Qualification Of Shipping Containers - WHO
QAS/14.598Supplement 13WHO VaccineQualification of shippingcontainersTechnical supplement toWHO Technical Report Series, No. 961, 2011Annex 9: Model guidance for the storage and transport of time andtemperature–sensitive pharmaceutical productsAugust 2014 World Health Organization 2014WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: 41 22 791 3264; fax: 41 22791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether forsale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: 41 22 791 4806; email: permissions@who.int).The designations employed and the presentation of the material in this publication do not imply the expression of anyopinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, cityor area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps representapproximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed orrecommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errorsand omissions excepted, the names of proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by the World Health Organization to verify the information contained in thispublication. However, the published material is being distributed without warranty of any kind, either expressed orimplied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World
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AcknowledgmentsThe authors of this document are Kevin O’Donnell, Exelsius Cold Chain ManagementConsultancy and member of the United States Pharmacopeia Expert Committee onPackaging, Storage and Distribution, 2010-2015 cycle, Ben VanderPlas, SonocoThermoSafe and Bill Mayer, Minnesota Thermal Science.Technical Supplement: Qualification of shipping containers3
ContentsAcknowledgments . 3Contents . 4Abbreviations . 5Glossary . 61.Introduction .101.1 Requirements . 101.2 Objectives. 121.3 Target readership . 122.Guidance .132.1 The three stages of qualification . 132.1.1Design qualification . 132.1.2Operational qualification . 142.1.3Performance qualification . 142.1.4Re-qualification of reusable container systems . 152.2 Associated materials and equipment . 152.2.1Test equipment for design and operational qualifications. 152.2.2Test equipment for performance qualification . 162.3 The performance qualification test protocol . 162.3.1Protocol title . 162.3.2Protocol approvals. 162.3.3Introduction . 162.3.4Purpose. 162.3.5Scope . 172.3.6Acceptance criteria. 172.3.7Responsibilities . 172.3.8Test procedure . 172.3.9Data analysis . 172.4 The performance qualification test . 182.5 The performance qualification report . 21References .22Revision history .23Technical Supplement: Qualification of shipping containers4
AbbreviationsASTMAmerican Society for Testing and MaterialsDQDesign QualificationEDLMElectronic Data Logging MonitorISPEInternational Society for Pharmaceutical EngineeringISTAInternational Safe Transit AssociationOQOperational QualificationPDAParenteral Drug AssociationPQPerformance QualificationSOPStandard Operating ProcedureTTSPPTime and Temperature-Sensitive Pharmaceutical ProductURSUser Requirement SpecificationTechnical Supplement: Qualification of shipping containers5
GlossaryActive systems: Externally powered or on-board powered systems using electricity orother fuel source to maintain a temperature-controlled environment inside an insulatedenclosure under thermostatic regulation (e.g. cold rooms, refrigerators, temperaturecontrolled trucks, refrigerated ocean and air containers).Advanced Phase Change Materials (PCMs): Temperature stabilizing media (sometimesreferred to as refrigerants), chemically engineered so that their latent heat of fusionoccurs at a temperature other than zero C, phasing from one state of matter to another(i.e. liquid to solid) at a pre-formulated temperature. Such materials are typicallycomprised of oils, salts, or paraffin.Ancillary packaging components: Packaging elements used to protect the TTSPP andsupport or enhance performance of the completed package. This may include retainers,dunnage, secondary protective packaging, and temperature data logging devices.Associated components: Articles of packaging that are typically intended to deliver thedosage form to the patient but are not stored in contact with the dosage form for its entireshelf life. These components are packaged separately in the market package and are eitherattached to the container upon opening or used only when a dose is to be administered.Examples: measuring spoons, dosing cups, measuring syringes.Cryogenic dry/vapour shipper: A temperature-controlled insulated packaging containeror system compatible with liquefied gasses such as nitrogen used for maintainingextremely low temperatures during shipping. A porous medium internal to the shippingcontainer absorbs and contains all the free flowing liquid and does not allow it to come incontact with the product – a process known as “charging”. A fully charged and undamageddry/vapour shipper containing nitrogen can maintain -196 C for up to 10 days, dependingon the unit size.Design qualification: The process of obtaining a nd documenting evidence that thepremises, equipment and supporting systems and processes have been designed inaccordance with the requirements for Good Manufacturing Practices (GMP)1.Dunnage: Loose packing material used to protect TTSPPs from damage during transport.Electronic Data Logging Monitor (EDLM): A small portable device that measures andstores temperature at a pre-determined time intervals by means of an electronic sensor.They have programmable alarm capabilities, integrated displays, and can create reportsand graphs which may be permanently stored, shared and analysed via proprietaryhardware, software, desktop application or through hosted databases.Electronic temperature monitoring and event logger system (EDLM): System forrecording and reporting air and/or product temperatures, with optional facilities forrecording and reporting specific events such as door-opening or defrost cycles, and forissuing alarms. Such systems may be user-programmable and may also be remotelymonitored via a satellite link.WHO Technical Report Series, No. 961, 2011. Annex 3: WHO good manufacturing practices forpharmaceutical products: main principles.1Technical Supplement: Qualification of shipping containers6
