{"id":"https://openalex.org/W2950344207","doi":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.123","title":"3PC-042 A science- and risk-based strategy to qualify sterilised prefilled syringes as primary packaging material in a hospital pharmacy","display_name":"3PC-042 A science- and risk-based strategy to qualify sterilised prefilled syringes as primary packaging material in a hospital pharmacy","publication_year":2019,"publication_date":"2019-03-01","ids":{"openalex":"https://openalex.org/W2950344207","doi":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.123","mag":"2950344207"},"language":"en","primary_location":{"id":"doi:10.1136/ejhpharm-2019-eahpconf.123","doi":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.123","is_oa":true,"landing_page_url":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.123","pdf_url":"https://ejhp.bmj.com/content/ejhpharm/26/Suppl_1/A56.1.full.pdf","source":{"id":"https://openalex.org/S3012707348","display_name":"European Journal of Hospital Pharmacy","issn_l":"2047-9956","issn":["2047-9956","2047-9964"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319945","host_organization_name":"BMJ","host_organization_lineage":["https://openalex.org/P4310319945"],"host_organization_lineage_names":["BMJ"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Section 3: Production and Compounding","raw_type":"proceedings-article"},"volume":null,"type":"conference-paper","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"bronze","oa_url":"https://ejhp.bmj.com/content/ejhpharm/26/Suppl_1/A56.1.full.pdf","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5047709383","display_name":"K Beld","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210146510","display_name":"Isala","ror":"https://ror.org/046a2wj10","country_code":"NL","type":"healthcare","lineage":["https://openalex.org/I4210146510"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"K Beld","raw_affiliation_strings":["ISALA Hospital, Clinical Pharmacy, Zwolle, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ISALA Hospital, Clinical Pharmacy, Zwolle, The Netherlands","institution_ids":["https://openalex.org/I4210146510"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5045606746","display_name":"Albert Kuiper","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210146510","display_name":"Isala","ror":"https://ror.org/046a2wj10","country_code":"NL","type":"healthcare","lineage":["https://openalex.org/I4210146510"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"A Kuiper","raw_affiliation_strings":["ISALA Hospital, Clinical Pharmacy, Zwolle, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ISALA Hospital, Clinical Pharmacy, Zwolle, The Netherlands","institution_ids":["https://openalex.org/I4210146510"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5014008816","display_name":"Stefan van Berkel","orcid":"https://orcid.org/0000-0002-9736-7436","observed_orcids":["https://orcid.org/0000-0002-9736-7436"]},"institutions":[{"id":"https://openalex.org/I4210146510","display_name":"Isala","ror":"https://ror.org/046a2wj10","country_code":"NL","type":"healthcare","lineage":["https://openalex.org/I4210146510"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"S Van Berkel","raw_affiliation_strings":["ISALA Hospital, Clinical Pharmacy, Zwolle, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ISALA Hospital, Clinical Pharmacy, Zwolle, The Netherlands","institution_ids":["https://openalex.org/I4210146510"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5012791352","display_name":"Henri Robben","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210146510","display_name":"Isala","ror":"https://ror.org/046a2wj10","country_code":"NL","type":"healthcare","lineage":["https://openalex.org/I4210146510"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"H Robben","raw_affiliation_strings":["ISALA Hospital, Clinical Pharmacy, Zwolle, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ISALA Hospital, Clinical Pharmacy, Zwolle, The Netherlands","institution_ids":["https://openalex.org/I4210146510"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5051345765","display_name":"Rommert Wijnsma","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210146510","display_name":"Isala","ror":"https://ror.org/046a2wj10","country_code":"NL","type":"healthcare","lineage":["https://openalex.org/I4210146510"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"R Wijnsma","raw_affiliation_strings":["ISALA Hospital, Clinical Pharmacy, Zwolle, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ISALA Hospital, Clinical Pharmacy, Zwolle, The Netherlands","institution_ids":["https://openalex.org/I4210146510"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5075426025","display_name":"Katja Taxis","orcid":"https://orcid.org/0000-0001-8539-2004","observed_orcids":["https://orcid.org/0000-0001-8539-2004"]},"institutions":[{"id":"https://openalex.org/I169381384","display_name":"University of Groningen","ror":"https://ror.org/012p63287","country_code":"NL","type":"education","lineage":["https://openalex.org/I169381384"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"K