Autoclave Steam Sterilizer

Perform general operational controls verification testing. 

Operate system throughout the range of operating design specifications or range of intended use. 

Perform vacuum pump evacuation rate test to verify that the vacuum pump evacuates the chamber at the rate specified. 

Perform chamber vacuum and positive pressure integrity verification studies to verify that the chamber does not leak. 

Perform controller security challenges to verify that sterilization cycle parameters cannot be altered without appropriate supervisory control. 

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The British Pharmacopoeia (1993) recognizes five methods for the sterilization of pharmaceutical products. These are (i) dry heat (ii) heating in an autoclave (steam sterilization) (iii) filtration (iv) ethylene oxide gas and (v) gamma or electron radiation. In addition, other approaches involving steam and formaldehyde and ultraviolet (UV) light have evolved for use in certain situations. For each method, the possible permutations of exposure conditions are numerous, but experience and product stability... 

Autoclave steam sterilization is a well-established and widely used procedure. Normally, steam enters through the top of the chamber (Fig. 9). Being lighter than air, it remains at the top of the chamber but steadily and continuously drives the air out of the chamber through the bottom vent throughout the sterilization cycle. The velocity of steam entering the... 

Autoclave (Steam Sterilizer) Heat Penetration Study of Once in a year ... 

Sterile radiopharmaceuticals may be divided into those which are manufactured aseptically and those which are terminally sterilized. In general, it is advisable to use a terminal sterilization whenever this is possible. Terminal sterilization is defined as a process that subjects the combined product/container/closure system to a sterilization process that results in a specified assurance of sterility [7], Since sterilization of solutions normally means autoclaving (steam sterilization), one must assure that the radiopharmaceutical product does not decompose when it is heated to temperatures above 120°C. Many radiolabeled compounds are susceptible to decomposition at higher temperatures. Proteins, such as albumin, are good examples of this. Others, such as 18F-fluodeoxyglucose (FDG), can be autoclaved in some formulation but not in others. 

Shrink wrapping machine Over printing machine Trays and rack washer Autoclave (steam sterilizer)... 

Medical parts and packages are typically sterilized using ionizing radiation (e-beams. X-rays, or gamma radiation), ethylene oxide (EtO) gas exposure and autoclave steam sterilization. Each has its advantages, as well as potential damaging effects on the polymer, especially if the PO is exposed to multiple treatments. 

To meet the demands in the health care and medical device markets, new transparent PEI blends with improved hydrolysis resistance under the autoclave, steam sterilization conditirms, were developed (Sanner 2011). Based on the known superior hydrolytic stability of the sulfone resins and the published patent literature (Kailasam et al. 2009), it is very likely that these clear, hydrolysis-resistant blends are the compatibilized blends of PEI and polyphenylsulfone (PPSU). 

Steam (qv) sterilization specifically means sterilization by moist heat. The process cannot be considered adequate without assurance that complete penetration of saturated steam takes place to all parts and surfaces of the load to be sterilized (Fig. 1). Steam sterilization at 100°C and atmospheric pressure is not considered effective. The process is invariably carried out under higher pressure in autoclaves using saturated steam. The temperature can be as low as 115°C, but is usually 121°C or higher. 

Great care is needed in the design of autoclaves and sterilization cycles because of the requirement for the presence of moisture. The autoclave must be loaded to allow complete steam penetration to occur in all parts of the load before timing of the sterilization cycle commences. The time required for complete penetration, the so-called heat-up time, varies with different autoclave constmction and different types of loads and packaging materials. The time may not exceed specific limits in order to guarantee reproducibility and, for porous loads, saturated steam. The volume of each container has a considerable effect on the heatup time whenever fluids are sterilized. Thermocouples led into the chamber through a special connector are often employed to determine heatup times and peak temperatures. The pressure is refleved at the end of each sterilization cycle. Either vented containers must be used or... 

The selection of an appropriate steam-sterilization cycle must be made after a carefiil study of the nature of the articles to be sterilized, the type and number of organisms present, type and size of each package, and type of packaging material used. Cycle-development studies may be conducted using fiiU autoclave loads. 

Steam sterilizers, or autoclaves as they are sometimes known, are stainless steel vessels designed to withstand the steam pressures employed in sterilization. They can be (i)... 

