This presentation provides information on minimizing contamination from human personnel in cleanrooms. It discusses how human skin naturally hosts many microorganisms and how cleanroom garments and practices aim to contain these microbes. Proper gowning techniques and high-quality, tightly woven fabrics are important to limit contamination from the billions of skin cells shed daily and prevent microbes from reaching sensitive products. Understanding the human microbiome helps improve strategies to exclude microorganisms from all body areas.
Includes cleanroom rules, cleanroom techniques, cleanroom behavior, protocol and practices. Movement in cleanroom, handling in the cleanroom, nature of cleanroom personnel and wrong practices in the cleanroom.
To maintain the desired SAL at the plant is task which demands great care and control over Man, Machine & Method. This summarize work will definitely help you as hand note.
Control on Cleanroom Environmental Monitoring (Pharmaceutical)Srinath Sasidharan
A general consideration of Environmental Monitoring in Pharmaceutical manufacturing area. Cleanroom Monitoring Tools and Utilities: Author Sreenath Sasidharan (Geltec Healthcare FZE)
Guidance on gloves maintenance in Isolator and RABSPalash Das
A faulty glove or sleeve assembly represents a route of contamination and a critical breach of Isolator integrity. Within this article we will discuss about all these aspects.
Contamination Control in Cleanrooms_Dr.A. AmsavelDr. Amsavel A
Basic’s of Contamination
Sources of Contamination
Environment Specification
Elements of Cleanroom Design and Qualification
Definitions
Control of Contaminations
People, Cleaning, Environment & Material
Operation, Monitoring and Control
Documents and Records
Includes cleanroom rules, cleanroom techniques, cleanroom behavior, protocol and practices. Movement in cleanroom, handling in the cleanroom, nature of cleanroom personnel and wrong practices in the cleanroom.
To maintain the desired SAL at the plant is task which demands great care and control over Man, Machine & Method. This summarize work will definitely help you as hand note.
Control on Cleanroom Environmental Monitoring (Pharmaceutical)Srinath Sasidharan
A general consideration of Environmental Monitoring in Pharmaceutical manufacturing area. Cleanroom Monitoring Tools and Utilities: Author Sreenath Sasidharan (Geltec Healthcare FZE)
Guidance on gloves maintenance in Isolator and RABSPalash Das
A faulty glove or sleeve assembly represents a route of contamination and a critical breach of Isolator integrity. Within this article we will discuss about all these aspects.
Contamination Control in Cleanrooms_Dr.A. AmsavelDr. Amsavel A
Basic’s of Contamination
Sources of Contamination
Environment Specification
Elements of Cleanroom Design and Qualification
Definitions
Control of Contaminations
People, Cleaning, Environment & Material
Operation, Monitoring and Control
Documents and Records
This presentation contains general guidelines and basic requirements of manufacturing of sterile medicinal products. This presentation is useful for training to the people involved in manufacturing of sterile pharmaceuticals or medicines.
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
This is the 1st part of our "All about cleanrooms". This presentation will take you through the history of cleanrooms, types and applications of cleanrooms.
Validation Of System For Compressed Air Quality Imtiaz Rastgar
Food, Pharma and several other manufacturing industries need compressed air with precise control on oil-in-air, dust particles and moisture levels. Instruments and standards of compressed air quality are described by Imtiaz Rastgar, Chairman Rastgar Group and Ex CEO of Engineering Development Board, Ministry of Industries, Government of Pakistan, Islamabad.
What is likely to go into the revised Annex 1, including:
Terminal sterilisation vs aseptic processing
WFI produced by reverse osmosis
Guidance for media simulation trials
This remains speculative
Good Manufacturing PracticeFor LVP,SVP, ophthalmic veterinary medicine, bulk chemicals & invitro diagnostic
For Good business Practice
A control process gives reproducibility & product consistency with in known limits
Provides license to do business.
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
This presentation contains general guidelines and basic requirements of manufacturing of sterile medicinal products. This presentation is useful for training to the people involved in manufacturing of sterile pharmaceuticals or medicines.
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
This is the 1st part of our "All about cleanrooms". This presentation will take you through the history of cleanrooms, types and applications of cleanrooms.
Validation Of System For Compressed Air Quality Imtiaz Rastgar
Food, Pharma and several other manufacturing industries need compressed air with precise control on oil-in-air, dust particles and moisture levels. Instruments and standards of compressed air quality are described by Imtiaz Rastgar, Chairman Rastgar Group and Ex CEO of Engineering Development Board, Ministry of Industries, Government of Pakistan, Islamabad.
