Sterilization plant requirements

Experiments to examine rhizodeposition can vary markedly in scale and complexity depending on the information required, the equipment available, and the plants concerned. In general, experiments to study exudates and other material lost from young roots are the simplest and are carried out in the laboratory under controlled conditions. Plants are grown in nutrient solution culture, sometimes with sand or other solid support systems, and compounds released into the culture solution are collected and analyzed chemically. The experiments are mainly short-term and the roots can be kept sterile if required. Techniques are also available to label plants growing in these systems with C and to monitor the presence of the isotopes in the rhizodeposits. 

The third critical part in a steam-sterilized plant is the valve between the chamber and condenser. Its design should influence the flow of water vapor from the chamber to the condenser as little as possible, and its component must be easily cleaned and sterilized. Several technical solutions are offered for this problem. In Fig. 2.48.1 a design is shown in which the valve plate is moved back-and-forth by a hydraulic cylinder. This fulfils the two requirements ... 

In a batch production of penicillin, 40 m3 capacity of the plant, sterile air is required to be supplied. The bioreactor requires 1 vvm (volume of air/volume of broth, min). The incoming air contains 3000cells/m3 of air, for 100 hours operation. Calculate the depth of filter, if the penetration of bacteria is 1 in 1 million. 

Tea flowers are globular, about 3 to 5 cm in diameter, white, and delicately fragrant. They are borne in the axils of scale leaves (small leaves that do not develop further) and may occur singly or in small clusters. There are five to seven petals and an equal number of sepals. The flowers are mostly self-sterile and are produced in cycles corresponding to leaf growth, and require 9 to 12 months to form mature, round seed pods 1 to 1.5 cm in diameter. The tea plant is not generally allowed to flower during production cycles, with only a small number of the plants allowed to go to seed production to maintain seed stock. 

Probably the most exciting aspect of molecular farming from the industrial perspective is the low initial capital investment compared with mammalian cell culture production. The reduced capital input reflects the lower costs of laboratory equipment and materials for plant molecular biology. For example, the costs involved in establishing small, non-sterile greenhouse facilities are dwarfed by those required for a sealed pilot fermentation plant. 

Steam sterilization is at presenzt the most used method [2.15] for freeze drying plants. It requires a temperature of +121 °C for 10 to 30 min, and thus the plant must be pressure-tight up to 2.5 bar. 

Basically the chamber plants described in Section 2.4 can be used for foodstuffs and other products, as described in Sections 5.1 and 5.2. Freeze drying plants for food and similar products have to handle large quantities of product. The cleaning requirements remain, but no sterilization is necessary. The product can be transported in trays as described in Section 2.2.2 and dried in cylindrical tunnels. Figure 2.52 shows the two systems most commonly used to day. Their characteristic features are ... 

In following text an attempt is made to give an example of the types of documentation that must be prepared within the validation master plant for the installation qualification (IQ) and the operational qualification (OP). The examples given are restricted to the process and installation engineering aspects, and exclude the many other aspects, e. g. sterility, biological or chemical requirements, corporate policies or the production environment. The information described are organized in six categories ... 

Sterile producfs for injection represent a particular challenge for the pharmaceutics development group. To prepare injectables, the pharmacists need not only sterile rooms in which to work at the laboratory, pilot plant, and production scales of operation, but they also require pyrogen-free wafer. Pyrogens are impurities, generally originating with... 

The cycle was mn per the previously mentioned parameters and plant SOP for sterilization of rubber stoppers. Minimum Fq value is obtained AAAA during three heat penetration studies and a six-log reduction was achieved. All results are found in compliance and within the acceptance criteria and meeting the requirements. On the basis of satisfactory revalidation results/data, the cycle is considered revalidated. 

Chlorination is the most widely used disinfecting or sterilizing process. Where daily water requirements arc not large, it is common practice to use a hypochlorite, but for large plants liquefied chlorine gas is used. Chlorination may be practiced before filtration (prechlorination), after filtration (post-chlorination), or both before and after. 

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