Microbiological Considerations for Ophthalmic Products: Sterility, Endotoxin Limits, and Preservatives

Hasegawa, Ayako; Gulmezian-Sefer, Melissa; Cheng, Ying; Srikumar, Ramakrishnan

doi:10.1007/978-3-030-76367-1_9

Cited by 1 publication

(1 citation statement)

References 32 publications

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“…At the same time for vials sealed with bromobutyl rubbers, the amount of endotoxins in all samples was less than 0.250 EU/ ml (Table 3). As expected, all vials and rubbers (bromobutyl, chlorobutyl) passed the endotoxin test as the results were less than the permitted 17.5 EU/ml according to USP regulations related to endotoxin limits for common injectable [31].…”

Section: Particle Size (µM)supporting

confidence: 71%

Sterilization Method for Borosilicate Glass Vials and Chlorobutyl, Bromobutyl Rubbers for Medical Purposes

Karapetyan,

Petrosyan

2024

Eurasian Chem.-Technol. J.

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For surgical and medical tools to prevent the spreading of infectious microorganisms to patients, disinfection and sterilization must be achieved by the use of disinfectants and sterilization procedures. Health care regulations must determine whether cleaning, disinfection, or sterilization is essential based largely on the item’s intended use because sterilizing all patient care equipment is unnecessary. In this work, successful sterilization of vials and rubbers used for medical purposes has been implemented. It can be claimed that the sequence of moist and dry heat is more practical for sterilizing primary packaging materials used in diagnostic or treatment facilities, especially for borosilicate vials and chlorobutyl, bromobutyl rubbers. It has been shown that the suggested sterilization method provides sterile and endotoxin-free vials and rubbers that can be used for medical purposes. Endotoxins and sterility tests have been implemented for microbiological analysis of borosilicate vials and chlorobutyl, and bromobutyl rubbers. Endotoxin levels in all vials and rubbers tested were within acceptable limits, and no microbial growth was observed in test specimens based on sterility tests. The suggested sterilization method was effective in producing sterile and endotoxin-free vials and rubbers suitable for medical use.

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Section: Particle Size (µM)supporting

confidence: 71%