What is likely to go into the revised Annex 1, including:
Terminal sterilisation vs aseptic processing
WFI produced by reverse osmosis
Guidance for media simulation trials
This remains speculative
Good Manufacturing PracticeFor LVP,SVP, ophthalmic veterinary medicine, bulk chemicals & invitro diagnostic
For Good business Practice
A control process gives reproducibility & product consistency with in known limits
Provides license to do business.
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
Cleanrooms | Minimizing Risk to ProcessesCleanrooms
The overarching objective of a cleanroom is to minimize risk to the process. The risk comes from a variety of pollutants such as dust, airborne microbes, aerosol particles and chemical vapors.
Pda book table of contents-environmental monitoring a comprehensive handbook ...Allan Marinelli
This is volume 7 of the Environmental Monitoring Handbook series. Each volume of this series discusses different aspects of environmental monitoring. One of the first topics discussed in this volume is the topic of cleanrooms and ways to prevent contamination. Subject matter experts Dr. Tim Sandle, Jan Eudy, Jim Polarine, John Lindsay and others describe new and/or better ways to do things.
The second section of the book describes various environmental monitoring techniques and methods and includes informative chapters from Ryan Burke, Allan Marinelli, Dr. Andrew Sage, Tim Cser, Sean Toler, Claire Fritz Briglia and others.
The third section of the book deals with changes to standards. Memarzadeh and DeBerandinis explain the changes that occurred for ANSI Standard 29.14 and how this is applicable in pharmaceutical environments and the last section of this volume talks about new technologies and aids that can be used in evaluating these methods with chapters from Dr. Sage and Dr. JP Jiang.
There is a wealth of useful information that you can use in establishing, maintaining and updating your environmental monitoring program!
Pfizer's Strategy for the Development and Manufacture of Linker-Payloads in A...World ADC
View a past presentation by Jeffrey Sperry, Principal Scientist, Process Chemistry, Pfizer from last year's HPAPI Summit.
Benchmark against Pfizer’s internal guidance for the handling and manufacture of HPAPIs.
Evaluate pros and cons of internal versus external manufacturing.
Take away insight on effectively managing outsourcing relationships to leverage external expertise.
Drug Regulations is a Not for Profit Organizations which provides free online resources for the Pharmaceutical Professional. This presentation is part A of series of presentations which addresses the current Good Manufacturing Requirements as per the US FDA. This presentation addresses Status , Scope & Definitions
Presentation highlighting Alkermes high potency capabilities in solid oral dosage manufacture. Included in the presentation is a case study on our success tech-transferring a highly potent compound for a large pharma company.
This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations.
Household Hazards - Potential Hazards of Home Cleaning Products v2zq
Household Hazards - Potential Hazards of Home Cleaning Products - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
Chem Fatale - Potential Health Effects of Toxic Chemicals in Feminine Care Pr...v2zq
Chem Fatale - Potential Health Effects of Toxic Chemicals in Feminine Care Products - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
Raimondo Villano - Elements of pharmaceutical safety and quality from the 's...Raimondo Villano
Conference-Raimondo Villano-Ordinary Academic A.I.S.F.
Italian Academy of the History of Pharmacy AISF National Congress - Trento, White Gallery Piedicastello (7/9 June 2013) Under the Patronage of: History Museum Foundation of Trento, Italian Federation of Pharmacists Orders, Unifarco for Culture, Unifarm
Saturday, June 8, 2012 - Morning Session-Communications on any subject
Abstract
Given the sense of memory focused on the combination of the man-in the history of medicine and science of the profession, you start with hints indicative prior to the twentieth century and an evolutionary context of the entire premise of the 'short twentieth century' to carry out a survey to the current times on the main elements of safety and quality in the pharmaceutical world or in areas related to it, and more specifically, in scientific research and in industrial production, in institutions and in the profession, identifying the traits essential operational or addresses of evolution. The conclusion focuses on the potential global importance of projective scenario beginning of the third millennium, not apart from the magisterium and the pastoral care of the Church.
R. Villano - Pharmaceutical safety & quality short twentieth century x slide ...Raimondo Villano
Conference by Raimondo Villano, Ordinary Academic A.I.S.F. - Italian Academy of the History of Pharmacy AISF
National Congress - Trento, White Gallery Piedicastello (7/9 June 2013) - Under the Patronage of: History Museum Foundation of Trento, Italian Federation of Pharmacists Orders, Unifarco for Culture, Unifarm, Brentonico City.
