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PubMed2005

Enterococcus species dominating in fresh modified-atmosphere-packaged, marinated broiler legs are overgrown by Carnobacterium and Lactobacillus species during storage at 6 degrees C.

In order to show which of the initial lactic acid bacteria (LAB) contaminants are also causing spoilage of a modified-atmosphere-packaged (MAP), marinated broiler leg product at 6 degrees C, LAB were enumerated and identified on the 2nd and 17th days following manufacture. A total of 8 fresh and 13 spoiled packages were studied for LAB levels. In addition, aerobic mesophilic bacteria and Enterobacteriaceae were determined. The average CFU/g values in the 8 fresh packages were 1.3 x 10(3), 9.8 x 10(3) and 2.6 x 10(2) on de Man Rogosa Sharpe agar (MRS), Plate Count Agar (PCA) and Violet Red Bile Glucose agar (VRBG), respectively. The commercial shelf life for the product had been set as 12 days, and all packages analyzed on the 17th day were deemed unfit for human consumption by sensory analysis. The corresponding CFU/g averages in the spoiled product were 1.4 x 10(9), 1.1 x 10(9) and 3.9 x 10(7) on MRS, PCA and VRBG agar, respectively. For characterization of LAB population, 104 colonies originating from the fresh packages and 144 colonies from the spoiled packages were randomly picked, cultured pure and identified to species level using a 16 and 23S rDNA HindIII RFLP (ribotyping) database. The results showed that enterococci (35.7% of the LAB population) were dominating in the fresh product, whereas carnobacteria (59.7%) dominated among the spoilage LAB. Enterococcus faecalis, Carnobacterium piscicola and Carnobacterium divergens were the main species detected. In general, when the initial LAB population is compared to the spoilage LAB, a shift from homofermentative cocci towards carnobacteria, Lactobacillus sakei/curvatus and heterofermentative rods is seen in this marinated product.

Animals↗
PubMed2005

Rapid, simultaneous determination of headspace oxygen and moisture in pharmaceutical packages using muGC.

The rapid, accurate determination of headspace oxygen and moisture in various pharmaceutical packages is important for both product packaging development and the implementation of new packaging technologies. Current headspace oxygen measurement techniques suffer from serious drawbacks in terms of potential sampling contamination, lengthy analysis times, and large required analysis volumes. In addition, relatively few techniques currently exist for the convenient determination of headspace moisture in packaging systems. Efforts herein focused on the development and application of a new method for the rapid and simultaneous determination of headspace oxygen and moisture in pharmaceutical packages using micro-gas chromatography (muGC). Studies showed that both headspace oxygen and moisture could be simultaneously quantified in <90 s on sample volumes of 50-100 microL by employing muGC with dual chromatographic analysis modules. Sampling issues common to manual syringe-based injections were also alleviated in the current studies by use of the built-in diaphragm pump sampling interface of the portable muGC system. The performance of the analytical approach was evaluated and shown to exhibit excellent linearity, accuracy, and precision for both analytes. High sensitivity for headspace oxygen was demonstrated, allowing for levels of oxygen as low as 0.03% to be accurately quantified. The subject method was applied to measure the headspace oxygen and moisture in pharmaceutical blister packaging and glass vials.

Chromatography, Gas↗
PubMed2006

Use of activated carbon inside modified atmosphere packages to maintain tomato fruit quality during cold storage.

Ethylene triggers the ripening process of tomato affecting the storage durability and shelf life (loss of quality) and inducing fruit decay. In this paper, an active packaging has been developed on the basis of the combination of modified atmosphere packaging (MAP) and the addition of granular-activated carbon (GAC) alone or impregnated with palladium as a catalyst (GAC-Pd). A steady-state atmosphere was 4 and 10 kPa for O2 and CO2 in control packages, while it was 8 and 7 kPa for O2 and CO2 in treated ones. The addition of GAC-Pd led to the lower ethylene accumulation inside packages, while the higher was obtained in controls. The parameters related to ripening showed that treated tomatoes exhibited a reduction in color evolution, softening, and weight loss, especially for GAC-Pd treatment. Moreover, these treatments were also effective in delaying tomato decay. After sensorial panel, tomatoes treated with GAC-Pd received the higher scores in terms of sweetness, firmness, juiciness, color, odor, and flavor. Results from the GC-MS analysis of the MAP headspace showed that 23 volatile compounds were identified in control packages, with these volatiles being significantly reduced in MAP-treated packages, which was correlated to the odor intensity detected by panelists after bag opening.

Adult↗
PubMed2002

Programme on the recyclability of food-packaging materials with respect to food safety considerations: polyethylene terephthalate (PET), paper and board, and plastics covered by functional barriers.

Stimulated by new ecology-driven European and national regulations, news routes of recycling waste appear on the market. Since food packages represent a large percentage of the plastics consumption and since they have a short lifetime, an important approach consists in making new packages from post-consumer used packages. On the other hand, food-packaging regulations in Europe require that packaging materials must be safe. Therefore, potential mass transfer (migration) of harmful recycling-related substances to the food must be excluded and test methods to ensure the safety-in-use of recycled materials for food packaging are needled. As a consequence of this situation, a European research project FAIR-CT98-4318, with the acronym 'Recyclability', was initiated. The project consists of three sections each focusing on a different class of recycled materials: polyethylene terephthalate (PET), paper and board, and plastics covered by functional barriers. The project consortium consists of 28 project members from 11 EU countries. In addition, the project is during its lifetime in discussion with the US Food and Drug Administrations (FDA) to consider also US FDA regulatory viewpoints and to aim, as a consequence, to harmonizable conclusions and recommendations. The paper introduces the project and presents an overview of the project work progress.

Consumer Product Safety↗
PubMed2005

Effectiveness of antimicrobial food packaging materials.

Antimicrobial additives have been used successfully for many years as direct food additives. The literature provides evidence that some of these additives may be effective as indirect food additives incorporated into food packaging materials. Antimicrobial food packaging is directed toward the reduction of surface contamination of processed, prepared foods such as sliced meats and Frankfurter sausages (hot dogs). The use of such packaging materials is not meant to be a substitute for good sanitation practices, but it should enhance the safety of food as an additional hurdle for the growth of pathogenic and/or spoilage microorganisms. Studies have focused on establishing methods for coating low-density polyethylene film or barrier films with methyl cellulose as a carrier for nisin. These films have significantly reduced the presence of Listeria monocytogenes in solutions and in vacuum packaged hot dogs. Other research has focused on the use of chitosan to inhibit L. monocytogenes and chlorine dioxide sachets for the reduction of Salmonella on modified atmosphere-packaged fresh chicken breasts. Overall, antimicrobial packaging shows promise as an effective method for the inhibition of certain bacteria in foods, but barriers to their commercial implementation continue to exist.

Animals↗
PubMedDate not supplied

Prospects for application of post-consumer used plastics in food packaging.

The two most widely used polymers in packaging in recent years are polyethylene terephthalate (PET) and polyethylene (PE). The biggest fractions of these polymers are not re-utilized, in spite of the fact that they possess excellent properties even after their first application. The ban on using recycled polymers in food packaging applications and the lack of good value outlets for these materials causes them to end up in landfills. The high cost nylon, used in packaging primarily as high gas barrier laminates with PE, also finds its way to landfills. In this case, the reason is the difficulty of recycling different polymers that are incompatible. Thus, the Municipal Solid Waste (MSW) stream transferred to landfills contains many plastic packages. These packages are being blamed as a major pollutant of the environment in spite of the fact that all plastics contribute only a small percentage to the weight of the garbage in landfills. If proper and cost effective applications for the recycled polymers could be developed, the waste related to their disposal could be limited. In addition, the contribution of plastic packages to the environmental problem could be diminished. In the present paper, the possibility of sandwiching a contaminated PET layer between two layers of the virgin material was studied. The aim of the study was to determine whether such an operation could lower the migration level of contaminants from a multilayer structure (containing a recycled layer of PET) to values below the limits required by regulatory agencies. The diffusion coefficients (required to determine migration) of four organic liquids in PET were determined. As a result of the sandwiching operation, the amount of pollutant (toluene) migrating into the food simulant was reduced by two orders of magnitude. The properties of PE/nylon blends were also studied. It was found that the high gas barrier properties of nylon are preserved in the blend when proper processing conditions are used. Therefore, the recycled material could be used as a centre layer in a multilayer structure providing good gas barrier properties to this structure.

Conservation of Natural Resources↗
PubMed2001

Naming, labeling, and packaging of pharmaceuticals.

The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains. Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.

Drug Industry↗
PubMed1998

Effects of dietary vitamin E supplementation on lipid oxidation and volatiles content of irradiated, cooked turkey meat patties with different packaging.

A study was conducted to determine the effects of dietary vitamin E supplementation on the storage stability and volatiles production in irradiated cooked turkey meat. Turkeys, raised with diets containing 25, 50, 75, or 100 IU of dl-alpha-tocopheryl acetate (TA)/kg diet from 1 to 105 d of age, were fed with diets containing 25, 200, 400, or 600 IU of TA/kg diet from 105 to 122 d of age. Breast and leg meat patties were prepared, irradiated at 0 or 2.5 kGy dose, cooked to an internal temperature of 78 C, and stored in either vacuum or aerobic packaging. Thiobarbituric acid reactive substance (TBARS) values gradually decreased as the dietary TA increased and > 200 IU TA/kg diet treatments were helpful in maintaining low TBARS values in irradiated breast and leg meat patties during the 7-d storage period. With vacuum-packaging, irradiated cooked breast patties developed more oxidation than nonirradiated patties but the prooxidant effect of irradiation in cooked leg meat patties was not consistent. In aerobic-packaged cooked meat, irradiated patties had lower TBARS than nonirradiated patties in both breast and leg meat stored in oxygen permeable bags for 7 d. Propanal, pentanal, hexanal, 1-pentanol, and total volatiles were highly correlated with the TBARS values of meat. However, hexanal represented the lipid oxidation status of cooked meat better than any other volatiles component. The amount of hexanal and total volatiles in cooked breast and leg meat shows decreasing trends as dietary TA increased. In vacuum packaging, irradiated breast and leg meat had higher hexanal and total volatiles content than nonirradiated meat at both 0 and 7 d of storage. In aerobic packaging, the amount of hexanal and total volatiles greatly increased in both irradiated and nonirradiated meat patties during the 7-d storage periods. The results illustrated that the antioxidant effect of TA was not strong enough to control lipid oxidation and off-odor generation in cooked meat stored under aerobic conditions because the progress of lipid oxidation in cooked meat under aerobic condition is very rapid. However, the combination of dietary TA and vacuum packaging of cooked meat immediately after cooking could be a good strategy to minimize oxidation and volatiles production in cooked meat.

Animal Feed↗
PubMed2003

Color stability of semitendinosus, semimembranosus, and biceps femoris steaks packaged in a high-oxygen modified atmosphere.

The objectives of this study were to evaluate visual and chemical attributes of beefsteaks from various USDA quality grades and muscles packaged in high-oxygen (80% O2/20% CO2) modified-atmosphere packaging (MAP). A total of nine carcasses were selected to represent Select (n = 3), low Choice (n = 3), and high Choice (n = 3) USDA quality grades. The semimembranosus (SM), semitendinosus (ST), and biceps femoris (BF) muscles were removed from each carcass and allotted to two packaging types (MAP or polyvinyl chloride over-wrap) and were displayed for up to 10 d, with evaluation on d 1, 3, 5, 7, and 10. Fifty-four steaks were evaluated on each day by a five-member trained panel for visual color (lean color and discoloration) and were also analyzed with a Minolta Chroma Meter CR-310 for L* and a* values (lightness and redness, respectively). Chemical properties measured included percentage of metmyoglobin formation and fat content. Visual color scores did not differ (P > 0.05) at d 1 and 3 with respect to all quality grades, but decreased after d 3, with a greater reduction (P < 0.05) in high Choice steaks for both lean color and discoloration. The low Choice steaks packaged in MAP displayedhigher (P < 0.05) lean color scores and less (P < 0.05) discoloration at d 7 and 10 than did Select and high Choice steaks. Redness (a*) values also decreased (P < 0.05) after d 3, whereas (lightness) L* values declined (P < 0.05) from d 1 to 5. The high Choice steaks had higher (P < 0.05) metmyoglobin content than low Choice and Select steaks, but packaging had no effect (P > 0.05) on metmyoglobin content. Muscle type did affect metmyoglobin content; however, the metmyoglobin content of the SM was greatest (P < 0.05), followed by the BF, with the ST having the lowest (P < 0.05) metmyoglobin formation. Results indicate that low Choice steaks react the best in MAP, and the ST maintained greater storage characteristics regardless of quality grade or packaging.

Animals↗
PubMed2001

Effect of various dairy packaging materials on the shelf life and flavor of ultrapasteurized milk.

Raw milk from three different dairies (each a separate trial: 1, 2, and 3) was standardized to 2% fat and processed at 140.6, 129.4, 118.3, and 107.2 degrees C (temperatures 1, 2, 3, and 4, respectively) for 2 s and packaged into six different packaging boards, [standard (A) milk boards with standard seam, juice boards with standard (B) and J-bottom (D) seams, barrier boards with standard (C) and J-bottom (E) seams and foil (F) boards with J-bottom seam], resulting in 24 different treatments. Standard plate count (SPC) was used to test for microbial quality, and taste panels were employed for flavor acceptability and difference in the milk stored at 6.7 degrees C at 1, 2, 3, 5, 10, and 15 wk. Lipolysis was measured by standard procedures for acid degree value (ADV) of milk. Statistical analysis of taste panel data showed that the flavor of 14 milk samples deteriorated over time. The flavor of UP milk packaged in standard (A) and juice (B and D) boards deteriorated at a faster rate than UP milk packaged in barrier (C and E) and foil (F) boards. At wk 6, a slightly hammy or cardboardy flavor was detected for milk packaged in boards with standard seams (A, B, and C) and a slightly cooked flavor was detected for milk packaged in barrier and foil boards with J-bottom (E and F) seams. The hammy or cardboardy flavor intensified with storage time, and all of the cooked flavor dissipated at wk 10. Milk processed at 118.3 and 129.4 degrees C maintained the lowest bacterial growth rates, and milk processed at 107.2 degrees C had the highest bacterial growth rates during 15 storage wk. More than 87% of milk processed at 118.3, 129.4, and 140.6 degrees C maintained acceptable level of bacterial counts at wk 15. The extent of lipolysis showed that ADV of milk increased with storage time. The ranges of ADV for trials 1, 2, and 3 were 0.76 to 0.85 (from 12 to 22 wk), 0.39 to 0.51 (from 6 to 16 wk), and 0.53 to 0.60 (from 6 to 16 wk), respectively.

Animals↗
PubMed1996

Risk of Clostridium botulinum type E toxin production in blue crab meat packaged in four commercial-type containers.

The aim of this investigation was to determine if a risk of Clostridium botulinum growth and toxin production existed in four different packaged crabmeat products. Freshly picked blue crab meat was inoculated with 10(3) to 10(4) spores per g of a mixed pool of four strains of C. botulinum type E (Beluga, Minnesota, G21-5, and 070). The lump crabmeat was packaged in four different packaging containers: (i) 12-oz copolymer polyethylene cups currently used by most crab processors; (ii) 12-oz copolymer polyethylene cups with heat-shrink, tamper-evident low-density polypropylene seals; (iii) 8-oz copolymer polyethylene cups with easy-open aluminum ends: and (iv) 8-oz copolymer polypropylene cups with integral tamper-evident pull-tabs. The packages were stored at either 4 degrees C for 21 days or 10 degrees C for 15 days. Storage at 10 degrees C was used to simulate temperature abuse. The mouse bioassay was used to detect the presence of C. botulinum toxin. Psychotrophic and anaerobic populations were enumerated and were found to increase with time regardless of packaging type. No botulinum toxin was detected in any of the four packaging types stored at 4 degrees C or 10 degrees C throughout the entire storage period.

Animals↗
PubMed1999

Growth and toxin production by Clostridium botulinum in English-style crumpets packaged under modified atmospheres.

To determine the safety of a high moisture bakery product, packaged under modified atmospheres, challenge studies were done on English-style crumpets (water activity [a(w)] 0.990, pH 6.5) inoculated postbaking with Clostridium botulinum types A and proteolytic B spores (5 X 10(2) spores/g). Products were packaged either in air, in air with an Ageless FX200 oxygen absorbent, or in a CO2/N2 (60:40) gas mixture, stored at ambient temperature (25 degrees C), and monitored for toxicity daily. All inoculated crumpets were toxic within 4 to 6 days and were organoleptically acceptable at the time of toxigenesis. Counts of C. botulinum increased to approximately 10(5) CFU/g at the time of toxicity. To determine the effect of baking on product safety, subsequent challenge studies were done on crumpets inoculated with 5 x 10(2) spores/g (baked weight basis) prior to baking. All crumpets were toxic after only 6 days, irrespective of packaging conditions, and toxigenesis again preceded spoilage. Temperature profile studies showed that the maximum internal temperature reached during baking was 97 degrees C, and the total baking process was equivalent to 0.03 min at 121 degrees C. The actual time to toxin production in both studies (4 to 6 days) correlated well with the predicted time (3.4 days) using the U.S. Department of Agriculture Pathogen Modeling Program (version 5.1) for proteolytic strains of C. botulinum. These studies confirm that high moisture bakery products, if contaminated with C. botulinum spores either pre- or postbaking, could pose a public health hazard, if packaged in air (in a high gas barrier package where O2 was depleted and CO2 was generated during storage) or under modified atmosphere packaging conditions and stored at ambient temperature.

Botulinum Toxins↗
PubMed2005

Eradicating Listeria monocytogenes from fully cooked franks by using an integrated pasteurization-packaging system.

Surface pasteurization by applying steam or hot water before or after packaging of processed foods may be used to eliminate pathogens such as Listeria monocytogenes from ready-to-eat meat and poultry products. Surface pasteurization treatment with a mixture of pressurized steam and hot water was integrated into a continuous vacuum-packaging system to reduce L. monocytogenes from fully cooked franks. The franks (2.54 cm diameter by 15.24 cm length) were surface inoculated to contain up to 6 log CFU/cm2 L. monocytogenes. The inoculated franks were treated at 121 degrees C for 1.5 s in an arrangement of six franks per packaging chamber followed by immediate vacuum sealing of the top films of food packages in the same unit. A 3-log CFU/cm2 reduction of L. monocytogenes on fully cooked franks was obtained using the integrated pasteurization-packaging system. The pasteurization depth was 1.27 mm below the surfaces of the franks. This process provides a commercially applicable means of ensuring food safety by effectively eradicating L. monocytogenes from ready-to-eat meat and poultry products at the very last possible step of food packaging before reaching retail consumers.

Animals↗
PubMed2001

A combination of high oxygen atmosphere and equilibrium modified atmosphere packaging to improve the keeping quality of red fruits.

When high-barrier material is used to package fresh whole fruit in high oxygen atmospheres, shelf life is limited due to the accumulation of its produced CO2 and its creation of an anaerobic atmosphere. In this study, the effect of the combination of High Oxygen Atmosphere and Equilibrium Modified Atmosphere Packaging was tested on the shelf life of two non-climacteric red fruits, particularly strawberries and raspberries, at 7 degrees C. Herefor, the following packaging systems are compared: the conventional method of packaging in a macroperforated high-barrier film (air conditions) (1), Equilibrium Modified Atmosphere (EMA, i.e. 3-5% O2 and 5-10% CO2-balance N2) (2) and two novel modified atmospheres: High Oxygen Atmosphere (HOA, i.e. > 70% O2-balance N2) in a high-barrier film (3) and HOA in a EMA film with an adjusted film permeability (4). The shelf life of the fruits was determined by evaluating the evolution of the internal oxygen, carbon dioxide and ethylene concentrations in the packages, the microbial and sensorial quality during the storage, the loss of weight due to transpiration and respiration of the fruit and the loss of marketable fruit due to visual decay or to Botrytis growth. The High Oxygen Atmosphere in the EMA film re-established after five days to an equilibrium of 3% O2 and 5% CO2. The High Oxygen Atmosphere in the high-barrier film remained high during the first five days of storage, but decreased then rapidly to anaerobic conditions, resulting in off-flavours and odours. To avoid an accumulation of ethylene inside the high-barrier package, an ethylene adsorbing monolayer was added. Shelf life of strawberries and raspberries, packed in air conditions, was limited by growth of moulds and yeasts, rather than by sensorial unacceptance. On the other hand, sensorial properties limited the shelf life of the fruits packed under modified atmosphere. Especially High Oxygen Atmosphere improved the microbial quality, due to the inhibiting effect on yeasts and moulds. However, when oxygen was depleted and carbon dioxide had accumulated, sensorial quality (odour, taste andfirmness) was deteriorated. As this is not the case with high O2 in an EMA film, the latter can be assumed as a promising configuration for respiring fresh produce, combining the beneficial effect of high O2 and EMAP.

Bacteria↗
PubMed2005

[Effects of packaging on the stability of vitamin E in peach kernels stored at high temperature].

Peach kernels with three different kinds of packaging, including routine, vacuum and edible film, were put into an accelerated test in order to study the effects of packaging on the stability of vitamin E, gamma-, alpha-, and delta-tocopherol. The result indicated that among the three kinds of packaging, the stability of vitamin E in the samples with vacuum packaging was the best, and with routine packaging was the worst. And for the samples with the same kind of packaging, the stabilities of gamma-, alpha- and delta-tocophero decreased one by one.

Drug Packaging↗
PubMed1986

A randomized trial of special packaging of antihypertensive medications.

This article reports a randomized controlled trial designed to test the effects of special packaging of antihypertensive medication on compliance and blood pressure control. One hundred eighty subjects who had exhibited elevated blood pressure greater than 90 mmHg in the two years prior to the study were recruited from patients receiving care at a community hospital-based family medicine practice. After completing preenrollment interviews and blood pressure measurements, subjects were randomly assigned to receive their antihypertensive medications either in the usual vials or in special unit dose-reminder packaging. Follow-up interviews, pill counts, and blood pressure measurements were performed at three-month intervals. There were no statistically significant differences between the control and experimental groups with regard to age, sex, race, employment, education, marital status, insurance coverage, or blood pressure regimens. Prior to the intervention, the experimental group had slightly lower diastolic blood pressure and reported better compliance than the control group. Analyses performed on 165 subjects completing the first follow-up visit revealed no significant improvements in blood pressure control or compliance for patients receiving special medication packaging. While some patients found it easy to remember to take pills packaged using this format, they also found the packages somewhat more difficult and inconvenient to use. In contrast to previously reported work, this study did not demonstrate any significant improvement in compliance with special packaging of antihypertensive medications.

Adult↗
PubMed1996

The safety effects of child-resistant packaging for oral prescription drugs. Two decades of experience.

OBJECTIVE: To evaluate the effectiveness of child-resistant packaging in reducing the mortality rate for children younger than 5 years from the unintentional ingestion of oral prescription drugs. DESIGN: Annual mortality rates for children younger than 5 years associated with the unintentional ingestion of oral prescription drugs are constructed for 1964 through 1992. The effect of child-resistant packaging on the child mortality rate during the postintervention period (1974 through 1992) is evaluated with a multivariate time series regression model. The analysis controls for changes in the consumption of oral prescription drugs over time and for long-term safety trends. SETTING: United States. SUBJECTS: Children younger than 5 years. MAIN OUTCOME MEASURE: Estimated reductions in the child mortality rate associated with the use of child-resistant packaging. RESULTS: After controlling for covariates, the use of child-resistant packaging was associated with an annual reduction in the oral prescription drug-related mortality rate of 1.40 (95% confidence interval, 0.85-1.95) deaths per million children younger than 5 years. This suggests a reduction of about 460 child deaths from 1974, the year oral prescription drugs became subject to child-resistant packaging requirements, through 1992-a mortality rate reduction of about 45% from levels projected without the child-resistant requirements. CONCLUSION: Child-resistant packaging reduces child mortality from the unintentional ingestion of oral prescription drugs.

Administration, Oral↗
PubMedDate not supplied

Microbial barrier assessment of Tyvek stopper packaging for rubber closures.

Two types of Tyvek and high density polyethylene or polypropylene packaging used for sterilization of rubber closures were evaluated for Microbial Barrier properties. The packaging evaluated was "Ready to Sterilize" (1) stoppers and a second test package (Test 2) which was designated as appropriate for a clean room, filled with washed and siliconized stoppers and then heat sealed. Each type of packaging was subjected to three different sterilization temperatures (125 degrees C, 128 degrees C and 131 degrees C) in a production sterilizer (15-18 psi). Following sterilization, a microbial barrier assessment was performed, using Bacillus subtilis niger (ATCC 9372), to determine whether the packaging could maintain a sterile barrier following sterilization. Results of the testing indicated that a microbial barrier was maintained for products in "Ready to Sterilize" packages at 125 degrees C and 128 degrees C. For products sterilized in the Test 2 container a microbial barrier could not be maintained at 128 degrees C, and no further testing was performed. Following sterilization at 131 degrees C physical defects were noted for the "Ready to Sterilize" bag and a microbial barrier could not be maintained.

Bacillus subtilis↗