Sterilizer parameters

Parameter Sterilizer Condensate Separator Sludge Hydrocyclone Water POME... 

Hospital sterilizer loads vary in composition, thus the challenge presented to the test organism can vary considerably, depending on the type and contents of packages in which they are placed. The benefits of a standardized test-pack constmction and test protocol are obvious, and such recommendation is made by AAMI for steam and ethylene oxide sterilizers (11). More recentiy in European (CEN) and International (ISO) standards, biological indicators are considered as additional information supplemental to the measurement of physical parameters. Indeed, for sterilization using moist heat (steam), the biological indicator information is not considered to be relevant. 

Monitoring by Electromechanical Instrumentation. According to basic engineering principles, no process can be conducted safely and effectively unless instantaneous information is available about its conditions. AH sterilizers are equipped with gauges, sensors (qv), and timers for the measurement of the various critical process parameters. More and more sterilizers are equipped with computerized control to eliminate the possibiUty of human error. However, electromechanical instmmentation is subject to random breakdowns or drifts from caUbrated settings and requires regular preventive maintenance procedures. 

Industrial sterilization cycles tend to vary considerably, not only from manufacturer to manufacturer, but often from product type to product type, depending on the bioburden present on a given load. Chemical indicators have historically been used only to differentiate between sterilized and nonsterilized packages. More recent developments have resulted in the availability of chemical dosimeters of sufficient accuracy to permit their appHcation either as total monitors or as critical detectors of specific parameters. 

The critical parameters of steam sterilization are temperature, time, air elimination, steam quaUty, and the absence of superheating. Temperature and time are interrelated, as shown in equation 8. The success of steam sterilization is dependent on direct steam contact which can be prevented by the presence of air in the chamber. The abiUty of steam to heat a surface to a given temperature is considerably reduced by the presence of air. Air elimination, therefore, is regarded as an absolute parameter. If the required amount of air has not been eliminated from the chamber and the load, no combination of time and temperature results in complete sterilization. 

The choice of a particular mining method depends on a number of parameters, typically the physical properties of the host matrix, the fiber content of the ore, the amount of sterile materials, the presence of contaminants, and the extent of potential fiber degradation during the various mining operations (33). However, most of the asbestos mining operations are of the open pit type, using bench drilling techniques. 

The existence and possible presence of bacterial spores determines the parameters, i.e. time and temperature relationships, of thermal sterilization processes which are used extensively by the food and pharmaceutical industry. These are defined below (see also Chapters 20 and 23). 

All disinfection and sterilization processes for equipment should be validated, for preference using a microbiological challenge with an organism of appropriate resistance to the disinfectant, sterilant or sterilizing conditions. Once the required log reduction of the challenge organism has been achieved, physical and/or chemical parameters can be set which form the critical control points for the process. 

Sterilization method Principle Device Parameter(s) monitored... 

Another issue in the preparation of reference material is the required shelf life. The shelf life of reference material is the time that it remains stable under proper storage conditions. Depending on the nature of the mechanisms affecting the stability of the material, various actions can be taken to improve the shelf life. Reduction of the moisture content is one of the first options to be considered. In many cases, moisture plays a key role in mechanisms leading to instability of the matrix and/or parameters. In other cases, sterilization or pasteurization of the material might be considered in order to stop bacterial activity. When preparing solutions, additives may increase the shelf life. Obviously, the shelf life of material is also a function of the storage conditions. 

The Ph Eur mentions the possibility of parametric release for certain terminal sterilization processes (saturated steam, dry heat and irradiation) where sterilization parameters can be accurately monitored and recorded and controlled. Much of the information in the two draft documents relates to parametric release of sterile products, but the possibility of parametric... 

Currently the main application of interest for parametric release is to replace the sterility test as a control method in appropriate cases (given the limited value of that test to predict sterility assurance due to statistical considerations, although it is also pointed out that a sterility test provides a final opportunity to identify a major failure, although other means should provide a more reliable way of detecting such failures). The concept is applicable to well-founded methods of sterilization where the product stability is known and development data have identified the critical process parameters. The measured parameters should be such as to ensure that correct processing of the batch provides sufficient assurance that the sterility assurance level intended has been achieved. 

In the case of heat sterilization processes, the supporting data required include heat distribution and heat penetration studies (usually at least three runs at the minimum process parameters), with calculation of... 

Tests performed on humans and animals under normal and pathological conditions showed that under normal conditions the ACW is a stable parameter specific to species and age. On the contrary it is very sensitive to any stress factors (bacterial and sterile inflammations, surgical and psychoemotional stress) and to the application of P-agonists [33],... 

AMSCO International Inc. [2.14] offers complete installations for VHP sterilization of freeze drying plants, which are programmable and automatic 4 to 400 g H202 per injection can be preset, as well as the parameter of the drying-, sterilization- and venting phases. The process is documented. Figure 2.47 shows an AMSCO-VHP generator. 

Batch manufacture, storage, and transfer should be carried out in aeeordanee with routine procedures involving the same operators. The maehine should be eleaned and sterilized by the usual proeedures, although if an overkill sterilization eyele is used routinely, a partial sterilization (although still meeting standard parameters) may be chosen as worst case. ... 

Male rats administered five oral doses of 20mg/kg had a temporary fertility loss, whereas a single lOOmg/1 dose caused spermatocele formation and probable permanent sterility. Eifty inhalation exposures at 50ppm for 6 hours each caused transient infertility in male rats no changes were observed in reproductive parameters of female rats rabbits remained fertile. There was no evidence of teratogenicity in rat fetuses at doses that caused death in some of the treated dams. ... 

Particle size is one of the most important characterization parameters for sohd hpid nanoparticle dispersions, and parameters relahng to particle size are consequently reported in all stndies on these systems. Particle size determinations are predominantly performed to conhrm that the desired colloidal size range has been obtained dnring preparation and that it is retained upon storage or further processing (e.g., during freeze drying or sterilization). 

The economic scale is compared between the United States and Japan with selected industrial parameters such as sterilization, semiconductors, radiographic testing, and radial tire production, because the very large industrial markets make a whole comparison difficult. The economic scale revealed in selected industrial fields was about 56 billion for the United States and 39 billion for Japan. The former is larger by a factor of — 1.4 [4]. 

If the system operates according to the specified operating parameter, begin to generate white visible smoke at the critical locations. A critical location is defined as any area where sterilized product or material is exposed to the working environment. 

Ability of the sterilizer to hold the required sterilization parameters... 

A review of all sterilization specifications assigned to the sterilizer under consideration shall be made, with the specifications cycle requiring the maximum peak dwell temperature and heating rate to be selected for the empty sterilizer heat distribution runs. During the empty sterilizer heat distribution runs, sterilizer parameters and equipment component status shall be visually monitored to confirm applicable control operations. 

All distribution runs must meet the parameter requirements of the corresponding specihcation and established production sterilization cycle. 

Cooling zone. In the cooling zone, an additional HEPA-hltered laminar how unit cools down the sterilized containers. When leaving the tunnel, the container temperature is about 10 to 20°C above room temperature. The laminar how unit and exhaust fan of the cooling zone are adjusted so that the tunnel remains pressurized, thus preventing any unsterilized air from entering. All critical process parameters are fully controlled by a... 

ABC Pharmaceutical Industries information. The equipment preparation pages of the master batch record specify the validated sterilization processes to be employed in the preparation of the equipment for (product name) USP. Cycle sterilization parameters are defined along with attributes such as loading patterns and the mechanics of operating the sterilizing equipment. The following lists the sterilization cycles utilized for the equipment required in the processing of (provide product name) USP ... 

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