Pharmaceutical products packaging

Keywords product safety pharmaceutical product packaging quality control AMDIS deconvolution unknown identification Mass Frontier spectrum interpretation... 

Pharmaceuticals. Pharmaceuticals account for 6% of the Hquid-phase activated carbon consumption (74). Many antibiotics, vitarnins, and steroids are isolated from fermentation broths by adsorption onto carbon foUowed by solvent extraction and distillation (82). Other uses in pharmaceutical production include process water purification and removal of impurities from intravenous solutions prior to packaging (83). 

SAN is also used for pharmaceutical and cosmetic packaging. Usage breakdown for Western Europe in the early 1990s has been estimated at 28% for household products, 21% for domestic electrical applications, 8% for battery casings, 12% for pharmaceutical/cosmetic packaging and a large figure of 31% for other applications. 

Nylon film has been used increasingly for packaging applications for foodstuffs and pharmaceutical products. The value of nylon in this application is due to low odour transmission and to some extent in the ability to boil-in-the-bag. Film of high brilliance and clarity, particularly from nylon 11, is available for point-of-sale displays. 

Packaging Similarly, information on the closure/packaging systems must be provided in terms of material specification, suitability/compatibility with the pharmaceutical product, dimensional specifications, water impermeability, and so on. Defence against microbial contamination should be discussed in the context of either packaging of sterile product or use of preservatives as appropriate. 

Legal requirements for pharmaceutical product assessment and registration specify how pharmaceutical production should be carried out, and lay down requirements concerning packaging, information to be provided by labels and inserts, methods of analysis, etc. 

Crystallisation is used for the production, purification and recovery of solids. Crystalline products have an attractive appearance, are free flowing, and easily handled and packaged. The process is used in a wide range of industries from the small-scale production of specialised chemicals, such as pharmaceutical products, to the tonnage production of products such as sugar, common salt and fertilisers. 

Pharmaceutical packaging is the means of providing protection, presentation, identification and information, containment, and convenience to encourage compliance with a course of therapy. The period from product manufacture to ultimate use or administration lies within the product shelf life interval. Criteria for selecting a satisfactory packaging system for pharmaceutical products are established by addressing a checklist of basic considerations ... 

Packaging of pharmaceutical dosage forms and medical devices have many requirements in common with other commercial products. Package design must address the finished products needs, including ... 

C. Eliasson and P. Matousek, Noninvasive authentication of pharmaceutical products through packaging using spatially offset Raman spectroscopy, Arml Chem., 79, 1696-1701 (2007). 

The Swedish Classification Scheme initiated in 2005 by the Swedish Association of Pharmacy Industries (LIF), the Swedish Medical Products Agency, Apoteket (National Corporation of Swedish Pharmacies), the Swedish Association of Local Authorities and Regions and the Stockholm County Council, take in account Persistence, Bioaccumulation and Toxicity (PBT) characteristics of pharmaceutical products. This voluntary scheme looks at the environmental hazard and the associated risk of pharmaceutical products. The environmental risk is calculated based on the ratio PEC/PNEC according to the EMEA guideline [17,124, 127]. The obtained information is only available on the website www.fss.se, since due to European restrictions it is not possible to include warning labels on the packaging of medications [17]. 

A 0.15-mm-thick film is required for use in packaging a pharmaceutical product at 30°C. The partial pressure of O2 is 0.21 atm outside the package and is 0.01 atm inside the package. Use permeability data from Table 4.17, and assume that the resistance to diffnsion ontside and inside the membrane are negligible compared to the resistance of the film. 

To gain FDA approval or license for marketing, a pharmaceutical product must be shown to be safe and effective for its proposed or intended use. The drug company or sponsor must also provide evidence to show that the processes and control procedures used for synthesis, manufacture, and packaging are independently validated to ensure that the pharmaceutical product meets established standards of quality. The overall effort from the inception of a new molecular entity and the establishment of analytical, scale-up, and quality control procedures, to the collection of safety and efficacy data for consideration by the FDA as part of an NDA or BLA, is called the drug development process. 

As a simple example, consider, that you are packaging a pharmaceutical product using a line that performs various process steps. Figure 5a illustrates one of these steps. It has input(s), output(s), control(s), and resource(s). These data... 

To show real-world high-technology examples of pharmaceutical product, process, manufacturing, assembly, and packaging system designs, in action, something we cannot do in static, printed books, we have created a supplementary video, in high definition, and compressed onto a DVD. This professionally edited DVD supports... 

Ranky, P. G., Ranky, G. N., and Ranky, R.G. (2006), Examples of pharmaceutical product/ process/manufacturing/assembly and packaging system designs, video on DVD, available www.cimwareukandusa.com. 

Even when water comphes with quality parameters as a raw material, it can present some impurities after being turned into a pharmaceutical product. Table 6 presents the level of some contaminants found in water for injection (WFI). Since the raw material should have passed in the quality test, contaminants either were below the allowed concentration level or were introduced after packaging. Contaminants introduced after packaging most Ukely originate from the packaging materials. Section 6.1.3.2 discusses containers as sources of contamination. 

Although metallic packaging is also used for pharmaceutical products, its use is restricted to blisters supports, which have no contact with the formulation, and tubes for ointments. 

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