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Effect of high-barrier packaging films with different oxygen transmission rates on the growth of Lactobacillus sp. on meat fillets.

The goal of this study was to determine the combined effect of (i) the oxygen transmission rate (OTR) of packaging film, often called oxygen film permeability or film permeability and (ii) temperature on the growth rate of the main prevailing organism, Lactobacillus sp., in 100% CO2-packed sterile meat fillets. Multifactorial experiments were designed to study the effect of OTR and temperature (0, 5, 8, and 10 degrees C) on the growth rate of Lactobacillus sp. inoculated on sterile meat fillets under 100% CO2 and aerobic conditions. The packaging conditions (air or 100% CO2) and the film OTR significantly affected the growth rate of Lactobacillus sp. only at temperatures higher than 0 degrees C. Low-permeable films with different OTRs did not affect the final population of the bacterium, but the growth rate was significantly changed. The correlation of an ephemeral microbial association with a low spoilage potential (e.g., lactic acid bacteria) or their growth retardation cannot always be assumed unless other determinants (e.g., OTR) of equal importance are taken into account. The present study provides information that can be of benefit to industry and the consumer.

Animals↗

Survival of Staphylococcus aureus and Listeria monocytogenes on vacuum-packaged beef jerky and related products stored at 21 degrees C.

In the manufacture of beef jerky, a thermal lethality step is followed by drying to prevent growth of pathogenic bacterial postprocessing contaminants on the finished product. Recent guidelines from the U.S. Department of Agriculture have raised the question of the maximum water activity (a(w)) in jerky products that will inhibit growth of pathogenic bacteria. The survival of the potential postprocessing contaminants Staphylococcus aureus and Listeria monocytogenes was evaluated on 15 vacuum-packaged beef jerky and related products with a(w) values ranging from 0.47 to 0.87, just below the 0.88 limit reported for anaerobic growth of S. aureus. Small individual product pieces were inoculated on the outer surface with five strains each of S. aureus and L. monocytogenes, repackaged under vacuum, and stored at room temperature (21 degrees C) for 4 weeks. Pathogen numbers were determined before storage and after 1 and 4 weeks. None of the 15 jerky products supported growth of either pathogen. Counts of S. aureus fell by 0.2 to 1.8 log CFU after 1 week of storage and by 0.6 to 5.3 log CFU after 4 weeks of storage. Numbers of L. monocytogenes fell by 0.6 to 4.7 log CFU and by 2.3 to 5.6 log CFU after 1 and 4 weeks of storage, respectively. Although factors other than a(w) may have some effect on pathogen survival, the results of the present study clearly support drying beef jerky to an a(w) of < or = 0.87 to ensure that bacterial pathogens cannot grow on vacuum-packaged product stored at room temperature.

Animals↗

Parenteral packaging waste reduction.

The consumption of pharmaceutical products generates waste materials which can cause significant environmental impact when incinerated or landfilled. The purpose of this work is to stimulate discussion among hospital pharmacists and purchasing managers relating to the waste management aspects of their purchasing decisions. As a case study example, a number of commercially available "single use" parenterals are evaluated from a waste reduction perspective, for both the product container and for the packaging of these containers. Glass vials are non-incinerable, and are currently non-recyclable due to the higher melting temperatures required for borosilicate glass. However, plastic vials are potentially both incinerable and recyclable. Packaging quantities are considerably lower for plastic vials on a unit container basis, and also vary to a measurable degree between different manufacturers for a given type of container material. From an environmental perspective, waste reduction potential should become an important criterion in the selection of pharmaceutical products for hospital use.

Drug Packaging↗

Packaging legislation. Objectives and consequences.

The recently published Directive on packaging and packaging waste makes new demands on the industry. This article highlights the key areas and raises some of the issues that must be confronted in the future.

Equipment and Supplies↗

Market report. Packaging.

Medical Device Technology's second annual packaging study looks at the materials and methods used by its readers throughout Europe. Rises in the level of use of some materials and certain packaging requirements are indicated and subcontracting shows increased demand.

Equipment and Supplies↗

Advances in medical packaging.

The specialist medical packaging sector is in a period of change. Product innovations, new manufacturing methods, and increasingly stringent demands are the features of today. Aside from the evolving requirements of medical device manufacturers, the driving forces for change are prompted by new packaging legislation, environmental pressures, and, above all, the need to maximize cost effectiveness. The adoption of new production processes and products looks set to increase.

Equipment and Supplies↗

Surface analysis of packaging materials. Part I.

The surface composition and chemistry of medical device packaging can affect critical characteristics, such as biocompatibility, of the enclosed device. Seal and interface failure of packaging can threaten the long-term sterility of the devices it holds. Techniques to examine all these factors are introduced in Part I of this two-part article, with particular reference to adhesion failure and additive migration.

Equipment Safety↗

Surface analysis of packaging materials. Part II.

The surfaces of medical device packaging can affect critical characteristics of the enclosed devices, such as biocompatibility and sterility. Techniques to evaluate surface modification and contamination in packaging applications are described in the second part of this two-part article.

Equipment Contamination↗

Detecting sterilization effects on packaging.

There must be evidence to show that medical devices and their packaging are compatible with the sterilization process that is used. Here, results from analysis of some medical-grade polystyrene packaging highlight the benefits offered by current surface analysis techniques.

