Integrity performance assessment of a Closed System Transfer Device syringe adaptor as a terminal closure for Luer-Lock syringes.

Objectives To investigate the container closure integrity of a Closed System Transfer Device syringe adaptor lock in combination with disposable Luer-Lock syringes as the terminal closure device. The UK NHS Pharmaceutical Quality Assurance committee requires syringe integrity data for final storage devices of aseptic products such as chemotherapy drugs when prepared in advance and stored prior to use as is standard practice for dose banded drugs. The assessment comprised both physical and microbial integrity testing of the combination closed system/ Luer-Lock syringes containers at syringe sizes: 1mL, 20mL, and 50mL. Methods Integrity testing was performed as described in the NHS Pharmaceutical Quality Assurance Committee Yellow Cover Document 2nd edition 2013 with ChemfortTM (Simplivia, IL) syringe adaptor lock devices as replacement for sterile blind hubs. Microbiological integrity was assessed according to Method 1 part 1.4 using Brevundimonas diminuta at 32oC for up to 14-days contact time. Physical integrity was assessed using Method 3 of the yellow cover document which is a dye intrusion method. Dye intrusion was assessed both visually and using a validated ultraviolet-visible spectrophotometer method. Results ChemfortTM syringe adaptor lock/ Luer-Lock syringe combinations were shown to be: (1) free of microbiological contamination after 14-days contact time, (2) free of dye intrusion at all syringe sizes tested (n=61 in total). The data demonstrates 100% closure integrity of the final container system when ChemfortTM syringe adaptor lock replaces the syringe hub as the terminal closure device. Conclusions Syringe adaptor lock components complied with the NHS Pharmaceutical Quality Assurance Committee Yellow Cover Document syringe integrity requirements when used as the terminal closure of Luer-Lock disposable syringes from 1mL up to 50mL. Therefore, syringe adaptor lock (ChemfortTM) can be used as the terminal closure system for pre-filled syringes of chemotherapeutic drug products prepared in advance in UK NHS Pharmaceutical Technical Services.

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Quality assurance of radiopharmaceuticals. Report of a joint working party: the UK Radiopharmacy Group and the NHS Pharmaceutical Quality Control Committee

Nuclear Medicine Communications ◽

10.1097/00006231-200108000-00010 ◽

2001 ◽

Vol 22 (8) ◽

pp. 909-916 ◽

Cited By ~ 8

Author(s):

&NA;

Keyword(s):

Quality Control ◽

Quality Assurance ◽

Working Party ◽

Pharmaceutical Quality ◽

The Uk

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Development of the medicines inspectorate in the UK and its role in pharmaceutical quality assurance

TrAC Trends in Analytical Chemistry ◽

10.1016/0165-9936(84)87002-8 ◽

1984 ◽

Vol 3 (7) ◽

pp. vi-viii

Author(s):

A.J. Middleton

Keyword(s):

Quality Assurance ◽

Pharmaceutical Quality ◽

The Uk

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Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device

Journal of Oncology Pharmacy Practice ◽

10.1177/10781552211030682 ◽

2021 ◽

pp. 107815522110306

Author(s):

Galit Levin ◽

Paul JM Sessink

Keyword(s):

Activated Carbon ◽

Closed System ◽

Membrane Filter ◽

Drug Transfer ◽

Glass Vessel ◽

Air Cleaning ◽

No Release ◽

Activated Carbon Filter ◽

Carbon Filter ◽

Transfer Device

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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An audit of UK audiological practice in specialist paediatric oncology centres regarding hearing assessment of children at risk of ototoxicity due to chemotherapy

The Journal of Laryngology & Otology ◽

10.1017/s0022215121000025 ◽

2021 ◽

Vol 135 (1) ◽

pp. 14-20

Author(s):

E C M Brown ◽

C Caimino ◽

C L Benton ◽

D M Baguley

Keyword(s):

High Frequency ◽

Good Practice ◽

Paediatric Oncology ◽

Chemotherapy Drugs ◽

Team Working ◽

Platinum Based Chemotherapy ◽

Hearing Assessment ◽

Self Test ◽

The Uk ◽

Monitoring Service

AbstractObjectivePlatinum-based chemotherapy drugs are associated with substantial ototoxicity. The hearing of children treated with these drugs should be closely monitored.MethodA questionnaire was sent out to the 19 audiology departments associated with national paediatric cancer specialist centres in the UK looking at current practice in ototoxicity monitoring.ResultsResponses were received from 17 of 19 centres (89 per cent). All offered some form of audiometric monitoring service. Extended high-frequency testing (9–20 kHz) was only utilised by 7 services (29 per cent). A majority of respondents were reluctant to consider self-test devices in paediatric ototoxicity monitoring (n = 9; 53 per cent). Provision of long-term audiological follow up is sporadic with only 4 (23 per cent) respondents keeping all children with normal hearing under review once treatment is completed.ConclusionWhile some good practice in paediatric ototoxicity was identified, opportunities exist to improve clinical practice and protocols, promote multidisciplinary team working and to utilise technologies such as extended high frequency and self-test audiometry.

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