Saturday, June 8, 2012, Morning Session,Communications on any subject.
Abstract: Given the sense of memory focused on the combination of the man-in the history of medicine and science of the profession, you start with hints indicative prior to the twentieth century and an evolutionary context of the entire premise of the 'short twentieth century' to carry out a survey to the current times on the main elements of safety and quality in the pharmaceutical world or in areas related to it, and more specifically, in scientific research and in industrial production, in institutions and in the profession, identifying the traits essential operational or addresses of evolution. The conclusion focuses on the potential global importance of projective scenario beginning of the third millennium, not apart from the magisterium and the pastoral care of the Church.
This presentation include microbiome involve in human health and disease. classification and categorization of microbiota is aslo given.Anatomical area in which these microbes present.
The Status of the Regulatory and Economic Landscape for Innovation in Big Pha...Lindsay Meyer
The purpose of engaging this topic is to: examine the current regulatory environment for new drugs, gain an understanding of breakthrough innovation in pharmaceuticals, evaluate the efforts of key players, and make projections about the future of this industry. As therapeutics has evolved away from their theistic origins, natural products, synthetic chemistry, and biopharmaceuticals have emerged. Yet many difficulties remain for this specialized industry. The approval process for a new drug can take upwards of eight years and cost $800 million. The progression from test tube to commercial distribution includes preclinical trials followed by three phases of clinical (human) trials, marked by ongoing dialogue between the Food and Drug Administration (“FDA”). Five of largest American pharmaceutical companies have intensified their efforts in Research and Development (“R&D”) in recent years. But in a space marked with competition from generic manufacturers and maturing biotech companies, understanding the dynamics of this highly scrutinized market requires an awareness of the political and economic climate these key players face. Where this industry is headed is much less clear than where it is coming from. Careful analysis is one lens through which to examine all of these intricate elements and is the focus of this research paper.
R. Villano - Pharmaceutical safety & quality short twentieth century'Raimondo Villano
Conference by Ordinary Academic A.I.S.F. Raimondo Villano (Saturday, June 8, 2013 - Morning Session - Communications on any subject) in the National Congress of Italian Academy of the History of Pharmacy AISF (Trento, White Gallery Piedicastello, 7/9 June 2013) Under the Patronage of: History Museum Foundation of Trento, Italian Federation of Pharmacists Orders, Unifarco for Culture, Unifarm; Chiron, CDD 230 VIL ele 2013, LCC CB3-482, pp. 44, Rome, June 2013;
Dr. Cheryl Stroud - What’s New In Efforts To Provide Information On Antibioti...John Blue
What’s New In Efforts To Provide Information On Antibiotic Use And Resistance To Different Audiences? - Dr. Cheryl Stroud, Executive Director, One Health Commission, from the 2018 NIAA Antibiotic Symposium: New Science & Technology Tools for Antibiotic Stewardship, November 13-15, 2018, Overland Park, KS, USA.
More presentations at https://www.youtube.com/playlist?list=PL8ZKJKD9cmEffjOrjbBvQZeN2_SZB_Skc
Domestic Detox - Pollution is Personal - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
Alternatives to Antibiotic Use in Food Animal ProductionPewEnvironment
Stephen Jay, M.D., professor of Medicine and Public Health and past founding chair, Department of Public Health, Indiana University School of Medicine.
Sick of Dust - Chemicals in Common Products, A Needless Health Risk in Our Ho...v2zq
Sick of Dust - Chemicals in Common Products, A Needless Health Risk in Our Homes - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~ cleanproduction.org
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
This presentation gives a overview of the new FDA draft guidance on Analytical Method Validation and compares it with the older version issued in the year 2000.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Understanding and Preventing Clean Room Contamination
1. This presentation is compiled by “ Drug Regulations” a
non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
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2. This presentation is compiled from freely available resources like
the websites of FDA, EMA ,WHO and research papers published
by experts in this field like
Sandle, T Reinmüller, B , Hyde, W,, Costello, E.K., Lauber, C. L.,
Hamady, M., Fierer, N., Gordon, J.I., Knight, R.
Paper published by T. Sandle on clean room contamination was
referred extensively for this presentation.
“Drug Regulations” is a non profit organization which provides
free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from
the world of Pharmaceuticals.
