Issue link: https://www.e-digitaleditions.com/i/1199406
30 January 2020 Tablets & Capsules Cooling. Some types of production equipment, such as large production spray dryers, require connections to chilled water or stand-alone chillers that use specialized refrigerants for cooling. This equipment often requires installation of process piping wrapped with non-shed- ding insulation to deliver the chilled water to its point of use in cleanrooms. Process piping installation requires that the affected cleanrooms be shut down for pipe pen- etration through the cleanroom walls as well as testing for refrigerant leakage. Water quality. Pharmaceutical manufacturing uses a variety of grades of water, four of which are typically produced and used on-site at manufacturing facilities: purified, water for injection, pure steam, and water for hemodialysis. Confirm the quality of water required for new equipment as well as the required pressure, flow rate, and temperature (as applicable). Some types of equip- ment, such as autoclaves, require clean steam directly but also typically require reverse osmosis/deionized water (RO/DI) indirectly as feed water for the clean steam gen- erators. When considering adding an autoclave or replac- ing an existing autoclave with a larger-capacity unit, it's important to add the consumption rates of all equipment using clean steam and equipment that uses only RO/DI. Clean gases. Pharmaceutical production settings often require nitrogen, oxygen, argon, carbon dioxide, clean compressed air and other specialty high purity gases to operate production equipment; in spray dry- ing applications; to fill head space in product containers; and for fermen- tation, extraction, and purification. A wide variety of utilities generate gases onsite and distribute them throughout a production facility to points of use in cleanrooms. Alternatively, some facili- ties use stationary tanks that can store 6,000 liters or more of gas (in liquid or vapor phase) and are configured with telemetry devices to alert service pro- viders to refill the tanks before the gas runs out. In either case, introducing new equipment that uses specialty gas requires an assessment to ensure the utility can meet the requirements of all connected equipment. In addition to the gas-generating and storage capacity, you must also evaluate the length and internal diameter of gas distribution piping to ensure that the gas flow will be able to keep up with the demand of adding another piece of equipment. Determine the flow rate, pressure, and volume requirements of each piece of equipment currently installed and compare them with the system's capacity. The last thing you want is to spend $2 million for a spray dryer and find out that the nitrogen system and piping is too small to satisfy the dry- er's consumption. the equipment purchaser is not the right person to make this determination, so an important element of change control is enlisting subject matter experts (in this case an electrician or competent facilities technician) to make technical assessments on critical parameters. Emergency generators. Emergency power genera- tion is the most ignored utility. Emergency generators are typically installed during facility construction, and their size reflects only the equipment that was on-site or projected to be on-site at that time. If the new piece of equipment must be connected to an e-power circuit and the equipment's power requirements are high, you should evaluate the emergency generator capacity in compari- son to the current load. You should not rely solely on the architectural as-built drawings, because new equipment and power connec- tions are frequently added without redlining the draw- ings. A qualified electrical contractor can install monitors at the power source to the facility and trend the power draw over a few weeks or a month. You can then compare the results of this test to the emergency generator's load rating to determine whether the generator has the capac- ity to meet the new equipment's power needs. Exhausting of solvents. In pharmaceutical and bio- pharmaceutical cleanrooms, removing any trace of haz- ardous vapors from the room or equipment is essential. The hazards of exhausting solvents include fire or explo- sion as well as the resulting contamination of produc- tion, storage, and cleanroom areas by smoke or other substances released by a fire. Solvents should be exhausted through non-corrosive and non-flam- mable ducting. Fluoropolymer coated stainless steel ducting can be safer and more effective than traditional pip- ing. Additionally, cleanroom exhaust, fume hoods, snorkels, walk-in reactor enclosures, and biological safety cabi- nets used to store chemicals with cor- rosive fumes, can all benefit from the use of fluoropolymer coated stainless steel duct, rather than pipe. Refer to the National Fire Protection Associa- tion's "Standard for the Protection of Semiconductor Fabrication Facilities" (NFPA 318) and local requirements for materials of construction for ducting in your area. Heat dissipation. While it doesn't usually receive much attention, heat generated by production equip- ment can impact temperature control in GMP produc- tion suites and make it difficult for the HVAC system to maintain temperature set points and operate within validated ranges. Rooms with heat-generating equipment such as product drying ovens or pan coaters for tablet coating should be configured with insulated ducting to remove the heat. The last thing you want is to spend $2 million for a spray dryer and find out that the nitrogen system and piping is too small to satisfy the dryer's consumption.