Repackaging of sterile empty bottles for eyedrops preparation
Hospital pharmacy prepares about 2000 multidose eyedrops. Preparation of such eyedrops requires a large supply of empty bottles, initially sterilized by gamma irradiation and packaged in bulk (1200 units). Such an amount is not adapted to the realization of hospital preparations (<300 units), this study reports the steps of aseptic unit repackaging of these empty bottles and the various controls carried out.
Eyedrops packaging is composed of a nozzle fitted on an opaque polyethylene bottle. A repackaging of 5 nozzles and 5 bottles in a heat-sealed double wrapped bag, previously sterilized to moist heat, has been established. All stages of repackaging and sealing of bags were performed under aseptic conditions in a controlled atmosphere area of class A. The reconditioned eyedrops packaging were stored in opaque containers.
To check the maintenance of sterility during repackaging operations, environmental, particulate and microbiological controls have been made inside and outside of bottles and nozzles for eyedrops. An aseptic filling validation with a culture medium by Mediafill was also performed. The maintenance of sterility was tested after 6 months of storage at 25°C.
All particulate and microbiological controls of bottles and nozzles for eyedrop were in compliance with European Pharmacopoeia at the end of repackaging and after six months of storage. The test of aseptic filling simulation confirmed the absence of contamination during repackaging operations.
This experience feedback, requiring a repackaging of a sterile medical device, lets face an urgent situation where the option of post-repackaging sterilization by gamma ray was expensive and not available for hospital pharmacy.
Bonnes Pratiques de Préparation, Bulletin officiel 2007/7bis-France
Bonnes Pratiques de Fabrication, Bulletin officiel 2014/1bis-France
Pharmacopée Européenne VIIIème Edition 2015