Sterilization products, process flow

Process Flow, Variables, and Responses Terminal Sterilization Products... 

PROCESS FLOW, VARIABLES, AND RESPONSES TERMINAL STERILIZATION PRODUCTS... 

Process flow, variables, and responses terminal sterilization products... 

Media Filling Trials Media fills are intended to simulate the risk of contamination that may arise from the aseptic assembly of sterile product elements by substitution of a sterilized placebo for the dosage form. The placebo should be chosen to be of similar flow/filling performance characteristics to the sterilized dosage form to mimic accurately the normal conditions of the production process. 

The architectural services integrate the design of the facility so that it can support the corresponding process the flows of people, materials, products and waste, product separation, sterile processing, sanitary design, biohazard containment, special utilities, and solvent recovery, handling and storage. 

Yokota [2.1] sprays the liquid to be frozen in to a film of cold n-hexane, which flows down the inner wall of a conical vessel. The frozen particles are sieved off. With this method, two problems need to be solved (i) The droplet size cannot be influenced, product parts can be extracted, and the product and n-hexane must to be completely separated, and (ii) the process must be sterile. 

Downstream processing is normally undertaken under clean room conditions, with the final steps (e.g. sterile filtration and aseptic filling into final product containers) being undertaken under Grade A laminar flow conditions (Figure 3.18). 

Unlike sterilizing and virus removal filters, tangential flow filtration (TFF) filters are often reused. Flow and integrity tests are necessary to ensure the filter remains the same after usage and cleaning. Consistency of filtrate and retentate streams is validated using relevant validated assays that are specific for each process and product. 

Diagrams for a synthetic chemical, single reaction step process (Fig. 3) and a typical single product fermentation (Fig. 4) are taken from Wintner s excellent article [ Environmental Controls in the Pharm. Industry. Pharm Eng (April 1993)]. Both flow diagrams feature about the same number of unit operations and start with raw material weighing procedures. The essential difference between the two figures is that the fermentation process features sterilization, inactivation, and preservation unit operations. 

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