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For testing the entire product rather than the fluid path alone, the additional issue of handling its external surfaces without contaminating them must be overcome. The second issue is that bioprocess systems or components tend to be quite expensive. Taken with the likelihood that such products are sold at very low volumes in the beginning of their life cycle, testing a relatively large number of actual articles could be prohibitive to their commercialization. Particular approaches that manufacturers take to address these issues must be developed specific to each case because they are typically a balance betweenA desire to avoid false results inflated bioburden estimates or false positive sterility test results caused by handling of unwieldy articles. Several common approaches can lessen the difficulties posed by those two issues. The following examples are intended to illustrate what may be done to overcome the issues; they are not intended to exclude other scientifically defensible approaches. Sample Item Portion SIP: The SIP approach allows for manufacturing and testing a reduced scale product. This reduces both the cost of the test article and difficulties with manipulating product in the laboratory. This approach increases experimentally determined bioburden estimates by a multiplier based on scale differences between the SIP article and the actual product represented. SIP multipliers can be determined through experimentation or simply by taking a ratio of the model to the largest system manufactured. Fluid Path: In some cases, it is appropriate to validate the sterility of a products fluid path.

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There can be peak and valleys in monthly, quarterly and annual FandA workloads. Businesses need to manage contingent staff on a regular basis and also need to make sure the entire activity is cost effective. When you outsource FandA to Accountants in Atlanta, you dont need to make any resource management planning. Also, FandA service providers take into account the scalability depending on the project scope and try to deliver to their clients lower per unit resource cost. The FandA service provider is more likely to have the much larger specialized staff to do the accounting work. The provider can also ensure a team of expert outsourced accountants can work on your project within complex rules and regulations or at crucial times. If you try to do this in house it would not be cost effective and could turn out to be hectic as well. Advanced financial technology solutions are often costly and so are the upgrades. When you outsource your accounting services, you dont have to invest in purchasing advanced financial solutions. The FandA service provider invests in all advanced technology solutions needed for their clients. Thus in an indirect way, your company gets benefits of advanced technology at lower costs.