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4. Staff gowning
Personnel behavior
How to minimize cleanroom risk
Basic training
◦ Cleanroom staff
◦ Cleanroom entry
◦ Gowning practices
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5. Cleanroom contamination can arise from a
number of sources.
Type of cleanroom
Its geographic location
The types of products processed
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6. Contamination sources can be divided into
following
◦ People
◦ Water
◦ Air and ventilation Surfaces
◦ Transport of items in and out of clean areas
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7. Most contamination can be traced to
humans working in cleanrooms.
◦ Conclusion based on organisms associated with
isolates from environmental monitoring in
controlled environments.
These microorganisms are transient or
residential to the human skin.
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8. Human personnel shed high numbers
of skin cells mostly as skin flakes.
The cleanroom garments worn by
personnel cannot contain all human
detritus.
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9. Trillions of microbial cells across the epithelial surface
and within the mouth and gut.
These microorganisms play a role in human physiology
and organ function including digestion and immunity.
The microorganisms also affect the outside
environment
This is due to shedding from the skin or deposited
through different orifices.
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10. This latter issue has important implications for
cleanrooms.
The outer layer of human skin can host up to one
million microorganisms per square centimeter.
The population, as well as the diversity, varies
according to anatomical locale.
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11. Microorganisms within Human Body
◦ Scalp: 1 million
◦ Saliva and nasal fluid: 10 million/gram
◦ Back: 100
◦ Groin: 1 – 20 million
◦ Forehead: 100 – 1000
◦ Hand: 10,000 – 100,000
◦ Armpit: 1 – 10 million
◦ Feet: 1 million
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12. Research suggests that a typical person sheds
1,000,000,000 skin cells per day of a size 33 μm x 44 μm x 4
μm
This is equivalent to a rate of 30,000 to 40,000 dead skin cells
shed from the surface of the skin every minute.
Of these approximately 10% of particles carry microorganisms.
There are, on average, four microorganisms per skin cell.
A term commonly used to describe skin flakes with adhered
microorganisms is “microbial carrying particles.”
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13. People are
A source of contamination,
Agents for transferring contamination possibly to locations
that could pose a product risk.
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14. Microorganisms are spread from
◦ Sneezing
◦ Coughing
◦ Touching
Microorganisms suspended in the air are less of a
concern
When such organisms gravitate towards a product
or critical location, they present a significant risk.
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16. The Human Microbiome Project (HMP)
◦ United States National Institutes of Health initiative.
◦ The project goal is to identify and characterize the
microorganisms found in association with both healthy and
diseased humans (the human microbiome).
Our understanding of the risk the people pose to
cleanrooms has been advanced
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17. The human microbiome describes the aggregate of
microorganisms and their genetic interactions that
reside
◦ On the surface and in deep layers of skin
◦ In the saliva and oral mucosa
◦ In the conjunctiva
◦ In the gastrointestinal tract
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18. Skin is a complex ecosystem
Supports a range of microbial communities
These live in distinct niches
These niches are affected by
◦ Available nutrients
◦ Several non-nutritional factors such as pH, humidity, and
temperature.
Epithelial cells are continually being shed,
Many microbial communities on the external surface are
rarely stable.
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19. Outer layer of Skin
Has High population
Considerable diversity of microbial species
across
There are approximately 1000 species of
bacteria from 19 phyla on human skin.
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20. Of these, most bacteria can be categorized
into following phyla:
◦ Actinobacteria (51.8%).
◦ Actinobacteria are a group of Gram-positive
bacteria with high guanine and cytosine content,
Such as Micrococcus, Corynebacteria and
Propionibacteria.
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21. Of these, most bacteria can be categorized
into following phyla:
◦ Firmicutes (24.4%).
◦ This includes the genera Clostridia and Bacillus.
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22. Of these, most bacteria can be categorized into
following phyla:
Proteobacteria (16.5%).
◦ This is a major phylum of bacteria
◦ Includes a wide variety of pathogens such as
Escherichia,
Salmonella,
Vibrio,
Helicobacter, and
many other notable genera.
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23. Of these, most bacteria can be categorized into
following phyla:
Bacteroidetes (6.3%).
The phylum Bacteroidetes is composed of three
large classes of
◦ Gram-negative
◦ Nonspore-forming
◦ Anaerobic
◦ Rod-shaped bacteria
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24. Reasons for the topographical variations relate
to the physicochemical properties of the skin.
