Endotoxin Testing is performed to ensure that injectable preparations and medical devices are free from pyrogens and safe for human use.
Pyrogens constitute a heterogeneous group of fever causing substances which comprise both microbial and non-microbial substances. The most potent and most widely known are the endotoxins or lipopolysaccharides (LPS), which are cell wall components of gram-negative bacteria. Gram-positive bacteria are also sources of pyrogens, in particular lipoteichoic acid (LTA), as are particles from yeasts and viruses. Non-microbial pyrogens often emanate from production environments. Small particles of packaging materials are a typical example.
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 an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
دورة مختصرة عن المعمل الميكروبيولوجى ودوره فى شركات ومصانع الادوية
المحتوى :
- Introduction to Microbiology
- Microbiology lab. Overview
- Microbiology Lab. Role
- Pharmaceutical Microbiology
- Microbiological tests for pharmaceuticals
الميكروبيولوجى ببساطة
It's all about the microbiological assay of antibiotics and there has different type of microbiological assay of antibiotics.It's main purpose how to determine the potency of antibiotics.
In this slide contains definition and biological assay of Adsorbed Diphtheria Vaccine.
Presented by: G.CHIRANJEEVI (Department of pharmaceutical analysis).
RIPER, anantapur
Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms.
The efficacy of antimicrobial preservation of a pharmaceutical preparation on its own or, if necessary, with the addition of a suitable preservative has to be ascertained during the development of the product.
The primary purpose of adding antimicrobial preservatives to dosage forms is to prevent adverse effects arising from contamination by micro-organisms that may be introduced inadvertently during or subsequent
to the manufacturing process.
However, antimicrobial agents should not be used solely to reduce the viable microbial count as a substitute for good manufacturing procedures.
There may be situations where a preservative system may have to be used to minimise proliferation of micro-organisms in preparations that are not required to be sterile.
دورة مختصرة عن المعمل الميكروبيولوجى ودوره فى شركات ومصانع الادوية
المحتوى :
- Introduction to Microbiology
- Microbiology lab. Overview
- Microbiology Lab. Role
- Pharmaceutical Microbiology
- Microbiological tests for pharmaceuticals
الميكروبيولوجى ببساطة
It's all about the microbiological assay of antibiotics and there has different type of microbiological assay of antibiotics.It's main purpose how to determine the potency of antibiotics.
In this slide contains definition and biological assay of Adsorbed Diphtheria Vaccine.
Presented by: G.CHIRANJEEVI (Department of pharmaceutical analysis).
RIPER, anantapur
Sterility Testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms.
The efficacy of antimicrobial preservation of a pharmaceutical preparation on its own or, if necessary, with the addition of a suitable preservative has to be ascertained during the development of the product.
The primary purpose of adding antimicrobial preservatives to dosage forms is to prevent adverse effects arising from contamination by micro-organisms that may be introduced inadvertently during or subsequent
to the manufacturing process.
However, antimicrobial agents should not be used solely to reduce the viable microbial count as a substitute for good manufacturing procedures.
There may be situations where a preservative system may have to be used to minimise proliferation of micro-organisms in preparations that are not required to be sterile.
Bioburden is the measure of living microbes on a surface that has not yet been sterilized. It is usually tested for on medical devices and other products that come in contact with patients during care at a medical facility.
Terminology
Introduction of Disinfectants
Classification of Disinfectants
Mode of action of Disinfectants
Factors affecting Disinfection
Evaluation of Anti-microbial agents and Disinfectants
Genotoxicity studies can be defined as various in-vitro and in-vivo tests designed to identify any substance or compounds which may induce damage to genetic material either directly or indirectly by various mechanisms. These tests should enable the identification of hazard with respect to DNA damage and fixation.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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
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micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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
3. 3
Lecture AGENDA
Our course of discussion for today’s presentation
• General Information & History
• Definitions of endotoxin
• Detection Methods
• Rapid Methods
• Low Endotoxin Recovery
• Importance of Sterile Manufacturing
• Contamination Control
4. 4
Endotoxin
Purpose and History of Endotoxin Testing
• Where do Endotoxins come from ? Endotoxin contamination can occur through water, raw materials, media, equipment, containers used
in the manufacturing.
• Manufacturing process must be microbiologically controlled to reduce and remove endotoxins by monitoring raw materials and in process
intermediates at critical steps.
• Why do we perform endotoxin testing? Code of Federal Regulations 21CFR 211.167(a) requires that any drug product claimed to be
sterile and non-pyrogenic be tested prior to release!
• The necessity to ensure that parenteral products are free from heat stable endotoxins and other pyrogens was recognized during World
War II when the need for intravenous fluids was huge.
• At the time the safety was ensured by conducting Rabbit Pyrogen Test (Florence Seribert) RPT became part of USP in 1942.
• LAL (Limulus amebocyte lysate) is an aqueous extract of blood cells from the horseshoe crab, developed by Frederick Bang and Jack
Levin found that amebocytes of horseshoe crab will clot in the presence of endotoxins.
