FDA recognizes that adopting innovative approaches to manufacturing may present both technical and regulatory challenges. Pharmaceutical companies may have concerns that using such technologies could result in delays while FDA reviewers familiarize themselves with the new technologies and determine how they may be evaluated within the existing regulatory framework. Through the program, industry representatives can meet with Emerging Technology Team ETT members to discuss, identify, and resolve potential technical and regulatory issues regarding the development and implementation of a novel technology prior to filing a regulatory submission. Participation in the program is appropriate if a the proposed technology has the potential to improve product safety, identity, strength, quality and purity, and b the new technology includes one or more elements subject to quality assessment for which the Agency has limited review or inspection experience.
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Industrial robot Autonomous research robot Domestic robot. Home automation Banking automation Laboratory automation Integrated library system Broadcast automation Console automation Building automation. Automated attendant Automated guided vehicle Automated highway system Automated pool cleaner Automated reasoning Automated teller machine Automatic painting robotic Pop music automation Robotic lawn mower Telephone switchboard Vending machine.
Automation is the technology by which a process or procedure is performed with minimal human assistance. Automation covers applications ranging from a household thermostat controlling a boiler, to a large industrial control system with tens of thousands of input measurements and output control signals.
In control complexity, it can range from simple on-off control to multi-variable high-level algorithms. In the simplest type of an automatic control loop , a controller compares a measured value of a process with a desired set value, and processes the resulting error signal to change some input to the process, in such a way that the process stays at its set point despite disturbances.
This closed-loop control is an application of negative feedback to a system. The mathematical basis of control theory was begun in the 18th century and advanced rapidly in the 20th. Automation has been achieved by various means including mechanical, hydraulic , pneumatic , electrical, electronic devices and computers , usually in combination.
Complicated systems, such as modern factories, airplanes and ships typically use all these combined techniques. The benefit of automation includes labor savings, savings in electricity costs , savings in material costs, and improvements to quality, accuracy, and precision.
The World Bank 's World Development Report shows evidence that the new industries and jobs in the technology sector outweigh the economic effects of workers being displaced by automation. Job losses and downward mobility blamed on Automation has been cited as one of many factors in the resurgence of nationalist and protectionist politics in the US, UK and France, among other countries since s. The term automation , inspired by the earlier word automatic coming from automaton , was not widely used before , when Ford established an automation department.
Fundamentally, there are two types of control loop; open loop control, and closed loop feedback control. In open loop control, the control action from the controller is independent of the "process output" or "controlled process variable".
A good example of this is a central heating boiler controlled only by a timer, so that heat is applied for a constant time, regardless of the temperature of the building. The process output is the building temperature.
In closed-loop control, the control action from the controller is dependent on the process output. In the case of the boiler analogy, this would include a thermostat to monitor the building temperature, and thereby feedback a signal to ensure the controller maintains the building at the temperature set on the thermostat. A closed loop controller, therefore, has a feedback loop which ensures the controller exerts a control action to give a process output the same as the "Reference input" or "set point".
For this reason, closed-loop controllers are also called feedback controllers. The definition of a closed loop control system according to the British Standard Institution is 'a control system possessing monitoring feedback, the deviation signal formed as a result of this feedback being used to control the action of a final control element in such a way as to tend to reduce the deviation to zero. Likewise, a Feedback Control System is a system which tends to maintain a prescribed relationship of one system variable to another by comparing functions of these variables and using the difference as a means of control.
One of the simplest types of control is on-off control. An example is a thermostat used on household appliances which either opens or closes an electrical contact.
Thermostats were originally developed as true feedback-control mechanisms rather than the on-off common household appliance thermostat. Sequence control, in which a programmed sequence of discrete operations is performed, often based on system logic that involves system states.
An elevator control system is an example of sequence control. A proportional—integral—derivative controller PID controller is a control loop feedback mechanism controller widely used in industrial control systems.
