Dissolution system, automated

From these selected references and others, we have confidence that the FDA and USP accept automation in general, and automated dissolution in particular. The references confirm the importance of maintaining the same basic chemistry and adhering to compendium design as closely as possible. This is not only a regulatory consideration but also one of practicality. It is extremely important that methods can be successfully transferred to other sites and apparatus (automated or otherwise). With this information we may proceed with our functional design of an automated dissolution system. 

System qualifications are quality checks. They are a part of the validation of a product. Validation is defined as, Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (5). A product that is validated is considered to be of much higher quality than one that is not validated. Automated dissolution systems need to be validated as a requirement of their use in regulated laboratories. 

The following activities may be performed to qualify the installation of an automated dissolution system ... 

For automated dissolution systems, OQ testing can include testing balance functionality, testing the functionality of individual components including bath communication, sample cannulae, waste cannulae, thermistor communication, tablet dispensers, sensors, valves, pumps, filter dispenser and holder, and testing fluid pathways. 

When designing instrument qualifications for automated dissolution systems, some key considerations are determining the functions to validate, cost, testing using equipment... 

The cornerstone of validation and qualification is testing to a set of specifications. Without specifications, proper qualifications cannot be performed. For an automated dissolution system, the specifications originate from a few sources, which include the USP, the manufacturer s FRS, and the manufacturer s detailed design specifications, which may include HDS and SDS. 

Functions to validate on automated dissolution systems may include bath operation, balance operation, media dispensing operations, media removal, sampling operations, media replacement, thermistor operation, robot operation, sample timing, sequence, and dilution. 

Instrument qualifications should be executed on a scheduled basis that can be determined with the help of manufacturer s recommendations. Automated dissolution systems that are used regularly are typically re-qualified every six months to one year. Re-qualification is also recommended for other reasons including moving equipment or replacing parts. Below is a typical system re-qualification policy. 

The diagram of a typical automated dissolution system with on-line... 

V. Fuerte, M. Maldonado, and G. D. Rees, The multicomponent automated dissolution system an alternative in the development and pharmaceutical analysis of generic polydrugs, J. Pharm. Biomed. Anal., 21, 267, 1999. 

Note The instruments used in the laboratories vary significantly in the design and operation complexity. The validation requirements should reflect the level of complexity of the instrument. It is obvious that the amount of effort required to validate a simple pH meter will be different from that required for a fully automated dissolution system. The Good Automated Manufacturing Practice (GAMP)... 

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