Journal of parenteral science and technology : a publication of the Parenteral Drug Association
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To say that the FDA preapproval inspection program has generated much interest is an understatement. There have been multiple Commissioner Exchange Meetings at various locations throughout the United States and several multi-day workshops sponsored by the industry to help clarify how to prepare for this inspection. ⋯ We will then look at the general trends that we have observed either directly from the preapproval inspections we have experienced or indirectly from 483 observations from other preapproval inspections. Finally, the ten steps which are used at Eli Lilly and Company to prepare for preapproval inspections will be presented.
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J Parenter Sci Technol · Jan 1993
Studies in phlebitis. IV: Injection rate and amiodarone-induced phlebitis.
Using a rabbit ear model and techniques developed previously (1) the relationship between injection rate and injection phlebitis is investigated for amiodarone HCl and its vehicle. A number of injection rates ranging from 0.02 to 3.0 ml/min are studied using this model. ⋯ The severity of phlebitis is found to be dependent upon the injection rate for amiodarone HCl while the vehicle did not produce phlebitis at any rate. Strong correlations between the thermal measurements and visual evaluations are found for both amiodarone HCl and its vehicle.
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J Parenter Sci Technol · Jul 1992
The Water Pressure Integrity Test--a new integrity test for hydrophobic membrane filters.
Sterilizing grade hydrophobic filters are used for the sterile filtration of gases in pharmaceutical and biological applications. Until now the integrity of these membrane filters and their ability to retain bacteria, has been correlated to a solvent based nondestructive integrity test. Current methods use solvents to wet the membranes in order to perform bubble point and diffusion integrity tests. ⋯ A prime advantage of WPIT is that it may be performed in situ post sterilization without any downstream manipulations. The test has been directly correlated to the retention of bacterial challenges. Data will be provided to show the reliability and sensitivity of this easy to perform test.
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J Parenter Sci Technol · May 1990
Quantitative evaluation of the stability and delivery of interleukin-1B by infusion.
The stability and delivery of IL-1 beta has been characterized in a polypropylene based syringe pump infusion system and in polyvinyl chloride based infusion bags, at concentrations ranging from 100 ng/mL to 1 microgram/mL. At higher concentrations (1 microgram/mL), minimal drug loss was observed in both systems. At low doses (100 ng/mL) in the syringe-pump system, the addition of 1% human serum albumin was necessary to prevent significant drug absorption to the polypropylene drug reservoir.