4.0 BASIC PRINCIPLES;

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1 TITLE:Transportation and Storage of for Off-Site 1.0 PURPOSE 1.1 To provide guidance for the packing, storage and transportation of vaccine to off-site immunization clinics. 2.0 SCOPE & GOAL 2.1 The scope of this guideline covers the cold chain maintenance guidelines to ensure vaccine potency and effectiveness are maintained during temporary storage conditions necessitated by the operation of off-site clinics. 2.2 s are sensitive biological substances. Their potency and effectiveness may be negatively affected if they are exposed to heat, direct sunlight or fluorescent light, or freezing temperatures (will damage most vaccines). 2.3 storage issues may occur in clinics/settings due to a malfunction of equipment, or human error. 2.4 s that have been improperly stored and handled can result in a reduced immune response. 3.0 BACKGROUND 3.1 Based on research conducted by the BC CDC, the guidance provided by the PHAC National Guidelines (2007), BC CDC Cold Chain Guidelines and the CDC Atlanta Cold Chain Guidelines, the following are packaging recommendations for the transport of vaccine to off-site clinics. 4.0 BASIC PRINCIPLES; 4.1 An insulated and temperature monitored container should be used. 4.2 Pack enough refrigerated or frozen packs to maintain cold chain (the number of which is dependent on the container size, ambient temperature and volume of vaccine). 4.3 If transporting container in a personal vehicle: Do not place container in trunk Avoid placing container in direct sunlight Avoid placing container in line with the vehicle s heater or air conditioner.

2 TITLE:Transportation and Storage of for Off-Site 4.4 Only pack the quantity of vaccine that you anticipate using, as most vaccines can only tolerate brief time out of refrigerator. Ensure good stock rotating principles and be sure vaccines that have been transported to clinics and returned to stock are marked to ensure that they are used first at the very next opportunity. 5.0 EQUIPMENT NEEDED FOR VACCINE TRANSPORT TO OFF SITE CLINICS 5.1 Insulated Containers (Coolers): Use hard sided insulated containers or newer Styrofoam coolers with at least 2 inch thick walls The temperature inside the cooler is maintained with ice packs and insulating materials Criteria for coolers: Must be large enough to store vaccines and icepacks during transport The external surface material is durable and robust The insulation thickness is 30mm to 80mm The lid is tight fitting It has strong handles for carrying. 5.2 Ice packs: Keep enough frozen icepacks available as needed for the duration of the event Direct contact between vaccines and ice packs may cause the vaccines to freeze, resulting in a cold chain failure (always ensure vaccines are insulated from the ice packs) The number and placement of frozen packs inside the container will depend on the container size and outside temperature. 5.3 Insulating Materials: Insulating materials include flexible insulating blankets, gel packs, shredded paper, cardboard, bubble wrap, paper rolls, or Styrofoam.

3 TITLE:Transportation and Storage of for Off-Site Flexible insulating blankets or gel packs can be used to wrap around the vaccines during transport. Keep these blankets/gel packs refrigerated when not in use, either in the door of the refrigerator, or on the refrigerator shelves The number and placement of cool gel packs inside the container will depend on the container size and outside temperature. Temperature Monitors and Temperature Monitoring: The use of a minimum/maximum thermometer or data logger is recommended for monitoring temperature inside the cooler during long or mass immunization clinics Note: There is no standard definition for a long or mass immunization clinic. Of coolers studied, when packed following packing guidelines, interior (vaccine) temperatures were kept at acceptable temperatures for at least 4-6 hours under clinic simulations The temperature monitor should be placed next to the vaccine and should not come in contact with the frozen packs. 6.0 PACKING ORDER (See Figure 1 Packing a Cooler for Transport to an Off-Site Clinic) 6.1 The contents of the container should be layered as follows: refrigerated/frozen packs, layer of barrier (insulating) material vaccine and temperature monitor layer of barrier (insulating) material additional refrigerated/frozen packs Pack vaccines in their original packaging between the barrier layers Fill spaces with crumpled paper or other filler to prevent shifting of contents during transport Do not remove vaccine vials from boxes.

4 TITLE:Transportation and Storage of for Off-Site 7.0 MAINTAINING COLD CHAIN DURING CLINIC OPERATIONS 7.1 It is important to remember that the insulated container (cooler) used for transport replaces the refrigerator at clinics. This means that the cooler should be treated in the same way as a biological refrigerator that is, only open the container when needed and monitor and document temperatures at regular intervals Temperature Monitoring and Immunization Monitor and document temperatures at regular intervals:: Before leaving the office Upon arrival at off-site clinic Every 3 hours At the end of the clinic Upon return to the office 8.0 VACCINE ORDERING PROCEDURES FOR LARGE IMMUNIZATION CLINICS 8.1 Sites are to order the amount of vaccine they need for the immunization clinics and arrange delivery according to program direction. 8.2 For clinics open for long periods, staff should arrange transportation of vaccine from the monitored fridges at the office to the immunization venue at intervals throughout the day. 8.3 At the end of the scheduled clinic, vaccine will be returned to the monitored vaccine fridge. 9.0 AT THE IMMUNIZATION CLINIC SITE 9.1 Keep the balance of the vaccine in the large insulated container (cooler). A minimum/maximum thermometer can provide for continuous temperature monitoring during the clinic. The temperature should be recorded on a Temperature Log at the beginning and end of the clinic, as well as every 3 hours during the clinic. (see Temperature Monitors and Temperature Monitoring above).

5 TITLE:Transportation and Storage of for Off-Site 9.2 Each vaccinator should take steps to ensure vaccine at work stations can be maintained within cold chain recommendations. This can be achieved through the use of: a separate small insulated container (cooler) at the workstation, or a work basket containing an ice pack, topped with an insulating layer on which the vaccine or pre-loaded syringes rest, then covered with another insulating layer. 9.3 The vaccine should be protected from freezing by separating it from the ice pack(s) with insulating material. 9.4 Techniques to streamline workflow and to minimize the time vaccine is exposed to temperatures outside of 2-8ºC, identified in the BC CDC cold chain project included: the use of a designated staff person to dispatch/re-pack vaccine from the main cooler to clinic sites ( to minimize the frequency of cooler opening) the use of labelled sections in coolers or separate coolers to differentiate vaccines at the off-site clinics minimize vaccine handling and clinical errors Only draw up the amount of vaccine to be administered within acceptable times (based on manufacturers recommendations)..

6 TITLE:Transportation and Storage of for Off-Site Leadershi p Team Figure 1 - Packing a Cooler for Transport to an Off-Site Clinic Frozen Ice Pack Frozen Ice Pack Conditioned Gel Pack - Fridge Temp Filler (prevents shifting of contents) Conditioned Gel Packs Conditioned Gel Pack Conditioned Gel Packs - Fridge Temp Temperature Gauge Frozen Ice Pack Frozen Ice Pack (min/max or data logger) Frozen Adapted from the North Carolina Storage and Handling Guide 10.0 VALIDATION 10.1 The National Storage and Handling Guidelines, RECOMMENDED READING 11.1 Manitoba Health Cold Chain Resources BC CDC Cold Chain Guidelines 11.3 CDC Atlanta Cold Chain Guidelines