The document provides guidelines for the manufacture of radiopharmaceuticals in the European Union. It outlines key principles of good manufacturing practice that must be followed, including preventing cross-contamination, protecting personnel from radiation, and ensuring strict quality control. Premises and equipment used in manufacturing must be qualified and validated. Personnel require specialized training. Sterile radiopharmaceuticals require an aseptic manufacturing environment. Distribution is permitted before complete testing due to short product shelf-lives.
Optimizationof fuselage shape for better pressurization and drag reductioneSAT Journals
Abstract
The fuselage of any aircraft is essentially to accommodate the payload. It is normally not as streamlined as the wing. Cabin pressurization has been a major concern in the manufacturing of aircrafts. Generally, a cylindrical shape is preferred from a pressurization point of view as it has a higher strength and weighs less too. On the other hand, a sphere is considered as the best pressure vessel among all the shapes, but, sphere being a bluff body is not suitable for carrying payloads. On this note, a cylinder is considered to be better than a sphere to carry the payload and mainly to achieve a streamlined flow. In this paper, the shape chosen is a combination of the sphere and the cylinder to achieve optimum results for pressurization as well as a better streamlined flow. Our prime aim is to convert this bluff body into something more efficient and useful, rather than only for carrying the payload. We have focused basically on two details viz. 1) Better Pressurization and 2) to assist in minimizing the drag, thereby increasing the overall lift of the aircraft and hence increasing the fuel efficiency. The proposed fuselage structure was designed in CATIA V5 software and structural analyses were done in Auto-Desk Multi-Physics software. As a result, a better structural load capacity was found. A load of 10 N/mm2 was applied on both the bodies under consideration (cylinder and ellipse) having the same material, surface area, volume and weight. For the proposed elliptical design, 78% reduction in the minimum stress value and 10% reduction in the maximum stress value were noticed.
Keywords: Fuselage, Lifting Fuselage, Drag Reduction, Pressurization, Hoop Stress, Multi body design, Toroidal Shells, Multi-cylinder, Channel Propeller Configuration, Carbon Fiber, Graphite Fiber, Stabilization and Carbonization.
This document is the table of contents for the Master Configuration Deviation List of an Airbus A320 airplane flight manual. It lists over 30 configuration deviation topics covered in the manual, each assigned a unique identifier code. The topics cover a range of airplane systems and components from air conditioning and communications to flight controls, fuel, landing gear, lights and more. Brief one line descriptions are provided for each deviation topic. Diagrams and illustrations related to some of the topics are also referenced.
Stealth refers to the act of trying to hide or evade detection.
Stealth technology is ever increasingly becoming a paramount
tool in battle especially “high technology wars” if one may
occur in the future where invincibility means invincibility.
Able to strike with impunity, stealth aircraft, missiles and
warships are virtually invisible to most types of military
sensors. The experience gained at the warfront emphasizes the
need to incorporate stealth features at the design stage itself.
The other purpose is to share the recent achievements related to
the advanced composite materials used on various aerostructures
across the globe. Also discussed are the possibilities
of achieving stealth capability on our existing fleet of fighter
and bomber aircrafts of our Indian Armed forces using
composite and smart materials.
Stealth technology also known as LOT (Low Observability
Technology) is a technology which covers a range of
techniques used with aircraft, ships and missiles, in order to
make them less visible (ideally invisible) to radar, infrared and
other detection methods.
Stealth Technology essentially deals with designs and materials
engineered for the military purpose of avoiding detection by
radar or any other electronic system.
Stealth aircraft are aircraft that use stealth technology to make
it harder to be detected by radar and other means than
conventional aircraft by employing a combination of features
to reduce visibility in the visual, audio, infrared and radio
frequency (RF) spectrum. Well known examples include the
United States' F-117 Nighthawk (1980s-2008), the B-2 Spirit
"Stealth Bomber," and the F-22 Raptor.
This document establishes requirements for service providers in India to develop and implement a Safety Management System (SMS) in compliance with International Civil Aviation Organization (ICAO) standards. It lays out the framework for SMS, including four components and twelve key elements that must be incorporated. The framework components are safety policy and objectives, safety risk management, safety assurance, and safety promotion. The document provides detailed definitions of terms related to SMS and specifies requirements for service providers to define their safety policy, conduct hazard identification and risk assessment, monitor safety performance, manage changes, and promote safety training.
During the Airbus Military Trade Media Briefing 2013, held on May 29th and 30th 2013,
Angel Barrio Cardaba Head of Engineering and Technology provided an overview on a number of technological developments at Airbus Military over the past year. But the key system highlighted was the C295 W.
According to Airbus Military:
Featuring winglets and uprated engines as standard, the new model will provide operators with enhanced performance in all flight phases but is particularly aimed at those operating at “hot and high“ airfields where payload increases in excess of 1,000kg are promised.
In intelligence, surveillance and reconnaissance (ISR) roles such as airborne early warning (AEW) the enhancements will increase endurance by 30-60min and permit an operating altitude up to 2,000ft higher than now.
The new features will also provide an overall reduction in fuel consumption of around 4% depending on configuration and conditions.
The C295W, assembled in Seville, Spain, is being offered to the market from now on and will be the standard version of the aircraft in all versions from the fourth quarter of 2014. Certification is expected in 2Q14.
Airbus Military is committing to the C295W following flight-trials with winglets fitted to its company development aircraft which showed positive results for a weight penalty of only around 90kg.
The engines are the Pratt & Whitney Canada PW127 turboprops which power all versions of the C295. New procedures recently certified by Canada and Spain permit operation in the climb and cruise phases at higher power settings at the discretion of the operator. As well as improved hot and high performance, the procedure improves operation over very high terrain such as the Andes or Himalaya mountains with only a minor influence on maintenance cost.
Cryogenic technology involves producing and studying materials and behaviors at very low temperatures below -150°C. It has various applications including rocket engines, power transmission, food storage, medical uses, sensors, and electronics. The presenter discusses the history and development of cryogenic technology, applications like its use in rocket engines, advantages like high energy density, limitations like low temperatures and leakages, and the future prospects of this field. India has independently developed cryogenic engine technology after initial difficulties in obtaining it from Russia in the 1990s.
Aviation History & How an Aircraft fliesshankar11122
The document provides an introduction to aviation history and aeronautics. It discusses key figures and inventions in the development of flight such as the Wright Brothers' first powered flight in 1903. The document also covers aerodynamic principles such as lift, drag, angle of attack and stall. It describes aircraft parts including wings, engines, tail and control surfaces such as ailerons, elevators and rudder. Finally, it discusses different types of aircraft including variations in speed from subsonic to hypersonic flight.
Este documento presenta el Módulo 10 de un curso sobre Sistemas de Gestión de la Seguridad Operacional (SMS). El módulo explica la implementación del SMS y del Programa de Seguridad Operacional del Estado (SSP) en fases. Propone dividir la implementación en 4 fases, cada una enfocada en componentes específicos del SMS. También describe los componentes clave del SSP y cómo este apoya la implementación del SMS de los proveedores de servicios. El objetivo final es lograr una integración entre el SSP y los SMS para una gestión
Optimizationof fuselage shape for better pressurization and drag reductioneSAT Journals
Abstract
The fuselage of any aircraft is essentially to accommodate the payload. It is normally not as streamlined as the wing. Cabin pressurization has been a major concern in the manufacturing of aircrafts. Generally, a cylindrical shape is preferred from a pressurization point of view as it has a higher strength and weighs less too. On the other hand, a sphere is considered as the best pressure vessel among all the shapes, but, sphere being a bluff body is not suitable for carrying payloads. On this note, a cylinder is considered to be better than a sphere to carry the payload and mainly to achieve a streamlined flow. In this paper, the shape chosen is a combination of the sphere and the cylinder to achieve optimum results for pressurization as well as a better streamlined flow. Our prime aim is to convert this bluff body into something more efficient and useful, rather than only for carrying the payload. We have focused basically on two details viz. 1) Better Pressurization and 2) to assist in minimizing the drag, thereby increasing the overall lift of the aircraft and hence increasing the fuel efficiency. The proposed fuselage structure was designed in CATIA V5 software and structural analyses were done in Auto-Desk Multi-Physics software. As a result, a better structural load capacity was found. A load of 10 N/mm2 was applied on both the bodies under consideration (cylinder and ellipse) having the same material, surface area, volume and weight. For the proposed elliptical design, 78% reduction in the minimum stress value and 10% reduction in the maximum stress value were noticed.
