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QAS/14.598
Supplement 16
WHO Vaccine
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
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2.6 CO2 emissions .................................................................................................................................... 12
2.9 Staff training ...................................................................................................................................... 15
Annex 1 – Montreal Protocol: non-Article 5 countries ......................................................... 17
Revision history .................................................................................................................................. 18
Technical Supplement: Environmental management of refrigeration equipment 5
Abbreviations
A2L An ASHRAE flammability class
ASHRAE American Society of Heating, Refrigerating & Air-Conditioning Engineers
ATP Agreement on the International Carriage of Perishable Foodstuffs and on the
Special Equipment to be Used for such Carriage: - UNECE
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 Hydrochlorofluorocarbons
HFC Hydrofluorocarbons
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 The United Nations Economic Commission for Europe (UNECE or ECE)
UNEP The United Nations Environment Programme
Technical Supplement: Environmental management of refrigeration equipment 6
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 0.3kg per capita on the date of entry of the Montreal Protocol, or at any time
thereafter within ten 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 included1.
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 attributes2.
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.
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.
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 IATA. 2013/2014 Perishable Cargo Regulations (ePCR) & Temperature Control Regulations (eTCR)
Technical Supplement: Environmental management of refrigeration equipment 7
Time and temperature sensitive pharmaceutical product (TTSPP): Any
pharmaceutical good or product which, when not stored or transported within pre-
defined environmental conditions and/or within pre-defined time limits, is degraded to
the extent that it no longer performs as originally intended.
Technical Supplement: Environmental management of refrigeration equipment 8
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 products3. 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;
• Minimise or eliminate the use of refrigerants with high global warming potential (GWP), and;
• Minimise CO2 emissions during operation.
Select equipment to minimise 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 SOP’s 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 the 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, whilst ensuring the efficacy of TTSPP storage and transportation.
1.3 Target readership
The target audience is principally the owners and operators of warehouses, pharmacies
and other stores and owners and operators of refrigerated vehicles used to transport
TTSPP’s. Some of the content may also be useful to equipment manufacturers and
Lawton, A.R., Marshall, N., Clarke, P. Counterfeit refrigerant in food transportation sea containers; IIR/IIF Cold Chain. Paris; 2013 http://www.crtech.co.uk/papers/CounterfeitRefrigerantInFoodTransportationContainers.pdf
Lawton, A.R., Marshall, R.E. Developments in refrigerated transport insulation since the phase out of CFC and HCFC refrigerants. International Congress of Refrigeration. Beijing, 2007. http://www.crtech.co.uk/papers/DevelopmentsInInsulation.pdf
Regulation (EC) no 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:286:0001:0030:EN:PDF
Regulation (EC) no 842/2006 of the European Parliament and of the Council of 17
UK Department for Environment, Food & Rural Affairs and Department for Business, Innovation & Skills. UNECE. Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment to be Used for such Carriage (ATP). http://www.unece.org/fileadmin/DAM/trans/main/wp11/wp11fdoc/ATP-2011_final_e.pdf
UNEP. 2010 Report of the refrigeration, air conditioning and heat pumps technical