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At least 19 recordsLinked to original sources

PubMed2003

Cold chain monitoring during cold transportation of human corneas for transplantation.

BACKGROUND: As recommended by international standards the cornea should be maintained in a specific temperature range (2 degrees -8 degrees C) to guarantee its viability. However, there is no standard packaging method to maintain these conditions during transport. Our packaging system is similar to those used by the main eye banks in Spain and elsewhere in Europe. The objective is to monitor the cold chain in the current packaging method to validate the maintenance of temperature within the adequate range for a minimum 24-hour period. METHODS: The effects of the following variables were studied: number and freezing temperature of the cold packs; air volume in the packaging system; position of the cornea in the packaging system; and the wall section of the container. Exterior temperature was maintained constant at 20 degrees to 24 degrees C. The cold chain was monitored using a device that measures temperature continuously and for which a histogram of temperature variation can be downloaded to a computer for further analysis. RESULTS: When the cold packs were frozen to -40 degrees C or the number of cold packs increased to four, the temperature decreased quickly to 0 degrees C and the transport period was not prolonged. The main objective was to improve isolation by reducing inner air volume, and maintaining the position of the cornea in the container. CONCLUSIONS: The currently used cold packaging systems (not frozen, 4 degrees C) do not maintain the temperature within the accepted range for the required distribution period. The improved system maintains the cornea at between 2 degrees C and 6 degrees C for a minimum of 24 hours.

Cornea↗

PubMedDate not supplied

Maintaining the cold chain for vaccines.

Cold chain for vaccines a is a system for storing and transporting vaccines at very low temperatures to maintain their effectiveness before use. Because vaccines are sensitive biological substances, their exposition to high temperatures directly affects the quality of vaccines and safety of immunization. The goal of this study was to assess the safety of cold chain for vaccines within the cold chain system in two services of Health Center Novi Sad. Cold Chain Monitors (CCM) and Freeze Watch (FW) indicators were used. A total of 155 (94.5%) Cold Chain Monitors (CCM) and 100 (95.2%) Freeze Watch (FW) indicators were analyzed. Only one CCM showed a breack in cold chain. A total of 3 CCMs indicated risk of vaccine wastage. A total of 9 CCMs were colorized without risk of vaccine wastage. FWs were positive in a high percentage in both services of Health Center Novi Sad. FWs were exposed to low temperatures during transport. Statistically significant differencies in the number of exposed CCMs to high temperatures and the number of exposed FWs to low temperatures were observed in these two services. A statistically significant difference in number of FWs exposed to low temperatures was observed in regard to the period of transport and the period of storage at the vaccination stations. The study shows high level of safety of the cold chain in two services of Health Center Novi Sad Cold Chain Monitor is a reliable indicator of the quality of cold chain for vaccines. Freeze Watch is a reliable indicator of the quality of cold chain during storage of vaccines, but not during their transport.

Drug Storage↗

PubMed1993

Monitoring the vaccine cold chain.

Maintaining the vaccine cold chain is an essential part of a successful immunisation programme. A continuous electronic temperature monitor helped to identify breaks in the cold chain in the community and the study led to the issue of proper guidelines and replacement of faulty equipment.

Cold Temperature↗

PubMed1993

Is the cold chain for vaccines maintained in general practice?

OBJECTIVE: To investigate the cold chain for vaccines and compliance with the local code of practice for storage. DESIGN: In a random sample of general practices orders for live vaccines (oral polio and measles, mumps, and rubella) were accompanied by a cold chain monitor which was activated on leaving the supplying pharmacy. The monitors were read at specified intervals and when all vaccines in the order had been used. Structured interview was used to check compliance with the local code of practice on storage. SETTING: West Berkshire and Aylesbury Vale district health authorities. SUBJECTS: 16 (25%) general practices in West Berkshire, and 13 (50%) in Aylesbury Vale. MAIN OUTCOME MEASURES: Compliance with code of practice. Changes in the cold chain monitor. RESULTS: For six key requirements within the code of practice compliance varied from 70% to 0%. Only 16 of 29 practices had a named person responsible for vaccine storage and only four were aware of the local code of practice. Vaccine was stored for longer and more breaks in the cold chain occurred in West Berkshire than in Aylesbury Vale. The potency of some vaccines in 10 of 26 orders became suspect before use. CONCLUSIONS: Knowledge of appropriate management of the cold chain in two districts was poor. Breaks in the chain were more frequent and compromised potency more likely when vaccine had been stored for more than eight weeks. Problems in maintaining the cold chain indicate the need for continuing audit, which should become a prerequisite for payments to general practitioners for immunisation.

