Validation of a new medical device devoted for autologous serum eye drops sterile preparation
1 Pharmaceutical Technology Department, Bordeaux University Hospital, France
2 ARNA ChemBioPharm U1212 INSERM – UMR 5320 CNRS, Bordeaux University, France
Autologous Serum Eye Drops (ASEDs) are prescribed for patients with dry eye syndrom. ASEDs are prepared at hospital pharmacy from patient’s own serum 20% diluted in Balanced Salt Solution, filtered through 0.22µm filter and transferred inside multiple use eye drop vials and stored at -20°C until 3 months. To improve both the process and microbiological preservation during patients’ use, we assessed a new device COL®B (Bexen medical) intended to transfer serum (closed system) in plastic ampoules for daily use instillation.
Materials and Methods
We compared our current process (CP) to the new COL®B process for practical handling considerations through a technicians’ survey (easiness, duration). Additionally, to validate the aseptic process with this new device, 3 Media Fill Test (MFT) were conducted to simulate the eye drops production by replacing the autologous serum with Tryptone Soya Broth (TSB) incubated 14 days at +32°C. Visual examination was performed at D1, D3, D7 and D14. Another MFT was implemented to reproduce real conditions of use. Three ampoules were opened 4 at 6 times per day to simulate the usual posology during 3 days. These simulations are conducted at D1, D7, M1 and M3 after freezing. Lack of microbiological growth was assessed by visual examination. Prior this test, TSB fertility test was achieved after 3 months freezing with the 6 strains referenced at European Pharmacopeia.
Results and Discussion
Tests were achieved by 4 pharmacy technicians. The device allowed to fill simultaneously 20 plastic ampoules with 2.5 mL through a sterile pyrogen-free tree connected to 0.22µm air filtration filter. One ampoule could be used up to a maximum of 3 days to limit the risk of accidental microbiological contamination by patient. This last point may be advantageous in comparison to current plastic vials used for 15 days and will be assessed by the “in-use simulation” which is still in progress. No filling difference was noticed between the 4 operators and all ampoules were successfully filled with the expected volume. In average, the process lasted 14 min and 10 min for COL®B and CP respectively. This difference may be related to the lack of training due to the novelty of the device and would be assessed again when implemented in our routine. Survey results showed that the 4 technicians were satisfied with both methods. However, 3/4 preferred the COL®B method vs 1/4 who had no preference. The operator choice was mainly driven by the easiness to maintain closed system. The aseptic process was safely validated by the lack of microbiological growth of the 4 MFTs.
The new device would optimize the patient safety by reducing the time use of each ampoule ASEDs. Before implementing the new device, a survey will complete our study to assess the easiness of drop extraction from ampoules by patients themselves in daily practice.