Seal testing is performed in the operation and performance qualification steps of validation. For PQ, ISO 11607 Part 2 says that three consecutive successful production runs are typically evaluated at the established sealing parameters. Manufacturers determine the frequency of subsequent in-process seal testing based on risk assessment considerations.
“The validation process is front-loaded,” he adds. “Most people can create a cogent validation, even with modest equipment. [But] production creeps away from the spirit of validation, as manufacturing is left to production and maintenance staff.”
“Testing cycles tend to be calamity-based, after failures occur,” Webb says. “Companies need to discover if there is a problem before they ship 100 cases to hospitals worldwide. The MS 451 PV prompts additional testing, performed in a mechanized and standardized fashion.”
The operator is prompted to perform the peel test at pre-set intervals. The system records testing events, pass or fail status, peel strength values, and time and date. If the seal fails to meet the seal strength specification, the machine locks up until a supervisor enters a four-digit code and investigates the problem.
“Many of our customers are doing hundreds of seals per day on machines with four to five times that capacity. If you are pulling one out of 100, that’s a statistically high sample population. Other customers are producing less than 25 pouches per day, and performing 100% inspection.”