Keywords: Fuselage, Lifting Fuselage, Drag Reduction, Pressurization, Hoop Stress, Multi body design, Toroidal Shells, Multi-cylinder, Channel Propeller Configuration, Carbon Fiber, Graphite Fiber, Stabilization and Carbonization.
This document is the table of contents for the Master Configuration Deviation List of an Airbus A320 airplane flight manual. It lists over 30 configuration deviation topics covered in the manual, each assigned a unique identifier code. The topics cover a range of airplane systems and components from air conditioning and communications to flight controls, fuel, landing gear, lights and more. Brief one line descriptions are provided for each deviation topic. Diagrams and illustrations related to some of the topics are also referenced.
Stealth refers to the act of trying to hide or evade detection.
Stealth technology is ever increasingly becoming a paramount
tool in battle especially “high technology wars” if one may
occur in the future where invincibility means invincibility.
Able to strike with impunity, stealth aircraft, missiles and
warships are virtually invisible to most types of military
sensors. The experience gained at the warfront emphasizes the
need to incorporate stealth features at the design stage itself.
The other purpose is to share the recent achievements related to
the advanced composite materials used on various aerostructures
across the globe. Also discussed are the possibilities
of achieving stealth capability on our existing fleet of fighter
and bomber aircrafts of our Indian Armed forces using
composite and smart materials.
Stealth technology also known as LOT (Low Observability
Technology) is a technology which covers a range of
techniques used with aircraft, ships and missiles, in order to
make them less visible (ideally invisible) to radar, infrared and
other detection methods.
Stealth Technology essentially deals with designs and materials
engineered for the military purpose of avoiding detection by
radar or any other electronic system.
Stealth aircraft are aircraft that use stealth technology to make
it harder to be detected by radar and other means than
conventional aircraft by employing a combination of features
to reduce visibility in the visual, audio, infrared and radio
frequency (RF) spectrum. Well known examples include the
United States' F-117 Nighthawk (1980s-2008), the B-2 Spirit
"Stealth Bomber," and the F-22 Raptor.
This document establishes requirements for service providers in India to develop and implement a Safety Management System (SMS) in compliance with International Civil Aviation Organization (ICAO) standards. It lays out the framework for SMS, including four components and twelve key elements that must be incorporated. The framework components are safety policy and objectives, safety risk management, safety assurance, and safety promotion. The document provides detailed definitions of terms related to SMS and specifies requirements for service providers to define their safety policy, conduct hazard identification and risk assessment, monitor safety performance, manage changes, and promote safety training.
During the Airbus Military Trade Media Briefing 2013, held on May 29th and 30th 2013,
Angel Barrio Cardaba Head of Engineering and Technology provided an overview on a number of technological developments at Airbus Military over the past year. But the key system highlighted was the C295 W.
According to Airbus Military:
Featuring winglets and uprated engines as standard, the new model will provide operators with enhanced performance in all flight phases but is particularly aimed at those operating at “hot and high“ airfields where payload increases in excess of 1,000kg are promised.
In intelligence, surveillance and reconnaissance (ISR) roles such as airborne early warning (AEW) the enhancements will increase endurance by 30-60min and permit an operating altitude up to 2,000ft higher than now.
The new features will also provide an overall reduction in fuel consumption of around 4% depending on configuration and conditions.
The C295W, assembled in Seville, Spain, is being offered to the market from now on and will be the standard version of the aircraft in all versions from the fourth quarter of 2014. Certification is expected in 2Q14.
Airbus Military is committing to the C295W following flight-trials with winglets fitted to its company development aircraft which showed positive results for a weight penalty of only around 90kg.
The engines are the Pratt & Whitney Canada PW127 turboprops which power all versions of the C295. New procedures recently certified by Canada and Spain permit operation in the climb and cruise phases at higher power settings at the discretion of the operator. As well as improved hot and high performance, the procedure improves operation over very high terrain such as the Andes or Himalaya mountains with only a minor influence on maintenance cost.
Cryogenic technology involves producing and studying materials and behaviors at very low temperatures below -150°C. It has various applications including rocket engines, power transmission, food storage, medical uses, sensors, and electronics. The presenter discusses the history and development of cryogenic technology, applications like its use in rocket engines, advantages like high energy density, limitations like low temperatures and leakages, and the future prospects of this field. India has independently developed cryogenic engine technology after initial difficulties in obtaining it from Russia in the 1990s.
Aviation History & How an Aircraft fliesshankar11122
The document provides an introduction to aviation history and aeronautics. It discusses key figures and inventions in the development of flight such as the Wright Brothers' first powered flight in 1903. The document also covers aerodynamic principles such as lift, drag, angle of attack and stall. It describes aircraft parts including wings, engines, tail and control surfaces such as ailerons, elevators and rudder. Finally, it discusses different types of aircraft including variations in speed from subsonic to hypersonic flight.
Este documento presenta el Módulo 10 de un curso sobre Sistemas de Gestión de la Seguridad Operacional (SMS). El módulo explica la implementación del SMS y del Programa de Seguridad Operacional del Estado (SSP) en fases. Propone dividir la implementación en 4 fases, cada una enfocada en componentes específicos del SMS. También describe los componentes clave del SSP y cómo este apoya la implementación del SMS de los proveedores de servicios. El objetivo final es lograr una integración entre el SSP y los SMS para una gestión
- The document compares existing Civil Aviation Safety Regulations to proposed new Parts 42, 66, 145 and 147 regulations.
- Key changes include introducing outcome-based legislation with acceptable means of compliance, separating continuing airworthiness management from maintenance activities, and requiring regular public transport operators to use approved continuing airworthiness management and maintenance organizations.
- Implementation will transition existing privileges to new licensing categories over time without loss of privileges.
The document provides an overview of the basic components and structures of aircraft, including the fuselage, wings, empennage, power plant, and landing gear. It describes the typical materials used in aircraft construction and gives examples of different structural designs for the fuselage, wings, empennage, and landing gear. Key terms related to aircraft components and structures are also defined.
5 IATA Guidance on electronic cigarettes new up dateMohamed Tayfour
The document provides guidance on electronic cigarettes on aircraft. It discusses that electronic cigarettes contain lithium batteries which can overheat and cause fires. It has noted several incidents of electronic cigarettes overheating in checked baggage on flights. The document outlines recommendations that electronic cigarettes and spare lithium batteries must be carried in carry-on baggage only, and recharging onboard is prohibited. Crew are provided checklist for responding to fires or leaks involving electronic devices.
1. A multistage rocket uses two or more stages, each with their own engines and propellant. Stages are discarded completely after their propellant is consumed.
2. There are two types of multistage rockets: series staging where the second stage fires after the first is finished, and parallel staging where upper stage engines are used during lower stage operation by arranging stages alongside each other.
