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Process validation

A Validation Master Plan (VMP) and its associated documents are available to detail the company's policy and plans on validations. Concurrent and retrospective process validation approaches can be used depending on the product and if it is a new or existing product.

Process simulation (Media Fill Test)

This test is conducted in accordance to ISO 13408-1 for Initial Performance Qualification in three successful consecutive batches of Soy Bean Casein Digest medium.

There are some major processes which need to be validated in aseptic processed such as sterilization and Depyrogenization.

Process simulation shall be controlled under condition that simulate routine manufacturing procedures and, as far as is reasonably practicable, include permissible worst-case conditions .

Simulation shall include:

-       maximum accepted frequency per number of filled units (e.g. Weight adjustments, container/closure or product resupply, sampling or environmental monitoring);

-       frequently occurring unscheduled interventions in representative number and with the highest degree of intrusion acceptable (e.g. corrections for container breakage or tip-over, corrections for leakage of fluid, corrections for stopper jams. Correction of line stoppage).

-       Process simulation shall be performed in conjunction with a comprehensive environmental monitoring program in static and dynamic condition .

-       Media fill evaluation units shall be incubated for 7 days at 22.5 ± 2.5 ºC and 7 days at 32.5 ± 2.5 ºC.

-       Media fill validation record

-       Microbial monitoring (areas, surfaces, gowns and gloves of personnel)

-       Monitoring of microbial and particulate (the staff)

-       Final microbial control

Growth Promotion Test

Verification of growth promotion of media used in specific media-fill runs shall be conducted before the simulation run.

The media selected for media-fill runs shall be capable of growing a wide spectrum of microorganisms. Growth-promotion test units shall be incubated for 24 hours at 37 ºC  in CO2 incubator.

The number of counted microorganisms shall be equivalent to the number of incubated microorganisms after the incubation period. (within the range of 550,000 to 600,000 cfu/ml)

Growth-promotion test unit should demonstrate growth if the test organisms in conformance with United State pharmacopeia (USP) requirements. Such tests should be conducted within the actual media-filled condition where possible.