PubMed · 7273742
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D S Jolliffe. 1981. A patch test reagent storage cabinet.. https://doi.org/10.1111/j.1600-0536.1981.tb04612.x
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The storage requirements for parenteral products vary with the characteristics of the medication in the product. Temperature, light, moisture, pH, composition of the container, type of infusion fluid, and exposure to other chemical substances are the major determinants of the stability of parenteral medication stored in the patient's home.
PURPOSE: Protein aggregates are thought to be involved in the immunogenicity of recombinant proteins in humans. To probe human IFN-alpha formulations for the presence of soluble protein aggregates, enzyme-linked immunosorbent assays (ELISA) were developed. METHODS: For the detection of IFN-alpha-IFN-alpha and HSA-IFN-alpha aggregates, sandwich ELISAs were developed using a monoclonal anti-IFN-alpha antibody as a capture antibody and the same anti-IFN-alpha antibody and an anti-human serum albumin (HSA) antibody (HRP-labeled), respectively. RESULTS: Marketed freeze-dried, HSA-containing IFN-alpha-formulations tested in the ELISAs all contained IFN-alpha-IFN-alpha and/or HSA-IFN-alpha protein aggregates, although in varying amounts. These aggregates were predominantly IFN-alpha dimers and 1:1 conjugates of HSA with IFN-alpha. Test formulations revealed that aggregation of IFN-alpha was strongly affected by the presence of pharmaceutical excipients, pH of the formulation, lyophilisation procedure, and storage temperature and time. CONCLUSIONS: The ELISAs are rapid, highly specific for aggregates in the presence of both IFN-alpha and HSA monomers and allow the direct detection of both types of aggregates in formulations in the nanogram range. The new assays will assist the monitoring of the aggregate-inducing processes during IFN-alpha formulation and storage in an early phase and the development of aggregate-free IFN-alpha formulations.
OBJECTIVE: To study the integrity of EPI vaccine storage during interruptions to the power supply. SETTING: Health centres in Colombo District. METHOD: An interviewer-administered questionnaire was used to collect information on staff compliance with regulations of the expanded program of immunisation (EPI) and alternative facilities available for refrigeration during power failure. The refrigerator and storage conditions were inspected. The stored vaccines were tagged with thermosensitive cold chain monitors, which were read on revisiting the clinic 14 days later. During the study period, power cuts of 2 hours' duration were in force daily. A control study was carried out when there was no interruption to power supply. RESULTS: Diphtheria-pertussis-tetanus (DPT) and measles vaccines had been exposed to temperatures outside the prescribed range during power cuts. Oral polio vaccine had adequate storage with power cuts of 2 hours' duration. CONCLUSION: Alternative facilities for vaccine storage during power cuts were not available and the potency of DPT and measles vaccines were compromised with interruptions to power of 2 hours' duration or more.