3. Stage separation can occur within the atmosphere using techniques like firing holes or ullage rockets, or out of the atmosphere in space using springs or solid propellant rockets. Selection of separation systems considers factors like joint rotation, reliability, and debris confinement.
This document provides information and guidelines for rural EMS crew members regarding safety procedures and aircraft familiarization for Medevac flights. It outlines definitions, standard operations such as pre-flight briefings, seatbelt use, loading/unloading patients, and considerations for helicopter operations. Specific aircraft are described including the King Air 200/300, Twin Otter, A-Star and Bell helicopters. The goal is for EMS crews to understand flight operations and safely work with Medevac crews.
Laporan Tugas Besar Studi Sertifikasi Lampu Anti-TabrakanAlvinIrwanto1
Laporan ini membahas studi sertifikasi anticollision lights berdasarkan regulasi FAA TSO-C96a. Ia menjelaskan spesifikasi anticollision lights menurut regulasi, produsen LRU di dalam dan luar negeri, serta proses pengujian dan tempat pengujian yang diperlukan untuk memperoleh sertifikasi kelayakan udara.
The document discusses the major components of aircraft, including the fuselage, wings, empennage, landing gear, and power plant. It describes the construction and design of aircraft fuselages, including open truss, monocoque, and semi-monocoque structures. It also briefly discusses wings, the empennage, landing gear, and factors considered in aircraft component design like fatigue life and material selection.
This document discusses the structural design of aircraft. It begins by describing the basic components of an aircraft structure, including wings, fuselage, tail, and control surfaces. It then discusses the functions of different structural elements like skin, spars, ribs, stringers, and frames. It provides details on fuselage types, wing structure, empennage, landing gear, and materials used in aircraft construction. It concludes with an explanation of the V-n diagram used for structural design and load factors specified by airworthiness authorities.
This document is an Airbus Aircraft Operating Manual (AOM) for the A319, A320, and A321 aircraft. It provides information on operating limits, systems, procedures, and abbreviations for these aircraft. Key sections include limits on weight, speeds, crosswinds, altitudes, and fuel. It also summarizes icing protection procedures, electrical, hydraulic, flight control and other aircraft systems.
Conceptual Design and Structural Analysis of Solid Rocket Motor Casingijceronline
This paper is concern with theoretical design of the 100 kg solid rocket motor with predefined values of the burning rate is 100 mm/ sec, specific impulse is 240 sec and chamber pressure is 1000 psi. confined with selection of the material and basic concept of the rocket motor and its aspect during static test. Rocket motor is a highly complex aerospace component that consists of a metal casting, ablative liner and propellant grain. Also to determine the design pressure and burst pressure of a solid rocket motor casing .Preliminary design provided key propulsion outputs that would later be refined and assessed in the final design.
The document summarizes various issues with the F-22 program including rising costs, reduced orders over time, maintenance problems discovered during production, very high operating costs compared to other fighters, insufficient numbers produced, and potential vulnerabilities to modern anti-stealth technologies. It argues the F-22's capabilities have been overstated and that the program has been mismanaged, producing an aircraft in numbers too small to be strategically significant.
IRJET- Static and Fracture Analysis for Aircraft Fuselage and Wing Joint with...IRJET Journal
This document discusses static and fracture analysis of aircraft fuselage and wing joints using composite materials. Finite element analysis software ANSYS and a post-processing program called 3MBSIF are used to determine stress intensity factors for cracks in longitudinal and circumferential fuselage joints under internal pressure loading. Residual strength is predicted using strain energy density theory of fracture. Fatigue life is represented using the Goodman curve. The structural component is designed and analyzed in CREO and ANSYS to calculate stresses and determine fatigue life for different loading conditions.
The document discusses airworthiness review requirements according to regulations. It distinguishes between carrying out a review and issuing a certificate, and notes the DGCA can always issue certificates based on CAMO recommendations. The DGCA may also conduct reviews when safety is threatened or for small aircraft if requested. Reviews are required for imported aircraft. Privileges and procedures are described for CAMOs conducting reviews and issuing or recommending certificates. Requirements are outlined for airworthiness review staff qualifications and record keeping.
Anuj Gupta presented on stealth technology and its applications in aircraft. Stealth techniques make aircraft almost invisible to radar by reducing their radar cross-section. This is achieved through shape design that buries engines and has acute angles, use of radar absorbing materials on surfaces, and reducing heat signatures. While stealth aircraft have military advantages like invisibility, they have disadvantages in payload capacity and maneuverability compared to conventional aircraft. Current and future stealth aircraft under development include the American F-22, Chinese J-20, and Russian-Indian T-50.
The document provides information about gas turbine engines, including their basic mechanics and operation. It discusses the classification of engines, principles of jet propulsion, theories of jet propulsion and gas turbine engines. It also covers the working cycle of gas turbine engines, factors that affect thrust, types of gas turbine engines like turbojet engines, and changes in velocity and pressure during operation.
This document discusses radiopharmaceuticals, which are radioactive substances used for diagnostic or therapeutic medical purposes. It covers their production, safety precautions when handling them, storage requirements, and applications. Radiopharmaceuticals are produced using machines like cyclotrons and nuclear reactors and strict good manufacturing practices must be followed. They are safely used for diagnostic tests and cancer treatments but precautions are needed when working with radioactive materials.
The document discusses good radiopharmaceutical practices (GRP) which provide guidelines for safely handling radiopharmaceuticals. GRP focuses on personnel, premises, equipment, preparation, quality control, and documentation. Personnel must be trained and premises must limit public access while allowing for sterile production. Quality control testing ensures product safety and sterility. Documentation of all production and testing is required to maintain standards. GRP aims to protect workers, patients, and the public from radiation hazards during radiopharmaceutical development and use.
Rogers Atebe presents a review of the challenges in production and use of radiopharmaceuticals in Kenya. Radiopharmaceuticals are unique medical formulations containing radioisotopes used for diagnosis and therapy through techniques like PET imaging. However, Kenya faces many challenges including a lack of specialized facilities, qualified personnel and regulatory frameworks for safe production according to GMP. Overcoming these challenges will require mainstreaming radiopharmaceutical regulations, training nuclear pharmacists, developing centralized production, and international collaboration to develop human and technical capacity for harnessing the benefits of nuclear medicine in Kenya.
Radiopharmacy deals with the preparation, quality control, storage, and dispensing of radiopharmaceuticals. Radiopharmaceuticals are medicinal products containing a radionuclide tracer which is used for diagnostic or therapeutic purposes. The radiopharmacist is responsible for formulating and dispensing prescribed radioactive tracers in compliance with regulatory requirements regarding licensure, facilities, environmental controls, and radiation safety. Proper documentation and oversight by a radiation safety committee are necessary when handling radioactive materials.
- The document compares existing Civil Aviation Safety Regulations to proposed new Parts 42, 66, 145 and 147 regulations.
- Key changes include introducing outcome-based legislation with acceptable means of compliance, separating continuing airworthiness management from maintenance activities, and requiring regular public transport operators to use approved continuing airworthiness management and maintenance organizations.
- Implementation will transition existing privileges to new licensing categories over time without loss of privileges.
The document provides an overview of the basic components and structures of aircraft, including the fuselage, wings, empennage, power plant, and landing gear. It describes the typical materials used in aircraft construction and gives examples of different structural designs for the fuselage, wings, empennage, and landing gear. Key terms related to aircraft components and structures are also defined.