• LAL did not completely replaced RPT because of interferences with the LAL assay.
5. 5
Endotoxin
What are endotoxins?
• Components of the outer cell membranes of Gram-negative bacteria.
• Shed as part of the normal bacterial life cycle or by other processes that disrupt cells
• Contaminants in pharmaceutical raw materials, water systems, in process samples, and finished products.
• They are the major contributors to the pyrogenic response observed with contaminated pharmaceutical products
• Administration of parenteral products contaminated with pyrogens including LPS can lead to development of fever, induction of
inflammatory response, shock, organ failure and death in humans.
• Endotoxins contain lipopolysaccharide (LPS) molecules surrounded by surface proteins, lipoproteins and phospholipids.
• Lipopolysaccharides – Biologically active component of the endotoxin complex
• Located in the outer cell membrane of gram negative bacteria.
• Composed of three regions
• Lipid A: Active toxic portion. This region important for maintaining structural integrity.
• Core oligosaccharide: less heterogeneous and conserved. Inner core and outer core.
• O-antigen: consists of repeating units of glycosyl residue and structure varies among different bacterial strands.
6. 6
Endotoxin
Purpose, Test Method, and Definitions
• Naturally Occurring Endotoxin (NOE)
• NOEs are environmental, shedding from Gram negative bacteria.
• Control Standard Endotoxin (CSE)/Reference Standard Endotoxin (RSE)
• RSE preparation supplied by the FDA
• RSE and CSE are used as calibration and test standards in BET.
• RSE and CSE are purified LPS and are distinguished from Natural Endotoxins.
• CSE (Control Standard Endotoxin) is a commercially prepared lyophilized endotoxin and its potency is
determined against RSE.
• Contains stabilizers like human serum albumin, Polyethylene Glycol, and starch
• CSE/RSE VS Endotoxin
• CSE and Endotoxin not considered to be the same. CSE – purified LPS
• LPS and endotoxin are physically, chemically and structurally different.
7. 7
Endotoxin
Test Methods - Bacterial Endotoxin Test (BET)
• Bacterial Endotoxin Test (BET) methods used:
• [USP <85> USP <151> USP <161>
• Gel-Clot method – qualitative method based on the formation of clotting of the test solution in presence of endotoxins
• Kinetic Chromogenic Method – quantitative method based on the color change of the reaction in the final test solution.
Measures the enzymatic reaction between bacterial endotoxin and the white blood cells of the horseshoe crab.
• Test compares sample or sample extract to standards prepared from Control Standard Endotoxin (CSE)
• Kinetic Chromogenic Test conducted by:
• Sample – test sample solution added to LAL reagent
• Positive Control - sample solution spiked with known amounts of CSE and added to LAL reagent.
• PPC Spike must recover 50-200% of CSE added
• <50% = Inhibition
• >200% = Enhancement
8. 8
Endotoxin
Test Methods - Bacterial Endotoxin Test (BET)
• As per USP <85> samples are prepared to “non interfering state” (dilution) where a nominal level of CSE activity can be quantitatively
recovered. (Inhibition/Enhancement or Validation)
• There is no requirement that CSE be recovered in undiluted products!
• Product interferences with LAL assay are known to occur as it as a highly sensitive test.
• Inhibition
• added known spike of CSE is “under estimated” activity is masked or diminished.
• Enhancement
• added known spike of CSE is “over estimated”
• Reagents used to overcome Inhibition/Enhancement: B-glucan blockers, cationic dispersing agents, divalent cations, heating.
9. 9
Endotoxin
Purpose, Test Method, and Definitions
• Low Endotoxin Recovery (LER)
• LER: “masking effect” caused by decline in the LAL reactivity to CSE after its addition to the test material.
• Is temperature dependent
• Primarily focus on Undiluted products
• Can be distinguished from interference commonly seen with the LAL assay that is normally overcome by dilution or other sample
preparation
• What causes LER?
• Precise mechanism of the LER matrix interference unknown but according to number of theories by industry researches there are
combination of factors that can cause LER.
• Polysorbate that is found in many protein formulations.
• Chelators
• Ionic nature of the protein
• Inhibition/Enhancement can be due to adsorption or aggregation, cation concentration, proteins.
FDA take on LER – Recommends hold time studies. FDA Q&A 2012 #3 “Firms should establish procedures for storing and
validating (which includes product mixing) samples of bacterial endotoxin analysis using laboratory data to demonstrate the
stability of assayable endotoxin content. Protocols should consider the source of endotoxin used in the study, bearing in mind that
endotoxins might react differently from native sources of endotoxins.
Why worry about LER? – contamination can occur during manufacturing process and finished product may contain endotoxins
(residual from the contamination) but if they cannot be detected by test methods, it can be a health and safety concern.