This is especially so for
◦ Temperature
◦ pH
◦ Amounts of oil
◦ Moisture
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25. From this, there are three main
ecological areas of the skin:
◦ Sebaceous
◦ Moist
◦ Dry
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26. Examples of microbial divergence include
◦ Propionibacteria and Staphylococci species dominating the Dry, calloused areas
(arms and legs)
◦ Gram-positive cocci (primarily the Micrococcaceae) are found on the arms and
legs
◦ Gram-positive rods are found in high numbers on the torso.
◦ Staphylococci and Corynebacteria are found together with some Gram-negative
bacteria in moist areas.
These types of microorganisms generally reflect the types recovered
from cleanrooms
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27. Gram-positive bacteria predominate across the
skin as
◦ The skin is generally a dry environment
◦ Any fluids present on the surface generally have a high osmotic
pressure
Thus Gram-positive bacteria are better adapted for
such environments, not least to being resistant to
desiccation.
◦ (especially the Staphylococci and Micrococci)
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28. Where other species occur this is due to
◦ Variations in temperature and
◦ With areas of higher sweat production
For example, this can lead to higher levels of fungi
on the feet
In relation to pharmaceutical manufacturing, the
presence of any such organisms remains
problematic.
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29. The ratio of the microorganisms recovered from
the skin is relatively evenly divided between the
aerobic and the anaerobic.
The aerobic microorganisms tend to live on the
outermost layers of the skin
The anaerobic microorganisms live in the deeper
layers of the skin and hair follicles
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30. The information from HMP introduces several
implications for cleanroom environmental monitoring.
◦ Whether gowning practices are adequate to exclude all
microorganisms from the richest areas of the skin microbiome.
Most bacteria free-floating in cleanroom air current are
not free-living
They are instead the result of
◦ Direct particle shedding of desquamated skin cells and
◦ Subsequent re-suspension of skin detritus in the air stream.
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31. The answer to earlier question should lead to a
consideration of:
◦ The types of cleanroom undergarments used
◦ An examination as to whether these provide an effective
barrier, especially for the more moist parts of the body.
◦ The importance of the outer gown covering all parts of the
body, including the forehead.
◦ The quality of cleanroom certified undergarments.
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32. The answer to earlier question should lead to a
consideration of:
◦ The level of training required for operators in relation to
gowning and the way that gowning qualification was
conducted.
◦ How long a cleanroom suit should be worn for in relation to
material integrity against operator perspiration.
◦ The environment in which gowns are donned, where higher
air-change rates might prove effective.
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33. The answer to earlier question should lead to a
consideration of:
◦ How often gowns should be recycled which involves
washing and irradiation.
◦ What types of testing is conducted on recycled gowns
◦ What the procedures are for rejecting gowns where a
loss of integrity is detected.
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34. Cleanroom microbiologists may wish to consider how
concerned they are with each of the items listed in
excluding microorganisms found on all regions of the
skin.
There must be good understanding of the environmental
monitoring methods used to assess cleanrooms.
These may not show how good or bad gown changing and
gown wearing is.
These concerns are best addressed through good gowning
practices
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36. Despite some advances with automation and robotics, in
most situations people cannot be eliminated from
cleanrooms.
Control of contamination from people in cleanrooms is
achieved by application of two principles:
◦ We “wrap” the people to minimize the amount of “shedding” of
microorganisms.
◦ We put localized protection around the product to minimize the amount of
contact with the people.
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37. The localized protection is achieved through local air
protection, such as
◦ Unidirectional airflow cabinets and
◦ Isolators.
With clothing, personnel working in cleanrooms are required
to wear special clothing designed for the clean environments.
Such clothing is necessary because the human body creates
its own microenvironment of potentially damaging particulate
contamination.
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38. To be effective, cleanroom clothing must:
◦ Form a particulate barrier for the human micro-
environment.
◦ Allow freedom of movement and be comfortable.
◦ Address any specialist requirement,
e.g. static dissipation.
Avoid being a significant particulate contributor in itself.
◦ Cleanroom garments must meet specific protection criteria.
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39. Not all cleanroom garments are of the same quality.
This involves manufacturing the garments from special
materials, following particular construction methods, and
then tailored for individual styling.
The gowns must be comfortable, easy to apply and practical
in use.
Some gowns are disposable and others are made to be re-
laundered and sterilized depending on the cleanroom grade.
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41. Fabrics used in the manufacture of cleanroom garments must
have the following features:
◦ Be low in particulate shedding.
