[ Engineering Forum. Alexander Delli Paoli, Jr. The HVAC Process Alexander Delli Paoli, Jr. Welcome to “Engineering Forum.” This feature discusses applied technical principles associated with engineering topics that focus on usefulness to practitioners in validation and compliance. We intend this column to be a resource for daily work applications. Engineering technology is a topic of great importance in contemporary pharmaceutical and medical device manufacturing. Validation and compliance professionals must become familiar with facilities, equipment, utilities, and other systems at their sites. Global regulatory agencies require more than just compliance to procedures in the modern manufacturing organizations. They require understanding of processes and topics controlled by site procedures. Sound procedures, policies, and literally everything involved in regulated manufacturing must be based on scientific principles whenever possible, must be appropriate for risk, and must be continually monitored and maintained. Outsourcing of manufacturing and testing functions has further extended these responsibilities. Engineering topics are not generally well known or understood beyond the engineering community. Personnel resources have been reduced, and individual responsibility has increased. Those with limited background and experience may find themselves involved in areas with which they have little expertise. Further, the technical information supporting their areas may be esoteric and incomprehensible for those not trained in the field. We intend to address engineering topics with these considerations in mind. These topics will be discussed clearly and in a meaningful way so that our readers will be able to understand and apply the principles discussed in daily work situations. For more Author information, go to gxpandjvt.com/bios 20 Journal The first series of articles will discuss HVAC processes for warehouses, offices, laboratories, cleanrooms, containment facilities, and other manufacturing environments. The series will also touch on specialized applications such as containment hoods, biological safety cabinets, and dust collection systems. Subsequent articles will address each of these topics in greater detail, driving toward a working familiarity of HVAC systems and their typical challenges. Reader comments, questions, and suggestions for discussion topics are needed to help us fulfill the column objective. Please send your comments and suggestions to column coordinator Alex Delli Paoli at [email protected] or to journal managing editor Susan Haigney at [email protected]. KEY POINTS The following key points are discussed: •Understand the reason your site needs different types of HVAC systems •Recognize all the HVAC components and their purpose •Understand how all the components interact •Be aware of the physics of air: Psychrometrics •Assure proper safety measures are in place •A system is only as good as its maintenance and compliance to design criteria. INTRODUCTION Heating, ventilation, and air conditioning (HVAC) systems are critical to pharmaceutical and medical device manufacturing. These systems comprise multiple components that are integrated in a reliable process to create a sustainable environment. This discussion provides an overview of the process used to bring air from the randomly variable mixture of [ ABOUT THE AUTHOR Alex Delli Paoli, Jr., P.E., is managing director of Engineered Strategic Visions, Libertyville, IL, USA. Engineered Strategic Visions, Inc. (www.engineervisions.com) is an engineering consulting firm specializing in project planning and management, manufacturing support, asset and energy management, and other areas of expertise. He may be reached by e-mail at [email protected]. of Validation T echnology [Autumn 2011] iv thome.com Alexander Delli Paoli, Jr. vapors and particles found in the atmosphere to a steady state condition acceptable for the environment the system serves. The following will be discussed: •HVAC definition—the scope of HVAC and what general areas are encompassed •The process of HVAC—HVAC systems include multiple equipment that transforms variable air states to achieve target attributes •Why process the environment?—the reasons that air must be processed •Components and function of the air handler (e.g., the preheat coil and filters, cooling coil, return fan, exhaust fan, and associated equipment) •Applications (e.g., warehouses, offices and records storage, laboratories, cleanrooms, containment facilities, and general manufacturing areas). HVAC DEFINITION HVAC is a hybrid engineering discipline based on aspects of classical mechanical, electrical, and chemical engineering practices. It includes knowledge of fluid mechanics, machine design, and instrument control. It further includes a working knowledge of the physical properties of several liquids and gases. Material compatibility knowledge is also important for avoiding chemical interaction with dissimilar metals, incompatibility with refrigerants, and other deleterious effects due to cleaning agents used in the facilities served by the HVAC units. Practical considerations such as physical layout and access for maintenance along with a good sense of aesthetics are also important to the discipline of HVAC. HVAC started as a formal practice during the Industrial Revolution when it was recognized that mines and factories needed to be ventilated (V) (i.e., air containing noxious fumes and particles needed to be replaced with fresh breathable air). Heating (H) was also a need