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Qualification of shipping containers
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Health Organization be liable for damages arising from its use The named authors alone are responsible for the views. expressed in this publication, Acknowledgments, The authors of this document are Kevin O Donnell Exelsius Cold Chain Management. Consultancy and member of the United States Pharmacopeia Expert Committee on. Packaging Storage and Distribution 2010 2015 cycle Ben VanderPlas Sonoco. ThermoSafe and Bill Mayer Minnesota Thermal Science. Technical Supplement Qualification of shipping containers 3. Acknowledgments 3, Contents 4, Abbreviations 5, Glossary 6. 1 Introduction 10, 1 1 Requirements 10, 1 2 Objectives 12. 1 3 Target readership 12, 2 Guidance 13, 2 1 The three stages of qualification 13. 2 1 1 Design qualification 13, 2 1 2 Operational qualification 14.
2 1 3 Performance qualification 14, 2 1 4 Re qualification of reusable container systems 15. 2 2 Associated materials and equipment 15, 2 2 1 Test equipment for design and operational qualifications 15. 2 2 2 Test equipment for performance qualification 16. 2 3 The performance qualification test protocol 16. 2 3 1 Protocol title 16, 2 3 2 Protocol approvals 16. 2 3 3 Introduction 16, 2 3 4 Purpose 16, 2 3 5 Scope 17. 2 3 6 Acceptance criteria 17, 2 3 7 Responsibilities 17.
2 3 8 Test procedure 17, 2 3 9 Data analysis 17, 2 4 The performance qualification test 18. 2 5 The performance qualification report 21, References 22. Revision history 23, Technical Supplement Qualification of shipping containers 4. Abbreviations, ASTM American Society for Testing and Materials. DQ Design Qualification, EDLM Electronic Data Logging Monitor.
ISPE International Society for Pharmaceutical Engineering. ISTA International Safe Transit Association, OQ Operational Qualification. PDA Parenteral Drug Association, PQ Performance Qualification. SOP Standard Operating Procedure, TTSPP Time and Temperature Sensitive Pharmaceutical Product. URS User Requirement Specification, Technical Supplement Qualification of shipping containers 5. Active systems Externally powered or on board powered systems using electricity or. other fuel source to maintain a temperature controlled environment inside an insulated. enclosure under thermostatic regulation e g cold rooms refrigerators temperature. controlled trucks refrigerated ocean and air containers. Advanced Phase Change Materials PCMs Temperature stabilizing media sometimes. referred to as refrigerants chemically engineered so that their latent heat of fusion. occurs 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 typically. comprised of oils salts or paraffin, Ancillary packaging components Packaging elements used to protect the TTSPP and.
support 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 the. dosage form to the patient but are not stored in contact with the dosage form for its entire. shelf life These components are packaged separately in the market package and are either. attached 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 container. or system compatible with liquefied gasses such as nitrogen used for maintaining. extremely low temperatures during shipping A porous medium internal to the shipping. container absorbs and contains all the free flowing liquid and does not allow it to come in. contact with the product a process known as charging A fully charged and undamaged. dry vapour shipper containing nitrogen can maintain 196 C for up to 10 days depending. on the unit size, Design qualification The process of obtaining a nd documenting evidence that the. premises equipment and supporting systems and processes have been designed in. accordance 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 and. stores temperature at a pre determined time intervals by means of an electronic sensor. They have programmable alarm capabilities integrated displays and can create reports. and graphs which may be permanently stored shared and analysed via proprietary. hardware software desktop application or through hosted databases. Electronic temperature monitoring and event logger system EDLM System for. recording and reporting air and or product temperatures with optional facilities for. recording and reporting specific events such as door opening or defrost cycles and for. issuing alarms Such systems may be user programmable and may also be remotely. monitored via a satellite link, 1WHO Technical Report Series No 961 2011 Annex 3 WHO good manufacturing practices for. pharmaceutical products main principles, Technical Supplement Qualification of shipping containers 6. External distribution Transport of TTSPPs through various steps in the customer s. supply chain i e transport from a pharmaceutical manufacturer s distribution centre to. commercial customers including wholesalers retailers and buying groups to clinical. facilities or direct to the patient Contrast with internal distribution. Installation qualification IQ The process of obtaining and documenting evidence that. the premises equipment and supporting systems have been provided and installed in. compliance with their design specifications, Internal distribution Transport of a TTSPP within a pharmaceutical manufacturer s. internal supply chain i e all internal transport from the manufacturing plant to the. packaging plant and onwards to warehouses and distribution centres Contrast with. external distribution, Maximum payload The amount of product intended to be shipped with the most amount.