5 IATA Guidance on electronic cigarettes new up dateMohamed Tayfour
The document provides guidance on electronic cigarettes on aircraft. It discusses that electronic cigarettes contain lithium batteries which can overheat and cause fires. It has noted several incidents of electronic cigarettes overheating in checked baggage on flights. The document outlines recommendations that electronic cigarettes and spare lithium batteries must be carried in carry-on baggage only, and recharging onboard is prohibited. Crew are provided checklist for responding to fires or leaks involving electronic devices.
1. A multistage rocket uses two or more stages, each with their own engines and propellant. Stages are discarded completely after their propellant is consumed.
2. There are two types of multistage rockets: series staging where the second stage fires after the first is finished, and parallel staging where upper stage engines are used during lower stage operation by arranging stages alongside each other.
3. Stage separation can occur within the atmosphere using techniques like firing holes or ullage rockets, or out of the atmosphere in space using springs or solid propellant rockets. Selection of separation systems considers factors like joint rotation, reliability, and debris confinement.
This document provides information and guidelines for rural EMS crew members regarding safety procedures and aircraft familiarization for Medevac flights. It outlines definitions, standard operations such as pre-flight briefings, seatbelt use, loading/unloading patients, and considerations for helicopter operations. Specific aircraft are described including the King Air 200/300, Twin Otter, A-Star and Bell helicopters. The goal is for EMS crews to understand flight operations and safely work with Medevac crews.
Laporan Tugas Besar Studi Sertifikasi Lampu Anti-TabrakanAlvinIrwanto1
Laporan ini membahas studi sertifikasi anticollision lights berdasarkan regulasi FAA TSO-C96a. Ia menjelaskan spesifikasi anticollision lights menurut regulasi, produsen LRU di dalam dan luar negeri, serta proses pengujian dan tempat pengujian yang diperlukan untuk memperoleh sertifikasi kelayakan udara.
The document discusses the major components of aircraft, including the fuselage, wings, empennage, landing gear, and power plant. It describes the construction and design of aircraft fuselages, including open truss, monocoque, and semi-monocoque structures. It also briefly discusses wings, the empennage, landing gear, and factors considered in aircraft component design like fatigue life and material selection.
This document discusses the structural design of aircraft. It begins by describing the basic components of an aircraft structure, including wings, fuselage, tail, and control surfaces. It then discusses the functions of different structural elements like skin, spars, ribs, stringers, and frames. It provides details on fuselage types, wing structure, empennage, landing gear, and materials used in aircraft construction. It concludes with an explanation of the V-n diagram used for structural design and load factors specified by airworthiness authorities.
This document is an Airbus Aircraft Operating Manual (AOM) for the A319, A320, and A321 aircraft. It provides information on operating limits, systems, procedures, and abbreviations for these aircraft. Key sections include limits on weight, speeds, crosswinds, altitudes, and fuel. It also summarizes icing protection procedures, electrical, hydraulic, flight control and other aircraft systems.
Conceptual Design and Structural Analysis of Solid Rocket Motor Casingijceronline
This paper is concern with theoretical design of the 100 kg solid rocket motor with predefined values of the burning rate is 100 mm/ sec, specific impulse is 240 sec and chamber pressure is 1000 psi. confined with selection of the material and basic concept of the rocket motor and its aspect during static test. Rocket motor is a highly complex aerospace component that consists of a metal casting, ablative liner and propellant grain. Also to determine the design pressure and burst pressure of a solid rocket motor casing .Preliminary design provided key propulsion outputs that would later be refined and assessed in the final design.
The document summarizes various issues with the F-22 program including rising costs, reduced orders over time, maintenance problems discovered during production, very high operating costs compared to other fighters, insufficient numbers produced, and potential vulnerabilities to modern anti-stealth technologies. It argues the F-22's capabilities have been overstated and that the program has been mismanaged, producing an aircraft in numbers too small to be strategically significant.
IRJET- Static and Fracture Analysis for Aircraft Fuselage and Wing Joint with...IRJET Journal
This document discusses static and fracture analysis of aircraft fuselage and wing joints using composite materials. Finite element analysis software ANSYS and a post-processing program called 3MBSIF are used to determine stress intensity factors for cracks in longitudinal and circumferential fuselage joints under internal pressure loading. Residual strength is predicted using strain energy density theory of fracture. Fatigue life is represented using the Goodman curve. The structural component is designed and analyzed in CREO and ANSYS to calculate stresses and determine fatigue life for different loading conditions.
The document discusses airworthiness review requirements according to regulations. It distinguishes between carrying out a review and issuing a certificate, and notes the DGCA can always issue certificates based on CAMO recommendations. The DGCA may also conduct reviews when safety is threatened or for small aircraft if requested. Reviews are required for imported aircraft. Privileges and procedures are described for CAMOs conducting reviews and issuing or recommending certificates. Requirements are outlined for airworthiness review staff qualifications and record keeping.
Anuj Gupta presented on stealth technology and its applications in aircraft. Stealth techniques make aircraft almost invisible to radar by reducing their radar cross-section. This is achieved through shape design that buries engines and has acute angles, use of radar absorbing materials on surfaces, and reducing heat signatures. While stealth aircraft have military advantages like invisibility, they have disadvantages in payload capacity and maneuverability compared to conventional aircraft. Current and future stealth aircraft under development include the American F-22, Chinese J-20, and Russian-Indian T-50.
The document provides information about gas turbine engines, including their basic mechanics and operation. It discusses the classification of engines, principles of jet propulsion, theories of jet propulsion and gas turbine engines. It also covers the working cycle of gas turbine engines, factors that affect thrust, types of gas turbine engines like turbojet engines, and changes in velocity and pressure during operation.
This document discusses radiopharmaceuticals, which are radioactive substances used for diagnostic or therapeutic medical purposes. It covers their production, safety precautions when handling them, storage requirements, and applications. Radiopharmaceuticals are produced using machines like cyclotrons and nuclear reactors and strict good manufacturing practices must be followed. They are safely used for diagnostic tests and cancer treatments but precautions are needed when working with radioactive materials.
The document discusses good radiopharmaceutical practices (GRP) which provide guidelines for safely handling radiopharmaceuticals. GRP focuses on personnel, premises, equipment, preparation, quality control, and documentation. Personnel must be trained and premises must limit public access while allowing for sterile production. Quality control testing ensures product safety and sterility. Documentation of all production and testing is required to maintain standards. GRP aims to protect workers, patients, and the public from radiation hazards during radiopharmaceutical development and use.
Rogers Atebe presents a review of the challenges in production and use of radiopharmaceuticals in Kenya. Radiopharmaceuticals are unique medical formulations containing radioisotopes used for diagnosis and therapy through techniques like PET imaging. However, Kenya faces many challenges including a lack of specialized facilities, qualified personnel and regulatory frameworks for safe production according to GMP. Overcoming these challenges will require mainstreaming radiopharmaceutical regulations, training nuclear pharmacists, developing centralized production, and international collaboration to develop human and technical capacity for harnessing the benefits of nuclear medicine in Kenya.
Radiopharmacy deals with the preparation, quality control, storage, and dispensing of radiopharmaceuticals. Radiopharmaceuticals are medicinal products containing a radionuclide tracer which is used for diagnostic or therapeutic purposes. The radiopharmacist is responsible for formulating and dispensing prescribed radioactive tracers in compliance with regulatory requirements regarding licensure, facilities, environmental controls, and radiation safety. Proper documentation and oversight by a radiation safety committee are necessary when handling radioactive materials.
EU GMP Annex 1 Draft - Closed System Design Consideration with Single-Use Sys...Merck Life Sciences
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. Please attend the webinar to learn more!
EU GMP Annex 1 Draft - Closed System Design Consideration with Single-Use Sys...MilliporeSigma
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. Please attend the webinar to learn more!