The theoretical understanding and application dates from the s, and they are implemented in nearly all analog control systems; originally in mechanical controllers, and then using discrete electronics and latterly in industrial process computers. Sequential control may be either to a fixed sequence or to a logical one that will perform different actions depending on various system states. An example of an adjustable but otherwise fixed sequence is a timer on a lawn sprinkler.
States refer to the various conditions that can occur in a use or sequence scenario of the system. An example is an elevator, which uses logic based on the system state to perform certain actions in response to its state and operator input.
For example, if the operator presses the floor n button, the system will respond depending on whether the elevator is stopped or moving, going up or down, or if the door is open or closed, and other conditions. Early development of sequential control was relay logic , by which electrical relays engage electrical contacts which either start or interrupt power to a device.
Relays were first used in telegraph networks before being developed for controlling other devices, such as when starting and stopping industrial-sized electric motors or opening and closing solenoid valves.
Using relays for control purposes allowed event-driven control, where actions could be triggered out of sequence, in response to external events.
These were more flexible in their response than the rigid single-sequence cam timers. More complicated examples involved maintaining safe sequences for devices such as swing bridge controls, where a lock bolt needed to be disengaged before the bridge could be moved, and the lock bolt could not be released until the safety gates had already been closed.
The total number of relays, cam timers, and drum sequencers can number into the hundreds or even thousands in some factories. Early programming techniques and languages were needed to make such systems manageable, one of the first being ladder logic , where diagrams of the interconnected relays resembled the rungs of a ladder.
Special computers called programmable logic controllers were later designed to replace these collections of hardware with a single, more easily re-programmed unit. In a typical hard wired motor start and stop circuit called a control circuit a motor is started by pushing a "Start" or "Run" button that activates a pair of electrical relays.
The "lock-in" relay locks in contacts that keep the control circuit energized when the pushbutton is released. The start button is a normally open contact and the stop button is normally closed contact. Another relay energizes a switch that powers the device that throws the motor starter switch three sets of contacts for three-phase industrial power in the main power circuit. Large motors use high voltage and experience high in-rush current, making speed important in making and breaking contact.
This can be dangerous for personnel and property with manual switches. The "lock-in" contacts in the start circuit and the main power contacts for the motor are held engaged by their respective electromagnets until a "stop" or "off" button is pressed, which de-energizes the lock in relay.
Commonly interlocks are added to a control circuit. Suppose that the motor in the example is powering machinery that has a critical need for lubrication. In this case, an interlock could be added to ensure that the oil pump is running before the motor starts. Timers, limit switches, and electric eyes are other common elements in control circuits. Solenoid valves are widely used on compressed air or hydraulic fluid for powering actuators on mechanical components.
While motors are used to supply continuous rotary motion, actuators are typically a better choice for intermittently creating a limited range of movement for a mechanical component, such as moving various mechanical arms, opening or closing valves, raising heavy press rolls, applying pressure to presses.
Computers can perform both sequential control and feedback control, and typically a single computer will do both in an industrial application. Programmable logic controllers PLCs are a type of special purpose microprocessor that replaced many hardware components such as timers and drum sequencers used in relay logic type systems.
General purpose process control computers have increasingly replaced stand-alone controllers, with a single computer able to perform the operations of hundreds of controllers. Process control computers can process data from a network of PLCs, instruments, and controllers in order to implement typical such as PID control of many individual variables or, in some cases, to implement complex control algorithms using multiple inputs and mathematical manipulations.
They can also analyze data and create real-time graphical displays for operators and run reports for operators, engineers, and management. Control of an automated teller machine ATM is an example of an interactive process in which a computer will perform a logic derived response to a user selection based on information retrieved from a networked database. The ATM process has similarities with other online transaction processes. The different logical responses are called scenarios.
Such processes are typically designed with the aid of use cases and flowcharts , which guide the writing of the software code. The earliest feedback control mechanism was the water clock invented by Greek engineer Ctesibius — BC.
It was a preoccupation of the Greeks and Arabs in the period between about BC and about AD to keep accurate track of time. In Ptolemaic Egypt , about BC, Ctesibius described a float regulator for a water clock , a device not unlike the ball and cock in a modern flush toilet.
