Final answer:
Compounded sterile products intended for lyophilization must be kept in an ISO Class 5, unidirectional laminar flow to ensure a sterile environment throughout the process, preserving long-term stability and protecting against microbial contamination.
Step-by-step explanation:
Compounded sterile products prepared for lyophilization shall be maintained in an ISO Class 5, unidirectional laminar flow air throughout sterilization, filling, and transport from the Primary Engineering Control (PEC) into the lyophilizer. This protocol ensures that the sterile products are free from contaminants, including vegetative microbes, endospores, and viruses, hence providing an optimal sterile field. Lyophilization is used for the long-term storage of laboratory materials and ensures the stability of samples. To maintain sterility, samples must be handled properly, using techniques to minimize potential airborne contamination, such as holding tubes or bottles at an angle during transport and passing them briefly through a flame before and after the transfer process.
Adhering to these standards is crucial since even though lyophilization deactivates microbes by desiccation, they may remain and can be rehydrated. This is why the mean concentration of the sterile product should remain within ± 15% of the nominal, indicating that appropriate sterility levels have been maintained after the process. Different sterilization protocols, including moist-heat sterilization via autoclaving, play a critical role in the overall aseptic technique used in laboratories and clinics to ensure short-term temperature stability, post-preparative stability, and freeze-thaw cycles.