Validation package

For carbonated products, for which heat treatment is not required, the level of carbonation at the time of consumption is likely to be important to the mouth-feel and flavour profile. Therefore, measuring carbonation levels during a realtime storage trial or even a shortened trial made at elevated temperatures (i.e. 35-40°C) will be an important part of the package validation protocol. 

The scope section describes what the process validation protocol covers, the number of batches, and what it does not cover. In this part, usually packaging validation or mouthpiece testing is included or excluded. Any worst-case tests may be briefly described. Stability commitments and stability protocols should be mentioned. 

Configurable software packages—validation life cycle with qualification of the hardware and application software... 

II. SUCCESSFUL PACKAGING VALIDATION INTEGRATED SYSTEM APPROACH... 

When the validation report is being assembled, most of the work of the team will in fact be completed, and the task only consists of adding supportive documents to the executed protocol. Basically a standard format can be developed for packaging validation at a given facility. The following suggestions could be included in the report, but this is subject to individual variations ... 

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. 

APV (1981) International Association for Pharmaceutical Technology Praxis der Validierung (Validation in Practice), Symposium (1981-1982, Gelsenkirchen) [6] Terminology, sterile, semisolid, and solid dosage forms in development and production, analytical methods and stability evaluation, packaging development and packaging validation transfer, cost-effectiveness... 

Dyke, Denis G., Medical Packaging Validation Complying with the Quality System Regulation and ISO 11607, Medical Device and Diagnostics Industry, August 1998. 

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