Question

Initially and after any change to the cleaning process or agents, what must a pharmacy do to validate a high-level disinfection process for the lyophilizer?

Answer 1

To validate a high-level disinfection process for the lyophilizer, a pharmacy must establish a cleaning process, perform a validation study, collect data, analyze the results, and repeat the process when there are changes.

Step-by-step explanation:

In order to validate a high-level disinfection process for the lyophilizer, a pharmacy must follow several steps:

1. Establish a cleaning process for the lyophilizer that includes the use of appropriate cleaning agents.
2. Perform a validation study to ensure that the cleaning process is effective. This may involve testing the disinfection process using a standard protocol, such as the AOAC protocol.
3. Collect data on the efficacy of the disinfection process by performing replicate tests on different batches of disinfectant and on different days.
4. Analyze the results of the tests and ensure that a minimum of 59 out of 60 replicates show no growth to achieve a passing result.
5. Repeat the validation process whenever there are changes to the cleaning process or agents used.

By following these steps, a pharmacy can ensure that the high-level disinfection process for the lyophilizer is validated and effective.