Taxis","raw_affiliation_strings":["University of Groningen, Unit of Pharmacotherapy- -Epidemiology and Pharmacoeconomics PTE2- Groningen Research Institute of Pharmacy, Groningen, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Groningen, Unit of Pharmacotherapy- -Epidemiology and Pharmacoeconomics PTE2- Groningen Research Institute of Pharmacy, Groningen, The Netherlands","institution_ids":["https://openalex.org/I169381384"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5008287871","display_name":"Henderik Willem Frijlink","orcid":"https://orcid.org/0000-0001-7901-8198","observed_orcids":["https://orcid.org/0000-0001-7901-8198"]},"institutions":[{"id":"https://openalex.org/I169381384","display_name":"University of Groningen","ror":"https://ror.org/012p63287","country_code":"NL","type":"education","lineage":["https://openalex.org/I169381384"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"E Frijlink","raw_affiliation_strings":["University of Groningen, Department of Pharmaceutical Technology and Biopharmacy, Groningen, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Groningen, Department of Pharmaceutical Technology and Biopharmacy, Groningen, The Netherlands","institution_ids":["https://openalex.org/I169381384"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":"A56.1","last_page":"A56"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.9771000146865845,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.9771000146865845,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T14189","display_name":"Intravenous Infusion Technology and Safety","score":0.003000000026077032,"subfield":{"id":"https://openalex.org/subfields/2204","display_name":"Biomedical Engineering"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.002899999963119626,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/hospital-pharmacy","display_name":"hospital pharmacy","score":0.5789999961853027},{"id":"https://openalex.org/keywords/aseptic-filling","display_name":"aseptic filling","score":0.7960000038146973},{"id":"https://openalex.org/keywords/extractables-and-leachables","display_name":"extractables and leachables","score":0.8389999866485596},{"id":"https://openalex.org/keywords/ph-dependent-stability","display_name":"pH-dependent stability","score":0.3700000047683716},{"id":"https://openalex.org/keywords/subvisible-particles","display_name":"subvisible particles","score":0.5139999985694885},{"id":"https://openalex.org/keywords/sterility","display_name":"sterility","score":0.4830000102519989},{"id":"https://openalex.org/keywords/polypropylene-syringes","display_name":"polypropylene syringes","score":0.6470000147819519},{"id":"https://openalex.org/keywords/regulatory-compliance","display_name":"regulatory compliance","score":0.36500000953674316},{"id":"https://openalex.org/keywords/patient-safety","display_name":"patient safety","score":0.3230000138282776}],"concepts":[{"id":"https://openalex.org/C2778571141","wikidata":"https://www.wikidata.org/wiki/Q273318","display_name":"Syringe","level":2,"score":0.819390058517456},{"id":"https://openalex.org/C104863432","wikidata":"https://www.wikidata.org/wiki/Q614304","display_name":"Pharmacy","level":2,"score":0.5010080337524414},{"id":"https://openalex.org/C190857496","wikidata":"https://www.wikidata.org/wiki/Q388618","display_name":"Hospital pharmacy","level":3,"score":0.475988507270813},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.47112059593200684},{"id":"https://openalex.org/C159110408","wikidata":"https://www.wikidata.org/wiki/Q121176","display_name":"Nursing","level":1,"score":0.13614773750305176},{"id":"https://openalex.org/C118552586","wikidata":"https://www.wikidata.org/wiki/Q7867","display_name":"Psychiatry","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1136/ejhpharm-2019-eahpconf.123","doi":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.123","is_oa":true,"landing_page_url":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.123","pdf_url":"https://ejhp.bmj.com/content/ejhpharm/26/Suppl_1/A56.1.full.pdf","source":{"id":"https://openalex.org/S3012707348","display_name":"European Journal of Hospital Pharmacy","issn_l":"2047-9956","issn":["2047-9956","2047-9964"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319945","host_organization_name":"BMJ","host_organization_lineage":["https://openalex.org/P4310319945"],"host_organization_lineage_names":["BMJ"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Section 3: Production and Compounding","raw_type":"proceedings-article"}],"best_oa_location":{"id":"doi:10.1136/ejhpharm-2019-eahpconf.123","doi":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.123","is_oa":true,"landing_page_url":"https://doi.org/10.1136/ejhpharm-2019-eahpconf.123","pdf_url":"https://ejhp.bmj.com/content/ejhpharm/26/Suppl_1/A56.1.full.pdf","source":{"id":"https://openalex.org/S3012707348","display_name":"European Journal of Hospital Pharmacy","issn_l":"2047-9956","issn":["2047-9956","2047-9964"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319945","host_organization_name":"BMJ","host_organization_lineage":["https://openalex.org/P4310319945"],"host_organization_lineage_names":["BMJ"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Section 