◦ Permit the body to breathe while trapping particles within the garment.
◦ The contaminant should be retained within the garment and not released
into the surrounding atmosphere.
◦ Be flexible enough for comfortable wearing.
◦ Withstand repeated cleaning and sterilization cycles.
◦ Meet any specific requirements such as control of static.
◦ Meet opacity requirements.
◦ Look and feel as good as possible. Be cost-effective.
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42. There are three broad categories of fabric used in the
construction of cleanroom garments:
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43. Woven fabrics.
◦ Woven or re-usable fabrics are the most commonly used fabrics in
cleanroom environments.
◦ Such garments are woven on sophisticated looms from yarns of
continuous filaments of polyester.
◦ The thickness of the yarn and filaments is important –
the finer the yarn, the tighter the weave can be made, and the better the filtration.
◦ The pattern and tightness of the weave is important to reduce the pore
size to a minimum.
◦ The use of continuous filament polyester means that there are few loose
ends from which particles may be shed.
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44. Laminated or membrane fabrics.
◦ Laminated fabrics are favored for some high-
grade microelectronic environments.
◦ These types of garments are not commonly used
in the pharmaceutical sector.
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45. Disposable or limited life materials.
◦ The most common of these non-woven fabrics are from spun
bonded olefin and polypropylene.
◦ Comprising a densely interlinked matt of fibers, these fabrics can
provide good results for a limited period.
◦ Garments from such materials need to be processed and
decontaminated before use in the cleanroom.
◦ Disposable or limited use garments are mainly used in those
environments where protection of the wearer against potentially
hazardous products is required.
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47. Garments are designed to provide protection for the head, body,
hands and feet.
In establishing a system for garment selection, it is important to
consider the broader aspects of cleanroom use:
◦ Suitability of fabric,
◦ Garment style,
◦ Layers,
◦ The nature of the tasks involved,
◦ Costs,
◦ Regulatory requirements, and
◦ Any specific customer requirements.
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48. The classification of the cleanroom will inevitably be the
major factor in determining the degree of personnel
protection required and the fundamental choice of garments.
One important issue with gowns is the maximum length of
time that a gown can be worn.
As people perspire, the integrity of the gown will weaken.
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49. Complicating factors are the temperature and humidity
of the cleanroom and the variations between people.
The length of time will also depend upon the grade of
the cleanroom.
In aseptic areas, such as ISO 14644 class 7 / EU GMP
Grade B areas, gowns are typically worn only for the
length of the shift
◦ (normally four hour periods to enable operators to take breaks).
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50. In lower grade cleanrooms, a gown might be worn
for several sessions during the course of the
working day.
Other factors affecting the lifespan of the gowns
that are subject to recycling are repairs and the
number of permitted washing cycles.
With repairs, it is prudent to have a repair policy.
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51. This will vary across facilities, and again, it will be affected by
the cleanroom class.
With aseptic areas, if a gown becomes torn it is normally
discarded.
In other grades of cleanroom, a gown can be repaired
depending upon the size of the hole and the impact on the
material.
Some organizations set a maximum size for any hole or tear
and for the number of times a gown can be repaired.
Gowns that are recycled are subject to laundering.
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52. Gowns are washed by special washing machines with suitable
detergents,
They are then dried, folded, and then wrapped in cleanroom packaging.
For gowns that are to be used in aseptic areas, such gowns are
irradiated.
A policy should be in place outlining how often a gown can be processed
-- typical times range between 20 and 40 times.
To make the tracking task easier, many gowns sterilized by irradiation or
gassing are fitted with barcodes and scanned.
It is further important to establish the extent that the sterilization
process affects the integrity of the gown material.
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53. In order to assess the contamination risks from re-
laundering, gowns are subject to particle counting.
There are different ways to do this
Most common means is the Helmke Drum particle
emission test.
With this, the test method simulates particle
shedding of clothing under movement.
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54. The garment under test is tumbled in a rotating drum
(approximately 10 revolutions per minute)
This releases particles from the surface of the
cleanroom garment in a controlled manner.
An automatic particle counter is used to sample the air
within the drum
Determination of the average particle concentration of
the air during the initial ten minutes of the test is
performed.
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55. The common standard is the IEST "Recommended Practice RP-CC003.3:
Garment System Considerations for Cleanrooms and Other Controlled
Environments".
An alternative measure is the Body Box test.
This method simulates particle filtration and release under real wear
conditions.
As a consequence it measures the contamination of the cleanroom by
the clothing/wearer.
