‘ne: Enloh idelines for the Safe Transport of infectious Substances and Diagnostic Specimens Geneva, 1997 WORLD HEALTH ORGANIZATION Division of Emerging and Other Communicable Diseases Surveilancs anc Coniro|Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens @ WORLD HEALTH oRGANZATION Division of Emerging and Othor Communicable Diseases Survetiance and Controlwuonmeys Safe Transport of Infectious Substances Table of Contents Introduction 1 Definitions : 2 Inet Sebaanes 2 Dagon Species 2 Packaging Labeling nd Documentation for Teanspor 3 Basic Faking Ste , oie fr lt Substances 5 siemens fr Dao Specs ’ ogre fr A Ma » © World Health Organization, 1997 face ie Lal urace Transport n Transport Panning 2 “Thi document i not a formal plication ofthe Word Heath Organzaion (WHO), and all ght are reserved by the Organization The document may, howevet be freely reviewed sbstecteg, reproduced and transite, in part rin whale, but tot forsale no for tse fe conjuction with commercial purpone, “This document was prepared by the Disectors of WHO Collaborating Contes fr Bosley and other adviserswHorEMCA73, Safe Transport of Infectious Substances Introduction ‘These guidelines are applicable to the transport of infectious substances aad agnostic specimens both nationally and internationally. They provide Information for identifying and lesfying the mater o be teanspored and forts eae packaging and transport. Te putdelines sree le impurtance of developing « working relatership between thr groups ivelved ~the sender, te cate and Ue eeivor~ inorder to provide forthe sale and expeditions taupe of tis materia. Pasta airline ardor anspor industry personne hod concse about ths paibilty of their being safectod a the weal of exposure to ieee ‘icoorganisos thal may eecape from brokin losing or unpeopery packaged Traloral: The packaging of ilectiour mater for teaser mel thertore ‘hides these conceme and be desigaed Uo minimise the potential fr damage ‘daring transport Inaiiion the packaging will serves ensurethe intel of ‘he material and Uinely proceringof specimens ‘hore are no recorded caste of lege atbulable tothe slew of specimens daring transport akhoagh there ate reported incidents af damage othe outer packaging of properly packaped esters. The shipment of unatked sid ‘tidied infections matorals improperly packages bously inert the ‘overall potential for exposure la all pero “Tre inernalional regulations forth transport of iets enteral by any mode of tansportarebased up the Recomiendatios of te United Nations ‘Commo of Exporis onthe Tanspor of Dungsroar Cowds(UN). Tle Urivereal Pixtal Union (UPU) reflects these recommendations ie regulations, particularly for packaging, The International Cuil Aviston Orpanzation (CAO) {nd the Inienational Air Transport Assocation (IATA) have also incorporated {We UN Recommendations in these respoctivo rogultions, us have other Jolerational uuasport organizations, The World Heh Orpanication serves in an advisory capacity to these bodies. Tas docament provides practical {uldancet feta compliance wilh current iternatial reglatone aka {ature date any medications mace n section of Uwe UN Recoenendalsong ‘nthe Transport of Dangerour Goods dealing, with iletious stare and ‘agnostic specimens these guidelines will he updated acconcngly.WHOPEMCST Safe Transport of Infectious Substances Definitions For the purpose of describing transport safety anaes the term “infectious substances" and “infectious materals” are considered synonymous, The teen, "afectious substances” wil eed in ths doce Infectious substances An infectious substance is defined a9 « substonce containing a viable ‘microorganiom suchas whicerum, virus, ical, para or Fungus that ‘known or renonably believed to cause disease in hemane o animal ‘Watrespectin pashaging and transport stations, efectiounsubetancoincad! 1. alleutures containing or uspected of containing an agent which may cause infection: 2. human or animal samples that contain auch an agent in quantities auticiot {o cause infection, should an exponure to them occur due tom taneport haps 8. sample(s) feta patent with a serious danas of unknown cau 44 other speciawens not included above and designated as infectious by & ‘ualifed person ea physician, acer, nate, ee * "This deliion i akan from the curent UN Recommendations om the “Tranoport of Dangerous Goods, Prone ae ot included inthis defining alhough they are considered tobe infectious agen Diagnostic specimens A duos specimen defined a any baman or animal aerial nclung, ‘atte oor thea and fe component tone and tne fade collected forthe parpoesof grt, bul exlading lve inetd smal, Diagnostic specimens renting from medical pase and research are considered & negli otf he pub heal, WHoEMcs73 Safe Transport