In addition to normal compression set test conditions, usually 22 hours at 70 °C in a hot air oven, pharmaceutical elastomeric closures may be subjected to compression set conditions simulating steam sterilization cycles in an autoclave for 30 minutes at 121 °C. Also, sterilizing cycles employing ETO, radiation, or dry heat are used. Comparison data between formulations are used to develop compression set values that will identify potentially acceptable compounds under these conditions. 

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. 

Component sterilizers steam sterilization process. A steam autoclave is used at ABC Pharmaceutical Industries to sterilize equipment and components used in aseptic processing. The following system description... 

Steam sterilization validation. All autoclave operations conform to the Master Validation Plan employed at ABC Pharmaceutical Industries. The autoclave has undergone installation qualification, operational qualification, and performance qualification. The autoclave is revalidated on an annual basis. The equipment steam sterilization cycle revalidation data for the autoclave are provided in validated archives. 

The qualification studies conducted indicated that the GMP steam sterilizer (autoclave) performance is satisfactory and in accordance with the operational parameters defined previously. 

The complexity of the sterile filtration operation and the CGMP regulations require the validation of sterilizing filter systems. The validation of a sterile filtration operation can be complex, with many operational parameters and their interactions needing to be identified, controlled, and predicted for each end product to demonstrate that sterility is adequately achieved by the filtration process. In the commonly used steam sterilization process, the heat parameters are identified and in-process controls specified such that a level of sterility assurance can be reproducibly obtained. In steam sterilization, the important parameter of heat, measured by temperature, can be accurately measured and continuously monitored to ensure the operational integrity of the autoclave however, unlike steam sterilization, filtration sterilization cannot be monitored on a continuous basis throughout the process. 

Steam sterilization by autoclaving at 121 °C is the most widely employed method today but it may induce hydrolysis and/or melting of the polymer matrix and is, in effect, not recommendable for degradable polymers [313,314]. Sterilization by dry heat requires temperatures of 160-170 °C for two hours or more. These conditions may cause melting, distortion, and/or degradation of the polymer and the technique is thus of limited use for most polymeric materials. 

At industrial scale, careful consideration of the materials of construction for the bioseparation equipment is vital to ensure that the product does not become contaminated, by rust, for example, and also to assure long plant life with good reliability to maximize throughput. Materials that were suitable on a laboratory or pilot scale may no longer be appropriate, where the process and mechanical demands on the equipment may be greater. For example, the plant could be located outside where there are greater extremes of temperature in summer and winter, or equipment may need to be steam sterilized in situ rather than being autoclaved. 

Heating of radioactive solutions, particularly under elevated pressure (e.g., steam sterilization), is also a matter of safety. In order to avoid any contaminated air to escape if a container or a seal is broken, autoclaves used for radioactive solutions should be placed inside negative-pressure sealed units. Autoclaves used for sterilizing high-energy y-emitting radiopharmaceuticals should in addition be supplied with proper lead shielding. 

Application of heat, vacuum, or a combination of both can accomplish removal of occluded moisture from stoppers. Vacuum drying is a simple procedure, i.e., merely the drying of stoppers in the autoclave following steam sterilization. Alternately, sterilized stoppers could be transferred to a dry-heat oven and dried at an appropriate temperature. 

The steam sterilization system (see Figures 5-9) used by S.G.D. Serail is designed with autoclave -type vessel construction to resist sterilization pressure combined with a control system permitting the validation of the sterilization cycles and eventual determination of the experimental FO sterilization value. 

A concentrated (60% w/v) PFOB/PFDB emulsion (Oxygent AF0144) is currently being produced in a commercial-scale facility. The emulsion is steam-sterilized in a rotary autoclave at or above 121 °C, using a procedure that achieves uniform heat penetration, maintains emulsion integrity, and provides the required probability of less than one non-sterile unit in 10 . As compared to Fluosol, Oxygent is characterized by use of PFCs having some lipophilic character, use of phospholipids as the emulsifier instead of polox-amer, a several-fold increase in PFC concentration, simplification of the overall formulation, considerable increase in stability, and consequently, far superior convenience of use. 

Steam sterilization in autoclaves has a long and strong scientific basis (see above). The essence of validation of steam sterilization processes is to demonstrate that temperature and time conditions are being achieved uniformly through every item included the autoclave load and that the lethality being achieved in practical situations corresponds to that which would be expected from sterilization theory. 

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