Sterile products, packaging

Sterile Product Packaging—Integrity Evaluation (1207), USP 29-NF 24 United States Pharmacopeia Rockville, MD, 2006 3035-3037. 

Morton Guazzo D (2010) Sterile product package integrity testing, current practice, common mistakes, new developments. Paper presented at PDA Metro Chapter Meeting, New Brunswick, 17 May 2010... 

The processing operations for fluid or manufactured milk products include cooling, centrifugal sediment removal and cream (a mixture of fat and milk semm) separation, standardization, homogenization, pasteurization or sterilization, and packaging, handling, and storing. 

The objective in packaging cool sterilized products is to maintain the product under aseptic conditions, to sterilize the container and its Hd, and to place the product into the container and seal it without contamination. Contamination of the head space between the product and closure is avoided by the use of superheated steam, maintaining a high internal pressure, spraying the container surface with a bactericide such as chlorine, irradiation with a bactericidal lamp, or filling the space with an inert sterile gas such as nitrogen. 

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. 

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... 

Ultra-High-Temperature (UHT) Sterile Milk. Rapid increases in the production and sales of sterile, fluid milk in Europe and its entry into new markets around the world merit its consideration in this chapter. Although the gross composition of UHT sterile, aseptically packaged milk is essentially the same as that of its pasteurized counterpart, differences in its properties and minor constituents should be mentioned. 

Packaging is vital in maintaining the state of a sterile product up to the moment that the packaging is opened for withdrawal or use of the product. The regulator-ies expect manufacturers to test finished packages to confirm package strength,... 

The manufacturer s test is to ensure beyond a reasonable doubt that the product remains in a sterile condition at the point of use. The validation of sterilization processes guarantees initial sterility, and package integrity testing verifies the continued sterility of the product device after processing, storage, and handling. 

One major advantage of the package is that it contains no head-space because the top seal is actually formed through a column of sterile product. This lack of headspace offers some protection, at least initially, to oxygen-sensitive products. 

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. 

Nonsolids The package must prevent the entry of organisms for example, packaging of sterile products must be absolutely microorganism proof—hence the continued use of glass ampules. Liquid injections are classified as small-volume parenterals (SVPs), if they have a solution volume of 100 mL or less, or as LVPs, if the solution volume exceeds lOOmL [10]. Liquid-based injectables may need to be protected from solvent loss. 

Some examples of plastic additives and parenteral drug administration devices used as packaging materials for sterile products can be seen in Tables 1 and 2. 

Cleaning and sterilization of equipment, packaging, and all other items to be in contact with the sterile product... 

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