of Infections Substances iagnnticspecinens claned fon palents wih suspect influ iseses ‘may contain imied quantities ofan infec agent. There are very lew agents ‘hich may be the sce of a infection asa result of a trnspert mishap. If xpoare 10 the specimen due to transprt mishap could rset na ct te Aiognosic specimen must be package, labelled and transported a infections sdstonce Diagnosis: specimensenced durian invrayationfancutbicak ‘of asernus disease of unknown cause must be hale! a ection tae Packaging, Labelling and Documentation for Transport Because ofthe dito of risks between infectious subsunand diagnostic specimens there ate variations t the pachaying, being al dcomentats rutements The packaging requirement are delernied by the UN und ate ‘onlained in CAO and TATA repslatonsin the fem of Pax kang nsewcions (P1602 end 50, The ruizements ate sujet a chage and upgrade by Use ‘organisations. The curent packaging reqetrements use dew ited below. UN. "proved packaging systone are aadable commercially. Basic triple packaging system The system consists of three layers as follows. 1. Primary recptaclo. A labeled primary watertight leak-proo!eeseptcle ‘containing the specimen. The rceplacle fe wrapped tm chouph absorbent tmatenal to absor all ud in cane of breakage 2 Secondary receptors. A second durable, Weleright, lak-proal recplle to encone und pct the primary cept). Several wrapped primary receptacles may be placed ia one secondary teceptacls Sullcent adlttonel sbscrbent mater] ust be used to cushion multiple peiary eeepc ker 4 Outer shipping package. The secondary receptacles ple in outer shipping package which proecte and ie condos frou dls evens Such as piysical damage aa wer when ran, Specimen data forms, lters and other types of information that ently or describe the specie std abo ently the shipper and rover should taped to the outside of the secondary receptacleWHOAEMCRTS Figure 1 Safe Transport of Infections Substances Triple packaging system wHORMC73 Safe Transport of Infections Substances Requirements for infectious substances The basic triple packaging system is used with the following additional specications and labelling and ocustenation roizemen, Infectious substances may only be transported in packaging which most the UN cass 6 24pecicationa and packaging struction (ij. Ths ensures st Sri performance tests which ince w nine melee drop teat and parctine test hive beon met. The outer shipping paskage must bea the UN Peekayany Specification Marking (igure 2). UN-epproved pashaging supper iting ay bo ableined from carriers of from the appropriate hated tiaiery oy department, ep the Mistry uf Transport Figaee 2 Packaging Specification Marking camp: AUCs 274 Gunde he packaging masking consists he United Nations packaging eymbol = vpeofpicking Betort-Chas 62" Ste ast wo digs he year of manure ofthe pacing sate sutorty sult sadewHommcn73 Safe Transport of Infectious Substances and cariage of mectious sabatancos strictly probed by international ie caret a 1s the ast of diplomatic pouches for tht parpone “Tho maximum net quant of infectious substances which cn be contained in “an outer shipping package & 30 mL or 3 f uanopont by pamenger sical ‘Otherwise the int per package i 4LAKe, for truneport by carga acral oF ‘other carriers Pramary recepucls exceeding 50 mln combination packing ‘ust be oneniedo the closures ae upward, and labels (arrows nda the "UP" direction must be placed om two opporit sides of the package The passenger azcaft quant linils do no apply to blood or bined predicts for ‘hich thre no reason to believe they conta infections vularers whem it "eceptaces of aot moe than 30 m-each and with atta volume of aa nore than HL inthe outer package. Figure Hazard labels for dangerous goods For all dangerous goods to be shipped by aifoight, specific hazard labo) must be ffced tot ouside of each package. Te following hazards label are of tmportanc fr culture collections or other rotations shipping Dsl substance, azand labels for tefectious substance ad for ‘genetically modified microorganisms which mest the LATA defination of an infections subatance Nae: Infections Substance Minimum dimensions: 100% 100 em Forsmall packagee: 50x50 mm @ackand wuormcn73 Safe Transport of Infections Substances Hazard lbs for noninfectious genaticaly nodiied skiorgnoasandiercatondemniembdcaye: off] Nase: Macelaeous al Ih, Sune ‘Minimum dimensions 100 100m Focsmall packages: 50x50 min (black ond * white) Huzaed abel fo auld trogen Name Nom flammable pas Miniowim diownsions: 100% 100 mm Forsmall packages: 5950 mm (green and white Packages containing liquid cutee of infections organism ad gooetically modified microorganism mast be packed so that the clonuseo) ofthe lanes pachapings)are upward the upright postion of he pacha neat ate by two “Package Oncolation” labels ack or rel arows). The labels nt be aie on oppose sides ofthe pachaysny A label “THIS SIDE UP" oe "THIS END UP" may abn be displayed onthe tp cover ofthe pacha Nain Package Onienation Miriam dimeasions: 74105 om (lack or rd and whit) For smal pckagos of infectious substances dimensions | me say be halve, ln case shipments insude only fraeze-deid caltates the quantity should be ‘ivenin gor mg, not nm. The “PACKAGE ORIENTATION" lel should be ‘ined wo avd any delaywHonengs73 Safe Transport of Infectious Substances Labeling ofthe outer package or shipment of infacious ebatences must nce the element Listed erent. 