{
  "abstract": "Objectives To 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.Methods Container 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 Brevundimonas diminuta at 32°C for 14 days. Physical integrity was assessed using the following dye intrusion methods: YCD Method 3 and European Pharmacopoeia 3.2.9 “Rubber closures for containers”. Readout for dye intrusion was reported visually and using a spectrophotometer. Positive (n=2) and negative (n=1) controls were assessed according to YCD for both arms of the test.Results ChemoClave 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.Conclusions ChemoClave 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.",
  "authors": [
    {
      "affiliations": [
        "Biopharma Stability Testing Laboratory Limited, Nottingham, UK"
      ],
      "name": "Alan Shaun Wilkinson"
    },
    {
      "affiliations": [
        "Biopharma Stability Testing Laboratory Limited, Nottingham, UK"
      ],
      "name": "Laima Ozolina"
    },
    {
      "affiliations": [
        "Biopharma Stability Testing Laboratory Limited, Nottingham, UK"
      ],
      "name": "Romana Bon"
    },
    {
      "affiliations": [
        "Biopharma Stability Testing Laboratory Limited, Nottingham, UK"
      ],
      "name": "Kate E Walker"
    },
    {
      "affiliations": [
        "Biopharma Stability Testing Laboratory Limited, Nottingham, UK"
      ],
      "name": "Andrew Wallace"
    }
  ],
  "title": "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",
  "uid": "3aea35c4-f9d5-55df-9f4b-4d7b21484818"
}