For this, particle counters determine the quantity of particles generated
by the wearer/garment that are emitted into the chamber.
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57. Cosmetics, such as powder, rouge, eye liner, mascara, and lipstick
must be banned in cleanroom environments.
Jewelry, such as rings, watches, necklaces, bracelets, earrings and
other items, together with all forms of visible piercing, are
commonly not allowed in cleanrooms.
The best method of changing into cleanroom garments is one that
minimizes contamination getting onto the outside of the garments.
Change areas can vary in design, but it is common to find them
divided into three zones:
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58. Pre-change zone.
Outside of changing rooms 'tacky mats' or polymeric flooring can be
positioned to help reduce the level of particles carried on footwear.
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59. Changing zone.
The changing room design contributes to the assurance of
appropriate personnel access and microbial contamination control.
The changing room should be provided with filtered air.
Intermediate (bag) filters will typically be suitable for this purpose,
though High Efficiency Particulate Air (HEPA) filtration may be used.
The air pressure should be negative with regards to the
manufacturing area corridor, but positive relative to external
adjacent areas.
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60. Cleanroom entrance zone.
This must be of the same grade or class as the main cleanroom into
which the area leads.
Ideally there should be separate routes through airlocks for material
required in cleanrooms.
Taking items through personnel change areas should be
discouraged.
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62. Personnel training in gowning is an important function.
Gowning practices must be assessed periodically and monitored
frequently.
Training programs should ideally include visual assessment and
microbiological assessment.
The microbiological assessment varies, but can include
◦ The exposure of settle plates during the change process and
◦ The assessment of gown cleanliness through post-use suit contact plates.
The results of the cleanroom sampling should not exceed those of the
room class.
If results are exceeded, the individual may be an unusually high shedder
of skin particles.
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63. Training required for staff who work in cleanrooms should
include:
◦ Introduction to micro-organisms and microbiological contamination
control.
◦ Entry and exit of production facilities (including gowning)
◦ Personal hygiene training
◦ Microbiological risks associated with specific production tasks.
◦ Training must be documented and regularly reviewed. Training must be
effective.
◦ Actual performance of personnel competency in gowning should be
demonstrated on a regular basis.
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65. Working in clean environments demands
Knowledge,
Discipline,
Motivation as well as
A thorough understanding of contamination risks among all
personnel involved.
Each individual cleanroom should have its own documented rules
and procedures.
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66. Training includes reminding personnel that they must not be
allowed to touch critical products and equipment with their naked
hands.
All critical work must be undertaken wearing gloves.
Critical activities requiring personnel contact such as aseptic
processing or sampling must be done through the use of clean
utensils such as tweezers, forceps, and the equivalent.
All devices and gloves used must fully comply with the cleanliness
demands of the cleanroom and work undertaken in the cleanroom.
They must be cleaned, disinfected, or sterilized as appropriate for
the criticality or activity and risk of contamination.
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67. Another aspect of best practice is in instructing personnel in the
appropriate behaviors within the cleanroom.
The generation of contamination is proportional to activity
conducted.
A person with head, arms, and body moving can generate about
1,000,000 particles ≥ 0.5 μm/min.
A person who is walking can generate about 5,000,000 particles ≥
0.5 μm/min.
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68. However a person in motionless position can generate only
100,000 particles ≥ 0.5 μm/min.
In addition, personnel should reduce activities like talking,
singing, whistling, coughing, sneezing etc., especially when
being close to the handled products and production
equipment.
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69. People working in cleanrooms and other forms of controlled
environments must be physically healthy.
Diseases in the upper respiratory tract as well as stomach disorders can
create problem in hygienic applications.
Another factor that can impact upon the environment is the number of
people in the cleanroom.
Only necessary and limited number of persons should be allowed in a
cleanroom at the same time.
The more persons simultaneously present in a cleanroom, then the
higher the contamination level will be,
◦ i.e., the higher concentration of particles in the air
This is particularly important in relation to changing rooms.
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71. Good personal hygiene is a requirement of all
pharmaceutical cleanroom activities.
However, studies show poor compliance is
common in relation to basic hand washing
technique.
Hand hygiene and glove hygiene are important
given the high numbers of microorganisms found
on the human body
They also pose risk of contamination by transfer
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72. Microorganisms associated with hands are found mainly
on the surface of the skin and under the superficial cells
of the stratum corneum.
