Records Packaging Materials

Polyesters enter our lives in a most ubiquitous manner as textiles, carpets, tire cords, medical accessories, seat belts, automotive and electronic items, photographic film, magnetic tape for audio and video recording, packaging materials, bottles, and so on. Their utility is illustrated by the vast range of their applications. This article describes the properties, synthesis, manufacture, and raw materials for the two most widely used thermoplastic polyesters polyCethylene terephtha-late) (PET) [25038-59-9] and poly(butylene terephthalate) (PBT) [26062-94-2]. In order of volume, PET comes first by virtue of its enormous market tonnage in polyester fibers and films, as well as the resin for blow-molded bottles, containers, and food packaging. 

The principal uses of polyfethylene terephthalate) film are electrical, particularly in capacitors, as slot liners for motors and for recording tape. Its high strength and dimensional stability have led to a number of drawing office applications. The film is also a useful packaging material whilst metallised products have a number of uses as a decorative material. 

Records of Raw Materials, Intermediates, API Labelling and Packaging Materials... 

A system of documentation should exist such that the history of each batch of the product, including details of starting materials, packaging materials, and intermediate, bulk and finished products, may be determined. Distribution records must be kept. This information is of paramount importance should a defective batch need to be recalled. 

These polymers commonly are described as PVC plastics or less specifically as vinyl. They are materials that may be either flexible or rigid according to what they are mixed with, and they are used in the manufacture of many familiar articles such as plastic curtains, rainwear, floor tile, synthetic leather goods, upholstery, table mats, phonograph records, insulation, plastic pipes, tubing, and packaging materials. 

Documentation and records (systems, specifications, raw materials, intermediates, labeling, packaging materials, master production and batch records, laboratory control records, batch production record review)... 

The explicit control of named contaminants requires that the possibility of their presence has been recognised and recorded in, for example, a negative list. Almost by definition, the majority of contaminants are not of this nature. Analysis for contaminants in packaging materials and for any migration of same, is difficult and almost open-ended. For this reason, much emphasis is needed on Good Manufacturing Practice and in record-keeping. 

The acquisition, handling, and quality control of primary and secondary packaging materials and of printed materials should be accomplished in the same way as that for the raw materials. The printed materials should be stocked in a reserved place so the possibility of unauthorized access is avoided. The labels and other rejected printed materials should be stored and transported with proper identification before being destroyed. There should be a destruction record of the printed materials. Each batch of printed material and packaging material should receive a specific reference number for identification. 

Records should be maintained for each shipment of labels and packaging materials showing receipt, examination, or testing, and whether accepted or reject. 

Drug product containers and closures specifications In-process materials Packaging material Labeling specifications Drug products specifications Procedures and specifications Batch production and control records, including Products from contractors Production records Packaging records... 

The USP/NF also requires that records be kept at the temperature where the dosage forms are stored and information on the packaging materials used in repackaging must be kept as well. 

Each distributor must furnish the results of raw material and packaging material testing for each lot or batch sold distribution records for each lot and batch of a drug and complaint records including the result of its investigation. 

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