{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T23:47:34Z","timestamp":1792453654101,"version":"4.5.0"},"reference-count":18,"publisher":"Georg Thieme Verlag KG","issue":"04","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Klin Monbl Augenheilkd"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>\n          Purpose To introduce a novel technique of the aseptic manufacture of autologous serum eye drops (ASEDs) with a prefiltered closed system and to analyze the sterility of the produced ophtioles between 2018 and 2022.<\/jats:p><jats:p>\n          Methods This is a prospective single-center study conducted at the Department of Ophthalmology at a Swiss University Hospital between 2018 and 2022. For regulatory reasons, closed systems for manufacturing ASEDs are strongly recommended. We attached an upstream sterile filter (Sterivex PES0.22\u2009\u00b5m Burlington, USA) to a commercially available closed system (COL System Modena, Italy) for manufacturing ASEDs. The goal of this novel approach was to reduce the microbiological contamination of the donated autologous blood. Using the presented manufacturing method, we are able to produce, on average, 56 ophtioles per batch, containing either 1.45\u2009mL or 2.5\u2009mL of autologous serum per ophtiole. For each batch of ASEDs, we performed a microbiological analysis by automated blood culture testing (BACTEC). This system examines the presence of bacteria and fungi.<\/jats:p><jats:p>\n          Results We analyzed all manufactured batches between 2018 and 2022. None of the 2297 batches and the resulting 129\u200a060 ophtioles showed bacterial or mycotic contamination. During the analyzed period, two batches were discarded: one due to fibrin-lipid aggregations, further microbiological and histological work-up excluded any contamination; another due to false-positive HIV in serological testing. Overall, the contamination rate was 0%, and the batch discharge rate was 0.09%.<\/jats:p><jats:p>\n          Conclusions The combination of upstream sterile filtration with a commercial closed system for manufacturing ASEDs proved to be effective in ensuring sterility without any contamination over the past 4 years. This is becoming crucial, as the demand for autologous blood products for treating ocular surface disorders, such as refractory dry eyes or nonhealing defects of the corneal epithelium, is on the rise.<\/jats:p>","DOI":"10.1055\/a-2249-0056","type":"journal-article","created":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T22:51:25Z","timestamp":1713912685000},"page":"392-397","source":"Crossref","is-referenced-by-count":6,"title":["A Novel Technique of Aseptic Manufacture of Autologous Serum Eye Drops (ASEDs) and Sterility Analysis of the Bottled Ophtioles"],"prefix":"10.1055","volume":"241","author":[{"given":"Frank","family":"Blaser","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Universit\u00e4tsSpital Z\u00fcrich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Meneau","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Universit\u00e4tsSpital Z\u00fcrich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Mihic-Probst","sequence":"additional","affiliation":[{"name":"Department of Pathology and Molecular Pathology, Universit\u00e4tsSpital Z\u00fcrich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel Rudolf","family":"Muth","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Universit\u00e4tsSpital Z\u00fcrich, Switzerland"},{"name":"Department of Clinical Neuro Science, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5431-4991","authenticated-orcid":false,"given":"Daniel","family":"Barthelmes","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Universit\u00e4tsSpital Z\u00fcrich, Switzerland"},{"name":"Save Sight Institute, University of Sydney CAR, Glebe, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7431-1774","authenticated-orcid":false,"given":"Sandrine","family":"Zweifel","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Universit\u00e4tsSpital Z\u00fcrich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2037-4766","authenticated-orcid":false,"given":"Sadiq","family":"Said","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Universit\u00e4tsSpital Z\u00fcrich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9957-9136","authenticated-orcid":false,"given":"Anahita","family":"Bajka","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Universit\u00e4tsSpital Z\u00fcrich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2024,4,23]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1002\/art.1780270415","article-title":"Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca","volume":"27","author":"R I Fox","year":"1984","journal-title":"Arthritis Rheum"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"544","DOI":"10.1007\/s10384-012-0175-y","article-title":"Effect of autologous platelet-rich plasma on persistent corneal epithelial defect after infectious keratitis","volume":"56","author":"K M Kim","year":"2012","journal-title":"Jpn J Ophthalmol"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"1245","DOI":"10.1097\/ICO.0000000000000271","article-title":"Long-term use of autologous serum 50\u200a% eye drops for the treatment of dry eye disease","volume":"33","author":"M