Cold Temperature↗

PubMed1987

Vaccine cold-chain status in the Elim health ward of Gazankulu.

The vaccine cold-chain is a fundamental component of any immunisation programme. This study used chemical-based temperature indicators to monitor the cold-chain constantly in the Elim Hospital health ward of Gazankulu. It was found that the cold-chain was adequately maintained at the hospital, but that as vaccine travelled towards the periphery severe breaks in the cold-chain occurred. Eighteen per cent of vaccines at the Elim Hospital store and up to 90% at the periphery were potentially exposed to temperatures high enough and for a sufficient length of time to have affected their potency. More emphasis needs to be placed on maintaining the cold-chain if we are to reach to EPI's goal of immunisation for all children by the year 1990.

Cold Temperature↗

PubMedDate not supplied

Evaluation of cold chain system in Chandigarh during PPI campaign 2001-2002.

OBJECTIVE: To evaluate the maintenance of cold chain system (CCS) in intensified pulse polio immunization (IPPI) programme, during December 2001 and January 2002 in Union Territory (UT) Chandigarh. MATERIALS & METHODS: A Cross sectional time bound study was conducted in seven centres, where OPV vials were stored prior to IPPI and 20 IPPI Booths in UT, Chandigarh. Booths were selected by stratified random sampling technique. The status of cold chain equipments was assessed at headquarter of IPPI, 6 regional (distribution) centres, 20 IPPI posts and 5 house to house teams. RESULTS: The cold chain sickness rate was found to be 9.7% in January, 2002. There were reports of breakdown of cold chain maintenance due to defective plugs and sockets, faults in thermostat, leakage of gas. But all vaccine samples picked up randomly were reported potent, as per the test reports provided by Central Research Institute (CRI), Kasauli during the period of study. OBSERVATION & DISCUSSION: Temperature charting and cold chain maintenance was found satisfactory, but necessity of improvement, specially regarding the handling of vaccines by the female health worker. Lids of vaccine carriers not closed tightly, frequent opening of lids during immunization, direct exposure of vaccine to atmospheric temperature, keeping the vaccine vial in hand or pocket. More emphasis is to be given on maintenance of cold chain system in orientation training programme of all Health functionaries before the Intensified Pulse Polio Immunization (IPPI) programme.

Cryopreservation↗

PubMed2000

Cold chain status at immunisation centres in Ethiopia.

BACKGROUND: Child immunisation is among the most cost-effective ways of preventing premature child deaths, and the potency of vaccines, crucial for vaccine efficacy, is dependent on effective management of the cold chain at all levels of vaccine handling. OBJECTIVE: To assess the status of the cold chain at peripheral vaccine stores in Ethiopia. DESIGN: Institution based cross-sectional survey in two rural and one urban administrative areas were included in the study. Sixty seven health institutions providing static vaccination services were included in the study but cold chain system was assessed fully in only sixty four. Data were collected by interviewing health workers and by directly observing the cold chain equipment and records using structured forms. RESULTS: Conditions of the cold chain system were described based on 64 of the 67 centres visited, three were excluded because of non-functioning cold chain. Complete temperature record was observed in 37 (57.8%) of the centres. Thermometer was not available in four (6.3%) and thermometer reading was found to be outside the optimal range in another seven (10.9%) centres. Vaccine storage in the refrigerator was not proper in 47 (73.4%) centres. Majority of the centres had neither trained personnel nor budget for maintenance of the cold chain. CONCLUSION: There is a real danger of vaccines losing their potency at these centres even if they were potent on arrival. Relevant training for those handling the cold chain, improving the maintenance conditions of refrigerators and introduction of cold chain monitoring devises are recommended.

Drug Storage↗

PubMed2001

[Technical problems associated with the cold chain].

After having covered the current status of the cold chain in France, the author highlights the economic impact of refrigerated storage and processing involving refrigeration. Lose reduction is such that the return on investments is estimated as being roughly 3 years. In years to come, progress will be achieved in the field of plant design. Some information on design trends is provided. Operators in general, and carriers in particular, are faced with an increasingly complex regulatory framework leading to a competition imbalance. The current cold chain developmental trend is characterized by complex computer management of logistics: the flow of goods is modulated in order to meet the production to the distribution needs as cost effectively as possible. This logistic strategy enables management of downstream to upstream interfaces involving various operators. Finally, the author indicates the main causes of non-compliance with the cold chain, generally at retail and consumer levels.

France↗

PubMedDate not supplied

[Evaluation of the cold chain during the national antipoliomyelitis vaccination days. Mexico, 1987-1988].