3: Production and Compounding","raw_type":"proceedings-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.9476000070571899}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320313991","display_name":"Universit\u00e9 Mohammed V de Rabat","ror":"https://ror.org/00r8w8f84"},{"id":"https://openalex.org/F4320320933","display_name":"Rijksuniversiteit Groningen","ror":"https://ror.org/012p63287"},{"id":"https://openalex.org/F4320333994","display_name":"Facult\u00e9 de M\u00e9decine et de Pharmacie de Rabat, Universit\u00e9 Mohammed V de Rabat","ror":null}],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W2950344207.pdf","grobid_xml":"https://content.openalex.org/works/W2950344207.grobid-xml"},"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W3125805248","https://openalex.org/W2886283823","https://openalex.org/W4393005424","https://openalex.org/W4386969832","https://openalex.org/W4408376858","https://openalex.org/W2613094870","https://openalex.org/W2180441578","https://openalex.org/W4393005359","https://openalex.org/W2303695313","https://openalex.org/W2048769219"],"abstract_inverted_index":{"Background":[0],"To":[1],"improve":[2],"medication":[3],"safety":[4,94],"in":[5,23,59,133,196,330],"hospitals,":[6],"The":[7,30,55,318],"Joint":[8],"Commission":[9],"International":[10],"standard":[11],"recommend":[12],"implementation":[13],"of":[14,26,33,74,118,178,229,231,238,240,247,339],"ready-to-administer":[15],"(RTA)":[16],"drugs.":[17],"Many":[18],"hospital":[19,135,332],"pharmacies":[20],"facilitate":[21],"this":[22,34],"aseptic":[24,46],"filling":[25,129],"polypropylene":[27],"single-use":[28],"syringes.":[29],"main":[31],"disadvantages":[32],"product,":[35],"though":[36],"the":[37,45,48,52,75,79,86,116,218,224,232,241,248,288],"container":[38],"is":[39,99],"not":[40,90],"meant":[41],"for":[42,115,174,200,326],"storage,":[43],"are":[44,320],"process,":[47],"short":[49],"shelf-life":[50],"and":[51,104,130,138,151,156,167,188,198,215,227,273,302,314],"refrigerator":[53],"capacity.":[54],"solution":[56,233,242],"was":[57],"found":[58],"a":[60,124,134,146,152,157,168,331],"cyclic":[61],"olefin":[62],"polymer":[63],"(COP)":[64],"syringe,":[65],"which":[66],"can":[67],"be":[68],"terminally":[69,119],"sterilised.":[70],"All":[71,279],"individual":[72],"components":[73],"syringe":[76,144,161],"comply":[77],"with":[78,123,145,162,181,283],"regulatory":[80],"demands":[81],"but":[82],"to":[83,107,287],"ensure":[84],"that":[85],"new":[87],"product":[88,96],"does":[89],"adversely":[91],"affect":[92],"patient":[93],"or":[95],"quality":[97],"qualification":[98],"required.":[100],"Purpose":[101],"A":[102,140],"science-":[103],"risk-based":[105],"strategy":[106],"qualify":[108],"COP":[109,143,160],"syringes":[110,122,319],"as":[111,322],"primary":[112,323],"packaging":[113,324],"material":[114,325],"production":[117],"sterilised":[120],"RTA":[121,328],"high":[125],"speed":[126],"(semi-)":[127],"automatic":[128],"closing":[131],"machine":[132],"pharmacy.":[136,333],"Material":[137],"methods":[139],"50":[141],"ml":[142,159],"polypropylene/butyl":[147],"rubber":[148,154,170],"tip":[149,165],"cap":[150,166],"butyl":[153,169],"stopper":[155,171],"5":[158],"an":[163],"elastomer":[164],"were":[172,202,221],"used":[173],"qualification.":[175],"Validation":[176],"batches":[177],"NaCl":[179,190],"0.9%":[180],"phosphate":[182],"buffer":[183],"pH":[184,246,293,311],"2,":[185,207],"5.8,":[186],"8":[187],"11,":[189],"0.9%,":[191],"isopropyl":[192],"alcohol":[193],"(IPA)":[194],"5%":[195],"water":[197,199],"injections":[201],"produced.":[203],"On":[204],"t=0,":[205],"1,":[206],"3,":[208],"4,":[209],"5,":[210],"6,":[211],"9,":[212],"12,":[213],"18":[214],"24":[216],"months":[217],"following":[219],"tests":[220,281],"performed":[222,280],"on":[223],"batches;":[225],"clarity":[226],"degree":[228,237],"opalescence":[230],"(Ph.":[234,243,251,256,260,267,275],"Eur.":[235,244,257,268,276,290],"2.2.1.),":[236],"colouration":[239],"2.2.2),":[245],"solution,":[249],"absorbance":[250],"Eur":[252,261],"3.2.2.1),":[253,258,262],"reducing":[254],"substances":[255],"transparency":[259],"weight":[263],"loss,":[264],"subvisible":[265],"particles":[266],"2.9.19),":[269],"silicon,":[270],"closure":[271],"integrity":[272],"sterility":[274],"2.6.1).":[277],"Results":[278],"complied":[282],"acceptance":[284],"criteria":[285],"according":[286],"Ph.":[289],"Monographs.":[291],"High":[292],"value":[294],"(11.8)":[295],"showed":[296],"higher":[297],"absorbance,":[298],"indicating":[299],"more":[300],"extractables":[301],"leachables;":[303],"maximum":[304,315],"0.06":[305],"at":[306],"t=24":[307],"months)":[308],"than":[309],"neutral":[310],"ranges":[312],"(5\u20138);":[313],"0.02.":[316],"Conclusion":[317],"suitable":[321],"producing":[327],"products":[329],"References":[334],"and/or":[335],"acknowledgements":[336],"No":[337],"conflict":[338],"interest.":[340]},"counts_by_year":[],"updated_date":"2026-11-02T09:45:03.842371","created_date":"2019-06-27T00:00:00"}