valued in the workforce.

We want to help you be more competitive for the life science workforce.

Our day to day activities are focused to:

  • Promote life sciences and biotechnology knowledge
  • Provide business and industry knowledge and skills to the science and technology personnel
  • Promote talent development

We are established in Puerto Rico, and now will be serving Florida and New York. Follow us on our social networks to receive our contents and information posts.

BB FL PROMO_STATE_NY-pr

Resumen del Foro “Carreras en la Industria Biomédica”

2El sábado, 16 de junio, se ofreció el Foro “Carreras en la Industria Biomédica”. El mismo se celebró en las facilidades de Piloto 151, centro de operaciones de Biobusiness Research en el área del Viejo San Juan.  Este foro forma parte de las iniciativas de Biobusiness Research para promover el aprendizaje e intercambio de conocimiento en áreas relacionadas a la industria biomédica y las biociencias.

La actividad contó con un grupo de panelistas que laboran en diferentes áreas funcionales en la industria farmacéutica, dispositivos médicos, biotecnología y academia. Los panelistas invitados presentaron sus experiencias en la industria y como lograron la transición de la academia al mundo laboral.

Los asistentes pudieron conocer acerca de diferentes roles como por ejemplo, auditorias, calidad de suplidores, líderes de proyecto, validaciones, transferencia de métodos, laboratorios (microbiología y química), investigadores de CAPA, iniciativas “lean”, entre muchas otras áreas. Además, se enfatizó en la importancia del trabajo en equipo y como estos roles se integran en el mercado global. La actividad inició con una conferencia en donde se describieron algunos roles y puestos de trabajo comunes en la industria.  La segunda parte fue el conversatorio con los invitados.

La audiencia, mayormente estudiantes del área de ingeniería biomédica, microbiología, biotecnología entre otros, tuvieron la oportunidad de realizar preguntas y clarificar dudas enfocadas en la experiencia de trabajo de los panelistas y sus recomendaciones para lograr la transición al mundo laboral.

Esta fue una de las varias conferencias ofrecidas  durante el año por Biobusiness Research para orientar y adiestrar a los estudiantes en los conceptos prácticos y necesarios en el mercado laboral.