The dominant species is Staphylococcus epidermidis
This is found on almost every hand, together with other
species of Staphylococcus and species of the genera
Micrococcus.
Hands must be washed with soap and water prior to
entry to the cleanroom.
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73. Hand washing facilities should not be located in an
actual cleanroom, but rather in an area leading to
the cleanroom changing room.
As an alternative, a hygienic handrub can be used.
Where gloves are required these should be put on
using a method designed to prevent the ungloved
hand from touching the clean or sterile outer part
of the glove.
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74. Once in the cleanroom, gloved hands should be
subject to periodic hand sanitization
When decontaminating hands with an alcohol-
based antiseptic hand rub,
◦ Apply product to palm of one hand and rub hands together,
◦ Covering all surfaces of hands, fingers and wrists,
◦ Until hands are dry
(alcohol-based hand rubs are not to be used with water).
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75. The process typically takes between thirty seconds
and one minute.
Follow the manufacturer’s recommendations
regarding the volume of product to use.
The technique for applying alcohol to gloved hands
is similar to applying a handrub to skin.
It is important to ensure that all surfaces are
covered.
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76. With glove sanitization, there are two alcohols of
choice:
Ethyl alcohol (ethanol) and isopropyl alcohol (IPA)
Other alcohols, such as methyl alcohol (methanol)
are unsuitable.
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77. IPA is slightly more bactericidal than ethanol
Ethanol has better viricidal properties
Another factor is application to the skin;
IPA can be quite harsh.
Thus, ethanol is more often applied to bare skin
(often in a denatured form)
Whereas IPA is more often applied to gloves.
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78. These sanitizers have bactericidal action against vegetative
cells but not spores.
The concentration of alcohol to water varies, although the
optimal range is 60 to 90% (volume/volume).
Below 60%, bactericidal action drops,
Above 90% there is insufficient water for the bacterial cell to
absorb water.
The alcohol does not enter the cell and is unable to denature
the bacterial proteins.
Most preparatory concentrations are 70%.
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79. While most bacteria are killed after ten seconds of
contact with alcohol contact times in practice are
longer due to the variability of hand rubbing.
Typical contact times are thirty seconds.
It is important that the selection of a hand sanitizer
is qualified.
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80. There are different approaches that can be taken
for qualification.
Most of these require
◦ Individuals to wear gloves
◦ Place their hands into broth containing a high concentration
of a non-pathogenic microorganism.
◦ Disinfectant is then applied
◦ Bacterial reduction is assessed through placing the treated
hands into broth and performing dilutions
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82. Assess the risk of personnel to the process by taking suit
contact plates of the gown as worn by the person as they
leave the aseptic area.
The gown must be discarded after the plates have been taken
This is due to the potential effect on the gown integrity when
an agar plate contacts the gown.
It is good practice to begin suit sampling with a higher
number of samples.
These can then be reduced over time.
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83. Some facilities perform more samples from the
gown during gowning test qualifications compared
with routine sampling.
Sites considered for selection include
◦ The top of the head
◦ The facemask
◦ Both arms
◦ Middle torso
◦ Both legs
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84. In terms of limits, for EU GMP Grade B/ISO class 7 areas, the aim is
often to adopt the same limits as per the limits applied to
fingerplates.
The action level for gowns is ordinarily 5 CU/25cm
Experience has shown that higher counts are obtained from the top
of the head,
This is perhaps because this is the warmest region of the body.
Care must be undertaken when sampling as so not to break the
integrity of the gown.
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85. In addition to gowning control, a procedure should be in
place for the notification of health conditions by staff.
Staff who are ill (coughs, colds, and so on) should not enter
cleanrooms.
This is because the illness may affect product quality.
It is important to control the potential risks from personnel
carrying Infectious disease.
Open lesions on any exposed part of body.
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86. Shedding skin conditions, such as eczema or psoriasis,
dermatitis, and dandruff
◦ (skin scales may harbor objectionable micro-organisms that may impact
pharmaceutical products and patients).
Gastric upsets.
Personnel with any of the above conditions must be excluded
from working within cleanrooms for the duration of their
illness.
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87. This presentation is compiled from freely available resources like
the websites of FDA, EMA ,WHO and research papers published
by experts in this field like
Sandle, T Reinmüller, B , Hyde, W,, Costello, E.K., Lauber, C. L.,
Hamady, M., Fierer, N., Gordon, J.I., Knight, R.
Paper published by T. Sandle on clean room contamination was
referred extensively for this presentation.
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