Phụ lục 1 tiêu chuẩn GMP EU về sản xuất thuốc vô trùng trong đó có các tiêu chuẩn về:
1. Hệ thống chất lượng thuốc vô trùng.
2. Nhân sự trong nhà máy thuốc vô trùng.
3. Nhà xưởng, trang thiết bị nhà máy thuốc vô trùng.
4. Hệ thống phụ trợ nhà máy thuốc vô trùng.
5. Công nghệ sản xuất.
6. Hệ thống giám sát, quản lý môi trường sản xuất và quá trình vận hành.
7. Kiểm soát chất lượng thành phẩm đầu ra
This document provides guidance on ensuring sterility in the manufacture of sterile pharmaceutical products through aseptic processing. It discusses quality systems, personnel requirements, facility design, environmental monitoring, equipment qualification, sterilization processes, and other key aspects of aseptic manufacturing. The guidance is intended to advise sterile product manufacturers and regulators on assuring sterility in compliance with regulations.
This document provides guidelines for good manufacturing practices for sterile pharmaceutical products. It discusses four grades (A, B, C, D) for clean areas where sterile products are manufactured, with Grade A being the highest standard for areas involving high-risk operations like filling. Grade A areas should maintain ISO 4.8 air quality with less than 3 particles ≥0.5μm and 20 particles ≥5.0μm per cubic meter. The document provides specifications for air quality, airflow rates, and other facilities requirements to minimize risks of particulate or microbial contamination during sterile product manufacturing.
This document provides guidelines for good manufacturing practices for sterile pharmaceutical products. It discusses four grades (A, B, C, D) for clean areas where sterile products are manufactured, with Grade A being the highest standard for areas involving high-risk operations like filling. Grade A areas should maintain ISO 4.8 air quality with less than 3 particles ≥0.5μm and 20 particles ≥5.0μm per cubic meter. The document provides specifications for air quality, airflow rates, and other facilities requirements to minimize risks of particulate or microbial contamination during sterile product manufacturing.
Phụ lục 3 tiêu chuẩn GMP EU về sản xuất thuốc thú y miễn dịch bao gồm:
1. Hệ thống chất lượng.
2. Nhân sự trong nhà máy thuốc thú y miễn dịch.
3. Nhà xưởng, trang thiết bị nhà máy thuốc thú y miễn dịch.
4. Hệ thống phụ trợ nhà máy thuốc thú y miễn dịch.
5. Công nghệ sản xuất.
6. Hệ thống giám sát, quản lý môi trường sản xuất và quá trình vận hành.
7. Kiểm soát chất lượng thành phẩm đầu ra
The document provides guidance on the manufacture of immunological veterinary medicinal products. It discusses several key aspects:
1) Personnel working in these facilities require specific training and protective measures due to the risks posed by handling pathogenic biological agents.
2) Premises must be designed to control risks to both products and the environment, with different containment levels depending on the pathogenicity of the agents. Live agents should be handled in contained areas.
3) Production processes require adherence to validated procedures and in-process controls due to the complex nature and variability of biological processes used. Special consideration is given to starting materials, media, and seed lot/cell bank systems.
Radiopharmaceuticals are radioactive substances or radioactive drugs used for diagnostic or therapeutic purposes. They consist of a radioactive isotope bound to a carrier molecule that delivers the isotope to the area of the body being examined or treated. Radiopharmaceuticals can be used therapeutically to treat cancers and other diseases by delivering radiation directly to diseased sites, or diagnostically to provide detailed images of organ morphology and function. Their production, quality control, safe handling and disposal are highly regulated to minimize risks from radiation exposure while maximizing benefits.
This document provides guidance for interpreting Good Manufacturing Practice (GMP) standards for pharmaceutical production as outlined in European Union directives. It discusses principles of production including competent personnel, written procedures, material checks, quarantining, storage conditions, cross-contamination prevention, and more. Revisions were made to sections regarding cross-contamination prevention and supplier qualification. The deadline for implementation is March 1, 2015, with some toxicological evaluation deadlines extending into 2015-2016.
The document discusses various methods for sterilizing operating theatres to reduce bacterial contamination and infection risks. It covers traditional fumigation methods using formaldehyde as well as newer alternatives like hydrogen peroxide and peracetic acid. Maintaining proper air flow, restricting unnecessary personnel, and regular cleaning are also important. While routine microbiological monitoring is not always practical, following proper sterilization and cleaning protocols can help ensure a safe surgical environment. Overall, adopting a multidisciplinary approach to infection control through staff training, environmental surveillance, and updated guidelines is key to minimizing infection risks in operating theatres.
AMH JOURNALS UK Publishes STERILIZATION OF OPERATING THEATRES by Dr.T.V.Rao MD
Methods to replace fumigation By Dr.T.V.Rao MD is a Professor and Head of the Department of Microbiology at Travancore Medical College in Kollam, India
Dr T V Rao is also a content provider on Medical Microbiology and Infectious Diseases for numerous international websites.
Translated into 91 global languages for benefit many in the remote corners in the Developing countries
Dr.T.V.Rao MD
This document provides guidance on good manufacturing practices for medicinal products. It discusses the importance of a pharmaceutical quality system to ensure that manufactured medicines are fit for use and comply with regulatory standards. Key elements of the quality system include good manufacturing practices, quality control, product quality reviews, and quality risk management. The quality system requires participation across all departments and levels of the company to ensure product safety, quality and efficacy.
This document discusses key aspects of designing pharmaceutical manufacturing facilities according to current Good Manufacturing Practices (cGMP). It covers process design tools like block flow diagrams, process flow diagrams, and piping and instrumentation diagrams that are used to design the facility layout and process flows. The document also discusses various unit operations in solid dosage manufacturing like material handling, milling, blending, compression, and coating. Facility design must meet regulatory requirements to facilitate operations, control materials, and prevent contamination according to cGMP.
This document lists various prequalified active pharmaceutical ingredients from the WHO. It includes the product ID, INN, grade, therapeutic area, applicant, date of prequalification, and confirmation date. There are over 400 entries listed with information about different APIs that have been prequalified for treatments of conditions like HIV/AIDS, malaria, tuberculosis, hepatitis, and others.
Danh mục 37 thuốc sản xuất trong nước được cấp giấy phép lưu hành tại Việt Nam - Đợt 185.
Quyết định được Cục Quản lý Dược Việt Nam ban hành vào tháng 7 năm 2023.
Danh mục 259 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 185.
Danh mục được ban hành bới Cục Quản lý Dược Việt Nam tháng 7 năm 2023.
Ngày 21/06 vừa qua, cục Quản lý Dược vừa ban hành quyết định về việc công bố danh mục thuốc biệt dược gốc - đợt 2 năm 2023.
Ban hành kèm theo quyết định này bao gồm 83 thuốc biệt dược gốc.
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP-EU.
Hướng dẫn thực hành này cung cấp thông tin cho các nhà sản xuất thức ăn có chất sát khuẩn không an toàn do thuốc chuyển sang thức ăn chăn nuôi không chứa thuốc hoặc một loại thức ăn khác. Mục đích của hướng dẫn này:
• “Sản xuất và phân phối thức ăn có chứa thuốc” đề cập đến việc sử dụng thiết bị để sản xuất, chế biến, đóng gói, giữ và phân phối thức ăn.
• “Thức ăn chăn nuôi” được sản xuất có thêm hóa chất bảo quản. Thức ăn cho động vật như vậy có thể được gọi trong hướng dẫn này là “thức ăn có tẩm thuốc” hoặc “thức ăn không có tẩm thuốc”, tùy thuộc vào việc thức ăn đó có được pha chế để chứa một loại thuốc mới dành cho động vật hay không. Để thuận tiện, chúng tôi gọi những loại thuốc mới dành cho động vật này đơn giản là “thuốc”.