beyond the home fireplace to warm shops and factories in northern climates. Air conditioning (AC) became practical with the invention of the mechanical refrigeration process. It was an obvious extension to H and V. Occasionally, R for refrigeration is included when refrigerators and freezers are involved in a project. This is typically shown as HVAC/R. THE PROCESS OF HVAC Traditional textbook explanations of HVAC systems often describe these systems as integrated pieces of equipment (e.g., air handler, fans, ductwork) having individual functions. These descriptions ignore the process of HVAC to produce a “product”—air with desired temperature, humidity, particulate level, and other quality attributes. gxpandjv t.com The HVAC process may be compared to a typical manufacturing process (see Figures 1 and 2). The manufacturing process utilizes individual pieces of equipment to process active drugs and excipients into a final pharmaceutical product in commercial packaging. The HVAC process utilizes multiple equipment components and operations to convert incoming air to processed air that meets facility needs. Most facilities require a broad scope of air quality. For example, a facility might include sterile product manufacturing, non-sterile product manufacturing, warehouses, docks, offices, and other areas—each of which will have differing HVAC requirements. Further, there may be different requirements within a given area. For example, a non-sterile manufacturing area may require rooms with very low humidity to process moisture sensitive drugs. The HVAC system and its component subsystems must provide the required environmental conditions. HVAC Process Comparison to Manufacturing Process The HVAC system process is generally similar to a product manufacturing process. Both convert input materials by means of process parameters into a final product meeting required quality attributes. There are important differences that the HVAC system must overcome to accomplish its objectives. These include input material considerations, process capability, and process changes. Input materials. The manufacturing process converts drugs and inactive materials to pharmaceutical products. The incoming materials should be well controlled by means of vendor approval and supply chain control. The HVAC process converts air from the external environment to air possessing the quality attributes required for the respective areas in the site. The input air is uncontrolled, may have unexpected content (e.g., fumes, particulates, pollen, and insects) and has seasonal variation. Winter air will have lower moisture content than summer air. Further, the summer humidity may approach 100% in tropical areas for extended periods during the rainy season. Process capability. The manufacturing process has defined process limits. These limits are usually not exceeded because input materials are well controlled. In contrast, the HVAC process may be challenged beyond the limit of design capabilities depending on environmental variation. Process changes. The manufacturing process is generally well established and remains relatively constant throughout the product lifecycle. The process is often approved by regulatory agencies and is not able to be changed without regulatory approval. In contrast, the HVAC process has significant seasonal variation requiring cyclical heating and cooling. These are significant process Journal of Validation T echnology [Autumn 2011] 21 Engineering Forum. Figure 1: Manufacturing process. MANUFACTURING PROCESS WHY PROCESS THE ENVIRONMENT? API Excipient Excipient Excipient Manufacturing process unit operation Equipment #1 (IQ, OQ, PQ)* Equipment #2(IQ, OQ, PQ) Equipment #3 (IQ, OQ, PQ) Excipient Excipient Manufacturing process unit operation Equipment #4 (IQ, OQ, PQ) Manufacturing process unit operation Equipment #5 (IQ, OQ, PQ) Equipment #6 (IQ, OQ, PQ) Bottles Caps Inserts Packaging process unit operation PRODUCT / PROCESS COMPLETED * IQ=Installation qualification; OQ=Operations qualification; PQ=Performance qualification. Figure 2: HVAC process. Outside Air Return Air Fan Roughing Filters Preheat Coil Mix Air Streams, Preheat and Filtration Filters Cooling Coil Humidifier Intermediate Filtration, Moisture Content Adjustment Supply Fan Refined filters Motive energy imparted to air, additional filtration Supply air distribution ductwork In-duct heating coils Supply delivery devices (diffusers, terminal filters) Trim air temperature, deliver and distribute to facility Return air distribution ductwork Collection devices (Fume hoods, etc.) Exhaust air ductwork Exhaust fan HVAC PROCESS COMPLETED (cycle repeats) 22 Journal changes. Periodic checks to assure the HVAC systems are operating as intended are key to consistent operation. of Validation T echnology [Autumn 2011] Any manufacturing, testing, or storage facility and their related processes strive for a steady state consistent environment to deliver reliable products to customers. Even offices are expected to be consistent so as not to distract employees from their responsibilities or create office equipment failures. HVAC Considerations The following are major parameters to consider when looking at a process and the environment’s impact: •Temperature. Temperature is sensible heat. This heat can be felt or sensed because it causes a rise or fall in temperature. • Humidity. Humidity is an indication of the level of water vapor in the air. Humidity is typically expressed as relative humidity. HVAC and facility professionals utilize dew point to