Hussain","year":"2014","journal-title":"Cornea"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"521315","DOI":"10.1155\/2013\/521315","article-title":"Topical 100\u200a% serum eye drops for treating corneal epithelial defect after ocular surgery","volume":"2013","author":"K Lekhanont","year":"2013","journal-title":"Biomed Res Int"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"1133381","DOI":"10.3389\/fmed.2023.1133381","article-title":"Challenges and concepts in the diagnosis and management of ocular graft-versus-host disease","volume":"10","author":"C Tappeiner","year":"2023","journal-title":"Front Med (Lausanne)"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"8906","DOI":"10.1038\/s41598-022-12879-x","article-title":"Comparison of epitheliotrophic factors in platelet-rich plasma versus autologous serum and their treatment efficacy in dry eye disease","volume":"12","author":"C Metheetrairut","year":"2022","journal-title":"Sci Rep"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"128","DOI":"10.1016\/j.ophtha.2019.08.018","article-title":"Autologous Serum-Based Eye Drops for Treatment of Ocular Surface Disease: A Report by the American Academy of Ophthalmology","volume":"127","author":"R M Shtein","year":"2020","journal-title":"Ophthalmology"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"1172345","DOI":"10.3389\/fcimb.2023.1172345","article-title":"Disturbances in the ocular surface microbiome by perioperative antimicrobial eye drops","volume":"13","author":"F Hotta","year":"2023","journal-title":"Front Cell Infect Microbiol"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"1364","DOI":"10.1080\/02713683.2020.1741008","article-title":"An Environmental Control Experiment for Contamination of the Production and Storage of 20\u200a% Autologous Serum Eye Drops","volume":"45","author":"Y Yang","year":"2020","journal-title":"Curr Eye Res"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"1116","DOI":"10.1097\/ICO.0b013e3182910036","article-title":"Contamination risk of 100\u200a% autologous serum eye drops in management of ocular surface diseases","volume":"32","author":"O Thanathanee","year":"2013","journal-title":"Cornea"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"570","DOI":"10.1016\/j.jen.2018.03.007","article-title":"Effectiveness of a Novel Specimen Collection System in Reducing Blood Culture Contamination Rates","volume":"44","author":"M Bell","year":"2018","journal-title":"J Emerg Nurs"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"1027","DOI":"10.1016\/j.jiac.2021.02.027","article-title":"Comparison of 0.5\u200a% chlorhexidine gluconate alcohol with 10\u200a% povidone-iodine for skin disinfection in children to prevent blood culture contamination","volume":"27","author":"N Maeda","year":"2021","journal-title":"J Infect Chemother"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"325","DOI":"10.1007\/s10096-018-3430-4","article-title":"Improvement of blood culture contamination rate, blood volume, and true positive rate after introducing a dedicated phlebotomy team","volume":"38","author":"B Moonsuk","year":"2019","journal-title":"Eur J Clin Microbiol Infect Dis"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"86","DOI":"10.2450\/2008.0026-08","article-title":"Reduction of the risk of bacterial contamination of blood components through diversion of the first part of the donation of blood and blood components","volume":"7","author":"M L Giancarlo","year":"2009","journal-title":"Blood Transfus"},{"key":"ref17","doi-asserted-by":"crossref","first-page":"200","DOI":"10.1097\/ICO.0b013e318186321e","article-title":"Time- and temperature-dependent stability of growth factor peptides in human autologous serum eye drops","volume":"28","author":"J C Bradley","year":"2009","journal-title":"Cornea"},{"key":"ref18","first-page":"120","article-title":"Autologous serum eyedrops for ocular surface disorders","volume":"20","author":"G Geerling","year":"2006","journal-title":"Cornea Ext Eye Dis"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"346","DOI":"10.1055\/a-1354-6565","article-title":"The Lucerne Protocol for the Production of Autologous Serum Eyedrops","volume":"238","author":"F Sanak","year":"2021","journal-title":"Klin Monbl Augenheilkd"},{"key":"ref20","first-page":"585","article-title":"Evaluation of Adsorption onto Syringe Filters Used to Prepare Autologous Serum Eye Drops. ARVO Annual Meeting Abstract","volume":"53","author":"Y Deguchi","year":"2012","journal-title":"Invest Ophthalmol Vis Sci"}],"container-title":["Klinische Monatsbl\u00e4tter f\u00fcr Augenheilkunde"],"original-title":[],"language":"de","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/a-2249-0056.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,5]],"date-time":"2024-11-05T16:28:17Z","timestamp":1730824097000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/a-2249-0056"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4]]},"references-count":18,"journal-issue":{"issue":"04","published-online":{"date-parts":[[2024,4,23]]},"published-print":{"date-parts":[[2024,4]]}},"URL":"https:\/\/doi.org\/10.1055\/a-2249-0056","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["0023-2165","1439-3999"],"issn-type":[{"value":"0023-2165","type":"print"},{"value":"1439-3999","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4]]}}}