Reprocessed material

Reprocess the material into a subsequent batch of excipient. The material should be reprocessed into the batch prior to the purification step. The quantity and batch identity of the reprocessed material should be noted on the batch record into which the excess material was added. 

List of other batches and products possibly affected, the results of their investigations, and any required corrective actions The comments and signatures of all production and quality personnel participating in the investigation and who may have approved any reprocessed material following additional testing... 

The choice of plastic material for automotive parts is influenced by its potential recyclability. One recent example shows that the use of recycled material gave the added benefit of an approximately 10% reduction in weight. This involved the use of recycled material in the Chrysler Neon rear spoiler. Major considerations in this respect are thermal and UV stabilities of the reprocessable material combined with low weight and mechanical protection performance characteristics. 

If the production batch contains reprocessed material, the expiration dating period should be computed from the date of manufacture of the oldest reprocessed material used. 

Equivalence of the quality of reprocessed material to the original material must also be evaluated and documented to ensure that the reprocessed batch will conform with all established standards, specifications and characteristics. There should be a sufficient investigation, evaluation and documentation to show that the reprocessed excipient is at least equivalent to other acceptable products and that the non-conformance did not result from an inadequate process. Obviously if the need for reprocessing resulted from human error, it will not reflect upon the process, but may indicate other deficiencies such as inadequate training or work instructions. 

The batch identifying numbers) and or clearance reference number(s) and amount of any recovered product residues or reprocessed materials used, if any ... 

Where such reprocessing occurs, written process change procedures should be approved by the quality control unit that clearly specify the conditions and limitations of repeating chemical reactions. In addition, the procedures should establish how this type of reprocessing will be evaluated, and what additional tests will be conducted on the reprocessed material to show that the resulting material is of a purity and quality comparable to that normally produced by the process. These tests should include, as appropriate, purity, impurity profiles, stability testing on initial reprocessed tots, and testing for physical attributes. 

Reprocessing by physical means involves the repetition of a step such as a recrystallization or remilling already routinely performed in the validated process. If the routine process does not include such a step, then it is not reprocessing but rather reworking. The actions to be taken in a reprocessing must be documented with a documented rationale for the reprocessing. Reprocessed materials must be evaluated to determine if additional testing is warranted. 

Further requirements are that the material should be suited for mechanical as well as energy recycling, to meet regulations in different countries. The proof of existing recycling technology and secondary applications for the reprocessed material would also be necessary to ensure environmental credibility. Several points would need to be fulfilled for an efficient recycling chain ... 

The existence of a reverse supply chain able to collect, separate, and reprocess materials can make a product recyclable. In other words, the materials used in the product might be recovered as a material for an additional use. Once this reverse pr(x ess is completed - and the used product is converted into a material from which a new pr(xluct is fabricated - it is said that the product was recycled. A recycled product can be... 

Another consideration of pellets from a resin supplier is the inclusion of an additive for processing stabilization, generally an antioxidant. Although this additive is often included in first-generation pellets, the percentage is usually low and provides limited effectiveness when a significant amount of reprocessed material is blended into the mix. Of course, pellets from a resin supplier are generally more expensive than reprocessed pellets. 

Some of the original PVC materials in post-consumer waste may have been coloured already and the reprocessed materials will therefore reflect... 

Poly(alkenes). There are different problems with the thermal reprocessing of poly(alkenes). Even within homopolymers such as HOPE and LLDPE, manufacturers produce materials with different and a range of additives to meet individual customer requirements. The diffusion of polymer molecules in melt or solution is very slow so that reprocessed materials tend to have lower tensile modulus than virgin materials which affects the markets for which the reprocessed material is suitable. 

The pre-det investigation of either an IND or RDD would seek to detect many of the same radionuclear analytes as for a post-det inquiry. Therefore, materials analysis of IND components would focus on actinide species and their isotopic ratios to estimate threat credibility. Fission products, perhaps at trace levels, could provide clues about radiochemical separation tactics used for reprocessed material. Even activation products, if the nuclear pit contained Pu, might supply information on the time elapsed since a device was assembled. 

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