indicate moisture content. A psychrometric chart is a necessary tool for understanding the current state of the air and water vapor mixture (Figure 3). Humidity changes in controlled environments usually contribute to the cooling load of a facility. This load is called latent heat. Latent indicates a phase change from vapor to liquid, or visa versa. At the other end of the control demand is humidification. In seasonally cooler climates, moisture must be added to air to increase humidity to within desired limits. •Particulate contamination. Particle load may occur from the outside or from within the facility. The wind and the season can play big parts in contributing to the amount of particulate in the air being introduced into an HVAC system. Internal particulate loading can come from people, corrugate, facility materials of construction, and manufacturing or testing contaminants. Particulate can be viable or non-viable. Both have their potential hazards to the facility environment. •Vapor contamination. Vapor contamination can come from internal and external sources similar to particulate contamination. A site HVAC system near a highway can draw in detectable levels of hydrocarbons. A diesel engine inadvertently operating outside the intake of a HVAC system can bring odors and vapors into warehouses, offices, laboratories, and manufacturing areas served by the unit, causing discomfort or illness to the building occupants. Improper amounts of outside ventilation air can cause carbon dioxide build-up with resulting oxygen deprivation concerns. iv thome.com Alexander Delli Paoli, Jr. •Pressure. Air pressure is assumed to be incompressible in most HVAC applications. This assumption comes into question when elevated pressure or vacuum is needed in a process environment. Sites located in higher elevations must also not make the same assumptions that those living nearer to sea level make about system component selection. Most component capacities are de-rated at higher altitudes. • Safety. Safety is an important system capability often assumed or not adequately considered. Fire protection considerations, adequate ventilation for personnel, fail-safe automatic controls, hazardous fume and particulate containment devices, and properly designed egress are among many facility safety concerns. Figure 3: Psychrometric chart (courtesy of Climate Solutions, copyright Trane). There are other factors that affect the way air is processed in an HVAC system, though one cannot analyze a single cubic foot of air to understand the impact of these design characteristics. Future articles in this series will address these factors in detail. The following are some of these factors: •Ratio of outside air (OA) to return (recirculated) air (% OA) •Amount of air moving through the HVAC system relative to the amount of air needed to heat or cool the facility •Localized heat, humidity, and particulate issues within a facility •Efficiency of air distribution and circulation within a facility. Water Content in Air Water must also be included in any discussion about HVAC. Water is included because it is an effective heat transport medium at temperatures at and above 100∘C (steam) as well as at temperatures approaching the freezing point of 0∘C. Water is often used in closed circuits transporting heat between HVAC systems and remotely located equipment such as water chillers to produce chilled water and boilers to make hot water and steam. It is also used in open circuits to transport the rejected heat from water chillers to large atmospheric heat exchangers called cooling towers. Evaporative cooling is used in these towers by spraying water into an airstream within the tower. This sensible and latent heat transfer cools the water to near dew-point gxpandjv t.com temperatures. The water is then returned to the water chiller to take heat away from the facility. Open water circuits require filtration to remove the same atmospheric contaminants to which air intakes are exposed. Both open and closed water circuits require treatment additives. All HVAC systems using water in any form contain additives to protect the piping and components from temperature extremes, corrosion, and bioburden. This article will not discuss further detail about additives. It is important that validation and quality professionals become familiar with the additives in the systems at their site. The potential impact of additives should be considered in any failure mode analyses performed. AIR HANDLER COMPONENTS AND FUNCTION The central point of an HVAC system is the air handling unit (AHU) or air handler. Figure 4 provides a schematic drawing of an air handler. Air is shown moving from left to right. This figure shows all the typical components used in an air handler. There are many variations in this type of equipment. The system described in Figure 4 will serve as an effective starting point. Components discussed include the following: •Preheat coil and filters •Filters •Cooling coil Journal of Validation T echnology [Autumn 2011] 23 Engineering Forum. •Return fan •Exhaust fan •Other components including ductwork, dampers, sensors, and smoke detectors. Preheat Coil and Filters Outside air (OA) and air returning (Return Air, RA) from the facility served by the unit are combined at the back end of the AHU and filtered to create air at some intermediate level of temperature, humidity, and cleanliness (mixed air). Space is provided between components within the air handler to allow access by maintenance personnel. The air then passes through a