Durable Medical Equipment↗

Daily packaging of non standard oral unit doses for pediatrics.

A pilot project to examine the feasibility of a computerized one-day supply packaging system for non-standard pediatric oral unit doses was performed on one nursing unit over a 41-day period. The results showed a waste of 18 percent compared to 32 percent for our non-computerized three-day supply system. Technician time to prepare doses decreased from 1.45 minutes to 0.98 minutes per dose when comparing the three-day supply to the one-day supply procedure. Due to the success of the pilot project, all existing unit dose beds were converted to the new system and 81 additional beds were added to the unit dose program without increasing the volume of daily packaging compared to other years.

Canada↗

Microbial ranking of porous packaging materials (exposure chamber method), ASTM method: collaborative study.

A collaborative study involving 11 laboratories was conducted to measure the microbial barrier effectiveness of porous medical packaging. Two randomly cut samples from each of 6 commercially available porous materials and one positive and one negative control were tested by one operator in each of 11 laboratories. Microbial barrier effectiveness was measured in terms of logarithm reduction value (LRV), which reflects the log10 microbial penetration of the material being tested. The logarithm of the final concentration is subtracted from that of the initial concentration to obtain the LRV. Thus the higher the LRV, the better the barrier. Repeatability standard deviations ranged from 6.42 to 16.40; reproducibility standard deviations ranged from 15.50 to 22.70. Materials B(53), C(50), D(CT), and E(45MF) differ significantly from the positive control. The microbial ranking of porous packaging materials (exposure chamber method), ASTM method, has been adopted First Action by AOAC INTERNATIONAL.

Bacteria↗

Materials for preformed rigid-tray packages.

This article assesses the materials used for medical device packaging that employs rigid preformed trays. It lists the basic requirements for these materials and summarizes the properties of each that make them useful for specific medical-packaging applications. A cost model illustrates how to properly select materials of similar properties on a cost-per-part basis.

Equipment and Supplies↗

Medical packaging: more for less?

The market for medical devices is governed by the need to have validated products and processes, clean manufacturing environments and proven shelf-life. All this, often for products that are disposable, low-unit-cost items and, as such, highly price sensitive. This, in turn, has an impact on the businesses supplying the market. This article considers one such supply market, packaging, and the steps taken by packaging manufacturers to respond to these pressures while maintaining long-term, viable products.

Cost-Benefit Analysis↗

Packaging and the environment: a regulation update.

This article reports on the progress that is being made on standards and associated documents to support the Packaging and Packaging Waste Directive. Potential revisions are also discussed.

Environmental Pollution↗

Pharmaceutical container/closure integrity. VI: A report on the utility of liquid tracer methods for evaluating the microbial barrier properties of pharmaceutical packaging.

The relationship between a liquid tracer package leak test (Mg ion ingress) and microbial immersion challenge test was demonstrated by direct and indirect correlation techniques. Rubber-stoppered glass vials with micropipette leaks were evaluated by a helium leak rate method, filled with broth, sterilized, and immersed in a bath containing microorganisms (E. coli/B. diminuta) and liquid tracer (Mg ions). After exposure and incubation, each unit was evaluated for liquid tracer ingress by atomic absorption spectrophotometry and for microbial ingress by visual inspection and blood agar streaking. Two hundred and eighty sterile broth-filled test units were challenged with microorganisms and liquid tracer. One hundred and fourteen units showed neither liquid tracer nor microbial ingress. One hundred and eight units were positive for both microbial and liquid tracer ingress. No test units were positive for microbial ingress but not for liquid tracer ingress. Fifty-eight units were positive for liquid tracer ingress but failed to show microbial ingress. Logistical regression was used to demonstrate that the probability of liquid tracer ingress was greater than microbial ingress at all leak sizes. The results indicate that the liquid tracer method studied herein was a useful indicator of the microbial barrier properties of pharmaceutical packaging. Additionally, the results support the contention that liquid penetration of a leak is required for microbial ingress.

Drug Packaging↗

Unit dose packaging of respiratory therapy solutions.

A program of preparing respiratory therapy medications in a tamper-proof, disposable, unit dose package was developed and evaluated. Comparisons were made between the old system of dispensing respiratory therapy solutions and the new unit dose system. The evaluation indicated that: (1) personnel costs between the two systems were similar; (2) patient charges increased under the unit dose system by approximately 10 cents per dose; (3) packaging technique and controls improved under the unit dose system; and (4) medication errors were reduced.

Costs and Cost Analysis↗

Faster introduction of cost-effective packaging films.

The introduction of more cost-effective packaging is restricted by the lack of resources and time that is available for validating new materials. New techniques are being developed to shorten approval times and reduce hold-ups in benefitting from innovative packaging solutions.

Cost-Benefit Analysis↗

[A short history of patient package insert in the EU].

In recent years the Japanese general public has become increasingly aware of health matters, and many people wish to know more about the medicines they receive from doctors. This means that Japanese patients have not been given medicinal product information fully by medical professionals, whereas many European countries have already introduced patient package inserts (PPIs) with near full disclosure leaflets in understandable language in all packages of dispensed medications. This article describes a short history of PPIs in European countries, centering on the development of PPIs in Germany and Belgium. It is expected that these European experiences contribute to our country in terms of providing patients with pharmaceutical information.

Drug Information Services↗