Closure liner

Closure liners of pulpboard or cork, unless specially treated with a preservative, foil or wax coating, are often a source of mould contamination for liquid or semi-solid products. A closure with a plastic flowed-in linear is less prone to introduce or support microbial growth than one stuck in with an adhesive, particularly if the latter is based on a natural product such as casein. If required, closures can be sterilized by either formaldehyde or ethylene oxide gas. 

A packaging component means any single part of a container closure system. Typical components are containers (e.g., ampules, vials, bottles), container liners (e.g., tube liners), closures (e.g., screw caps, stoppers), closure liners, stopper overseals, container inner seals, administration ports [e.g., on large-volume parenterals (LVPs)], overwraps, administration accessories, and container labels [4],... 

Product optimisation of the pack should initially focus on defining the primary packaging (sometimes referred to as primary container or immediate container ). This is most relevant to regulatory authorities because it is the primary packaging that is in direct contact with the drug product, including the closure, liner, and any other surface contacting the product. 

No metal closures PP or HDPE/EVA closures and closure liners preferred on PET bottles HDPE, LDPE or PP closures preferred on HDPE, PP, and PVC bottles. 

Erucamide is a particularly popular lubricant. Emcamide is also used, almost universally, as a slip agent in polyolefin closures. In this role, the emcamide functions to reduce the coefficient of fnction between the closure liner (or closure shell) and the container finish. Without such a slip agent, removal torques for such closures would be unacceptably high. Emcamide is widely used as a slip agent and lubricant because of its low cost and useful properties. Emcamide is a C22 fatty acid amide that possesses a double bond at the C13 position. Ozone, in particular, is extremely effective at selectively cleaving this double bond, creating the C9 aldehyde nonanal. ... 

The site conditions for an on-site landfill, such as location, geology, hydrogeology, physiography, climate, and so on, should also be suitable. Landfill should meet the minimum technology requirements and regulations for hazardous waste landfills such as double liners and leachate collection and removal systems, leak detection systems, closure procedures and final cover, and construction quality assurance.59... 

FIGURE 26.2 Double-liner designs. (Adapted from U.S. EPA, Requirements for Hazardous Waste Landfill Design, Construction, and Closure, EPA/625/4-89/022, U.S. Environmental Protection Agency, Cincinnati, OH, August 1989.)... 

Final cover systems are another important component of waste containment systems used at landfills. While liner systems are installed beneath the waste, final cover (or closure) systems are installed over the completed solid waste mass. For hazardous waste landfills, 40 CFR 264 requires that the landfill be closed with a final cover system that meets certain performance criteria, most notably, that they have a permeability less than or equal to the permeability of any bottom liner system or natural subsoils present. U.S. EPA guidance documents517 recommend that final cover systems for hazardous waste landfills consist of at least the following, from top to bottom ... 

This section presents an overview of collector design and materials, followed by a discussion of the three parts of a liquid management system the LCRS above the primary liner, the secondary leak detection, collection, and removal (LDCR) system between the primary and secondary liners, and the surface water collection system above the closure of the completed facility. The section concludes with a discussion of gas-collector and removal systems. 

Filter layers, frost penetration, and cap-liner connections are other factors to consider in designing the closure system for a hazardous waste landfill. Before using geotextiles for filter layers in closures, one should conduct pressure tests and clogging tests on the material. Freeze-thaw cycles probably have little effect on membranes, but their impact on clay is still not known. Because of this lack of knowledge, membrane and clay layers should be placed below the frost penetration layer. Finally, a cap membrane should not be welded to the primary FML. Differential settlement in the cap can put tension on the cap membrane. In such a situation, the seam could separate and increase the potential for integration of the surface water collection system into the LDS. 

The main applications of butyl rubber are in wire and cable applications, inner tubes, inner liners in tubeless tyres, tyre curing bladders, and pharmaceutical closures, the latter utilising the low... 

A typical container closure system is a plastic (usually HDPE) bottle with a screw-on or snap-off closure and a flexible packaging system, such as a pouch or a blister package. A typical closure consists of a cap — often with a liner — frequently with an inner seal. If used, fillers, desiccants, and other absorbent materials are considered primary packaging components. 

Drug substances are generally solids, but some are liquids or gases. The container closure system for storage or shipment of a bulk solid drug substance is typically a drum with double LDPE liners that are usually heat sealed or closed with a twist tie. A desiccant may be placed between the bags. 

The application (or Type II DMF) should include a detailed description of the complete container closure system for the bulk drug substance as well as a description of the specific container, closure, all liners, inner seal, and desiccant (if any), and a description of the composition of each component. A reference to the appropriate indirect food additive regulation is typically considered sufficient to establish the safety of the materials of construction. The tests, methods, and criteria for the acceptance and release of each packaging component should be provided. Stability studies to establish a retest period for bulk drug substance in the proposed container closure system should be conducted with fillers or desiccant packs in place (if used). Smaller versions that simulate the actual container closure system may be used. 

Closures made with a liner (or wad)-type sealing system break the seal faster, thereby allowing more time to vent the carbonation gases. The technology of liners has developed significantly over recent years. This development has improved the reliability of the seal across a wide range of bottles, both glass and plastic, and offers the potential for an improved barrier in the closure. All this has meant that most closures in the soft drinks and juice market today have liners of one form or another. There are two types of liner a loose liner pushed into the cap after the cap is moulded and a moulded-in liner, which is formed at the time the closure is made. 

Plastic closures can be made by injection moulding, where the mould has two parts - a core which has the inside features of the closure and a cavity which has the features of the outside of the closure. Molten plastic is injected into the mould, which is water-cooled. The plastic solidifies, and the mould opens and the completed closure is ejected. If the closure is a two-piece design (i.e. fitted with a loose or flowed in-liner), then this is added later. Another technology for moulding plastic closures for the beverage market is compression moulding. A hot pellet of PP is positioned in a mould, similar to the cavity of an injection mould. As the mould closes, the pellet is squashed and defoimed into the shape... 

Finally, if high-level waste is considered to be hazardous waste under RCRA, requirements on construction, operation, and closure of a disposal facility, including the provision of a liner system, leachate collection and removal system, and leak detection system (see Section 4.2.2), would need to be addressed. Such requirements are impractical at a geologic repository for disposal of high-level waste... 

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