preheat coil (heat exchanger) to raise the temperature of the air to a temperature that will not expose subsequent components to freezing hazards. The preheat coil is not required in warmer climates where temperatures never go below the freezing point of water. The preheat coil is usually heated by steam or antifreeze-treated hot water. Filters The air then continues through a finer set of filters to continue removal of finer particulates. Each successive set of filters is more efficient that the previous set. This is done to keep larger atmospheric dust particles from plugging the finer downstream filter(s). Cooling Coil The air next passes through a cooling coil. As it passes through this heat exchanger, the air temperature drops to a prescribed temperature chosen so the air can effectively cool the facility it is serving. The air will likely get to its dew-point temperature during the cooling process. At this point and as it continues to cool, the air has become saturated with water vapor. Liquid water will form on the cooling coil surfaces and run down the coil surfaces to a drain pan. The water is then removed from the air handler through a drain. The cool saturated air is then drawn through a fan, which imparts the energy needed to generate the pressure necessary to drive the air through all the Figure 4: Schematic diagram of a HVAC system. 24 Journal of Validation T echnology [Autumn 2011] iv thome.com Alexander Delli Paoli, Jr. air handler components and the ductwork distribution system. At this point, the air is heated by fan as it passes through the system. This raises the air temperature a few degrees, bringing the air above its dew-point temperature and avoiding condensation that could occur if the air was still saturated. At the other extreme, if the humidity of the air was very low as happens in cooler seasons in northern climates, the dew-point temperature would never be reached, and the HVAC control system could detect the need to add moisture to the environment. A humidifier using steam or atomized water would then achieve the desired humidity level by adding this vapor into the air stream. Return Fan A return fan is also shown on the schematic. It is common to have an HVAC system with only one fan. Systems operating in a compliance-oriented industry tend to have more components that create more pressure drops as the air passes through each. Rather than having one fan that gets larger and larger with a greater pressure demand, it is desirable to use two fans—a return fan and a supply fan. The return air fan draws the air through the return side of the ductwork distribution system. The supply fan draws air from the outside and also draws the mixed air stream through all the air handler components. The supply fan also drives the air through the supply ductwork distribution system. The two-fan arrangement also offers a push-pull configuration that is desirable in several applications. Exhaust Fan When fumes, particulate, or other contaminants are generated in a facility, an exhaust system is required. The typical components are fan filters, cyclone separators, scrubbers, and a purpose-specific capture apparatus. The apparatus can include fume hoods, biological safety cabinets, and other custom-made enclosures all intended to confine and conduct the contaminants to the exhaust ductwork. Once in the ductwork, the contaminant-laden air is treated in potentially many different ways. If the contaminant is not an environmental hazard such as simple particulate, the exhaust could go to the atmosphere with minimal processing. As the complexity and hazardous nature of the exhaust air increases, differing types and degrees of filtration and other treatments can be applied. The Rest of the System Other system components are usually located in the supply and return ductwork, including, but not limited to, the following: gxpandjv t.com •The actual ductwork. Ductwork must allow minimal leakage to assure the intended volumes and condition of air is delivered. Improperly constructed ductwork can be noisy, creating rattling or “tin c anning” when system adjustments happen. Above all, the ductwork must be of the correct size and made of materials compatible with the vapor stream flowing within it. Typical ductwork is usually constructed on galvanized sheet metal. High levels of water vapor or corrosive vapors flowing through an exhaust duct could dictate the need for an alternate material. •Manual dampers for balancing airflow throughout the air distribution system. •Automatic dampers to control airflow in the system. •Automatic control system sensors to measure temperature, humidity, airflow volume and air pressure at key positions. •Heating coils to warm air being delivered to specific rooms for individual temperature control. •Life safety components such as smoke detectors, heat detectors, and fusible link fire dampers. •Terminal filters where a cleanroom type environment is desired. These filters are typically of high efficiency, and they are the last item the air passes through as it is introduced to the clean room. APPLICATIONS HVAC systems are present in every facility and have a wide range of applications. Some applications might seem simple on the surface until regulatory implications and unintended consequences are discussed. The subtleties of each application may be touched upon in this article, but will be addressed in greater depth in subsequent articles in this series. Warehouses The word warehouse may suggest images of a large boxy building with fork trucks running