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Aseptic simulation test for cytotoxic drug production in isolators
Amandine Savry1, Florian Correard, Youssef Bennis
1Amandine Savry, Pharm.D., Ph.D., is Pharmacist; Florian Correard, is Pharmacy Intern; and Youssef Bennis, Pharm.D., Ph.D., is Pharmacist, Oncopharma Unit, Pharmacy Department, La Timone University Teaching Hospital, Marseille, France. Sophie Roubaud, Pharm.D., is Pharmacist, Plein Ciel Clinic, Mougins, France. Laurence Gauthier-Villano, Pharm.D., is Pharmacist, Oncopharma Unit, Pharmacy Department, La Timone University Teaching Hospital. Pascale Pisano, Pharm.D., Ph.D., is Pharmacist, Pharmacology Laboratory, Faculty of Pharmacy, Aix Marseille University, Marseille. Bertrand Pourroy, Pharm.D., Ph.D., is Pharmacist, Oncopharma Unit, Pharmacy Department, La Timone University Teaching Hospital.
Purpose:
The results of a media-fill test (MFT) study to validate processes for cytotoxic drug preparation inside and outside aseptic compounding isolators are presented.
Methods:
Using an MFT protocol adapted to institution-specific production conditions, the pharmacy team at a hospital in France performed a series of tests to verify the efficacy of decontamination and sterile compounding procedures, as required by French compendial standards, while assessing the performance of its team of 12 isolator operators; all operators were tested on three occasions, producing 10 MFT samples per test for a total of 30 samples per operator. The team also tested alternative compounding systems (i.e., two closed-system transfer devices and a classic spike system) for use during power outages or other emergencies precluding drug preparation within isolators. MFTs were performed using a standard tryptone soy broth-based test kit under worst-case conditions.
Results:
The hospital's facilities for cytotoxic drug preparation were found to be in conformance with applicable sterility standards. Bacterial growth was not detected in any of the MFT samples produced by isolator operators during the study (total n = 360). In one instance, an MFT sample prepared using a closed-system transfer device was found to be contaminated due to improper cleaning of the medication vial, highlighting the importance of strict adherence to proper decontamination procedures.
Conclusion:
A hospital's practices for preparation of sterile products according to applicable good manufacturing guidelines, as well as emergency procedures for cytotoxic drug preparation outside isolators, were validated by the results of an MFT study.
Insights
A media-fill test (MFT) validated sterile cytotoxic drug preparation processes inside and outside isolators. The study confirmed facility compliance with sterility standards, emphasizing decontamination protocols for safe compounding.
Area of Science:
- Pharmaceutical Compounding
- Sterile Product Manufacturing
- Hospital Pharmacy Operations
Background:
- Cytotoxic drug preparation requires stringent aseptic techniques to prevent contamination.
- Media-fill testing (MFT) is crucial for validating sterile compounding processes.
- French compendial standards mandate verification of cytotoxic drug preparation procedures.
Purpose of the Study:
- To validate cytotoxic drug preparation processes within and outside aseptic compounding isolators.
- To assess the efficacy of decontamination and sterile compounding procedures.
- To evaluate the performance of isolator operators during MFT.
Main Methods:
- An MFT protocol was adapted to hospital-specific conditions.
- 12 isolator operators each produced 30 MFT samples over three testing occasions.
- Alternative compounding systems were tested for emergency use; all MFTs used tryptone soy broth under worst-case conditions.
Main Results:
- All 360 MFT samples produced by isolator operators met sterility standards.
- The hospital's cytotoxic drug preparation facilities were in conformance with sterility standards.
- One MFT sample using a closed-system transfer device showed contamination due to improper vial cleaning, stressing decontamination importance.
Conclusions:
- The hospital's sterile product preparation practices, including emergency procedures, were validated by MFT.
- The study confirmed the reliability of aseptic compounding isolators for cytotoxic drug preparation.
- Adherence to decontamination protocols is critical for maintaining sterility in pharmaceutical compounding.
