Package Process Validation

The primary objective of a package process validation should be to provide the medical device manufacturer with a high degree of assurance that the product will reach the user in a condition suitable for optimum functionality and for its intended purpose. 

This oxygen sensor system has been successfully used by us with a number of different types of packaged foods and packaging processes, being continuously developed and optimized in these real-life conditions and applications. It was validated in several small laboratory scale and medium industrial scale trials19,30 with the following foods and processes ... 

To establish a microbial-limit testing history, all development, clinical, scale-up and process validation batches of new nonsterile dosage forms would be tested to verify that the pharmaceutical ingredients, manufacturing process, and packaging does not contribute to the bioburden of the product. After the testing history has been... 

Proper control of food irradiation applications should fulfill the requirements for both food technologies and radiation technologies. Application of well-established methods for measurement of absorbed radiation dose and the dose distribution helps to provide assurance that the radiation treatment is both effective and legally correct [133]. Computer tomography (CT) can provide detailed, high-resolution, and accurate dose maps for any arbitrary product and package configurations [134]. Such dose maps are an essential part of process validation. 

The formal validation is often completed after the PAI, where three-batch process validation will be conducted in accordance with the protocol approved during the preapproval inspection. The primary objective of the formal process validation exercise is to establish process reproducibility and consistency. Such validation must be completed before entering the market. The formal validation studies continue through packaging and labeling operations (in whole or in part), so that machinability and stability of the finished product can be established and documented in the primary container-closure system. 

The FDA process validation guidelines [1] refer to a quality assurance system in place that requires revalidation whenever there are changes in packaging (assumed to be the primary container-closure system), formulation, equipment or processes (meaning not clear) which could impact on product effectiveness or product characteristics and whenever there are changes in product characteristics. 

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. 

Raw materials, solvents, catalysts, gases, processing aids, processing water, steam, packaging materials and bioburden Process validation protocol Sampling and testing strategy... 

Operational qualification is the step in a validation process that will ensure the reproducibility and acceptability of the packaging process. Formally, it is an investigation of the control of variables in any given individual piece of equipment or in a given subprocess. In this way it is possible to verify that the sequencing of events is in the proper order and that the process equipment is operating consistently within the design limits. 

All companies must recognize that validation of packaging line equipment is required by the authorities in order to provide documented evidence that then-specific packaging processes will consistently meet specifications. 

A validation team member from the Packaging department is responsible to participate in performing the validation steps during packaging processes and equipment qualification. The Packaging department should prepare the necessary SOPs for the new packaging process or equipment and assist in the collection of validation data. 

Process Validation (PV) verifies the performance of the overall product manufacturing process. PV is performed on the entire product manufacturing process, which includes all support, processes, preparation of media, components, buffers, formulation, filtration, filling, and packaging. 

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