External distribution: Transport of TTSPPs through various steps in the customer’ssupply chain (i.e. transport from a pharmaceutical manufacturer’s distribution centre, tocommercial customers (including wholesalers, retailers and buying groups), to clinicalfacilities or direct to the patient). Contrast with internal distribution.Installation qualification (IQ): The process of obtaining and documenting evidence thatthe premises, equipment and supporting systems have been provided and installed incompliance with their design specifications.Internal distribution: Transport of a TTSPP within a pharmaceutical manufacturer’sinternal supply chain (i.e. all internal transport from the manufacturing plant to thepackaging plant and onwards to warehouses and distribution centres). Contrast withexternal distribution.Maximum payload: The amount of product intended to be shipped with the most amountof thermal mass.Minimum payload: The amount of product intended to be shipped with the least amountof thermal mass.Operational qualification (OQ): The process of obtaining and documenting evidence,under controlled conditions, that the premises, equipment and supporting systemsoperate in accordance with their design specifications.Packout: An assembled package that includes the product to be shipped (alternatively,simulated product in its commercial presentation primary packaging form), the insulatedshipper / container, any and all necessary auxiliary and/or associated components andancillary packaging components such as temperature stabilizing medium, secondarypackaging, partitions, bubble wrap, data loggers or other temperature monitoring units,and dunnage.Passive systems: Systems which maintain a temperature-controlled environment insidean insulated enclosure, with or without thermostatic regulation, using a finite amount ofpre-conditioned coolant in the form of chilled or frozen gel packs, phase change materials,dry ice or others.Performance qualification (PQ): The process of obtaining and documenting evidencethat the premises, equipment and supporting systems, as connected together, willconsistently perform in accordance with the approved process method and specifications.Pharmaceutical product: Any product intended for human use or veterinary productintended for administration to food producing animals, presented in its finished dosageform, that is subject to control by pharmaceutical legislation in either the exporting or theimporting state and includes products for which a prescription is required, productswhich may be sold to patients without a prescription, biologicals and vaccines. Medicaldevices are not included2.Pre-qualified shipping container system: A packaging container or packaging system inwhich a DQ and OQ have already been established and documented by the manufacturerDefinition from WHO/QAS/08.252 Rev 1 Sept 2009. Proposal for revision of WHO good distributionpractices for pharmaceutical products – Draft for comments.2Technical Supplement: Qualification of shipping containers7
and the user has acquired sufficient documentation to meet their user requirementspecification (URS).Qualification protocol: A written and approved plan detailing how a qualification will beconducted including test parameters, product characteristics, equipment and acceptancecriteria.Qualification: Action of proving that any premises, equipment and supporting systemswork correctly and actually lead to the expected results. The meaning of the wordvalidation is sometimes extended to incorporate the concept of qualification.Refrigeration equipment: The term ‘refrigeration’ or ‘refrigeration equipment’ meansany equipment whose purpose is to lower air and product temperatures and/or to controlrelative humidity.Seasonal packaging solution: (Also called a dedicated packaging solution). A packedshipping container system, whose effective performance in different seasons requiresmore than one packing configuration. These configurations depend on seasonal variantssuch as summer and winter or hot and cold season exposure.Secondary pack or carton or market package: The package presentation intended forthe end user (e.g. bottle cap liner dose cap leaflets carton) but not includingpackaging used solely for transport purposes (e.g. Tertiary carton or Insulated shipper).The secondary pack may contain multiple units of product.Shipping system: All components constituting a completed package including: the outershipping container, all internal ancillary packaging components and temperaturestabilizing medium.Standard Operating Procedure (SOP): A set of instructions having the force of adirective, covering those features of operations that lend themselves to a definite orstandardized procedure without loss of effectiveness. Standard operating policies andprocedures can be effective catalysts to drive performance improvement and improveorganizational results.Storage temperature: The temperature range listed on the TTSPP label, and within theregulatory filings, for long-term storage.Temperature excursion: An event in which a TTSPP is exposed to temperatures outsidethe range(s) prescribed for storage and/or transport. Temperature ranges for storage andtransport may be the same or different; they are determined by the product manufacturer,based on stability data.Temperature stabilizing medium: Ice or gel packs; gel bricks, bottles or pouches; coolwater or warm water packs, phase change materials, dry ice, rapid evaporation mediawhich limit exposure of packed product to excessively high or low temperatures duringtransport: also referred to as refrigerants or coolants.Temperature-controlled: Includes any environment in which the temperature is activelyor passively controlled at a level different from that of the surrounding environmentwithin precise pre-defined limits.Time and temperature sensitive pharmaceutical product (TTSPP): Anypharmaceutical good or product which, when not stored or transported within preTechnical Supplement: Qualification of shipping containers8