• “Thuốc mang theo” đề cập đến sự hiện diện của thuốc trong lô thức ăn chăn nuôi tiếp theo.
• “Ô nhiễm không an toàn”: đề cập đến mức độ nhiễm bẩn, do một loại thuốc được phép sử dụng trong thức ăn chăn nuôi, gây ra rủi ro không thể chấp nhận được đối với sức khỏe con người hoặc động vật.
Nói chung, các tài liệu hướng dẫn của FDA không thiết lập các trách nhiệm có thể thực thi về mặt pháp lý. Thay vào đó nó mô tả Cơ quan về một chủ đề và chỉ nên được xem dưới dạng khuyến nghị, trừ khi các yêu cầu pháp lý hoặc quy định cụ thể được trích dẫn. Việc sử dụng từ nên trong hướng dẫn của Cơ quan có nghĩa là điều gì đó được gợi ý hoặc khuyến nghị, nhưng không bắt buộc.
Xem thêm các tài liệu khác trên trang của công ty cổ phần tư vấn thiết kể GMP EU.
Cục Quản lý Thực phẩm và Dược phẩm Hoa Kỳ đưa ra hướng dẫn cho các nhà sản xuất và phân phối sữa cho trẻ sơ sinh về các yêu cầu ghi nhãn nhất định đối với các sản phẩm này. Hướng dẫn này đặc biệt chú trọng đến số lượng các công thức sữa cho trẻ sơ sinh có bao bì tương tự nhưng khác nhau về thành phần hoặc mục đích sử dụng. Ngày càng nhiều các sản phẩm ghi sai nhãn về hàm lượng chất dinh dưỡng, do vậy hướng dẫn này cung cấp thông tin có thể giúp các nhà sản xuất hiểu và tuân thủ các yêu cầu ghi nhãn liên quan.
Hướng dẫn này không bao gồm đầy đủ tất cả các quy định liên quan đến việc ghi nhãn sữa công thức dành cho trẻ sơ sinh. Vì vậy bạn có thể xem thêm các hướng dẫn khác tại www.fda.gov/FoodGuidances hoặc các tài liệu trên kênh của công ty cổ phần tư vấn thiết kế GMP EU.
Ngày 25/05 vừa qua, Cục quản lý Dược vừa ban hành danh mục 69 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184.
Theo đó, ban hành kèm theo Quyết định này danh mục 69 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184, cụ thể:
1. Danh mục 64 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam hiệu lực 05 năm (Phụ lục I kèm theo).
2. Danh mục 05 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam hiệu lực 03 năm (Phụ lục II kèm theo).
Xem thêm các tài liệu khác trên trang của công tư cổ phần tư vấn thiết kế GMP EU.
Ngày 25/05 vừa qua, Cục quản lý Dược đã ban hành quyết định số 352/QĐ-QLD về việc ban hành danh mục 231 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 184.
Theo đề nghị của Trưởng phòng Đăng ký thuốc, Cục Quản lý Dược quyết định:
Ban hành kèm theo Quyết định này danh mục 231 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184, cụ thể:
1. Danh mục 172 thuốc sản xuất trong nước được gia hạn giấy đăng ký lưu hành hiệu lực 05 năm (Phụ lục I kèm theo).
2. Danh mục 52 thuốc sản xuất trong nước được gia hạn giấy đăng ký lưu hành hiệu lực 03 năm (Phụ lục II kèm theo).
3. Danh mục 07 thuốc sản xuất trong nước được gia hạn đăng ký lưu hành đến 31/12/2025 (Phụ lục III kèm theo).
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP EU.
Ngày 26/05 vừa qua, Cục Quản lý Dược đã ban hành quyết định số 371/QĐ-QLD về việc công bố danh mục thuốc biệt dược gốc Đợt 1 - năm 2023.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục Quản lý Dược, quyết định:
Công bố Danh mục 56 thuốc Biệt dược gốc Đợt 1 - Năm 2023 tại Phụ lục kèm theo Quyết định này.
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP EU.
Ngày 26/05 vừa qua, Cục Quản lý Dược vừa ra quyết định số 370/QĐ-QLD về việc ban hành danh mục 50 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 111 bổ sung.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục Quản lý Dược quyết định:
Ban hành kèm theo Quyết định này danh mục 50 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 111 bổ sung, bao gồm:
1. Danh mục 41 thuốc nước ngoài được cấp giấy đăng ký lưu hành hiệu lực 05 năm - Đợt 111 bổ sung (tại Phụ lục I kèm theo).
2. Danh mục 01 thuốc nước ngoài được cấp giấy đăng ký lưu hành hiệu lực 03 năm - Đợt 111 bổ sung (tại Phụ lục II kèm theo).
3. Danh mục 07 thuốc nước ngoài được gia hạn giấy đăng ký lưu hành hiệu lực 05 năm - Đợt 111 bổ sung (tại Phụ lục III kèm theo).
4. Danh mục 01 thuốc nước ngoài được gia hạn giấy đăng ký lưu hành đến 31/12/2025 - Đợt 111 bổ sung (tại Phụ lục IV kèm theo).
Ngày 24/05 vừa qua, Bộ Y tế vừa ban hành quyết định về việc công bố danh mục thuốc có chứng minh tương đương sinh học đợt 2 - năm 2023.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục quản lý Dược, quyết định:
Công bố Danh mục 28 thuốc có chứng minh tương đương sinh học Đợt 2 - Năm 2023 tại Phụ lục kèm theo Quyết định này.
Xem thêm các tài liệu khác của Công ty cổ phần Tư vấn thiết kế GMP EU.
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Title: Unlocking the Wonders of the Special Senses: Sight, Sound, Smell, Taste, and Balance
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Basics of Electrocardiogram
CONTENTS
●Conduction System of the Heart
●What is ECG or EKG?
●ECG Leads
●Normal waves of ECG.
●Dimensions of ECG.
● Abnormalities of ECG
CONDUCTION SYSTEM OF THE HEART
ECG:
●ECG is a graphic record of the electrical activity of the heart.
●Electrical activity precedes the mechanical activity of the heart.
●Electrical activity has two phases:
Depolarization- contraction of muscle
Repolarization- relaxation of muscle
ECG Leads:
●6 Chest leads
●6 Limb leads
1. Bipolar Limb Leads:
Lead 1- Between right arm(-ve) and left arm(+ve)
Lead 2- Between right arm(-ve) and left leg(+ve)
Lead 3- Between left arm(-ve)
and left leg(+ve)
2. Augmented unipolar Limb Leads:
AvR- Right arm
AvL- Left arm
AvF- Left leg
3.Chest Leads:
V1 : Over 4th intercostal
space near right sternal margin
V2: Over 4th intercostal space near left sternal margin
V3:In between V2 and V4
V4:Over left 5th intercostal space on the mid
clavicular line
V5:Over left 5th intercostal space on the anterior
axillary line
V6:Over left 5th intercostal space on the mid
axillary line.
Normal ECG:
Waves of ECG:
P Wave
•P Wave is a positive wave and the first wave in ECG.
•It is also called as atrial complex.
Cause: Atrial depolarisation
Duration: 0.1 sec
QRS Complex:
•QRS’ complex is also called the initial ventricular complex.
•‘Q’ wave is a small negative wave. It is continued as the tall ‘R’ wave, which is a positive wave.
‘R’ wave is followed by a small negative wave, the ‘S’ wave.
Cause:Ventricular depolarization and atrial repolarization
Duration: 0.08- 0.10 sec
T Wave:
•‘T’ wave is the final ventricular complex and is a positive wave.
