Injectable products autoclaving

The physical parameters of the process are monitored in normal production runs to obtain additional information on the process and its reliability. Extra temperature-sensitive devices installed in an autoclave or dry-heat sterilizer (in addition to probes used routinely) will permit an in-depth study of the heat distribution for several loads. Heat-penetration measurements are recommended for injectable products of higher viscosity or with volumes larger than 5 ml. A tableting press equipped with pressure-sensitive cells will be helpful in collecting statistical data on the uniformity of die-fill and therefore on mass uniformity. 

The alloys can be processed into parts requiring hydrolytic and autoclave stabiHty, such as desalinization filter frames and medical devices. Foamed products are used in cabinets for business machines, computers, and copiers. Automotive seat backs are made by blow mol ding and replacements for metal parts by injection mol ding. 

The hydrogenation of ehtyl pyurvate (EtPy) was carried out at 23 °C in a SS autoclave equipped with an injection chamber for separate introduction of the modifier Cinchonidine (CD) and Troger s base (TB) was used as modifiers. Different batches of EtPy, (Fluka) and Pt/Al203 catalysts (Engelhard E 4759, 5 %w Pt, Dpt = 25 %) were used. Experimental details incliding GC analysis can be found elsewhere [3,12]. The optical yield was calculated as e.e. = ([R]-[S])/([R]+[S]). The e.e. values were corrected for the amount of racemic product formed in minor amount in the reactor prior to the injection of CD. 

Although some types of pharmaceutical products, like ophthalmic and injectable preparations, are sterilized by physical methods, including autoclaving, dry heat, or by bacterial filtration during their manufacture, many of them additionally require the presence of an antimicrobial preservative to maintain their aseptic condition throughout the period of their storage and use. Other types of preparations that are not sterilized during their... 

Polyarylsulfones offer materials with good thermal-oxidative stability, solvent resistance, creep resistance, and good hydrolytic stability. Their low flammability and smoke evolution encourage their use in aircraft and transportation applications. They hold up to repeated steam sterilization cycles and are used in a wide variety of medical applications such as life support parts, autoclavable tray systems, and surgical and laboratory equipment. Blow-molded products include suction bottles, surgical hollow shapes, and tissue culture bottles. PPS has a number of automotive uses including as an injection-molded fuel line coimector and as part of the fuel filter system. 

CDS of surfaces/equipment coming into direct contact with the product requires special consideration. While CDS procedures of guaranteed efficiency must be applied, it is imperative that no trace of the CDS agents subsequently remain on such surfaces, as this would result in automatic product contamination. The final stage of most CDS procedures, as applied to such process equipment, involves exhaustive rinsing with highly pure water (water for injections WFI). This is followed if at all possible by autoclaving. 

Hydrolysis that occurs to some degree on autoclaving and storage results in the production of corresponding lyso-compounds, phospholipids without one of the acyl chains. These materials are called lyso- because, on their own, lyso-compounds produce lysis of red blood cells and are generally regarded as toxic. Analytically it is not difficult to demonstrate that there are significant quantities of these compounds present in injectable emulsions but there have never been any clinical reports of toxicity. The probability is that these materials form some type of association complex with the other phospholipids present and are not available on their own to exert any effect which would result in toxicity. 

Into a 5-liter autoclave, continuously stirred at a speed of 450 rpm, water, a dispersing agent, and polyethylene (powder or pellets) are introduced in the proportions set forth in Table II. After introduction of the initiator, the vinyl chloride is injected in such a quantity that, at the polymerization temperature, the vinyl chlorides partial pressure is lower than the vapor pressure of pure vinyl chloride at the same temperature. The vinyl chloride quantities compatible with this condition are easily determined by the absorption isotherms. When the pressure has dropped to at least half of its maximum value, the nontransformed vinyl chloride is removed. After filtering, washing, and drying, the product is collected. 

More recent studies (14),(15) have employed a rapid injection autoclave, where coal is injected into a preheated supercritical solvent. After the reaction is over, the products are quenched by passing water through internal cooling coils. This method allows precise measurement of the reaction times corresponding to the conversions. It is used in this study. 

The autoclave reactor is a small cylindrical reactor, built to withstand high pressures, used to evaluate the kinetics of high-temperature, high-pressure reactions and the production of small quantities of specialty chemicals. The reactor is typically packed with a supported catalyst, and reactant is added by injection. Pressure in the system is elevated by increasing the temperature of the autoclave. Additional pressure, if needed, can be obtained with the injection of additional gaseous reactant or an inert. 

Machinery and processing conditions applicable to the injection moulding of PVC medical products have been examined (218). Details are also available of the design of an autoclavable PVC-P medical device which was injection moulded (178). 

Equistar Chemicals L. D. Polyethylene, high pressure autoclave LDPE and EVA resins Ethylene, vinyl acetate Proven reliable resin production for film, injection molding and wire and cable grades. VA content up to 30% film, adhesives, etc. 10 1988... 

The major process for poly(vinyl chloride) production is the suspension system. Typical reaction temperatures are 50-65 C. As the reaction proceeds, a conversion ( 76%) is reached at which the only monomer left in the system is that absorbed in the polymer particles. This occurs when the monomer concentration is about 30 wt % in the particles. The occurrence of this phenomenon is signaled by a drop in the reactor pressure. Normal pressures in the autoclaves are initially about 150 psig (pounds per square inch, gauge), and it is usual to carry out polymerizations until the pressure drops to about 20-70 psig, depending on the reaction temperature. Water may be injected into the reaction vessel as the polymerization proceeds, to compensate for the volumetric contraction between monomer and polymer. This also helps prevent the reaction mixture from becoming too viscous. As well, the water addition enhances the cooling capacity of the reactor because it increases the heat transfer area on the walls. 

Wet heating is more effective for bran stabilization for oil extraction than is dry heating. Lipase is inactivated in 3 minutes at 100°C (37). The equipment that can be used include steam cookers, blanchers, autoclaves, and screw extruders with injected steam and water (30). Extrusion with steam injection and up to 10% added water reduces the temperature required for lipase inactivation. Temperatures are reduced to 100-120°C. Product may be held at 100°C for 1.5-3.0 minutes before drying to a stable moisture content. Bran expands as it exits the extruder, and water flashes to steam (8). Porous pellets assist in solvent percolation during oil extraction. Fines are agglomerated as well. 

In a typical application, the filters are sterilized by autoclaving or steaming in place and flushed with water for injection or buffer before filtering the actual process solution. A postuse integrity test is performed after the product solution has been filtered to ensure that the required retention performance was obtained during the filtration process. 

---