RFP for New Insulated Containers and Carriers for Vaccine

Long-term Cold Storage Containers and Carriers for Heat/Freeze-sensitive Vaccines: Target Performance Criteria by Steve McCarney, PATH Project Optimize, a collaboration between the World Health Organization (WHO) and PATH, seeks to develop and galvanize support around a vision for the future of immunization systems and technologies. Over the course of the five-year project this vision will be shaped by work on technology and system innovations as well as through demonstration projects in several low- to middle-income countries (LMICs). Need:Many new and expensive vaccines are being introduced within the next five to ten years. The vaccine cold chain faces an enormous physical change that will result in an estimated four-fold increase in storage volume requirements. Much of the vaccine delivered to LMICs will be delivered into rural areas, often without access to reliable electricity for refrigeration. The United Nations Children's Fund reports that over fifty-percent of their refrigeration equipment procurements were destined for areas where electricity is either unreliable or not available. These areas have traditionally been supplied with gas- or kerosene-fueled absorption refrigerators with icepack freezing capability. Increasingly, solar refrigeration is chosen because it has the lowest whole life cost, taking account of rising energy costs. However, for the smaller, more remote health facilities that have limited access to maintenance and repair, it is anticipated that vaccine delivery and/or storage containers will increasingly need to operate as passive cooling sources for periods longer than the current practice. Eventually these passively cooled cold boxes and vaccine carriers would need to be recharged from offsite sources with cold packs, icepacks, batteries, etc. Project Optimize anticipates the need for vaccine storage containers and carriers with high thermal efficiency coupled with state-of-the-art passive cooling technology to provide extended cold storage within the acceptable temperature range for vaccine storage which is between 2º and 8ºC. The goal is to attain functional vaccine storage cold boxes and carriers with a seven- to thirty-day cold life in 32º to 43ºC ambient environments—preferably with no energy input after initial cool down. Vaccine storage capacity for two sizes of containers have been anticipated. A mobile three-liter vaccine carrier was specified as it is typical of the type used in outreach efforts and range in size from 0.5 to 5 liters. Stationary 3-liter and 60-liter cold boxes were specified because these sizes match the target facility size and needs. The 3 liter cold box capacity is intended for facilities that only need to provide continuous cool storage between 2º and 8ºC for birth-dose vaccines (including oral polio, Hepatitis B, and bacillus calmette-guerin). A 60-liter cold box can hold sufficient vaccine for 240 births which is estimated to be adequate for a health center serving a population of 52,000 persons with a birth rate of 30 per 1000 persons. Standard Practices:There are three standard practices currently used in immunization programs for cooling vaccines and their diluents during different types of immunization sessions: 1) Fixed immunization sessions. All vaccine vials required for the session are drawn from the refrigerator before the session and kept in a vaccine carrier cooled by water/icepacks. The mouth of the vaccine carrier is often fitted with a soft foam pad that is pierced in order that it can be held upright and to in order to cool opened vials ready for use. Unopened vials lie below in the body of the carrier cooled by the packs, and they are taken for use when opened vials are empty. 2) Outreach immunization sessions. Vaccine vials required for the session are drawn from the refrigerator before traveling to the site of the session and kept in a vaccine carrier cooled by water/icepacks. The vaccines are drawn from the carrier in one of two ways: • The carrier is fitted with an internal soft foam pad, as already described. • The vaccines are packed in a resealable (e.g., Ziploc®) plastic bag to protect them from melting ice and condensation. Unopened vials lie below in the body of the carrier, cooled by the packs. Long outreach journeys sometimes require that a second vaccine carrier is carried full of cool packs. Vaccines are either taken for use, as in a fixed session, or vials are withdrawn one by one and returned to the carrier when immunization is performed house-to-house. 3) Birth dose or “on-demand” immunizations. At health facilities that offer immunization “on-demand”, or provide birth doses to newborns, the vaccines are kept cool and used in one of two ways: • If demand is low opened vials are arranged in an open box in the refrigerator and are taken for use each time they are needed. This may entail that the door of the fridge is opened several times per day for short durations. • If demand is high and access is frequent an adequate number of vaccines for the day are kept in a vaccine carrier and accessed as described in 1) Fixed immunization sessions, and 2) Outreach immunization sessions. Approach:WHO and PATH anticipate funding shipment, laboratory testing and field demonstrations of promising technologies supporting immunization. If modeling, laboratory testing, and field evaluations confirm benefits, then these new vaccine cooling devices will be proposed for addition to the WHO PQS quality, and safety norms paving the way for entry into developing-country vaccine storage markets. We invite your proposal to demonstrate any of the three different passively cooled products described below—a 60-liter stationary cold box, a 3-liter stationary cold box, and a 3-liter, mobile outreach vaccine carrier. You may offer designs or finished products for any or all of the devices described below. No product operating as an absorption or compression refrigerator will be considered for this invitation. Each submittal must be accompanied by a product development strategy, available test results, and manufacturing plans. Respondents may be individual organizations or documented partnerships/collaborations. Submittals will be reviewed for both commercialization plans and the technical aspects as described in the Target Performance Criteria shown below. For each product award a complete sample will be sent for testing including container, cooling system and recharge system (i.e. if recharge system is different than a typical refrigerator or freezer). Deadline for submission is September 15, 2009. Send questions and submissions to [[email protected]][email protected][/email]. Product 1 Target Performance Criteria: 3 liter vaccine carrier (mobile) Category Specification Weighting factor Vaccine storage capacity 3 liters (±1 liter) configured for vaccine storage and easy access to health center staff. Existing product of alternate size will be considered. Required. Performance Cold life of 3 days in a 32ºC ambient environment while maintaining vaccine storage temperature within range of 2º to 8ºC with no outside energy input. Ten times per day (every 2.4 hours) the vaccine carrier will be opened for 10 seconds and then closed. No target is set for cold life at 43ºC; however, test results will be considered. Warm life to be tested at a -20ºC ambient environment while maintaining a vaccine storage temperature within range of 5º to 0.5ºC. No target set; however, test results will be considered. Freeze protection: No part of the vaccine load can reach 0ºC in either cold or warm life tests. Note: products that require recharging during cold life test will not be considered. 75% Cooling system User friendly, passive systems preferred. Least cost and least environmental impact preferred. 15% External dimensions Not defined: preference for products with least space requirements 5% Features Option 1: Carrying handle. Option 2: Carrying strap. Option 3: Backpack style. Required (1 type minimum). Locks and catches Maintenance free closure. Once engaged it must not be possible for the catch to open accidentally nor for it to open if dropped. Required. IP Rating IP 56. Required. Insulation foaming agents Any gas complying with the Montreal Protocol on the elimination of ozone depleting chemicals. Required if foaming agent is used. Materials Robust, long life, waterproof, non-corrodible, and made of nonhazardous materials with minimal end-of-life disposal impacts. 5% Weight