4.1 Manufacturers' recommendations on storage must be observed and care should be taken to ensure that, on receipt, vaccines are checked against the order, examined for leakage or other damage and immediately placed under the required storage conditions. Vaccines must not be kept at temperatures below 0°C as freezing can cause deterioration of the vaccine and breakage of the container.
4.2 A pharmacist or other suitably trained person should be nominated for each clinic as being responsible for the safe storage of vaccines, and should work to a written procedure developed to meet local needs. This person should have a designated deputy to cover in times of absence. General medical practitioners should make similar arrangements.
4.3 Care should be taken to avoid over-ordering or stockpiling vaccines. Systems should be developed to ensure stock rotation, and regular checks should be made to remove time expired vaccines.
4.4 Vaccines should be stored in the refrigerator, allowing air to circulate around the packages. They should not be stored on the shelves or in storage compartments of the refrigerator door.
4.5 Food and drink should not be stored in refrigerators used for vaccines. Door opening should be kept to a minimum.
4.6 Domestic refrigerators are not designed for storage of vaccines and wherever possible should not be used. Refrigerators specifically for storage of medicinal products are available from a number of suppliers (see 4.16).
4.7 Care should be taken to ensure that the electricity supply to the vaccine storage refrigerator cannot be accidentally interrupted e.g. by using a switchless socket or by placing cautionary notices on plugs and sockets.
4.8 A maximum/minimum thermometer should be used in refrigerators where vaccines are stored, irrespective of whether the refrigerator incorporates a temperature indicator dial. Such thermometers may be purchased from reputable laboratory suppliers, some of whom are able to provide a certificate of conformance/calibration (see 4.16). More sophisticated temperature recording devices are available which may be particularly useful for validation and periodic audit of storage and transport facilities.
4.9 The maximum and minimum temperatures reached should be monitored and recorded regularly - preferably daily but at least at the beginning of each immunisation session. Temperature record logs are best kept close to the refrigerator for ease of reference. The written procedure referred to in 4.2 should indicate the action to be taken in the event of the temperature going outside the specified range.
4.10 Refrigerators should be defrosted regularly. Special care should be taken during defrosting to ensure that the temperature of the vaccine does not go outside the specified range. An alternative refrigerator or insulated containers should be used for vaccine storage during defrosting of refrigerators.
4.11 If vaccines have been despatched by post, they should not be accepted by the recipient if more than 48 hours have elapsed since posting. The date and time of dispatch should be clearly marked.
4.12 The use of cool-boxes or insulated containers to transport vaccines should be validated to ensure that the required temperature is maintained throughout the period of transit. Care should be taken to keep frozen icepacks out of direct contact with the vaccine as this can cause the product to freeze.
4.13 Reconstituted vaccine must be used within the recommended period, varying from one to four hours, according to the manufacturer's instructions. Single dose containers are preferable; once opened, multi-dose vials must not be kept after the end of the session and any vaccine left unused must be discarded.
4.14 Unused vaccine, spent or partly spent vials should be disposed of safely, preferably by heat inactivation or incineration. Contaminated waste and spillage should be dealt with by heat sterilisation, incineration or chemical disinfection as appropriate. Those providing or handling live vaccines should consult their local Consultant in Communicable Disease Control, Consultant in Public Health Medicine (CPHM), Consultant in Communicable Disease and Environmental Health (CD & EH) in Scotland, or Infection Control Committee about suitable procedures.
4.15 The procedures being followed for storage, distribution and disposal of vaccines should be audited regularly to ensure that they comply with the written procedure (see 4.2).
4.16 Advice on suppliers of refrigeration equipment and accessories is available from:
Communicable Disease Branch, Department of Health, Area 708, Wellington House, 133-155 Waterloo Road, London SE1 8UG, (Tel 0171 972 4472).
or Pharmaceutical Division, Scottish Office, Department of Health, St Andrew's House, Edinburgh, EH1 3DE
The safe disposal of clinical waste. Health and Safety Commission: Health Services Advisory Committee, 1992.HMSO ISBN 0 11 883641 2.