Outer Packaging Research Articles

HIV and STD prevention update. Alternatives to the male condom.

In 1993 the US Food and Drug Administration approved Reality a female condom as a contraceptive and a means to prevent transmission of disease. Reality is a lubricated polyurethane sheath that can be inserted as many as 8 hours before intercourse and is secured with an internal and an external ring. In the US the product is marketed over the counter for approximately $9 for a box of 3 and it is targeted to women aged 18-30. While the outer package claims that Reality can help prevent pregnancy and disease transmission the package insert notes that it was only tested in vivo during development for its contraceptive effectiveness. A UN study however found a one-third reduction in mean incidence of sexually transmitted diseases among sex workers in Thailand who were given both male and female condoms versus the incidence among those who only had access to male condoms. Sales of the product grew 207% in 1 year and 76% of first-time users indicated that they would use Reality again. However the package insert reports that the annual pregnancy rate with Reality may be as high as 25% and is 12% with perfect use. If the condom fails to prevent pregnancy it will also fail to prevent disease. Therefore women are advised to continue to rely on the male condom and calls have been made for further testing of the female condom. Currently UN member states can purchase the female condom at greatly discounted prices for AIDS programs and large-scale shipments have been sent to Ghana Indonesia Papua New Guinea Costa Rica Zimbabwe Uganda and the Ivory Coast.

The influence of ionising radiation (Beta/gamma) on various polymers based on the result of the cytotoxicity test

Ever more frequently, manufacturers of medical devices are being questioned by official authorities regarding the possibility of radiolysis products arising when medical devices and outer packaging of pharmaceuticals are sterilised by means of radiation. The determination of the growth inhibition via the cytotoxicity test in Dubbecco's modified Eagle's medium (DMEM) with 10% fetal calf serum (FKS) makes possible a reliable prediction as to whether questionable radiolysis products arise. The result of the most diversified plastic product materials usually ised as raw material for the production of medical devices, will be presented. Furthermore, the influence of the sterilization method (Beta and Gamma [Co-60] rays) and the results of the various irradiation doses will be investigated. These results enable the manufacturers to select suitable raw materials for their medical devices prior to their production.

Patient information leaflets on over–the–counter (OTC) medicines: the manufacturer's perspective

A survey was undertaken to assess the views of the manufacturers of over-the-counter (OTC) products about (i) the value of patient information leaflets (PILs), (ii) the recent European Community directive relating to PILs and (iii) the procedures which are in place for producing and testing PILs. Although approximately half (15/31) of the respondents (response rate 31/58) thought that PILs were more important for OTC than prescription only medicines, this view was not unanimous. A majority (18/28) thought that the new EC directive would provide too much information to patients although only a small number (2/27) thought that the regulations were unnecessary. Indication for the product was thought to be the most important information for the immediate outer packaging. Only about one-third (35%) of patients are thought to read PILs, in contrast to the majority who read the outer packaging. A wide variety of departments contribute to preparing PILs. The marketing department had a major input particularly with respect to layout and testing of leaflets. On the whole the design and production of PILs involves considerable effort but their testing appears less structured and thorough.

GRACE: the problem specification stage. II

In this paper we continue and complete the description of the problem specification stage of the Graphical R-matrix Atomic Collision Environment (G RACE). In particular we describe that part of the graphical user interface which controls the construction and editing of the input data required by a new outer region package FA RM. The corresponding event-driven software system, which can be used as a stand alone GUI for FA RM, is also published and described.

電気亜鉛めっき鋼板のはんだ性に及ぼす後処理の影響

Steels electroplated with Pb-Sn alloys are generally used as a solderable outer package materials for electrical machinery. Solderable electrogalvanized steels have been developed as a replacement of such steels.This paper reports various post-treatments for electrogalvanized steel that resulted in both good solderability and good corrosion resistance, and the soldering mechanism is discussed. A large number of post-treatment solutions containing surfactants, waxes and corrosion inhibitors were prepared and coated on the steel. The addition of a styrene-maleic acid copolymer and a wax to a post-treatment solution that contained a phosphoric acid ester and CrO3 increased corrosion resistance without decreasing solderability.In terms of the soldering mechanism, it is assumed that the Zn layer elutes into the soldering bath so that while small amount of zinc remains in the layer, the major portion is concentrated on the solder surface.

Nosocomial epidemic of Serratia marcescens septicemia ascribed to contaminated blood transfusion bags

Two cases of transfusion-related Serratia marcescens bacteremia prompted extensive epidemiologic investigations in three independent hospitals. Test tubes and plasma from donors whose blood was drawn into bags from a single production batch were cultured. Analysis of the ribotype of S. marcescens isolates was performed. For comparison, a strain from the production plant and eight other, unrelated bacteremia isolates were examined. In addition, a retrospective national survey was carried out. S. marcescens was cultured from 11 (0.73%) of 1515 blood units, and an additional (third) bacteremic patient was identified. The clinical isolates from three patients, the three units of blood transfused, and the plant-derived strain shared a unique ribotype. The incident is interpreted as a sporadic, bacterial contamination of blood bags with the S. marcescens epidemic strain, occurring during the manufacturing or packaging. A similar incident has not previously been reported. Attention is drawn to the possibility of significant contamination during the complex production of multiple-bag blood collection systems. Guidelines for improved registration and handling of transfusion complications in wards are suggested. Manufacturers should be encouraged to provide blood packs with sterile exteriors, in appropriate, single, outer packages.

Safety Testing and Evaluation of Radioactive Material Transport Packages

These tests adopt the packaging test programme of the IAEA's Type A packaging standard, including the water spray, free drop, puncture and stacking tests. The results of the tests on radioactive material packages under normal transport conditions show that the most frequent damage is indentation occurring at a rate of 36.7%. Splitting the outer shell is second at 6.6%, punctures occur at 4.3%, while the least frequent is deformation and breakage of the outer packaging. The total damage rate is 49.4%. The most serious cause of damage is perforation, causing 40% of cases. At the same time an on-the-spot investigation was made into the in-service damage occurrences. This showed that de-hooping of package casks was as high as 1.7% and the occurrence of splitting was 0.4%. There are few cases of holing and breaking. The total in-service damage rate was 2.2%.

Long-Term Isolation of High-Level Radioactive Waste in Salt Repositories Containing Brine

At present, only one concept, the Swedish design utilizing a thick-walled copper waste package, has been accepted as being capable of isolating high-level waste for hundreds of thousands of years in a granite-type repository.Theoretical arguments show that after the relatively short times required for salt consolidation selfshielded thin-walled copper waste packages have no significant failure or degradation reactions in anoxic neutral and acid brines.Thermodynamic analyses of reactions after consolidation (constant-volume reactions under lithostatic pressures in the absence of oxygen) show that miniscule amounts of metal reacting with brine can produce very large hydrogen pressures. For copper waste packages, almost no consumption of copper is required to produce the small equilibrium hydrogen pressure needed to prevent reaction. Reaction under these conditions no longer depends on poorly understood corrosion mechanisms, but results from hypothetical mechanisms that allow the equilibrium hydrogen to migrate away from the waste package.Analyses of gamma radiolysis and diffusion processes show that in an array of thousands of waste packages removal of hydrogen from the outer packages should be negligible for a properly selected salt repository.