Evidence map›Paper›PMID 41218912›Full record

ArticleEuropean journal of hospital pharmacy : science and practice2026

NHS Yellow Cover Document integrity performance assessment of two needle-free closed system transfer devices as terminal closure/access for Luer-Lock syringes and IV bags.

Alan Shaun Wilkinson, Laima Ozolina, Romana Bon, Kate E Walker, Andrew Wallace

Abstract read
In one paragraph

Article in European journal of hospital pharmacy : science and practice, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Alan Shaun WilkinsonBiopharma Stability Testing Laboratory Limited, Nottingham, UK alan@biopharmatesting.co.uk.ORCID http://orcid.org/0000-0001-6994-1966
Laima OzolinaBiopharma Stability Testing Laboratory Limited, Nottingham, UK.
Romana BonBiopharma Stability Testing Laboratory Limited, Nottingham, UK.ORCID http://orcid.org/0000-0002-2840-1979
Kate E WalkerBiopharma Stability Testing Laboratory Limited, Nottingham, UK.
Andrew WallaceBiopharma Stability Testing Laboratory Limited, Nottingham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the container closure integrity of needle-free Closed System Transfer Device (CSTD) components (ChemoClave and ChemoLock) combined with Luer-Lock (LL) syringes and IV bags as a terminal closure/access device. The UK NHS Yellow Cover Document (YCD) requires containment data for final storage devices of aseptic chemotherapy drugs when prepared in advance in pharmaceutical technical services (PTS). Assessment of both physical and microbial integrity of all combinations was performed: syringe adapter/LL syringes and vented bag adaptor/IV bags. All container combinations were subject to an additional vibrational challenge, with three-axis vibrational data logging representing a typical transportation excursion.

methodsContainer integrity testing was performed according to YCD requirements "Protocols for the Integrity Testing of Syringes" for ChemoClave and ChemoLock syringe adapters (CH2000S/CL2000S) and for ChemoClave and ChemoLock vented bag spikes (CH-14/CL-14) as terminal closure devices. Microbiological integrity was assessed according to Method 1, Part 1.4 using

resultsChemoClave and ChemoLock syringe adapters and vented bag spikes/IV bags were shown to be free of microbiological contamination (n=160) and free of dye intrusion (n=80 in total). The data support both ChemoClave and ChemoLock CSTD components as closure for aseptic preparations of pharmaceutical drug products in PTS. 100% closure integrity was demonstrated.

conclusionsChemoClave and ChemoLock CSTD components showed 100% container integrity in accordance with YCD requirements as terminal closure for LL syringes and IV bags in PTS. ChemoClave and ChemoLock syringe adapters and vented bag spike components can be used for the preparation of chemotherapeutic drug products prepared in advance in UK PTS.

Indexed as

Drug ContaminationDrug PackagingDrug StoragePharmacy Service, HospitalSyringesAntineoplastic AgentsHumansUnited KingdomAntineoplastic AgentsAdministration, IntravenousAntineoplastic AgentsDrug Administration RoutesDrug CompoundingDrug StorageManufacturing and Industrial FacilitiesMicrobiologyPATIENT SAFETYPHARMACISTSPHARMACY ADMINISTRATIONPHARMACY SERVICE, HOSPITAL

Identifiers

PMID41218912
PMCPMC13311974

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.