all around and truck dock doors routinely open to the atmosphere. Perhaps there is no issue ventilating the space with all that help from nature, but it could be a real challenge to heat, cool, and keep clean with the aforementioned openings to the environment and potential sources of contamination. Most warehouses operating in a regulated environment are under much closer control. Truck docks are often treated with close fitting dock door seals and localized heating, cooling, and filtration as a first defense to keeping the atmosphere out of the controlled environment. Pest control measures are in place to keep rodents and flying insects from penetrating too far before being intercepted. Ceiling–mounted propeller fans move warm air from the underside of the roof down, creating a circulation pattern Journal of Validation T echnology [Autumn 2011] 25 Engineering Forum. that draws cooler air up. This allows for a reasonably uniform temperature distribution throughout the warehouse. This is particularly important if the product being stored must reside within restricted temperature limits. Air handlers serving warehouses must have a first set of filters to remove coarse atmospheric dust. A second set of finer filters is often included in the air handler to keep atmospheric dust fines from becoming visible deposits on the materials and products stored in the area. Heating and cooling coils will likely be present in the air handler if the warehouse has operating limits for temperature and humidity. Humidity is important to control to keep the product packaging from developing mold or other environmentally introduced blemishes. The warehouse air handler will obviously need a supply fan to drive the air through all its components and the supply distribution ductwork. A return fan is often not included unless the HVAC system has return distribution duct work. The amount of outside air the air handler is required to introduce to the warehouse facility is dependent on the amount of exhaust air required, the minimum ventilation air required by local building codes, and the number of gas-powered forklift trucks operating in the building. Additional outside air may also be introduced to pressurize the warehouse building to form another barrier against atmospheric contaminants. An exhaust system is definitely required over electric forklift battery charging areas to capture hydrogen. Other exhaust systems could also be needed to support warehouse operations requirements to keep fumes, particulate, and other potential hazards from being introduced into the general building environment. Office and Records Storage HVAC systems serving office environments are usually not captured in any product compliance regulations unless samples to be ultimately sold are brought into office areas for testing or inspection. This could also apply to documentation storage areas. The areas used for such functions could come under scrutiny, bringing the entire air handler into the qualification and validation arena. Baring that situation, a typical office HVAC system includes two sets of filters, preheat and cooling coils, a supply fan, supply and return air distribution systems, and a return fan. Exhaust systems are required in toilets and kitchens, and they may be required in break areas and printing and reproduction areas. Ventilation is generally specified by the governing local building code. This can take the form of air changes of outside air per hour or cubic feet per minute of outside air per person occupying the facility. Either way, the build26 Journal of Validation T echnology [Autumn 2011] ing manager should have a procedure for periodically verifying that the proper ventilation rate is being met. This could be done continuously with airflow measurement by the control system, or by periodic physical testand-balance reviews. In either method, a history record should be maintained demonstrating a consistency across reviews. This discipline applies to all HVAC systems with a life-safety element, and not just office systems. Laboratories The basic laboratory HVAC system is similar to an office HVAC system. Laboratories need a desk either in the lab or in a segregated area adjacent to the lab. Laboratory facilities are usually served by an isolated HVAC system dedicated to the laboratory environment. While the desks and offices for lab personnel are often on the lab system, it is not considered good practice to expose personnel in general office areas to laboratory risks (e.g., solvent fumes and particulates) that are controlled in the laboratory facilities. Many different types of laboratory environments exist. They can be wet or dry described by the type of activities occurring in the facilities. Much of the electronics industry uses dry labs where testing and assembly occurs. They have their own set of considerations for ventilation air and exhaust containment. Wet labs typically use liquids as the basis for their science. Sink and water sources are located throughout to source water and allow personnel to wash hands and have access to safety appliances such as emergency eyewashes and safety showers. Airflow in a laboratory is important. The following are potentially conflicting purposes to be addressed with the lab HVAC system: •General circulation. Effective ventilation circulated throughout air supplies and returns must be distributed across the lab in a way that promotes effective currents and room-air-change-turnover to avoid stagnant dead spots. •Cooling of lab instrumentation. The air distribution