An evaluation of the cold chain used during the "National Vaccination Days Against Poliomyelitis" in January and March of 1987 and 1988 was performed in 32 states of Mexico, both the potency of the trivalent Sabin vaccine and completion of requirements for the maintenance of the cold chain were evaluated at each level in the Ministry of Health's structure. Only 56 percent of the refrigeration units exclusively stored vaccines, more than 10 percent of refrigerators were broken, and 44 percent of the persons responsible for the cold chain system considered the storage capacity inadequate. A correlation was found between non-fulfillment of maintenance requirements for cold chain and a decreased in vaccine potency.

Drug Stability↗

PubMedDate not supplied

An evaluation of cold chain system for vaccines in Bangalore.

The cold chain plays a major role in the universal immunization programme which helps in preventing against six major killer diseases in children. We collected 144 study samples randomly from different parts of Bangalore to know the training status of personnel, refrigeration facilities, storage, monitoring and potency of vaccines. It was observed that 6.6% of general practitioners were trained under Universal Immunization Programme, monitoring was not satisfactory, and two of the OPV samples from medical practitioners had an unsatisfactory titre dose. Comprehensive orientation/training on cold chain is essential for medical practitioners and other professionals.

Cold Temperature↗

PubMed2006

Monitoring temperatures in the vaccine cold chain in Bolivia.

This study monitored vaccine cold chain temperatures during routine DTP-HB-Hib vaccine shipments from central stores to 11 communities in 3 provinces of Bolivia. In all 11 monitored shipments, vaccines were exposed to freezing temperatures at one or more points. In each of the shipments, temperatures below 0 degrees C were recorded for 2-50% of the monitoring period. Freezing occurred at almost every level of the cold chain distribution system, especially during district and health center storage and during transport to the province and district levels. Seven of the 11 shipments were exposed to temperatures above 8 degrees C, although none were exposed to excessive heat longer than 1.3% of the total monitoring period.

Bolivia↗

PubMed1995

An evaluation of cold chain in Maharashtra & Karnataka states by potency testing of field samples of oral poliovirus vaccine.

The cold chain for oral poliovirus vaccine was monitored in Maharashtra and Karnataka by potency testing of vaccine vials collected from various stages of the delivery system. Results showed that cold chain maintenance improved in the state of Maharashtra within a period of three years as the monitoring began in 1987. Of the 6289 samples of trivalent OPV collected from all 30 districts of the state during 1990 to 1992, 5834 (92.8%) had retained virus titre of at least 10(5.81) TCID50/dose. In comparison, 72 per cent of the 1660 samples collected from the state of Karnataka during the same period were found to contain this minimum required virus titre. Defects in cold chain maintenance in Karnataka could be demonstrated by plotting virus titre of samples of individual batches collected from different outlets. It was concluded that potency retesting of OPV samples for cold chain monitoring will ensure proper storage, transport and use of potent vaccine in the field.

Cryopreservation↗

PubMed1990

Transport and storage of vaccines in Hungary: the first cold chain monitor study in Europe.

With assistance from WHO the Hungarian Ministry of Health organized two cold chain studies: the first in three counties in summer (1 July to 30 September 1987), the second in six counties (including the previous three) in winter (1 January to 31 March 1988). The counties were chosen according to their distance (50-300 km) from Budapest, individual districts and child health centres being selected randomly. All participants were trained before beginning the studies. The vaccines (DPT, measles and BCG) for immunization, with attached cold chain monitors, were transported from the manufacturers to the child health centres using the normal distribution systems in the country. The whole cold chain process was analysed with regard to (1) actual exposures to adverse temperatures and delays in distribution; (2) the places where such exposure or delay occurred; (3) the percentage of vaccines at risk of deterioration (actual and predicted) at the end of the study; and (4) the performance of refrigerators of different types. Evaluation of the results (using WHO's EPIC software) showed significant deviations from acceptable standards. This first cold chain study in a European country proves that even in a temperate climate and with a reasonably well-organized public health service there can be significant weaknesses in the transportation and storage of vaccines. Recommendations to overcome these deficiencies are given.

Drug Storage↗

PubMed1995

Evaluation of cold chain system in rural areas of Haryana.

Evaluation of cold chain system was done in a time bound study during August and September months of 1992 in two districts of Haryana as there were frequent breakdowns of icelined refrigerators during the previous year. The study revealed that defective stabilizers and electricity plugs and sockets were the reason of breakdown in many cases. Temperature maintenance and functioning of deep freezers was satisfactory. Retrospective analysis showed that the polio vaccine samples picked up during 1990-92 were found to be satisfactory by CRI, Kasauli. Use of two ice-pick carrier and thermos flasks was associated with poor temperature maintenance. Seven vaccine carriers out of 25 examined had cracked wall lining. Lids of carriers were also not kept tight during vaccination sessions. Response lag of the health workers and medical officers in case of breakdowns was delayed. A one day refresher course exclusively on cold chain maintenance at community health centre level is recommended.

