Operators in Aseptic Process

Working in a cleanroom under GMP isn’t easy, you have your gowning to consider, your movements, your equipment.

Qualifying aseptic operators poses a significant challenge, not because it’s extremely difficult but because it requires great care and attention to detail.

Training

The more relevant experience the person has, the easier the training and qualification will be. You would ideally like to hire an aseptic operator with at least five years of experience in GMP production. When a person is hired, he or she will enter into the training program.

For new and existing aseptic operators, there should be a continuous training program on theoretical and practical GMP aspects, including microbiology and hygiene.

Only having aseptic operators re-watch the same online training course every month is not a suitable curriculum for an aseptic operator. Consider the trends, consider operator input; what are the problems at the moment? Any area’s for improvement? Any new techniques or equipment the operators should be aware of? the employees trained to ensure that they take adequate precautions to prevent cross-contamination when they pass from one area to another?

Gowning

Operators must always wear gowning according to the appropriate area classification. Good personal hygiene is the foundation of proper gowning in GMP manufacturing environments. Even though it should be common knowledge we still see make sure there is a cheat-sheet on GMP gowning procedures in the gowning area and that it’s in line with the gowning SOP.

Behavior

People should move slowly and deliberately; body parts should be kept out of the laminar airflow, and gowns should be kept as clean as possible.Necessary product manipulations should be approached in a way that avoids compromising sterility.

Only qualifying your operators through a one-off training program is not accepted; many systems, people, and checks can make or break a cleanroom operator qualification trajectory. To reduce contamination risk, there must be a continuous feedback loop both top-down and between operators themselves.

Read also:

• Moist Heat or Steam Sterilization Working Principle
• Difference between Sterilization and Depyrogenation

Resource Person: Ch/Ahmed Mahmoud