Interchangeability studies aim to ensure that the technical, functional and performance conditions between two or more pieces of equipment are similar and, therefore, they can be used interchangeably in a process without deviations or any impact on the performance of the process and/or final product.
Interchangeability studies are evidence that equipment of the same class and subclasses behave in a similar way and, therefore, can be qualified as interchangeable or equivalent in the process.
Type/Class is an objective and direct definition of the type of equipment.
Subtype/Subclass is an objective and direct definition that identifies the equipment, such as its operational capacity.
When the studies conclude that the equipment of the production routes qualify as interchangeable, the process validation can be carried out only once, without the need to monitor 03 batches in each route or equipment.
When studies conclude that the equipment of the production routes does not qualify as interchangeable, process validation will have to be carried out with the monitoring of the process in triplicate in each route or equipment.
Through the interchangeability studies it will be possible to reach one of the following conclusions:
§ Identical/Twin Equipment = Interchangeable.
§ Similar = Potentially Interchangeable
§ Different = Not interchangeable.
Interchangeability studies qualify as a Lean resource for companies because they eliminate the need for process validation of the same product in each of the routes planned for production. Qualifying interchangeable routes and reducing the number of process validation studies is valuable as it generates:
§ flexibility for production scheduling;
§ ease of meeting seasonal demands for certain products;
§ reduction in the demand for the preparation of protocols and reports for multiple process validations;
§ decrease in the demand for batches to be monitored for multiple process validations; and
§ consequently, the number of validation samples to be analyzed by Quality Control decreases.
In general, the results obtained with the studies of interchangeability of process equipment can impact on increased productivity and the capacity to absorb new demands by the Production, Quality Control and Quality Assurance sectors.