Drug Storage↗

PubMed1999

At-birth immunisation against hepatitis B using a novel pre-filled immunisation device stored outside the cold chain.

We evaluated the immunogenicity of hepatitis B (HB) vaccine in UniJect, a pre-filled, non-reusable injection device, stored at tropical temperatures for up to one month and used to give the first dose of HB vaccine to newborns. Infants in Tabanan district, Bali, Indonesia, were given their first dose of HB vaccine with UniJect stored out of the cold chain, UniJect stored in the cold chain; or standard syringe, needle and multidose vial stored in the cold chain. Subsequent doses were given by usual means and blood samples drawn 4-6 weeks after the third dose. No significant differences were found in seroconversion rates or geometric mean titres of HB surface antibody between the three groups.

Cold Temperature↗

PubMedDate not supplied

Andhra Pradesh cold chain system marching beyond routine to obtain WHO accreditation.

The GOAP-PATH partnership project provided an opportunity to carryout situational analysis of the cold chain system in the State of Andhra Pradesh. Apart from identifying areas of work many quality issues like freezing of vaccine were brought to light, which lead to development of a comprehensive plan of action for total overhauling of cold chain system. Introduction of new technologies, training, infrastructure and software development has reformed the cold chain system. The EVSM (Effective vaccine stores management initiative) self assessment was done recently for the Central vaccine stores at Hyderabad and the results of this self assessment has raised the confidence of health personnel to aim for WHO, EVSM accreditation for central vaccine store at Hyderabad.

Accreditation↗

PubMed1996

Evaluation of cold chain monitoring in Kelantan, Malaysia.

An analysis was carried out on a total of 883 cold chain monitor (CCM) cards, which had been attached to batches of poliomyelitis, measles, DPT (diphtheria, pertussis, tetanus) and hepatitis B vaccines, during their transport and storage from the central store in Kuala Lumpur to Kelantan, a state in north-eastern Malaysia; 234 freeze watches attached to hepatitis B vaccines were also analysed. The monitor cards and freeze watches were observed at six levels between the central store and the periphery during distribution of the vaccines, and a colour change in any of the four windows (A, B, C, D) on the CCM cards or the freeze watches was recorded. In addition, 33 unopened vials of oral poliovirus vaccine (OPV), collected from refrigerators in 29 health facilities in Kelantan, were tested for potency using the tissue culture infective dose 50 (TCID50) method; 14 of them (42%) did not meet the WHO criteria for potent vaccines. The results showed that at the final destination 13.4% of all cards remained white while a colour change to blue was observed in 65% in window A, 16.6% in window B, and 4.4% in window C; none had turned blue in window D indicating that the vaccine had not been subjected to temperatures > or = 34 degrees C for 2 hours. All but 2 of the 234 freeze watches had turned purple, which indicates exposure of the hepatitis B vaccines to temperatures below 0 degree C. These results will assist health planners to correct the weaknesses identified in the cold chain system.

Cold Temperature↗

PubMed2004

Hepatitis B vaccine freezing in the Indonesian cold chain: evidence and solutions.

OBJECTIVES: To document and characterize freezing temperatures in the Indonesian vaccine cold chain and to evaluate the feasibility of changes designed to reduce the occurrence of freezing. METHODS: Data loggers were used to measure temperatures of shipments of hepatitis B vaccine from manufacturer to point of use. Baseline conditions and three intervention phases were monitored. During each of the intervention phases, vaccines were removed progressively from the standard 2-8 degrees C cold chain. FINDINGS: Freezing temperatures were recorded in 75% of baseline shipments. The highest rates of freezing occurred during transport from province to district, storage in district-level ice-lined refrigerators, and storage in refrigerators in health centres. Interventions reduced freezing, without excessive heat exposure. CONCLUSIONS: Inadvertent freezing of freeze-sensitive vaccines is widespread in Indonesia. Simple strategies exist to reduce freezing - for example, selective transport and storage of vaccines at ambient temperatures. The use of vaccine vial monitors reduces the risk associated with heat-damaged vaccines in these scenarios. Policy changes that allow limited storage of freeze-sensitive vaccines at temperatures >2-8 degrees C would enable flexible vaccine distribution strategies that could reduce vaccine freezing, reduce costs, and increase capacity.

Cold Temperature↗