Specifications packaging

Note that Systnme Internationale (SI) units are employed in this article preceding English units. In U.S. trade practices and packaging specifications, however, English units are employed to the virtual exclusion of metric units. 

Packing is an activity and packaging a material in this context. A Packing Specification defines how an item should be packed, whereas a Packaging Specification details the nature of the package. 

Machin et al. (1997) provide extensive tables in relation to sample size calculations and include in their book the formulas and many examples. In addition there are several software packages specifically designed to perform power and sample size calculations, namely nQuery (www.statsol.ie) and PASS (www.ncss.com). The general statistics package SPLUS (www.insightful.com) also contains some of the simpler calculations. 

Although much of the packaging specification will be determined by the product and process requirements, the pack size, material, neck size and closure will be determined by the market and commercial requirements. 

Stability profile of the product Produced during process development Primary packaging specification... 

Drug substance Description, including physical and chemical characteristics and stability, manufacturers, methods of manufacture and packaging, specifications and analytical methods for the drug substance, solid-state drug substance forms and their relationship to bioavailability. 

Earthcycle has developed a line of packaging specific for fresh vegetable and fruit. The packaging trays are water resistant and are available in two colours, natural fibre and vanilla. Other colours are available upon request, using vegetable dyes, so the biodegradability and compostability of the product is not jeopardised. 

AQUAlibrium is a software package specifically designed for calculating fluid phase behavior in mixtures of natural gas and water. It is designed for use with sweet and sour gas and more particularly, acid gas. It can also handle liquefied gases. This makes AQUAlibrium... 

The GRID force field represents the basis for several software packages specifically developed for application to pharmacodynamic aspects of drug research, including the programs ALMOND, Pathfinder, and FLAP or, in the ADME field, the programs VolSurf and MetaSite. 

Polystyrene (PS) as normally prepared is essentially linear and atactic. Isotactic polymers can be made but this is not of commercial interest because of increased brittleness and more difficult processing than the atactic product. The major application of polystyrene is in packaging. Specific additives are incorporated to achieve product characteristics that depend on the end usage. 

There have been some concerns about how the label elements should appear on different packagings. Specific examples are provided in Annex 7. 

In case the packaging specifications are not identical, the results of both accelerated and long-term tests, for a duration of 6 months of at least 2 pilot batches must be included in the initial submission for registration. 

Previously, packaging specifications allowed the use of a rubberized cloth bag. However, during the long-term storage study discussed below, it was shown that the use of the rubberized bags results in deterioration of the lead azide and necessitates the destruction of the lead azide. 

Once several batches of raw materials have been reviewed and tested to demonstrate that they will conform with the functional and quality requirements, the full excipient and packaging specifications can be finalised. Excipient and pack performance should be evaluated from a stability evaluation of the product and feedback from experience in clinical trials. Ideally, the specifications should be finalised for the start of Phase III clinical trials. If for some reason, the excipient or packaging material has to be changed for Phase III supplies, then some or all of the steps involved in the selection of materials, compatibility and stability studies may have to be repeated. 

At all stages attention must be paid to GLP, GMP and validation. Having surveyed the broad functions of the pack, further emphasis should be placed on the role of the packaging specification and the method of pack assembly. Attention to these two factors is highly important to both the development and the ongoing production situation. 

When quantities of the label are requisitioned against the packaging documentation, (based on the packaging specification) they should first be visually identified, counted and code checked (preferably by machine reading) and then signed off by the authorised store issuer. The materials are then securely held away from the packaging line area, awaiting use. 

Packaging material (primary or immediate packaging) Specifications and routine tests, covering ... 

Polyethylene terephthalate is a low-cost polymer that exhibits excellent optical and mechanical properties. PET is commonly used in the field of packaging, specifically plastic bottles. PET is also used as flexible substrate in organic solar cells. Exposing this polymer to environmental atmosphere changes its external appearance, modifies its surface, and degrades its properties. 

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