of thermal mass, Minimum payload The amount of product intended to be shipped with the least amount. of thermal mass, Operational qualification OQ The process of obtaining and documenting evidence. under controlled conditions that the premises equipment and supporting systems. operate 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 insulated. shipper container any and all necessary auxiliary and or associated components and. ancillary packaging components such as temperature stabilizing medium secondary. packaging partitions bubble wrap data loggers or other temperature monitoring units. and dunnage, Passive systems Systems which maintain a temperature controlled environment inside. an insulated enclosure with or without thermostatic regulation using a finite amount of. pre 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 evidence. that the premises equipment and supporting systems as connected together will. consistently perform in accordance with the approved process method and specifications. Pharmaceutical product Any product intended for human use or veterinary product. intended for administration to food producing animals presented in its finished dosage. form that is subject to control by pharmaceutical legislation in either the exporting or the. importing state and includes products for which a prescription is required products. which may be sold to patients without a prescription biologicals and vaccines Medical. devices are not included2, Pre qualified shipping container system A packaging container or packaging system in.
which a DQ and OQ have already been established and documented by the manufacturer. 2Definition from WHO QAS 08 252 Rev 1 Sept 2009 Proposal for revision of WHO good distribution. practices for pharmaceutical products Draft for comments. Technical Supplement Qualification of shipping containers 7. and the user has acquired sufficient documentation to meet their user requirement. specification URS, Qualification protocol A written and approved plan detailing how a qualification will be. conducted including test parameters product characteristics equipment and acceptance. Qualification Action of proving that any premises equipment and supporting systems. work correctly and actually lead to the expected results The meaning of the word. validation is sometimes extended to incorporate the concept of qualification. Refrigeration equipment The term refrigeration or refrigeration equipment means. any equipment whose purpose is to lower air and product temperatures and or to control. relative humidity, Seasonal packaging solution Also called a dedicated packaging solution A packed. shipping container system whose effective performance in different seasons requires. more than one packing configuration These configurations depend on seasonal variants. such as summer and winter or hot and cold season exposure. Secondary pack or carton or market package The package presentation intended for. the end user e g bottle cap liner dose cap leaflets carton but not including. packaging 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 outer. shipping container all internal ancillary packaging components and temperature. stabilizing medium, Standard Operating Procedure SOP A set of instructions having the force of a. directive covering those features of operations that lend themselves to a definite or. standardized procedure without loss of effectiveness Standard operating policies and. procedures can be effective catalysts to drive performance improvement and improve. organizational results, Storage temperature The temperature range listed on the TTSPP label and within the. regulatory filings for long term storage, Temperature excursion An event in which a TTSPP is exposed to temperatures outside.
the range s prescribed for storage and or transport Temperature ranges for storage and. transport 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 cool. water or warm water packs phase change materials dry ice rapid evaporation media. which limit exposure of packed product to excessively high or low temperatures during. transport also referred to as refrigerants or coolants. Temperature controlled Includes any environment in which the temperature is actively. or passively controlled at a level different from that of the surrounding environment. within precise pre defined limits, Time and temperature sensitive pharmaceutical product TTSPP Any. pharmaceutical good or product which when not stored or transported within pre. Technical Supplement Qualification of shipping containers 8. defined environmental conditions and or within pre defined time limits is degraded to. the extent that it no longer performs as originally intended. Transport temperature profile Anticipated ambient temperature variation and. duration to which a TTSPP may be exposed during transport. Universal Packaging Solution A shipping container whose proper performance does not. require more than one packing configuration regardless of seasonal variants such as. summer and winter or hot and cold exposure, User Requirement Specification URS The attributes assigned by the user in advance. of a qualification test to establish minimum performance limits Sometimes referred to as. a Functional Requirements Document, Validation Documented testing performed under highly controlled conditions. demonstrating that processes methods and systems consistently produce results meeting. pre determined acceptance criteria 3, 3PDA Technical Report No 39 Guidance for Temperature Controlled Medicinal Products.
Maintaining the Quality of Temperature Sensitive Medicinal Products through the Transportation. Environment 2007, Technical Supplement Qualification of shipping containers 9. 1 Introduction, This technical supplement has been written to amplify the recommendations given in. Sections 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 sensitive. pharmaceutical products4 The document covers the qualification to all single use and. reusable active passive hybrid and cryogenic dry vapour shipping containers or systems. used for the transport of a TTSPP in external distribution. The principal focus is on performance qualification PQ The document also includes a. brief introduction to the requirements and technical resources needed for design and. operational qualification DQ and OQ because these activities need to be understood by. those responsible for assessing and procuring third party container systems The. supplement should be read in conjunction with the companion Technical Supplement. Transport route profiling qualification, What is qualification. Technical Supplement Qualification of shipping containers 6 Glossary Active systems Externally powered or on board powered systems using electricity or other fuel source to maintain a temperature controlled environment inside an insulated enclosure under thermostatic regulation e g cold rooms refrigerators temperature

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