Packaging line processes

The packaging lines receive substances from the mixing and/or extrusion processes. From the pack, storage, packaging material is provided to the packaging lines. The packaging lines insert the received substances into the provided packaging material... 

In this definition, the key words are documentation, specific process, product specifications, and quality. This automatically means that validation will play a vital role in guaranteeing the safety, identity, quality, and stability of all pharmaceutical, biological, and medical device products. We will now present an outline of the most important requirements for ensuring that packaging line equipment complies with the guidelines of the authorities. 

All companies must recognize that validation of packaging line equipment is required by the authorities in order to provide documented evidence that then-specific packaging processes will consistently meet specifications. 

Two main decision levels, the level of plants and the level of customers, are considered in the Provimi Pet Food supply chain problem. Customers have certain demands for products which can be produced in the plants. The production process is modeled as being consisted of two consecutive steps. Semi-products are produced in production lines. These semi-products are subsequently mixed and packaged in packaging lines. This packaged product is the final product of the plants, and is transported to the customers. The semi-products can be transported between plants, i.e. a packaging line can package semi-products produced in another plant. 

They should also have been formally trained on the particular machines that are in use on the packaging line, particularly in safety and observation, and have a thorough knowledge of how the marketable pack should look at all stages of its packaging. There should be SOPs for codes of dress, discipline, line processing, clean-down, etc. Training records should be archived. 

During the packaging process the packaging line should be continually monitored to ensure that the integrity of the finished product is not in any way compromised. Written procedures and tabulated check lists should be signed at regular intervals by competent and suitably trained people. 

An on-line analyzer must be packaged much more robustly than a laboratory instrument to withstand the process environment which, for example, may have an explosive atmosphere and significantly variable ambient temperature. It must also be capable of continuous, unattended operation over long periods of time. Clearly, the simpler the instrument the better. Of the methods listed in Table 1, WDXRF, polarized EDXRF, and Pyro-microcoidometry have not been adsqrted to on-line process instrumentation, whereas the other methods have. The relative simplicity of Pyro-EC makes it particularly suitable for adaptation to process instrumentation. The sulfur dioxide sensor is a small, plug-in, low cost electrochemical cell, easily replaceable and with an expected lifetime of over one year. The UV lamp, UV optics, and photomultiplier used in Pyro-UVF are not required. The X-ray tube (or radioactive source). X-ray detector, and X-ray optics used in all the XRF instruments are not required. 

Alternative removal methods have been reported, but none is widely used. Of these, one involves sliding a hot wire, through which current is passed, between the substrate and package. This process simultaneously softens and slices through the adhesive bond line. Another method consists of inserting a resistance heater on the underside of the substrate to generate additional localized heating at the adhesive interface. 

For the fast packaging lines, 20 to 30 corrugated cardboard cases per minute, only the hot melt adhesives are suitable, because they may be applied at high speeds such as 20 m per min, and they set very fast, in 1 to 3 s, so that the cases may be processed further on the line immediately (stacking, storage and shipment). 

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