This was the earliest feedback controlled mechanism. The introduction of prime movers , or self-driven machines advanced grain mills, furnaces, boilers, and the steam engine created a new requirement for automatic control systems including temperature regulators invented in ; see Cornelius Drebbel , pressure regulators , float regulators and speed control devices. Another control mechanism was used to tent the sails of windmills.
It was patented by Edmund Lee in The design of feedback control systems up through the Industrial Revolution was by trial-and-error, together with a great deal of engineering intuition. Thus, it was more of an art than a science. In the midth century mathematics was first used to analyze the stability of feedback control systems.
Since mathematics is the formal language of automatic control theory, we could call the period before this time the prehistory of control theory. In Richard Arkwright invented the first fully automated spinning mill driven by water power, known at the time as the water frame. The centrifugal governor , which was invented by Christian Huygens in the seventeenth century, was used to adjust the gap between millstones.
Bunce of England in as part of a model steam crane. The governor could not actually hold a set speed; the engine would assume a new constant speed in response to load changes. The governor was able to handle smaller variations such as those caused by fluctuating heat load to the boiler.
Also, there was a tendency for oscillation whenever there was a speed change. As a consequence, engines equipped with this governor were not suitable for operations requiring constant speed, such as cotton spinning. Several improvements to the governor, plus improvements to valve cut-off timing on the steam engine, made the engine suitable for most industrial uses before the end of the 19th century. Advances in the steam engine stayed well ahead of science, both thermodynamics and control theory.
The governor received relatively little scientific attention until James Clerk Maxwell published a paper that established the beginning of a theoretical basis for understanding control theory. Development of the electronic amplifier during the s, which was important for long distance telephony, required a higher signal to noise ratio, which was solved by negative feedback noise cancellation.
This and other telephony applications contributed to control theory. In the s and s, German mathematician Irmgard Flugge-Lotz developed the theory of discontinuous automatic controls, which found military applications during the Second World War to fire control systems and aircraft navigation systems. Relay logic was introduced with factory electrification , which underwent rapid adaption from through the s. Central electric power stations were also undergoing rapid growth and operation of new high-pressure boilers, steam turbines and electrical substations created a large demand for instruments and controls.
Central control rooms became common in the s, but as late as the early s, most process control was on-off. Operators typically monitored charts drawn by recorders that plotted data from instruments. To make corrections, operators manually opened or closed valves or turned switches on or off. Control rooms also used color-coded lights to send signals to workers in the plant to manually make certain changes.
Controllers, which were able to make calculated changes in response to deviations from a set point rather than on-off control, began being introduced the s. Controllers allowed manufacturing to continue showing productivity gains to offset the declining influence of factory electrification.
Industrial robot Autonomous research robot Domestic robot. Home automation Banking automation Laboratory automation Integrated library system Broadcast automation Console automation Building automation. Automated attendant Automated guided vehicle Automated highway system Automated pool cleaner Automated reasoning Automated teller machine Automatic painting robotic Pop music automation Robotic lawn mower Telephone switchboard Vending machine. Automation is the technology by which a process or procedure is performed with minimal human assistance. Automation covers applications ranging from a household thermostat controlling a boiler, to a large industrial control system with tens of thousands of input measurements and output control signals.
Good Manufacturing Practices for Pharmaceuticals. With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings. General Provisions Subpart A. Chapter 16 Contracting and Outsourcing.
И, похоже, понимаешь людей слишком - Правда нелегко давалась и нашему обществу, - прокомментировал Арчи. - Один из его фундаментальных принципов гласит: новые оптимизаторы всегда должны говорить правду.
Допускается утаивать информацию, если того требует политика, но лгать. Самые младшие оптимизаторы жаждут говорить правду, не учитывая последствий.SEE VIDEO BY TOPIC: Medical Device Product Development: the process is more than design controls
В уме убрала мешки под глазами и все морщинки, изменила цвет волос и бровей с серого на черный, даже умудрилась представить себя юной, прекрасной и несовершеннолетней. Коротко вспыхнула тоска по тем дням.
