Supplement 16 Environmental management of refrigeration equipment Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products May 2015 © World Health Organization 2015 WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate 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 or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and 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 this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The named authors alone are responsible for the views expressed in this publication. Contents Abbreviations 3 Acknowledgements 4 Glossary 5 1. Introduction 7 1.1 Requirements 7 1.2 Objectives 7 1.3 Target readership 8 2. Guidance 9 2.1 Associated materials and equipment 9 2.2 Montreal Protocol 9 2.3 Selection of refrigerants and blowing agents 10 2.3.1 Use of chlorofluorocarbons (CFCs) 10 2.3.2 Use of hydrochlorofluorocarbons (HCFCs) 10 2.3.3 Use of hydrofluorocarbons (HFCs) 10 2.3.4 Use of hydrofluoroolefin (HFO) 11 2.3.5 Use of hydrocarbons (HCs) 11 2.3.6 Ammonia and carbon dioxide 11 2.3.7 Other cooling technologies 12 2.4 Counterfeit refrigerants 12 2.5 Thermal insulation 13 2.6 CO2 emissions 13 2.6.1 Kyoto Protocol 13 2.6.2 CO2 emissions from prime mover 13 2.6.3 ODP and high GWP refrigerants 14 2.7 Installation and maintenance 15 2.8 Decommissioning 15 2.9 Staff training 16 Bibliography 17 Annex 1 Montreal Protocol: non-Article 5 countries 19 Revision history 20 2 WHO Technical Report Series, No. 992, Annex 5 Supplement 16 Abbreviations A2L An ASHRAE flammability class ASHRAE American Society of Heating, Refrigerating and Air- Conditioning Engineers ATP Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment to be Used for such Carriage BS EN British Standard European Norm CFC chlorofluorocarbons EN 378 European Norm (standard) on the safety of refrigerants F-Gas fluorinated gas GWP global warming potential HC hydrocarbon HCFC hydrochlorofluorocarbon HFC hydrofluorocarbon HFO hydrofluoro-olefin MOP-19 Nineteenth Meeting of the Parties to the Montreal Protocol ODP ozone depletion potential ODS ozone depleting substance SOP standard operating procedure TEWI total equivalent warming impact TTSPP time- and temperature-sensitive pharmaceutical product UNECE United Nations Economic Commission for Europe UNEP United Nations Environment Programme 3 WHO Expert Committee on Specifications for Pharmaceutical Preparations Acknowledgements The author of this document is Richard Lawton, Technical Director, Cambridge Refrigeration Technology, Cambridge, England. 4 WHO Technical Report Series, No. 992, Annex 5 Supplement 16 Glossary Article 5 country: The main objective of the Multilateral Fund for the Implementation of the Montreal Protocol is to assist developing country parties to the Montreal Protocol whose annual per capita consumption and production of ozone-depleting substances (ODS) is less than 0.3 kg to comply with the control measures of the Protocol. Currently, 147 of the 196 parties to the Montreal Protocol meet these criteria (they are referred to as Article 5 countries). Non-Article 5 country: Parties to the Montreal Protocol that have an ODS consumption of greater than 0.3 kg per capita on the date of entry of the Montreal Protocol, or at any time thereafter within 10 years of the date of entry into force of the Protocol. 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 included.1 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. Service level agreement (SLA): A service level agreement or contract is a negotiated agreement between the customer and service provider that defines the common understanding about materials or service quality specifications, responsibilities, guarantees and communication mechanisms. It can either be legally binding, or an information agreement. The SLA may also specify the target and minimum level performance, operation or other service attributes.2 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. 1 Definition from WHO/QAS/08.252 Rev 1 Sept 2009. Proposal for revision of WHO good distribution practices for pharmaceutical products – Draft for comments. 2 Definition from International Air Transport Association (IATA). 2013/2014 Perishable cargo regulations (ePCR) and Temperature control regulations (eTCR). 5 WHO Expert Committee on Specifications for Pharmaceutical Preparations Third party accreditation: Accreditation or certification by an organization that issues credentials or certifies third parties against official standards as a means of establishing that a contractor is competent to undertake a specific type of work. Third-party accreditation organizations are themselves formally accredited by accreditation bodies; hence they are sometimes known as "accredited certification bodies". The accreditation process ensures that their certification practices are acceptable, typically meaning that they are competent to test and certify third parties, behave ethically and employ suitable quality assurance. Time and temperature-sensitive pharmaceutical product (TTSPP): Any pharmaceutical good or product which, when not stored or transported within predefined environmental conditions and/or within predefined time limits, is degraded to the extent that it no longer performs as originally intended. 6 WHO Technical Report Series, No. 992, Annex 5 Supplement 16 1. Introduction This technical supplement has been written to amplify the recommendations given in section 10.2 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products.3 It gives guidance on the selection of refrigerant gases and blowing agents so that countries can minimize the environmental impact of cold chain equipment used in fixed storage and transport operations. Related topics are covered in the Technical Supplement: Maintenance of refrigeration equipment. 1.1 Requirements Ensure that all new refrigeration equipment for temperature-controlled storage and transport is specified to: ■ use refrigerants that comply with the Montreal Protocol; ■ minimize or eliminate the use of refrigerants with high global warming potential (GWP), and; ■ minimize carbon dioxide (CO2) emissions during operation. Select equipment to minimize whole-life environmental impact and employ best practice to eliminate leakage of refrigerant into the environment during installation, maintenance and decommissioning of refrigeration equipment. Follow standard operating procedures (SOPs) for purchase, maintenance and end of equipment life disposal, and ensure compliance with international protocols and accords on climate change and environmental protection. Train staff to avoid excessive release of refrigerants. 1.2 Objectives The objectives of this Technical Supplement are to provide guidance on how to meet the above requirements with regard to the environmental impact of fixed and mobile refrigeration equipment, while ensuring the efficacy of TTSPP storage and transportation. 3 http://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf 7 WHO Expert Committee on Specifications for Pharmaceutical Preparations 1.3 Target readership The target audience is principally the owners and operators of warehouses, pharmacies and other stores and owners