Cause:Ventricular repolarization Duration: 0.2 sec
Intervals and Segments of ECG:
P-R Interval:
•‘P-R’ interval is the interval
between the onset of ‘P’wave and onset of ‘Q’ wave.
•‘P-R’ interval cause atrial depolarization and conduction of impulses through AV node.
Duration:0.18 (0.12 to 0.2) sec
Q-T Interval:
•‘Q-T’ interval is the interval between the onset of ‘Q’
wave and the end of ‘T’ wave.
•‘Q-T’ interval indicates the ventricular depolarization
and ventricular repolarization,
i.e. it signifies the
electrical activity in ventricles.
Duration:0.4-0.42sec
S-T Segment:
•‘S-T’ segment is the time interval between the end of ‘S’ wave and the onset of ‘T’ wave.
Duration: 0.08 sec
R-R Interval:
•‘R-R’ interval is the time interval between two consecutive ‘R’ waves.
•It signifies the duration of one cardiac cycle.
Duration: 0.8 sec
Dimension of ECG:
How to find heart rhytm of the heart?
Regular rhytm:
Irregular rhytm:
More than or less than 4
How to find heart rate using ECG?
If heart Rhytm is Regular :
Heart rate =
300/No.of large b/w 2 QRS complex
= 300/4
=75 beats/mins
How to find heart rate using ECG?
If heart Rhytm is irregular:
Heart rate = 10×No.of QRS complex in 6 sec 5large box = 1sec
5×6=30
10×7 = 70 Beats/min
Abnormalities of ECG:
Cardiac Arrythmias:
1.Tachycardia
Heart Rate more than 100 beats/min
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GMP EU annex 3
1. 1
EUROPEAN COMMISSION
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL
Consumer goods
Pharmaceuticals
Brussels, 01 September 2008
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
EU Guidelines to
Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use
Annex 3
Manufacture of Radiopharmaceuticals
Release for public consultation December 2006
Deadline for comments March 2007
Agreed by GMP/GDP Inspectors Working Group
December 2007
Adopted by European Commission August 2008
Deadline for coming into operation 01 March 2009
The annex has been revised in the light of new GMP requirements for actives substances used as
starting materials (GMP Part II) and updated for all relevant aspects of GMP for radiopharmaceuticals.
Commission Européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel – Belgium. Telephone: (32-2) 299 11 11
2. 2
Annex 3
Manufacture of Radiopharmaceuticals
Principle
The manufacture of radiopharmaceuticals shall be undertaken in accordance with the principles of
Good Manufacturing Practice for Medicinal Products Part I and II. This annex specifically addresses
some of the practices, which may be specific for radiopharmaceuticals.
Note i. Preparation of radiopharmaceuticals in radiopharmacies (hospitals or certain pharmacies),
using Generators and Kits with a marketing authorisation or a national licence, is not
covered by this guideline, unless covered by national requirement.
Note ii. According to radiation protection regulations it should be ensured that any medical
exposure is under the clinical responsibility of a practitioner. In diagnostic and
therapeutic nuclear medicine practices a medical physics expert shall be available.
Note iii. This annex is also applicable to radiopharmaceuticals used in clinical trials.
Note iv. Transport of radiopharmaceuticals is regulated by the International Atomic Energy
Association (IAEA) and radiation protection requirements.
Note v. It is recognised that there are acceptable methods, other than those described in this
annex, which are capable of achieving the principles of Quality Assurance. Other
methods should be validated and provide a level of Quality Assurance at least equivalent
to those set out in this annex.
Introduction
1. The manufacturing and handling of radiopharmaceuticals is potentially hazardous. The level of risk
depends in particular upon the types of radiation, the energy of radiation and the half-lives of the
radioactive isotopes. Particular attention must be paid to the prevention of cross contamination, to the
retention of radionuclide contaminants, and to waste disposal.
2. Due to short shelf-life of their radionuclides, some radiopharmaceuticals may be released before
completion of all quality control tests. In this case, the exact and detailed description of the whole
release procedure including the responsibilities of the involved personnel and the continuous
assessment of the effectiveness of the quality assurance system is essential.
3. 3
3. This guideline is applicable to manufacturing procedures employed by industrial manufacturers,
Nuclear Centres/Institutes and PET Centres for the production and quality control of the following
types of products:
ƒ Radiopharmaceuticals
ƒ Positron Emitting (PET) Radiopharmaceuticals
ƒ Radioactive Precursors for radiopharmaceutical production
ƒ Radionuclide Generators
Type of manufacture Non - GMP * GMP part II & I (Increasing) including relevant annexes
Radiopharmaceuticals
PET Radiopharmaceuticals
Radioactive Precursors
Reactor/Cyclotron
Production
Chemical
synthesis
Purification
steps
Processing,
formulation and
dispensing
Aseptic or final
sterilization
Radionuclide Generators Reactor/Cyclotron
Production
Processing
* Target and transfer system from cyclotron to synthesis rig may be considered as the first step of
active substance manufacture.
4. The manufacturer of the final radiopharmaceutical should describe and justify the steps for
manufacture of the active substance and the final medicinal product and which GMP (part I or II)
applies for the specific process/manufacturing steps.
5. Preparation of radiopharmaceuticals involves adherence to regulations on radiation protection.
6. Radiopharmaceuticals to be administered parenterally should comply with sterility requirements for
parenterals and, where relevant, aseptic working conditions for the manufacture of sterile medicinal
products, which are covered in Eudralex Volume 4, Annex 1.
7. Specifications and quality control testing procedures for the most commonly used
radiopharmaceuticals are specified in the European Pharmacopoeia or in the marketing authorisation.
Clinical Trials
8. Radiopharmaceuticals intended for use in clinical trials as investigational medicinal products should
in addition be produced in accordance with the principles in Eudralex Volume 4, annex 13.
Quality assurance
9. Quality assurance is of even greater importance in the manufacture of radiopharmaceuticals because
of their particular characteristics, low volumes and in some circumstances the need to administer the
product before testing is complete.
4. 4
10. As with all pharmaceuticals, the products must be well protected against contamination and cross-
contamination. However, the environment and the operators must also be protected against radiation.
This means that the role of an effective quality assurance system is of the utmost importance.
11. It is important that the data generated by the monitoring of premises and processes are rigorously
recorded and evaluated as part of the release process.
12. The principles of qualification and validation should be applied to the manufacturing of
radiopharmaceuticals and a risk management approach should be used to determine the extent of
qualification/validation, focusing on a combination of Good Manufacturing Practice and Radiation
Protection.
Personnel
13. All manufacturing operations should be carried out under the responsibility of personnel with
additional competence in radiation protection. Personnel involved in production, analytical control and
release of radiopharmaceuticals should be appropriately trained in radiopharmaceutical specific aspects
of the quality management system. The QP should have the overall responsibility for release of the
products.
14. All personnel (including those concerned with cleaning and maintenance) employed in areas where
radioactive products are manufactured should receive appropriate additional training specific to these
types of procedures and products
15. Where production facilities are shared with research institutions, the research personnel must be
adequately trained in GMP regulations and the QA function must review and approve the research
activities to ensure that they do not pose any hazard to the manufacturing of radiopharmaceuticals.
Premises and equipment
General
16. Radioactive products should be manufactured in controlled (environmental and radioactive) areas.
All manufacturing steps should take place in self-contained facilities dedicated to radio-
pharmaceuticals
17. Measures should be established and implemented to prevent cross-contamination from personnel,
materials, radionuclides etc. Closed or contained equipment should be used whenever appropriate.