"Ты всегда пропадала, Кэти, - подумала Николь. - Так или иначе я не сумела уберечь тебя". Николь ощутила, как отчаянно колотится сердце, когда Арчи наконец ввел ее в комнату, где не было ничего, кроме кресла, большого стола и экрана на стене. Арчи указал Николь на кресло. - Прежде чем я научу тебя пользоваться оборудованием, - проговорил октопаук, - мне следует сказать две вещи. Во-первых, как ответственный за вашу группу оптимизатор, я должен дать ответ на просьбу той части людей, которая хочет возвратиться к прочим представителям вашего вида в Новом Арчи сделал паузу.
Николь собралась. Ей было сложно даже на миг выбросить Кэти из своей памяти, но она понимала, что придется сконцентрироваться целиком на том, что Арчи намеревается ей сообщить. Члены ее группы будут рассчитывать на пространные объяснения по этому - Боюсь, - продолжил Арчи несколько мгновений спустя, - что в ближайшем будущем никому из вас нельзя будет отправиться.
Я не могу рассказать вам больше, чем разрешила Верховный Оптимизатор на собрании старшего персонала.
Ты серьезно. - Она нетерпеливо ждала, чтобы глаза вновь привыкли к темноте. - Да, - ответил Ричард.
Николь кивнула головой. - Наверное, ты не нашел своего призвания, - проговорила .
Я находилась внутри птичьего подземелья, когда Ричард явился, чтобы спасти. - Николь смолкла, припомнив, что уже рассказывала эту повесть Синему Доктору, а октопауки, как известно, ничего не забывают. - Тебе не скучно.
- спросила. - Пожалуйста, продолжай, - ответила октопаучиха. - Но за все время, проведенное нами на острове, никто так и не узнал, что в здания можно войти. Разве не удивительно. О как бы мне хотелось, чтобы Ричард был сейчас жив. вот бы увидеть его лицо, когда Орел открыл дверь в октаэдр. Ричард был бы потрясен. - Как бы то ни было, - продолжила Николь, - Ричард вернулся внутрь Рамы, чтобы отыскать .
Например, ярко-красный купол на поверхности океана был окружен восемью красными длинными и тонкими спицами, расположенными через равные промежутки. Все строения города укладывались внутрь круга, очерченного восемью цветными куполами. Николь сразу понравилось странное бурое сооружение, плававшее на воде. Оно оказалось почти столь же огромным, как центральные купола.
Сверху прямоугольник напоминал многослойный каркас из плотно утрамбованной ячеи, набитой птичьим пухом.
А что, мы с Эпониной согласны рискнуть, - усмехнулся Макс. - Иначе я рано или поздно влопаюсь в какую-нибудь серьезную свару с Накамурой. - А как Патрик. - Ему идея понравится. Но боюсь, что он может проговориться Кэти. У них свои взаимоотношения. Макс замер на полуслове, увидев Роберта, появившегося у двери с усталой дочерью на руках. - Вот ты где, Элли. А я уже решил, что вы с Максом заплутали в амбаре. Николь очень устала, а мне завтра рано вставать.
А знаешь, я очень тебя люблю, - вдруг проговорил он, с пылом обнимая - Чего это. - спросила Николь несколько секунд спустя, удивленная неожиданным взрывом эмоций.
"Куда же идти теперь?" - спросила себя Николь во сне. "Пойдем со мной", - сказала Женевьева, выходя из леса и прикасаясь к "Что ты делаешь здесь?" - удивилась Николь.
Отдельные цвета не представляли собой знаков алфавита в строгом смысле этого слова. Иногда слово определялось шириной полос. Сочетание жженой сиены и розовато-лилового цвета означало "понимать", только если обе полосы были примерно равной ширины.
Королева Чаматеви, правившая в Харипунджайе. - А кто это, миссис Ватанабэ.