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Where a process cannot be 100% verified, it must be validated to a suitable confidence level to ensure that the output matches the requirements intended. This is typically completed by conducting the following:
We offer a range of testing services for sterile barrier integrity as listed in ISO11607 during all validation activities. Accelerated & real time aging
All tests listed are conducted in line with the requirements of the associated standards and will be agreed and discussed before commencement of any study.
Where the requirements fall outside the scope of current capabilities, Riverside has test partners we work closely with to ensure all requirements are met to recognised standards.
Through assessment of either known or established optimal settings, a window of operation is created, taking into account such things as machine alarms, settings bias and machine calibration tolerances to obtain a lower and upper limit for machine variables. Once set, the process is then tested at these limits to a specific sample plan to give the required confidence as an output of the process.
The process now has an operational window and must be challenged at the perceived optimal settings. This time we are looking at the output of the actual process to provide product suitable for the end user. The variables challenged are typically batch size, operator, material batches and tool changes. This validation gives confidence of the process to consistently produce good product to the desired output volume and as such, should be challenged to a higher confidence than the above Operational Qualification. This validation normally consists of a minimum of three production representative batches.
Where ultrasonic cleaning is required prior to final packaging of product, a validation should be considered to ascertain the cleanliness of the device/product in question. This validation is always bespoke, but typically follows the OQ/PQ approach listed above with a cleanliness specification being generated against the final end user requirement. Testing is conducted to establish to an agreed sample plan that will provide objective evidence that the process is capable of cleaning products that meet these requirements.
Once the process is established and a shelf life is claimed on a device that is intended to be sterile; stability and performance testing should also now be conducted
Through a combination of accelerated and real time aging, products having gone through both worst case manufacturing and sterilisation processing are subjected to a test plan to prove the sterile barrier system maintains its integrity over time. This is what the end user (customer) experiences first hand so will have the highest criticality of all the sample plans used to date. The validation will usually consist of multiple time points to capture a baseline as well as shorter intervals that can aid a faster release to market with a shorter shelf life whilst further testing is ongoing.
Products having gone through both worst case manufacturing and sterilisation processing are subjected to a test plan to prove the sterile barrier system maintains its integrity through anticipated worst case shipping routes. This should include climatic considerations as well as the actual shipping method. Once defined, the samples will be subjected to a simulation to recreate this before being tested to prove the sterile barrier system and shipping configuration maintains its integrity. Depending on shipping configuration variability, this could be a complex study and time should be set aside to fully consider the many variables feed into the requirements of this testing.