Evidence map›Paper›PMID 35410874›Full record

ArticleEuropean journal of hospital pharmacy : science and practice2023

Integrity performance assessment of a closed system transfer device syringe adaptor lock as a terminal closure for Luer-Lock syringes.

Alan Shaun Wilkinson, Kate E Walker, Laima Ozolina, Romana Machníková, Andrew J Johnson, Navneet Bhogal, Kate Pegg

Open access · hybridAbstract read
In one paragraph

Article in European journal of hospital pharmacy : science and practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.5field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
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

7 authors at 1 institution in 1 country.

Alan Shaun WilkinsonR&D, Biopharma Stability Testing Laboratory Ltd, Nottingham, Nottinghamshire, UK alan@biopharmatesting.co.uk.ORCID 0000-0001-6994-1966
Kate E WalkerR&D, Biopharma Stability Testing Laboratory Ltd, Nottingham, Nottinghamshire, UK.
Laima OzolinaR&D, Biopharma Stability Testing Laboratory Ltd, Nottingham, Nottinghamshire, UK.
Romana MachníkováR&D, Biopharma Stability Testing Laboratory Ltd, Nottingham, Nottinghamshire, UK.ORCID 0000-0002-2840-1979
Andrew J JohnsonR&D, Biopharma Stability Testing Laboratory Ltd, Nottingham, Nottinghamshire, UK.
Navneet BhogalQA Pharmacy, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, Derbyshire, UK.
Kate PeggQA Pharmacy, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, Derbyshire, UK.
University Hospitals of Derby and Burton NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo 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 National Health Service (NHS) Pharmaceutical Quality Assurance Committee (PQAC) requires syringe integrity data for final storage devices of aseptic products such as chemotherapy drugs when prepared in advance and stored before 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 syringe containers at syringe sizes of 1 mL, 20 mL, and 50 mL.

methodsIntegrity testing was performed as described in the NHS Pharmaceutical Quality Assurance Committee yellow cover document, second edition 2013 'Protocols for the Integrity Testing of Syringes', with Chemfort (Simplivia, IL) syringe adaptor lock (SAL) devices as replacement for sterile blind hubs. Microbiological integrity was assessed according to method 1 part 1.4 using

resultsChemfort syringe adaptor lock/Luer-Lock syringe combinations were shown to be: (1) free of microbiological contamination after 14 days of contact time (n=60); and (2) free of dye intrusion at all syringe sizes tested (n=61 in total). The data demonstrate 100% closure integrity of the final container system when the Chemfort syringe adaptor lock replaces the syringe hub as the terminal closure device. All positive control devices demonstrated system suitability as container integrity was compromised in all positive control tests. All negative controls were negative for microbial and dye intrusion.

conclusionsSyringe 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 1 mL up to 50 mL. Therefore, syringe adaptor lock (Chemfort) can be used as the terminal closure system for pre-filled syringes of chemotherapeutic drug products prepared in advance in UK NHS pharmacy technical services.

Indexed as

Drug PackagingSyringesDrug ContaminationPharmaceutical PreparationsState MedicinePharmaceutical PreparationsDrug CompoundingMEDICAL ONCOLOGYMicrobiological TechniquesOCCUPATIONAL MEDICINEPHARMACEUTICAL PREPARATIONSPHARMACY ADMINISTRATIONPHARMACY SERVICE, HOSPITAL

Identifiers

PMID35410874
PMCPMC10800267
OpenAlexW4223488952

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

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.