Where open equipment is used, or equipment is opened, precautions should be taken to minimize the
risk of contamination. The risk assessment should demonstrate that the environmental cleanliness level
proposed is suitable for the type of product being manufactured.
18. Access to the manufacturing areas should be via a gowning area and should be restricted to
authorised personnel.
5. 5
19. Workstations and their environment should be monitored with respect to radioactivity, particulate
and microbiological quality as established during performance qualification (PQ).
20. Preventive maintenance, calibration and qualification programmes should be operated to ensure that
all facilities and equipment used in the manufacture of radiopharmaceutical are suitable and qualified.
These activities should be carried out by competent personnel and records and logs should be
maintained.
21. Precautions should be taken to avoid radioactive contamination within the facility. Appropriate
controls should be in place to detect any radioactive contamination, either directly through the use of
radiation detectors or indirectly through a swabbing routine.
22. Equipment should be constructed so that surfaces that come into contact with the product are not
reactive, additive or absorptive so as to alter the quality of the radiopharmaceutical.
23. Re-circulation of air extracted from area where radioactive products are handled should be avoided
unless justified. Air outlets should be designed to minimize environmental contamination by
radioactive particles and gases and appropriate measures should be taken to protect the controlled areas
from particulate and microbial contamination.
24. In order to contain radioactive particles, it may be necessary for the air pressure to be lower where
products are exposed, compared with the surrounding areas. However, it is still necessary to protect the
product from environmental contamination. This may be achieved by, for example, using barrier
technology or airlocks, acting as pressure sinks.
Sterile production
25. Sterile radiopharmaceuticals may be divided into those, which are manufactured aseptically, and
those, which are terminally sterilised. The facility should maintain the appropriate level of
environmental cleanliness for the type of operation being performed. For manufacture of sterile
products the working zone where products or containers may be exposed to the environment, the
cleanliness requirements should comply with the requirements described in the Eudralex Volume 4,
Annex 1.
26. For manufacture of radiopharmaceuticals a risk assessment may be applied to determine the
appropriate pressure differences, air flow direction and air quality.
27. In case of use of closed and automated systems (chemical synthesis, purification, on-line sterile
filtration) a grade C environment (usually “Hot-cell”) will be suitable. Hot-cells should meet a high
degree of air cleanliness, with filtered feed air, when closed. Aseptic activities must be carried out in a
grade A area.
28. Prior to the start of manufacturing, assembly of sterilised equipment and consumables (tubing,
sterilised filters and sterile closed and sealed vials to a sealed fluid path) must be performed under
aseptic conditions
6. 6
Documentation
29. All documents related to the manufacture of radiopharmaceuticals should be prepared, reviewed,
approved and distributed according to written procedures.
30. Specifications should be established and documented for raw materials, labelling and packaging
materials, critical intermediates and the finished radiopharmaceutical. Specifications should also be in
place for any other critical items used in the manufacturing process, such as process aids, gaskets,
sterile filtering kits, that could critically impact on quality.
31. Acceptance criteria should be established for the radiopharmaceutical including criteria for release
and shelf life specifications (examples: chemical identity of the isotope, radioactive concentration,
purity, and specific activity).
32. Records of major equipment use, cleaning, sanitisation or sterilisation and maintenance should
show the product name and batch number, where appropriate, in addition to the date and time and
signature for the persons involved in these activities.
33. Records should be retained for at least 3 years unless another timeframe is specified in national
requirements.
Production
34. Production of different radioactive products in the same working area (i.e. hot-cell, LAF unit), at
the same time should be avoided in order to minimise the risk of radioactive cross-contamination or
mix-up.
35. Special attention should be paid to validation including validation of computerised systems which
should be carried out in accordance in compliance with Eudralex Volume 4, annex 11. New
manufacturing processes should be validated prospectively.
36. The critical parameters should normally be identified before or during validation and the ranges
necessary for reproducible operation should be defined.
37. Integrity testing of the membrane filter should be performed for aseptically filled products, taking
into account the need for radiation protection and maintenance of filter sterility.
38. Due to radiation exposure it is accepted that most of the labelling of the direct container, is done
prior to manufacturing. Sterile empty closed vials may be labelled with partial information prior to
filling providing that this procedure does not compromise sterility or prevent visual control of the filled
vial.
7. 7
Quality control
39. Some radiopharmaceuticals may have to be distributed and used on the basis of an assessment of
batch documentation and before all chemical and microbiology tests have been completed.
Radiopharmaceutical product release may be carried out in two or more stages, before and after full
analytical testing:
a) Assessment by a designated person of batch processing records, which should cover production
conditions and analytical testing performed thus far, before allowing transportation of the
radiopharmaceutical under quarantine status to the clinical department.
b) Assessment of the final analytical data, ensuring all deviations from normal procedures are
documented, justified and appropriately released prior to documented certification by the
Qualified Person. Where certain test results are not available before use of the product, the
Qualified Person should conditionally certify the product before it is used and should finally
certify the product after all the test results are obtained.
40. Most radiopharmaceuticals are intended for use within a short time and the period of validity with
regard to the radioactive shelf-life, must be clearly stated.
41. Radiopharmaceuticals having radionuclides with long half-lives should be tested to show, that they
meet all relevant acceptance criteria before release and certification by the QP.
42. Before testing is performed samples can be stored to allow sufficient radioactivity decay. All tests
including the sterility test should be performed as soon as possible.
43. A written procedure detailing the assessment of production and analytical data, which should be
considered before the batch is dispatched, should be established.
44. Products that fail to meet acceptance criteria should be rejected. If the material is reprocessed, pre-
established procedures should be followed and the finished product should meet acceptance criteria
before release. Returned products may not be reprocessed and must be stored as radioactive waste.
45. A procedure should also describe the measures to be taken by the Qualified Person if unsatisfactory
test results (Out-of-Specification) are obtained after dispatch and before expiry. Such events should be
investigated to include the relevant corrective and preventative actions taken to prevent future events.
This process must be documented.
46. Information should be given to the clinical responsible persons, if necessary. To facilitate this, a
traceability system should be implemented for radiopharmaceuticals.
47. A system to verify the quality of starting materials should be in place. Supplier approval should
include an evaluation that provides adequate assurance that the material consistently meets
specifications. The starting materials, packaging materials and critical process aids should be purchased
from approved suppliers.
8. 8
Reference and Retention samples
48. For radiopharmaceuticals sufficient samples of each batch of bulk formulated product shall be
retained for at least six months after expiry of the finished medicinal product unless otherwise justified
through risk management.
49. Samples of starting materials, other than solvents gases or water used in the manufacturing process
shall be retained for at least two years after the release of the product. That period may be shortened if
the period of stability of the material as indicated in the relevant specification is shorter.
50. Other conditions may be defined by agreement with the competent authority, for the sampling and
retaining of starting materials and products manufactured individually or in small quantities or when
their storage could raise special problems.
Distribution
51. Distribution of the finished product under controlled conditions, before all appropriate test results
are available, is acceptable for radiopharmaceuticals, providing the product is not administered by the
receiving institute until satisfactory test results has been received and assessed by a designated person.
10. Glossary
Preparation: handling and radiolabelling of kits with radionuclide eluted from generators or
radioactive precursors within a hospital. Kits, generators and precursors should have a marketing
authorisation or a national licence.
Manufacturing: production, quality control and release and delivery of radiopharmaceuticals from
the active substance and starting materials.
Hot –cells: shielded workstations for manufacture and handling of radioactive materials. Hot-cells
are not necessarily designed as an isolator.
Qualified person: QP as described in Directives 2001/83/EC and 2001/82/EC. QP responsibilities
are elaborated in Eudralex Volume 4, annex 16.