10. 10
Endotoxin
Test Methods
• Rabbit Pyrogen Test (RPT)
• RPT commonly used to detect endotoxin in products that is unable to be detected by LAL
method.
• in vivo [USP <151>] used to detect endotoxin in pharmaceutical products by monitoring the
increase in temperature or a fever following the intravenous injection of a test solution and is
designed for products that can be tolerated by the test rabbit in a dose not to exceed 10mL /kg
injected intravenously within a period of NMT 10 minutes.
• Limitations with RPT due to large number of use of animals for testing, continue to encourage
new methods.
• Rabbits may develop tolerance to endotoxin
• RPT may be waived if any other method demonstrated to be equivalent.
11. 11
Endotoxin
Alternative Methods – What other methods?
• Recombinant Factor C – delivers same reliability as LAL
• Activation of the first component in the LAL cascade
• No animal resources
• No false positive reactions from beta glucans
• Monocyte activation test (MAT).
• Alternative to rabbit pyrogen test
• Can test for
• Gram Negative
• Gram Positive
• Other biological pyrogens (eg yeast)
• Parasitic pyrogens
• Viral Pyrogens
• Uses cryopreserved human blood as source of monocytes (immune response cells)
• Monocytes recognize pyrogens and respond by releasing fever-inducing signal molecules
• Fever inducing molecules detected by ELISA.
• Eliminates interference from turbidity, color, or clotting
• Rapid Detection Methods
• Reduce cost, ease of use, time.
• Optical, Electrochemical, and mass based biosensors
• Still in Research and development
12. 12
Ph. Eur Sterile Products guidance
Future Update
• European guidelines under review – to revise annex 1 on manufacturing of sterile products
• Sterile manufacturing of pharmaceutical medicines plays an important role for microbiological contamination.
• Main risk concerns:
• Viable microorganisms
• Particulate matter
• Pyrogens (including bacterial endotoxin)
• Minimize risks
• Sterility achieved through
• Protective controls
• Good manufacturing practice
• Skill, training, and attitudes of personnel important.
• Quality assurance – to make sure carefully established and validated methods are strictly followed.
13. 13
Water for Pharmaceutical Use
US vs Ph. Eur – European guidelines under review
• USP vs Ph. Eur WFI water systems
• USP: WFI can be produced using either Distillation or Reverse Osmosis.
• Ph. Eur only permits Distillation to be used. May allow both after update.
• Distillation: process where component substances from a liquid mixture are separated
through the combination of selective evaporation and condensation
• Good for removing endotoxin
• Reverse Osmosis: uses a semi-permeable membrane to remove larger particles from
water through the application of an applied pressure.
• RO used to be less efficient
• Water for Pharmaceutical use typically Water for Injection
15. 15
Bioburden Contamination Control
Pharmaceuticals, medical devices and personal care product manufacturing
• To minimize product contamination and to monitor the environments within such
products are produced.
• All aspects of the operation should be designed to establish, implement and maintain
a quality system that ensures the delivery of pharmaceutical and health care products.
• Facilities
• Equipment
• Personnel
• Monitoring incoming raw materials
• Water systems
• Sanitizers
16. 16
Matrix
Overview of contamination control
Validation Control Monitoring
Facility Qualification of Clean
Room area and HVAC
system
Maintenance of facilities sanitization,
Revision of Barriers, Traffic Patterns, or
Air Balance
Environmental
Monitoring (EM)
HVAC Qualification of the Clean
Room area and HVAC
System
Certification and Preventative
Maintenance (PM) of System, Repair of
HEPA Filters
EM
Water Qualification of Water
System
Certification and PM Regular
Sanitization of System
Bioburden Monitoring
of Water System
Equipment Qualification of the
Equipment as Suitable for
its Intended Use
Certification and PM Regular
Sanitization
EM, Finished Product
Release Testing
17. 17
Matrix
Overview of contamination control
Validation Control Monitoring
Sanitization
Validation of Cleaning, Sanitization
and Sporicidal Treatments
Regular cleaning and
Sanitization of facilities and
equipment
EM
Personnel Proficiency criteria, participation in
media fills, trending data by
operator
Training Discipline
Personnel Monitoring
Trending Data by
Operator
Process
Process Validation
Acceptance Testing of Raw
Materials and Containers
In-Process Bioburden
Monitoring
Finished Product
Release Testing
18. 18
Conclusion
Overview of contamination control
• Some thoughts do not reflect those of FDA or other regulation
• LER is a concern of FDA and Biologics License Applications
• No cases associated with endotoxin contamination since 1987.
• Further research needed for LER, Rapid endotoxin, new technologies
• Guidance's under review
• Process controls for Endotoxin
19. 19
CONTACT US
Gibraltar Laboratories is conveniently located
GIBRALTAR
LABORATORIES
122 Fairfield Road
16 Montesano Road
(Shipping/Receiving)
Fairfield, New Jersey 07004
(973) 227-6882
kkohan@gibraltarlabsinc.com
www.gibraltarlabsinc.com
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