Clean steam

The following types of steam systems are normally found in modern 

Feed water Portable, softened, or deionized water Water for injection (distilled, reverse osmosis) or purified water 

Material system construction Iron or steel or stainless steel Stainless steel 

Chemical investigation is performed according to the pharmacopial monograph, Water for Injection. Take a minimum of three condensate samples (sample volume 1 1 each) from each supply point. 

---

Steaming-out the steam distillation apparatus. After the cleaned steam -distillation apparatus (Fig. 88) has been assembled, it is essential to pass steam through it for some time to remove readily soluble alkali. All the taps on the apparatus are opened and the water in the steam generator boiled vigorously. The steam will gradually pass into the apparatus. After a few minutes, the tap of the tap-funnel C may be closed and soon afterwards the tap Ti of the steam-trap finally the tap Tj of the funnel G may be closed, Steaming-out should then be continued for not less than one hour, the receiver J not being in place. 

The cracked products leave as overhead materials, and coke deposits form on the inner surface of the dmm. To provide continuous operation, two dmms are used while one dmm is on-stream, the one off-stream is being cleaned, steamed, water-cooled, and decoked in the same time interval. The temperature in the coke dmm is in the range of 415—450°C with pressures in the range of 103—621 kPa (15—90 psi). Overhead products go to the fractionator, where naphtha and heating oil fractions are recovered. The nonvolatile material is combined with preheated fresh feed and returned to the furnace. The coke dmm is usually on stream for about 24 hours before becoming filled with porous coke, after which the coke is removed hydraulically. 

Where steam is used for sterilization, hospital duty, food and drug manufacturing processes, or steam humidification purposes, there generally is a reluctance (or mandated prohibition) to employ amines as a treatment for steam-condensate line corrosion protection. Clean-steam... 

Larger clean-steam generator designs typically employ a pressure vessel (shell) containing a U-shaped tube bundle. The heat source is primary steam supplied to the shell side (which may be amine treated), and secondary clean steam is generated within the tubes. 

Carbon filters find particular application as prefilters for RO and ion-exchange processes in the production of high purity FW. They are also used in clean-steam boilers and other types of steam generators where the steam is ultimately destined for application in food or beverage production, pharmaceuticals, electronics, surgical instrument sterilization, and similar processes. 

High-quality or high-purity steam applications, e.g., clean steam generators for use in hospitals... 

Humidifiers serving clean areas and process areas should use only clean steam for humidification. Carbon steel piping and headers are not acceptable 316L grade stainless steel should be used. All humidifier components (main body, valves, piping, manifold, etc.) should be made of 316L stainless steel. 

Clean steam systems are normally constructed of nonrusting (stainless steel) materials and typically use either distilled or deionized water as feed water no additives are allowed to be used due to contact with products. 

The investigations should be performed at the initial validation and should be repeated after maintenance and repair work on the clean steam system. 

Steam system. Clean steam is used for all equipment that comes into contact with containers, solution, or closures prior to product assembly. Pure steam is produced by a generator fed by deionized water. Steam traps are installed to collect condensate when necessary. The quality of pure steam condensate is the same as water for injection. The quality of pure steam is monitored through a quality analyzer system that measures the conductivity of condensed pure steam. 

Clean steam is supplied to the sterilizer jacket and the chamber via the clean steam generator. Compressed air is supplied to the chamber through a (provide filter pore size) xm hydrophobic filter by an oil-free (manufacturer name) compressor. 

The surface condenser is an improvement on the barometric condenser, because it permits recovery of clean steam condensate. Other than this factor, the old-fashioned barometric condenser is more efficient than the more modern surface condenser. 

The solution is straightforward. Do not condense the steam by direct contact with cold water, as is done in the barometric condenser. Condense the steam by indirect contact, with the cold surface of the tubes in a shell-and-tube condenser. Hence the name surface condenser, a sketch of which is shown in Fig. 18.2. Compare Fig. 18.1 with the surface condenser. Is there really much difference Other than recovering clean steam condensate for reuse, there is no difference at all. I last used a surface condenser in 1976, on a sulfuric acid plant reactor feed gas boost blower, and it worked just fine. 

Facility design is critical. Likewise, individual utilities require qualification. The most important of these are heating, ventilation, and air conditioning (HVAC), water (including clean steam), and compressed gases. 

A bioreactor containing 20 m3 of medium at room temperature (25°C) is ready for sterilization by direct injection of saturated clean steam. The typical bacterial count of the medium is about 10 x 1012/m3, which needs to be reduced to a level so that the chance for contaminant surviving the sterilization is 1 in 1000, that is, a level of 1 x 10 3 for the vessel. 

Jets of high-speed steam are used in spray cleaning. Steam at 15.0 bar with 150 C of superheat is fed to a well-insulated valve at a rate of 1.00 kg/s. As the steam passes through the valve, its pressure drops to 1.0 bar. The outlet stream may be totally vapor or a mixture of vapor and liquid. Kinetic and potential energy changes may be neglected. 

Fluent steam cycle consists of injecting steam into the freeze-dryer while the drain is open. This creates a high condensation of clean steam in the chamber and the resulting condensates are flowing particulate down to the drain with an associated cleaning effect. 

Besides its direct use in the final product, water is used in breweries as a utility, for purposes such as cleaning, steam generation, etc. Another common utility in breweries are gases, such as air and carbon dioxide, which sometimes might contain impurities that need to be removed in order to ensure the quality and uniformity of the hnal product. Besides traditional methods, i.e., activated coal treatment, purification of utihties can also be successfully done by membrane filtration. Some membrane manufacturers (i.e., Pall Corporation, Donaldson Ultrafilter Inc., Sartorius, Millipore, CPM, etc.) offer commercial membrane separation equipment that is specihcaUy designed for the purification of water, steam, air, or carbon dioxide. This enables breweries to produce sterile and particle-free utihties for the brewing processes. 

Humidifiers should be avoided if possible as they may become a source of contamination (e.g. microbiological growth). Where humidification is required, this should be achieved by appropriate means such as the injection of steam into the air stream. A product-contamination assessment should be done to determine whether pure or clean steam is required for the purposes of humidification. 

Perform Installation Qualification of deionizer and distillation equipment, holding tanks, clean steam generator, and distribution system. 

Verify that clean steam is fed by a purified water system or WFI system. 

Steam used for sterilisation should not contain additives at a level which could cause contamination of product or of equipment. Clean steam generators are recommended. 

Purified Water is used as feed water for Water for Injection (WFI) systems and clean steam generators. WFI is produced either by distillation or reverse osmosis. 

---