must deliver the correct quantity of air to the vicinity of heat-producing lab instruments to keep both the equipment and the lab occupants operating properly. •Avoidance of stray air currents near containment devices. Discharging air at relatively high velocities near a fume hood or other containment device can cause eddy currents that negate the collection airflow of the device and introduce contaminants into the lab. Attention to this detail should obviously be a high priority. •Room pressurization versus containment. It is desirable to keep some labs at a positive air pressure relative to adjacent areas to keep potential stray iv thome.com Alexander Delli Paoli, Jr. contaminants from entering the laboratory workspace. This desire is often in conflict with life safety requirements dictating that exit corridors and other evacuation routes should be pressurized to permit safe egress from the facility. There is no one answer to this conflict. The best answer is found when the lab owners, the facility management, and local loss prevention authorities meet and come to a sensible compromise after evaluating all the risks. Cleanrooms The HVAC demand in cleanroom facilities is significant. Often the amount of air being circulated has more to do with room air change rate per hour than it does with the heat load requirements. Air volume demands can range from a historical “conventional” cleanroom with 20 air changes per hour to complete unidirectional cross-flow or down-flow airflow with room air changes occurring several times per minute. The type of cleanroom style is dependent on several factors. The amount, source, and consequences of contamination must be understood. If the particulate generator(s) can be isolated using containment devices, or if a critically clean area can be isolated in a pressurized device, there is a good chance a more conventional approach to the cleanroom HVAC system can be taken. This helps minimize the size and operating costs of the system. Often the biggest contamination source in a cleanroom is its human occupants. Minimizing the number of people in the room along with appropriate garments for those that remain can help lessen the clean-up demands on the HVAC system. If this is not possible and if the contamination control needs are great, it may be necessary to go to a more complex cleanroom design. Positive pressurization is usually desirable in cleanrooms to help keep the surrounding environment out. Pressurization requires airflow through every door and opening around the perimeter of the cleanroom, along with unfound cracks and gaps that seem to occur in cleanrooms from time to time. The air flowing out of the facility must be replaced with outside air, putting a greater demand on the air handler to process that air. This typically means more frequent filter changes, higher dehumidification loads on the cooling coils, and higher demands on the site’s infrastructure supporting the HVAC system. Heat and humidity generation can be an issue in a cleanroom. Heat and humidity generation must be considered in conjunction with the placement of heat generating equipment and the attire occupants must wear. These garments often increase the propensity for perspiration. gxpandjv t.com The more a critical operation can be isolated in a “mini” cleanroom environment, the less costly the operation can become. This is especially true where a specific process must be conducted in a cleanroom while requiring containment for some recognized hazard. Isolators are containment devices that can serve both needs. While the cost of the isolator may seem high, the overall cost of the facility may make it a worthwhile investment. This is particularly true when trying to adapt an existing facility and all its equipment and infrastructure to a new use. Containment Facilities Containment facilities are unique HVAC system applications that work in conjunction with the facilities’ physical layout, materials of construction, and operating procedures to create an environment that isolates the object or process from the adjoining area. This is typically more than a fume hood in a laboratory. It includes facilities for potent drugs, biological hazards, radiological hazards, explosion hazards, and many other unique applications. Non-Aseptic General Manufacturing Facilities Many manufacturing areas have elements of the facilities described herein. Temperature requirements, humidity restrictions, microbial controls, and other design and operational requirements may be needed depending on the type of product manufactured and associated processes. It is important to define the level of a controlled environment before designing or modifying an HVAC process to serve it. SUMMARY The reader should by now have related some aspect of this discussion to their individual experiences. This article is an overview intended to bring all readers to a base level understanding of HVAC systems along with typical applications containing anecdotal information. All the topics discussed will be revisited in greater detail in subsequent articles. We will discuss specific applications, the functional nature of system components, validation, maintenance, operational consistency and sustainability. All readers are encouraged to submit questions to be addressed as the details unfold. JVT ARTICLE ACRONYM LISTING AHU Air Handling Unit HVAC Heating, Ventilation, and Air Conditioning OAOutside Air RAReturn Air Journal of Validation T echnology [Autumn 2011] 27
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