1. The Intemational Infectious Substance Label, 21. Amaiddros label withthe folowing information: 1 the receiver’ (consignee) name, address and telephone number 1+ the shippor' (conagnos) name, addon and slephone number + the UN shipping name (infectious Substances Affecting Humans oF ‘Animal athe cave may be) followed by the cientfic nase of the abstarce + the UN Numbor (Humans UN2BIS, Animals UNZ300) + tomporstar storage requirements (options) tbe outer package is farther packed nan overpack with ry ce for instance) hath outerpack and overpack must cary the above information, and the ‘verpeck must have «label stalin “INNER PACKAGES COMPLY WITH, PRESCRIBED SPECIFICATIONS" 3. Required shipping documents these are obtained from the carrier and ere ‘beet the outer package + the shippo's Declaration of Dangerous Goods (Figure 4s one example) + a packing Ist/proforma invoice which incudes the receiver's addr tho namber of packages, deta ofcontenis, weight, valuo (note sate at ‘hare fo commercial vale” asthe ea ae supplied fee of charge) + Anairwaybllf shipping by ar 4. Animport and/or export permit and/or declaration if require. 5. Ifthe outer package contains prsuary receptacles exceeding 50 min ‘combination leat two "Orientation Labels (arrows) mut be placed on ‘opposite side of the package showing comoctanentation ofthe package wuronncars Safe Transport of Infections Substances Requirements for diagnostic specimens ‘The basic tuple packaging rystom is used withthe following specications and labeling requirement Diagnoatic specimens may be transported in packaging which meets the packaging utrcon (P1630. The UN speescation marking mk reir. Primary receptacles may contain up to 500ml each, the total volume sn the ‘outer package not to exceed 1, Labeling of the outer package forthe shipment of disgnostic specioens include te following, 1. Amaadress label withthe following information + the zecelver's conigne) name, audces and Wwlephone number + tho shippers (Consignor name address and telephone number + the statement "Deagnostic Specimen, Not Restricted, Packed in Compliance with Packing lasrucion 63" 2. Requzed shipping documents these are lane fom he cai ‘beets tho outer package! + a puching lit proforma invoice which ince the ceiver’ adaess Ths aumber of packages detalofcoent, weight wale (ote ate Ua Uhre is "no comercial value” a the soon are suppl free of care) 1+ asairwaybll a shipping by at 3. Aniport and/or expott peroul and/or declaration (segue) [Note:The nfetious substance abe and the shipper’ declare pode ere not ruined for digas operons, of dangerouswHtoyeMca73 Safe Transport of Infectious Substances Requirements for Air Mail Infectious substances and diagnostic specimens may bo shipped by riterad sir mail The baie ile packaging ayetem i used with the same requtements tr for other means of conveyance “Te deen label must display the word “LETTRE” and the green Custos Declaration Label for Postal Mal i roguired for international ang, Digostc peamene ary tobe denied with the vole UPU"PERSHABLE BIOLOGICAL SUBSTANCES” label. Infectious substances are to be identified with the Tnterstional lection Substance abel (oe Figure 3) Iecous pastes mist daho be accompanied with» shippers Declaration of Dangerous Goods form {ce Figure 4a the end of the document. Because of lral/intemationel restrictions, pri contac should he made with he local post ofice to ancertain whether the packaged material wil be accepted Dy the postal service Refrigerants Ice or dry ice when wed ina shipment must be paced ostids the secondary receplacle If wet ce used ial be ina leakproof container and the onter package must abo be leak prook ‘The secondary receptacle mast be accured within the outer package o prevent damage aftr the rergoant har melt or disipale Dry ce mut not be paced inside the primary rsevndary receptacle becaune ofthe risk explonone. An ‘verpack(spevally designed insulated over package) maybe weed to contain ‘hy tee. The outer package must poral the ease of exrbon docide gas ry tee fuse UN Packing Instruction 