Container closure systems functionality

First, consider container closure system functionality the container closure system may be designed to improve patient compliance (e.g., a cap that contains a counter), minimize waste (e.g., a two-chamber vial or IV bag), improve ease of use (e.g. a prefilled syringe), or have other functions. 

Sterilization by filtration is a major unit operation used in aseptic processes. Aseptic processes require the presterilization of all components of the drag product and its container. Then all of the components are brought together in a controlled aseptic environment to create the finished sterile product sealed within its container/closure system. The level of sterility attained by an aseptic procedure is a cumulative function of all the process steps involved in making the product. Therefore, the final level of sterility assurance for such a product cannot be greater than the step providing the lowest probability of sterility. Each step in the aseptic process must be validated to known levels of sterility assurance [43],... 

The container closure system should perform function in the manner in which it was designed. 

Before other functions, e.g. tamper-evidence/resistance, child-resistance, accuracy of delivery, can be discussed, general technical factors associated with ingress and egress need further consideration. Since these are common to seal efficiency (i.e. ingress and egress) and may define seal quality, they were not covered under the headings used earlier. In the example used below a continuous screw threaded container—closure system has been employed as an indication of the typical variables involved. These are listed in Table 11.2 and then briefly discussed. 

Description of the container/closure system—K brief description of the primary and minimally functional secondary materials used in the packaging of the finished developmental API should be provided (e.g., double high-density polyethylene liner inside a fiberboard container/closure). Consideration should also be given to including appropriate acceptance criteria for the primary (i.e., product contact) material. The container/closure described in this section should be consistent with that used for stability testing of the compound, or exceptions should be noted. 

The main postulate of quantum mechanics is that the whole information of a general system under study is contained in the total wave functions Tjt). This is known as completeness of the quantum-mechanical description. Such a circumstance is coherent with Eq. (6) since 2 is assumed to carry the whole information of the investigated system. This is formally expressed through the closure relation for the exact orthonormalized basis Tfc) ... 

For separations outside the hard core, the direct correlation functions have to be approximated. Classic closure approximations recently applied to QA models axe the Percus-Yevick (PY) closure [301], the mean spherical approximation (MSA) [302], and the hypernetted chain (HNC) closure [30]. None of these relations, when formulated for the replicated system, contains any coupling between different species, and wc can directly proceed to the limit n — 0. The PY closure then implies... 

Whether these requirements can be met depends on the model considered and on the closure relation involved for the calculation of the correlation functions. Examples for which Eq. (7.54) has actually been used pertain to the class of simple QA systems, that is, QA systems with no rotational degree of freedom where the interaction potentials contain a spherical hard-core contribution plus (at most) an attractive perturbation. For such sj stems, the free energy has been calculated on the basis of correlation functions in the mean sphericfxl approximation (or an optimized random-phase approximation) [114, 298). 

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