defined environmental conditions and/or within pre-defined time limits, is degraded tothe extent that it no longer performs as originally intended.Transport temperature profile: Anticipated ambient temperature variation andduration to which a TTSPP may be exposed during transport.Universal Packaging Solution: A shipping container whose proper performance does notrequire more than one packing configuration regardless of seasonal variants such assummer and winter or hot and cold exposure.User Requirement Specification (URS): The attributes assigned by the user in advanceof a qualification test to establish minimum performance limits. Sometimes referred to asa Functional Requirements Document.Validation: Documented testing performed under highly controlled conditions,demonstrating that processes, methods, and systems consistently produce results meetingpre-determined acceptance criteria.3PDA Technical Report No. 39: Guidance for Temperature Controlled Medicinal Products:Maintaining the Quality of Temperature-Sensitive Medicinal Products through the TransportationEnvironment, 2007.3Technical Supplement: Qualification of shipping containers9
1. IntroductionThis technical supplement has been written to amplify the recommendations given inSections 6.8.1, 6.8.3 and 6.8.4 of the WHO Technical Report Series No. 961, 2011, Annex 9:Model guidance for the storage and transport of time- and temperature-sensitivepharmaceutical products4. The document covers the qualification to all single-use andreusable active, passive, hybrid, and cryogenic dry/vapour shipping containers or systemsused for the transport of a TTSPP in external distribution.The principal focus is on performance qualification (PQ). The document also includes abrief introduction to the requirements and technical resources needed for design andoperational qualification (DQ and OQ) because these activities need to be understood bythose responsible for assessing and procuring third party container systems. Thesupplement should be read in conjunction with the companion Technical Supplement,Transport route profiling qualification.What is ‘qualification’?In the context of this series of Technical Supplements, qualification is an inspection andtesting process used to establish that a piece of equipment or a physical installation is fitfor purpose in the operational context within which it will be used. There are typicallythree stages in the process. Each stage must be successfully completed before the next onebegins.Design qualification (Stage 1 for equipment): Establish by laboratory testing undertightly controlled conditions that a specific item of equipment performs in accordancewith the user requirements specification (URS). Whilst design qualification demonstratescompliance with the URS and associated test protocols; it does not prove that theequipment will be suitable in a specific operating environment because the URS and thetest procedures are unlikely to reflect the full range of operating conditions.Installation qualification (Stage 1 for installations): Establish by documentedinspection and testing that an installation5 that has been assembled in a specific location isfully in accordance with the user requirements specification and installation drawings.Operational qualification (Stage 2): Establish by further documented testing undercontrolled conditions that this equipm
Qualification protocol: A written and approved plan detailing how a qualification will be conducted including test parameters, product characteristics, equipment and acceptance criteria. Qualification: Action of proving that any premises, equipment and supporting systems work correctly and actually lead to the expected results.
Shipping Containers and architecture Shipping containers usually have a life-span of 10 years, after which they can be sold and repurposed. Since the late 1980’s one of the post-mortem uses of shipping containers is habitable structures. The last few years has seen an increase in shipping containers for different structures.
SHIPPING INDUSTRY Institutional shareholders currently investing 1,200 in shipping companies listed in the US 49 Shipping companies currently listed in the US 35 Analysts who follow shipping industry 20.5B Total Market Cap in the Shipping Industry 13.8B Held by institutional and retail shareholders 2 Shipping Industry Overview
I. Limited use non-bulk containers J. Solid – Holding containers K. Mixed load containers L. Radioactive shipping containers and packages Video - Containers . At the completion of Section One, Part 1, the student will be able to: Utilize the ERG, NIOSH, and SDS to determine evacuation/isolation distances,
hipping container architecture could be defined as that type of architecture that is generally characterized by the re-use of steel shipping containers as a structural element and Ar- . Any shipping container is composed of 6 planes, floor, top, and four sides, made of steel, in regular corrugations that help .
current day shipping container, and the elements that comprise home and community to better understand how shipping containers may be modified to fit into these settings. So in my study of shipping containers and the process involved in transforming the containers into a housing module, I have explored three community settings and the way
SHIPPING CONTAINER SIZES - Mini Containers 6FT Mini Container 8FT Mini Container 10 11 from 3450 gst from 3680 gst. MILLIMETERS Outside Length 2991mm . SHIPPING CONTAINERS SIZES - 21ft Tradies Storage 21FT Extended for 6M lengths 14 15 from 3775 gst (USED) also available for hire.
5.D Qualification of water supplies 5.D.1 Introduction 5.D.2 Risk analysis 5.D.3 Design qualification 5.D.4 Installation qualification 5.D.5 Operational qualification (OQ) 5.D.6 Transfer to the user 5.D.7 Process validation/performance qualification (PQ) 5.D.8 Qualification report 5.E Operation of water supplies
On Getting What You Want: Our Method of Manifestation This point cannot be overemphasized. You need to see that the way it is now is the way you have chosen it to be on some level.