904 mut be observed, 1 dey ice i used for infrtons substances, the deals must eppear on the shiper’s ecaration fr Dangerous Good In particulate oer ont pach, {et carry Uhe “MISCELLANEOUS” hazard Ibe for day ie (ce Papare 3) Iai trogen used a a refeigecant,epecial arrangements must be made tnadvance withthe carr Primary recptaclos mst be caoble of witlstanding fxtrmely low temperatures and appropriaie packaging requirement of the ‘vier must be observed. In particular, the outer most packing must carry the “NON FLAMMABLE GAS" lnbel for liguid itogen ote Figure 3) wHoreMc973 Safe Transport of Infectious Substances Local Surface Transport Eampies include transport of specimens from a doctors offie/surgery to 2 laboratory, from a hospital toa diagostic laboratory or from one laboratory to nother Such courvr services maybe operated by a hows orator} heath service or oer approved ogency or organisation, “The priocple ofan ansport by thismeanes the seme a fra orinternational Iranaport =the meter should nol have any possiblity of escaping fom the package under normal conditions of anspor The following practices should he observed 1. spesimen container shoud be watertight and lesk-prool 2 ifthe specimen container tube it must be ightly capped and placed in ack to mainlain tin an upright poston: 1. specimen container and racks should be placed in obust leakproof plastic ‘of mela raneport boxes with secure, ight Bing ove 4. the transport ox shouldbe secured inthe anspor vehicle 45, each tramp box should be labelled appropriately consistent with ibs 46, specimen date forms and identification data should accompany sech ‘Wansport box 7, spilt contr: absorbent materia a chlorine disinftan leak-proof ‘waste diposelcontainar and heavy daly reusable gloves should be kept {he taneport vehicle [Note:The practices 1-7 dosed shove are rot intended to supers al ‘or national requiemnents 10wuonmen73 Sefe Transport of Infectious Substances Transport Planning Lis the respon ofthe sender ensure te core desigration packaging, labelling and documentation of all infectious substances and diagnostic specu: ‘The efficient transport and transfer of infections materials equites good ‘coordination between the sender, the carrer and the receiver (receiving Iaboratory) to ensurethat the materia raneported safely and arrives ome and in god condition. Such coordination depends upon well-established ‘communication and w partner eationsip between the three pation Allhave spit eaponabiitie to cary out in the rant effort The sender 1. nakes advance arrangements withthe rcsiver ofthe specimens including {avestialing the ned for an import pera, 2. makes advance arrangements with he carte lo enwure ‘+ that the shipment will accepid fr appropriate transport + that the shipment (direct tranportf posible) undertaken the ost direct routing, avoiding erival at weekends, 2. prepares necessary documentation incdleg permits, dispatch and shipping ocumeot, ‘4 otis the rocelver of wansportation arrangements once these have been ‘ade, well advance of expected arrival tte ‘The cartier 1. provides tho sender withthe necseary shipping docuaents and ceractiont for their completion, wuonnce73 Safe Transport of Infections Substances 2, provides advice othe sender shout coreet packaging: 3. sist the sender in aranging the moet direct routing and then nim the routing: 4 maintains and archives the documeotation for shipenent and trenspoet; ‘5. morutor required holding conditions ofthe shipment while in rans 6, otf the sender of any anticipated (or actual) delays in ans ‘The receiver 1. blaine the necessary authorisations) from national authorities for the Importation ofthe material, 2, provides the sender with the required import perat(s), letter(») of suthoriation, or other docuanent(s) requir bythe national eathoris 3 arranges forthe mest tna and lfisent colotion on aeival A. mmedatey acknowledges receipt Lo the sender, ‘Shipments should wot be dispetched until + advance arrangements have been made between the sender, cari and + thoreceiver ha confirmed withthe nan authorities tha the materia nay be legally imported + the mceiver has confirmed tht thete will be no delay incurred the livery ofthe package tt destination. ‘Detaed information on reponse and emergency safety measures trap: ssoocieted accidents cane fund in abonatary Blafty Manna Second eon (0990), Geneva: World Health Orpasication (pp. 52-4). 2 rnwHoreMCn73 Safe Transport of Infectious Substances Figure 4A. Standard shipment of infectious substances wuormens Safe Transport of Infectious Substances Figure 4B, Shipment of infetious substances using dy ice ve, N S RN ‘ NS S IN s x ~ ~ 8 : 8 S N S y 1 x S N k S < S XN x rl N onnEN fan ‘ y XN < iN ~ y iu ‘ S nN X s jan s s 1 i i x K S s