Camellia Zamiri, Danielle L Leiske, Patricia F Hughes, J Paul Kirwan, Evelyn Der, Emily Cox, Rob Warburton, Monica Goss, Sarah Weiser, Janet Perez-Brown, Ganapathy Gopalrathnam, Jing Liu, Shyam B Mehta, Shebeer Shereefa, Sebastian Specht, Sandra J Aedo, Pierre Goldbach, Feng Jia, Barbara Kuehnle, Scott Page, Liesbeth Voeten, Li Yi, Chen Zhu
Microbial challenge in-use studies are performed to evaluate the potential for microbial proliferation in preservative-free single dose biological products after first puncture and potential accidental contamination during dose preparation (e.g. reconstitution, dilution) and storage. These studies, in addition to physicochemical in-use stability assessments, are used as part of product registration to define in-use hold times in Prescribing Information and in the pharmacy manual in the case of clinical products...
October 17, 2023: PDA Journal of Pharmaceutical Science and Technology