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Microbiological contamination of manufactured products: official and unofficial limits
Published in R. M. Baird, S. F. Bloomfield, Microbial quality assurance in cosmetics, toiletries and non-sterile Pharmaceuticals, 2017
The first microbiological standards were based upon the criterion of sterility and initially applied only to that most critical group of pharmaceutical products, the injectable preparations. The sixth edition of the British Pharmacopoeia (BP) (Anon. 1932) introduced the requirement that injectable products were to be sterilized by various means (heating in an autoclave, tyndallization or filtration) and additionally were to pass a test for sterility. Surprisingly, the requirement for sterility was not applied to ophthalmic drops and lotions of the British Pharmaceutical Codex until a supplement was published in 1966 (Anon. 1966). Considerable documentary evidence had meanwhile accumulated from the early 1940s onwards, warning of the hazards of using contaminated eye drops (Allen 1959, Dale et al. 1959, Crompton 1962). In particular, fluorescein eye-drops had frequently been found to be a source of Pseudomonas aeruginosa, a notorious pathogen in ocular infections; indeed, some samples had been held responsible for the development of eye infections and subsequent loss of sight. In comparison, eye ointments were presumed to be less susceptible to contamination owing to the nature of their composition, until an antibiotic eye ointment was reported in 1964 to be the source of an outbreak of P. aeruginosa eye infections in Sweden (Kallings et al. 1966). A requirement for sterility was subsequently applied to eye ointments listed in the BP of 1968 (Anon. 1968a).
Biology of microbes
Published in Philip A. Geis, Cosmetic Microbiology, 2006
In the cosmetics industry, some of the more common raw materials to be contaminated with Bacillus spores include Aloe vera and a variety of thixotropic agents such as quaternized clays. Pasteurization of aloe vera gel will not eliminate Bacillus because its spores are not susceptible. Instead, tyndallization (a repetitive heating process) is required. Tyndallization is repeated several times on three successive days to allow the spores to germinate and become susceptible to the heating processes. Alternatively, irradiation can be used, particularly for the clays because they are not harmed by the process.
Can the CRP/albumin Ratio be Used as a New Indicator of Activation in Patients with Uveitis?
Published in Ocular Immunology and Inflammation, 2021
Erdinç Bozkurt, Ersin Muhafiz, Dilek Sengul, Turgay Uçak, Mahmut Atum
This retrospective, cross-sectional study was conducted in accordance with the principles of the Helsinki Declaration and after obtaining ethical approval from the local ethics committee with the number 80576354-050-99/156. All cases included in our study underwent a detailed ophthalmologic examination. The best-corrected visual acuity (BCVA) and the logarithmic responses of the minimum resolution angle (LogMAR) of these values were determined. The intraocular pressures of the patients were measured by an automatic pnömotonometer (Tomey, FT-1000, USA). Anterior segment and dilate fundus examination findings of all cases were recorded. Anterior and posterior segment tindalization was examined by averaging the values indicated blindly by two different investigators in the same time period. Anterior uveitis was classified according to flare and cell density in the anterior chamber in accordance with the criteria determined by the Standardization of Uveitis Nomenclature.23 Grades 1 and 2 were classified as mild uveitis (group A) and Grades 3 and 4 (group B) were classified as severe uveitis based on the following indications: