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At least 523 records · Page 29Linked to original sources
PubMed1981

Prescription drug products; patient package insert requirements--Food and Drug Administration. Final rule.

The Food and Drug Administration(FDA) is amending its patient package insert regulations to make the distribution requirements for patient package inserts for drug products in unit-of-use containers the same as the requirements for products in bulk containers. The agency is also amending its antibiotic drug regulations to permit manufacturers and distributors of antibiotics to make changes in labeling to comply with the patient package insert regulations without advance approval by FDA. This action will conform the requirements for implementing FDA's patient package insert regulations for antibiotics to the requirements currently applicable to the other drugs in the program.

Drug Labeling↗
PubMed1991

Kinetics of water sorption in packaging materials for food.

The water content of paper and its time dependence are of great importance for the use of paper and cardboard as packaging materials. The physical process of water sorption and the mechanisms of water "binding" in paper, as fundamental principles of the kinetics, are discussed. Water exists in up to four different "states" (i.e. domains of mobility) in paper: the first layer at the primary sites on the surface of the fibers; the multimolecular layers, with less "binding" energy, on these inner surfaces; condensed water in the voids; and dissolved water in the cellulose fibers. All these "states" influence the shape of the sorption isotherm and correspond to a different water content and to different transport mechanisms. The various types of water "binding" on paper were studied by measuring the transversal relaxation rate, T2, using a pulsed Nuclear Magnetic Resonance spectrometer (minispec pc 120). In addition, a non-destructive, fast method of determining the water content in packaging materials with NMR spectroscopy is described.

Adsorption↗
PubMed1982

Prescription drug products; revocation of patient package insert requirements--Food and Drug Administration. Final rule.

The Food and Drug Administration (FDA) is revoking its final rule establishing requirements for the preparation and distribution of patient package inserts (PPI's) for prescription drug products for human use. This action is taken because the agency has determined that a mandatory pilot PPI program is unjustifiable, and that it is now preferable to encourage alternative patient information efforts. The agency believes that cooperation with health professionals and others in both the public and private sectors and reliance upon expanding privately sponsored initiatives in patient education should serve to provide patients with needed information about prescription drugs.

Drug Labeling↗
PubMed2006

Food contamination with organic materials in perspective: packaging materials as the largest and least controlled source? A view focusing on the European situation.

The comparison of the various sources of food contamination with organic chemicals suggests that in the public, but also among experts, the perception of risk is often distorted. Firstly, neither pesticides nor environmental pollutants contribute the most; the amount of material migrating from food packaging into food may well be 100 times higher. Secondly, control of these large migrants is often lagging behind the standards set up for other sources, since many of the components (particularly those not being "starting materials") have not been identified and, thus, not toxicologically evaluated. Finally, attitudes towards different types of food contaminants are divergent, also reflected by the legal measures: for most sources of food contamination there are strict rules calling for minimization, whereas the European packaging industry has even requested a further increase in the tolerance to as close as possible to the limit set by the toxicologists. This paper calls for a more realistic perception and more coherent legal measures-and improvements in the control of migration from packaging material.

Europe↗
PubMed2006

Nutritional information about sodium: is it worth its salt?

This study examined whether members of the general public were able to accurately interpret the nutritional information regarding salt on the packaging of food products. 226 participants answered brief questions about their salt intake awareness and were asked to estimate the salt content of a food product, using the nutritional information panel on the packaging as required. Results indicated that most participants did not know how to interpret the nutritional information, and that many underestimated the salt content of the product by confusing it with sodium content. This finding suggests that the sodium information on packaged foods in New Zealand is not easily understood by the target population, and is therefore of little use in its current form.

Adult↗
PubMed1996

Theoretical treatment of pollutant transfer in a finite volume of food from a polymer packaging made of a recycled film and a functional barrier.

The problem of pollutant transfer in food from a polymer packaging made of a recycled film and a functional barrier is studied from a theoretical point of view. In the present case, the process is controlled by Fickian diffusion through the two films of the polymer packaging in perfect contact and by convection into the food. A numerical model is built, taking all the facts into account: the diffusion of the pollutant through the two polymer films, a convective coefficient of mass transfer on the surface, a partition factor, the volume of the liquid and the thicknesses of the polymer films. The results are expressed by using dimensionless numbers so that they can be used for various cases, viz the kinetics of pollutant transferred into the food and the profiles of concentration of the pollutant through the packaging.

Diffusion↗
PubMed2005

Test method for measuring non-visible set-off from inks and lacquers on the food-contact surface of printed packaging materials.

The main objective was to develop a technique to expose spots of invisible set-off of inks and lacquers on the food-contact surface of food-packaging materials. Set-off is the unintentional transfer of components of printing inks from the outer printed surface onto the food-contact surfaces. The target sensitivity was 20 microg cm(-2) and the technique should be capable of examining large areas of printed substrate for no more than 4% coverage by set-off. These requirements equate to an ability to detect a worst-case migration potential of less than 50 microg kg(-1). Other objectives were the industrial requirements that the equipment should be inexpensive, should be easy to use by existing personnel and should preferably be non-destructive with a clear criterion for pass or fail. The approaches investigated included chemical analysis of solvent extracts, Fourier-transform infrared spectroscopy and microbeam analytical techniques, but these were found to be cumbersome and had only limited success. The objectives were achieved using an optical approach to excite and observe luminescence from invisible set-off. In model experiments, resins were applied to different substrates (plastic, paper and cartonboard). For a given resin on a given material, the key to success was to maximize the discrimination between the luminescence from the resin and that from the substrate by selecting the optimal combination of exciting wavelength and viewing goggles with selective wavelength filters. The required level of detection (20 microg cm(-2)) was achieved or exceeded for all ten resins tested on three different plastics. It was also achieved for two different papers and in all but four cases of the resins on three different cartonboards. Quantitation was achieved by the use of a calibration palette prepared using different quantities of resin spotted onto the relevant blank packaging material.

Electron Probe Microanalysis↗
PubMed2002

Active and intelligent packaging: applications and regulatory aspects.

Changes in the way foods are produced, distributed, stored and retailed, reflecting the continuing increase in consumer demands for improved quality and extended shelf-life for packaged foods, are placing ever-greater demands on the performance of food packaging. Consumers want to be assured that the packaging is fulfilling its function of protecting the integrity, quality, freshness and safety of foods. To provide this assurance and help improve the performance of the packaging, innovative active and intelligent packaging concepts are being developed and applied in various countries. In Europe, however, the development and application of active and intelligent packaging systems have been limited thus far. The main reasons are legislative restrictions and a lack of knowledge about consumer acceptance, the efficacy of such systems, and the economic and environmental impact they may have. Therefore, in 1999, a European study was started within the framework of the EU FAIR R&D programme. It aims to initiate amendments to European legislation for food-contact materials to establish and implement active and intelligent systems within the current relevant regulations for packaged food in Europe. This paper presents an overview of existing active and intelligent systems and their current and future food-related applications. In addition, developments and trends in active and intelligent food packaging are discussed. The objectives and the work programme of the European project are reviewed and the results obtained so far are presented. The benefits for both the European consumer and the European food and food-packaging industries are highlighted.

Europe↗
PubMed2005

Multisensor system for characterization of packaging emissions: prediction of total solvent amount and odor scores.

This work shows a fast and economic screening of packaging materials for food using a multisensor system. The multisensor system comprises a sampling system (in most cases a headspace sampler), a sensor array, and operation and evaluation electronics. The added value of the inclusion in the sampling system of a separation unit (e.g., chromatographic column) was proved for two different cases. The first is the elimination of a major interfering gas (e.g., water vapor); this was achieved with a short packed polar column that separated water vapor and organic solvents into two peaks. The second case is the extension of the correlation capability to human sensory panels. This was made possible by the use of a long capillary column that separates the high-concentration solvent components, which might not have a strong odorous effect, from the trace odorous ones. The latter are thus detected due to the high sensitivity of the sensor array.

Food Packaging↗
PubMed2004

A pilot study of routine quality control of sampling by the SAD method, applied to packaged and bulk foods.

A recently proposed method of looking at sampling uncertainty has been tested by its application to the sampling and analysis of several types of food and an animal feedstuff. In this 'SAD' method, increments comprising the conventional sample (that is, collected in the fashion prescribed by the standard sampling protocol) are allocated to either of two equal sized 'splits', which are prepared and analysed separately. The absolute difference between the analytical results for the two splits (the split absolute difference, or SAD) is plotted on a one-sided control chart. A non-compliance indicates that the combined uncertainty of sampling or analysis is larger than expected and the result of the measurement (the mean of the two split results) is possibly not fit for purpose. In addition, the SAD results give rise to a rugged estimate the uncertainty associated with the sampling protocol, often a major part of the total measurement uncertainty.

Animals↗
PubMed2004

Explorative multivariate analyses of 16S rRNA gene data from microbial communities in modified-atmosphere-packed salmon and coalfish.

Modified-atmosphere packaging (MAP) of foods in combination with low-temperature storage extends product shelf life by limiting microbial growth. We investigated the microbial biodiversity of MAP salmon and coalfish by using an explorative approach and analyzing both the total amounts of bacteria and the microbial group composition (both aerobic and anaerobic bacteria). Real-time PCR analyses revealed a surprisingly large difference in the microbial loads for the different fish samples. The microbial composition was determined by examining partial 16S rRNA gene sequences from 180 bacterial isolates, as well as by performing terminal restriction fragment length polymorphism analysis and cloning 92 sequences from PCR products of DNA directly retrieved from the fish matrix. Twenty different bacterial groups were identified. Partial least-squares (PLS) regression was used to relate the major groups of bacteria identified to the fish matrix and storage time. A strong association of coalfish with Photobacterium phosphoreum was observed. Brochothrix spp. and Carnobacterium spp., on the other hand, were associated with salmon. These bacteria dominated the fish matrixes after a storage period. Twelve Carnobacterium isolates were identified as either Carnobacterium piscicola (five isolates) or Carnobacterium divergens (seven isolates), while the eight Brochothrix isolates were identified as Brochothrix thermosphacta by full-length 16S rRNA gene sequencing. Principal-component analyses and PLS analysis of the growth characteristics (with 49 different substrates) showed that C. piscicola had distinct substrate requirements, while the requirements of B. thermosphacta and C. piscicola were quite divergent. In conclusion, our explorative multivariate approach gave a picture of the total microbial biodiversity in MAP fish that was more comprehensive than the picture that could be obtained previously. Such information is crucial in controlled food production when, for example, the hazard analysis of critical control points principle is used.

Animals↗
PubMed1999

Efficacy of oxonia active against selected spore formers.

Alternatives to hydrogen peroxide are being sought for use in aseptic packaging systems because this sterilant is efficacious at temperatures higher than some of the newer packaging materials can tolerate. Earlier in this century, peracetic acid was known to be bactericidal, sporicidal, and virucidal but was not widely used because of handling, toxicity, and stability problems. Sanitizer suppliers have capitalized on the efficacy of hydrogen peroxide, acetic acid, and peracetic acid stabilized with a sequestering agent. Formulations have been improved and marketed as Oxonia Active, and its use as an alternative sterilant to hydrogen peroxide merits evaluation. Oxonia was assessed at a concentration of 2% and a temperature of 40 degrees C against a number of spore-forming organisms, including foodborne pathogens. Spores tested in aqueous suspension showed an order of sensitivity (least to greatest) to Oxonia as follows: Bacillus cereus > B. subtilis A > B. stearothermophilus > B. subtilis var. globigii > B. coagulans > Clostridium sporogenes (PA3679) > C. butyricum > C. botulinum type B (nonproteolytic) > C. botulinum type B (proteolytic) = C. botulinum type A = C. botulinum type E. B. subtilis A and B. stearothermophilus spores tested in the dry state were less sensitive to Oxonia than when tested in aqueous suspension. B. cereus, a foodborne pathogen, proved to be markedly less sensitive to Oxonia under the described test conditions. The decreased sensitivity to Oxonia by the foodborne pathogen B. cereus raises concern about the efficacy of the sterilant for aseptic packaging of low-acid foods. Further work will be needed to determine if this decreased sensitivity is an inherent property of the organism that affords unusual protection against Oxonia or if the challenge parameters selected were at the minimum conditions for efficacy.

Acetates↗
PubMed2001

An ABAC comparison of two intensive interventions for food refusal.

An ABAC comparison of two treatment packages for food refusal, physical guidance and nonremoval of the spoon, was conducted with two children with limited food acceptance. Both of these treatment packages included prevention of escape from presented food. Subsequent to baseline, one of the two treatment packages was implemented for each child. The treatment packages were implemented ABAC for one child and ACAB for the other child. Once the percentage of bites accepted had increased to at least 75% with the initial exposure to a treatment package, that treatment was withdrawn with a subsequent exposure to the second treatment package. The results indicated that both treatment packages were effective in establishing food acceptance. Also, initial exposure to either of the two treatment packages facilitated acquisition of food acceptance during the second exposure. Parental preference of the treatment package may have been influenced by the order of exposure to the treatment conditions.

Behavior Therapy↗
PubMedDate not supplied

Active and smart packaging for meeting consumer demands for quality and safety.

Over the past few decades, many new packaging techniques have been introduced in the quest for natural preservation of foods and on-time quality monitoring of packaged food to ensure good product quality and safety for the consumer. This paper discusses scientific, technological, commercial and legislative development, as well as consumer aspects and acceptance of the active and smart food packaging techniques with current or potential commercial value, and the elements that both the manufacturers of these packaging systems and the food industry should take into account before launching products using these techniques.

Carbon Dioxide↗