Formulation and packaging-sterile

The production of sterile products is profoundly impacted both by formulation and the selection of primary packaging components. Design parameters for a facility and selection of appropriate manufacturing technologies for the product require that the formulation process and packaging components be chosen and evaluated in advance. 

Obtaining stable, biocompatible, small-sized, narrowly distributed emulsions of an excretable PFC was crucial. The extreme hydrophobicity of PFCs can, however, render the obtaining of a stable emulsion difficult. Further critical aspects of PFC emulsion development involve emulsion formulation, physical and biological characteristics, scale-up, sterilization, and packaging, as well as its user-friendliness and strategy of use. 

The provision of sterile areas in a packaging and formulation plant means that such a plant may cost as much as a conventional manufacturing plant for the active ingredient. The tableting and packaging equipment are relatively inexpensive, and most of the money is spent on equipment to produce a controlled environment. 

D. The work room for the operations occurring subsequent to formulation performed for sterilization (excluding labeling and packaging) shall meet the following requirements. Proviso ... 

Radiation chemistry of PP has been extensively reviewed (162). Under suitable conditions, radiation treatment can lead to desirable branching reactions (163) with rheological characteristics favorable for thermoforming, foaming, blow molding, and extrusion coating. Resistance to radiation sterilization is an important requirement in some medical applications, and requires specialized formulation and stabilization packages. 

It is quite rare that the composition or the packaging of an ophthalmic pharmaceutical will lend itself to terminal sterilization, the simplest form of manufacture of sterile products. Only a few ophthalmic drugs formulated in simple aqueous vehicles are stable to normal autoclaving temperatures and times (121°C for 20-30 min). Such heat-resistant drugs may be packaged in glass or other heat-de-formation-resistant packaging and thus can be sterilized in this manner. The convenience of plastic... 

USP Type III has been found acceptable in packaging some dry powders that are subsequently dissolved to make a buffered solution and for liquid formulations that prove to be insensitive to alkali. Type III glasses are usually not used for those products that are sterilized in their final container. Type II glass containers can be dry heat sterilized and filled under aseptic conditions. 

Inhalation solution and suspension drug products are typically aqueous-based formulations that contain therapeutically active ingredients and can also contain additional excipients. Aqueous-based oral inhalation solutions and suspension must be sterile (21 CFR 200.51). Inhalation solutions and suspensions are intended for delivery to the lungs by oral inhalation for local or systemic effects and are used with a specified nebulizer. Unit-dose presentation is recommended for these drug products to prevent microbial contamination during use. The container closure system for these drug products consists of the container and closure and can include protective packaging such as foil overwrap. 

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