Package integrity

API Std 672, Packaged, Integrally Geared Centrifugal Air Compressors for Petroleum, Chemical, and Gas Industry Services, 3rd Edition, September... 

API Standard 672, Packaged, Integrally Geared, Centrifugal Plant and Instrument Air Compressors for General Refinery Services, Second Edition, W shington, D C. American Petroleum Institute, 1988, Reaffirmed 199 . 

Opening the packages and testing for package integrity and changes in food color, flavor, odor, or taste. 

T oods packaged in flexible containers and processed for commercial sterilization are a part of the trend toward improved quality in convenience foods. The retorted pouch has the package integrity of the metal can coupled with the food quality, reheating, and serving convenience of frozen, boil-in-the-bag foods (1). Its use for combat rations has especially interested military R D personnel because of the functional advantages over the metal can (2). 

Whether life sciences informatics software ultimately becomes a commodity, with the commercial rewards for software companies being in packaging, integration, support, and deployment (in a similar way to the Linux community), and what impact the open source movement will have. In bioinformatics and chemoinformatics, open source, free software, and shareware are increasing in quantity, and it is becoming common for smaller software companies at least to release reduced-functionality versions of their software into the public domain at no cost. 

M. J. Akers, in Parenteral Quality Control Sterility, Pyrogen, Particulate, and Package Integrity Testing, Vol. 1 (J. R. Robinson, ed.), Marcel Dekker, New York, 1985, pp. 207-209. 

What will the package integrity issues be Can the mechanical, climatic, biological, and chemical hazards be addressed adequately by the packaging system ... 

The ideal elastomeric closure is nonreactive physically and chemically, a complete barrier to vapor/gas permeation, easily penetrable via needle or spike, re-sealable, resistant to coring and fragmentation, and maintains package integrity at the seal surface. 

Among some of the test procedures that may be used for monitoring package integrity over time are dye immersion testing using either pressure or vacuum,... 

Warning Package integrity may be compromised when using coated elastomers, especially for vacuum-sealed or gas-flushed vials [11]. 

PDA Technical Report No. 27, Pharmaceutical Packaging Integrity, Bethesda, MD, April, 1998. 

Parenteral Drug Association (PDA) (1998), Pharmaceutical package integrity, Technical Report 27, PDA Bethesda, MD. 

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. 

The validation of sterile package integrity begins with the development of a validation master plan. The plan should include the following ... 

Nondestructive method. This involves determining packaging integrity by visual inspection of package seals, and is only suitable for packages with at least one transparent material component. It uses high-intensity light to observe the continuity and uniformity of the seal. 

When the development and validation of the packaging manufacturing process are completed, the standard testing procedures (e.g., ASTM) should be used to ensure sterile medical device package integrity and the sterility of the product after additional production processes. 

A guide for developing packaging performance characteristics and specifications is given in Figure 2. In order to establish if any element or step in the development process causes a loss of package integrity, each step must be validated. 

Again, processes could affect the performance of the package by degrading its components or seal properties (e.g., brittleness, loss of adhesion), and thus lead to a loss of package integrity. The effects of aging can be determined after... 

The overall protocol for packaging validation remains the same whether microbial challenge test methods or physical test methods are used. At each stage in the development and production process of a package for a medical device package integrity must be verified. 

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