Correction to: Sterility testing using a closed system transfer device in oncology medication compounding: a novel method for testing partially used vials

Purpose The purpose of this study was to test the efficacy of ChemfortTM, an air filtration closed-system drug transfer device to prevent release of chemotherapy drug vapors and aerosols under extreme conditions. The air cleaning system is based on the adsorption of drug vapors by an activated carbon filter in the Vial Adaptor before the air is released out of the drug vial. The functionality of the carbon filter was also tested at the end of device’s shelf life, and after a contact period with drug vapors for 7 days. Cyclophosphamide and 5-fluorouracil were the chemotherapy drugs tested. Methods The Vial Adaptor was attached to a drug vial and both were placed in a glass vessel. A needle was punctured through the vessel stopper and the Vial Adaptor septum to allow nitrogen gas to flow into the vial and to exit the vial via the air filter into the glass vessel which was connected to a cold trap. Potential contaminated surfaces in the trap system were wiped or rinsed to collect the escaped drug. Samples were analyzed using liquid chromatography tandem mass spectrometry. Results Cyclophosphamide and 5-fluorouracil were detected on most surfaces inside the trap system for all Vial Adaptors without an activated carbon filter. Contamination did not differ between the Vial Adaptors with and without membrane filter indicating no effect of the membrane filter. The results show no release of either drug for the Vial Adaptors with an activated carbon filter even after 3 years of simulated aging and 7 days of exposure to drug vapors. Conclusions Validation of air cleaning CSTDs is important to secure vapor and aerosol containment of chemotherapy and other hazardous drugs. The presented test method has proven to be appropriate for the validation of ChemfortTM Vial Adaptors. No release of cyclophosphamide and 5- fluorouracil was found even for Vial Adaptors after 3 years of simulated aging and 7 days of exposure to drug vapors.

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6ER-026 Reduction in contamination with antibiotics on surfaces and in environmental air in nursing departments in three hospitals following implementation of a closed-system drug transfer device

10.1136/ejhpharm-2018-eahpconf.518 ◽

2018 ◽

Author(s):

P Sessink

Keyword(s):

Closed System ◽

Drug Transfer ◽

Environmental Air ◽

Transfer Device

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Pre and post intervention study of antiblastic drugs contamination surface levels at a Pharmacy Department Compounding Area using a closed system drug transfer device and a decontamination process

Regulatory Toxicology and Pharmacology ◽

10.1016/j.yrtph.2018.03.001 ◽

2018 ◽

Vol 95 ◽

pp. 1-7 ◽

Cited By ~ 1

Author(s):

Silvia Valero ◽

Eduardo López-Briz ◽

Nieves Vila ◽

Antonio Solana ◽

Mar Melero ◽

...

Keyword(s):

Closed System ◽

Intervention Study ◽

Post Intervention ◽

Drug Transfer ◽

Pharmacy Department ◽

Transfer Device

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Comprehensive Study Identifies a Sensitive, Low-Risk, Closed-System Model for Detection of Fungal Contaminants in Cell and Gene Therapy Products

Journal of Clinical Microbiology ◽

10.1128/jcm.01357-21 ◽

2021 ◽

Author(s):

Nicole E. Putnam ◽

Anna F. Lau

Keyword(s):

Closed System ◽

Test Performance ◽

The United States ◽

Diverse Range ◽

Sterility Testing ◽

Delayed Entry ◽

Test Sensitivity ◽

Food And Beverage ◽

Testing Algorithm ◽

Fungal Contaminants

The United States Food and Drug Administration (FDA) regulates manufacturing and testing of advanced therapeutic medicinal products (ATMPs) to ensure the safety of each product for human use. Gold standard sterility testing (USP<71>) and alternative blood culture systems have major limitations for the detection of fungal contaminants. In this study, we evaluated the performance of i LYM media (designed originally for the food and beverage industry) to assess its potential for use in the biopharmaceutical field for ATMP sterility testing. We conducted a parallel evaluation of four different test systems (USP<71>, BacT/ALERT, BACTEC, and Sabouraud Dextrose Agar [SDA] culture), three different bottle media formulations ( i LYM, i FA + , and Myco/F Lytic), and two incubation temperatures (22.5°C and 32.5-35°C) using a diverse set of fungi ( n =51) isolated from NIH cleanroom environments and previous product contaminants. Additionally, we evaluated the effect of agitation versus “delayed entry” static pre-incubation on test sensitivity and time to detection (TTD). Overall, delayed entry of bottles onto the BacT/ALERT or BACTEC instruments (with agitation) did not improve test performance. USP<71> and SDA culture continued to significantly outperform each automated culture condition alone. However, we show for the first time, that a closed-system, dual-bottle combination of i LYM 22.5°C and i FA + 32.5°C can provide high fungal sensitivity, statistically comparable to USP<71>, when tested against a diverse range of environmental fungi. Our study fills a much-needed gap in biopharmaceutical testing and offers a favorable testing algorithm that maximizes bacterial and fungal test sensitivity whilst minimizing risk of product contamination associated with laboratory handling.

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