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PubMed2003

Compliance issues in manufacturing of drugs.

The therapeutic process relies on the assumption that the prescription written by the clinician is what is dispensed to the patient. In this article, we review the many factors involved in the manufacture of pharmaceutical products so that they consistently meet quality standards as approved by regulatory agencies. Industry and government agencies have developed procedures and laws to assure quality in Chemistry, Manufacturing and Controls (CMC) for pharmaceuticals, addressing conditions that may be harmful to patient health. This includes procedures for receipt of materials, production, packaging, labeling, quality control, release, storage and distribution, known as current Good Manufacturing Practice. Special control considerations for ophthalmic products include foreign particulate matter control, preservative effectiveness tests, sterility and leaching of chemicals from the packaging into the product. We also describe the "form, fill and seal" manufacture process as used in unit-dose, non-preserved ophthalmic products; product expiration dates; stages of drug development; and financial considerations for pharmaceutical companies.

Journal Article↗

PubMed2005

Parametric analysis of environmental performance of reused/recycled packaging.

Annual environmental performance of packaging products which are reused at least once per year is analyzed with respect to three specific criteria: (1) waste quantities, (2) virgin material demand and resource depletion, and (3) environmental impacts from manufacturing. Packaging flow performance is assessed via a combined reuse/ recycle rate index expressed solely in terms of two dimensionless parameters: the conventional recycling rate and the mean number of reuse trips. Quantitative expressions describe the effect of the following physical quantities: annual reuse frequency, lifetime, maximum number of reuse trips, amount of packaging present in the market, annual production plus net trade imports, recycle rate of consumer discard, reuse rate and consumer discard. The results may serve for packaging monitoring and assessment of alternative packaging systems and for setting more efficient environmental policy targets in terms of the reuse/recycle rate.

Conservation of Natural Resources↗

PubMed1973

Microbiological evaluation of suture items before radiation sterilization.

Microbiological contamination levels of suture samples taken at various stages of the manufacturing process in a new hygienically controlled plant were determined by employing a membrane filturation technique. Both raw material and materials handled manually in the production process were tested to assess the effect of manual handling on the product contamination level. Evaluation of the efficacy of contamination control, however, was directed primarily to the finished, packaged products, just prior to the processing with cobalt 60. The suture material for testing was divided into two groups, namely, wet and dry products, the wet being packaged in a special "tubing" fluid consisting mainly of isopropyl alcohol. Initial contamination results are reported as the average of values obtained on the test day and the preceding 9 consecutive production days. A total of 1,787 suture samples tested in the dry group showed daily averages varying between 2.1 and 14.8 contaminants per suture. The 2,980 wet-packaged suture samples tested gave daily averages varying from 0.7 to 4.2 contaminants per suture. The highest values obtained for an individual suture were 400 for the dry and 89 for the wet. Identification studies of the contaminants revealed that fungi predominated. Most of the bacterial contaminants proved to be spore-forming rods.

Alcohols↗

PubMed2005

Forgery: 'fingerprinting' documents and packaging.

We have found that almost all paper documents, plastic cards and product packaging contain a unique physical identity code formed from microscopic imperfections in the surface. This covert 'fingerprint' is intrinsic and virtually impossible to modify controllably. It can be rapidly read using a low-cost portable laser scanner. Most forms of document and branded-product fraud could be rendered obsolete by use of this code.

Journal Article↗

PubMedDate not supplied

Radiofrequency identification technology: protecting the drug supply.

The FDA has stepped up its efforts to improve the safety and security of the nation's drug supply by encouraging the use of a state-of-the-art technology that tags product packaging electronically. The technology, called radiofrequency identification, or RFID, allows manufacturers and distributors to more precisely track drug products through the supply chain.

Consumer Product Safety↗

PubMed1993

Changes in the microflora on commercial beef trimmings during their collection, distribution and preparation for retail sale as ground beef.

A commercial process for ground meat production, from the collection of meat plant trimmings to the retailing of consumer packs of ground beef, was examined. The selected process compiled with current concepts of Good Manufacturing Practice. During storage for up to 18 days before grinding, most trimming developed a flora of lactobacilli, of up to 10(7) CFU/g. Numbers of coliforms and of Escherichia coli on stored trimmings increased little and not at all, respectively. Increased total counts, and numbers of both coliforms and E. coli in displayed product indicated loss of control of the temperature of the displayed packaged product. It appears that the need to store a product, taking into account the unpredictable fluctuations in supply and demand, will inevitably result in much ground beef carrying large numbers of spoilage bacteria. Furthermore, currently accepted Good Practice in the retail handling of ground beef does not adequately control either spoilage or the growth of pathogenic bacteria.

Animals↗

PubMed1986

Ethical, economic, and professional issues in home health care.

Important ethical, economic, and professional issues in home health care (HHC) are identified and discussed. Patient services issues in HHC involve the ethics of providing high-technology feeding therapies to terminally ill patients and the controversies surrounding drug products, such as the appropriate amount of drug to be dispensed, the appropriate individual to compound home-care drug products, acceptable types of product packaging, and the impact of a switch in venders on the drug products supplied to patients. Economic issues include reasonable profit for HHC services, methods used to charge for products and services, payments to physicians for patient referrals, and pharmacies owned and operated by the HHC industry. Pharmacy relations issues center on the influence of nonpharmacists on pharmacy-based HHC services and the effect of HHC services on intraprofessional relations. How pharmacists resolve the many ethical, economic, and professional issues in HHC will determine the quality of services provided to patients, the nature of the working relationships between pharmacists and other health professionals, and the direction that pharmacy HHC services will take in the future.

Drug Industry↗

PubMedDate not supplied

Minimizing the residual oxygen in modified atmosphere packaging of bakery products.

The total elimination of air represents a serious hurdle in modified atmosphere packaging of bakery products, due both to the high spin-rates of the packaging lines and, particularly, to the typical texture of bakery products which retain large quantities of air inside their porous structure. Simulating the gas-flushing modified atmosphere packaging with laboratory equipment and measuring the oxygen concentration directly inside bread rolls, by means of a gas analyser connected with the internal portion, it was possible to follow the rate of atmosphere substitution, evaluating the effects of different baking treatments (7, 12 and 23 min at 230 degrees C) and the role played by different gases (nitrogen, argon, helium, nitrous oxide and carbon dioxide). The oxygen content inside the products, plotted versus time, led to typical logistic 'dose-response' curves which made it possible to forecast the time needed to reach established values of residual oxygen concentration and to emphasize the effects of the different conditions used. The gas properties particularly affected the rate of oxygen substitution and the less water-soluble was the gas, the faster was the oxygen reduction; the larger was the gas molecule, the slower was the process. Also baking time was shown to have, to a different extent, some measurable effects on the rate of oxygen substitution and hence, its optimization as well as the choice of gas mixture can contribute to improve modified atmosphere packaging of bakery products.

Argon↗

PubMed2003

Comparative assessment of gastrointestinal irritant potency in man of tin(II) chloride and tin migrated from packaging.

Tin is present in low concentrations in most canned foods and beverages, the highest levels being found in products packaged in unlacquered or partially lacquered tinplate cans. A limited number of case-reports of acute gastrointestinal disorders after consumption of food containing 100-500 mg/kg tin have been reported, but these reports suffer many insufficiencies. Controlled clinical studies on acute effects of tin migrated from packaging suggest a threshold concentration for adverse effects (AEs) of >730 mg/kg. Two separate randomised, single-centre, double-blind, crossover studies, enabling comparison of the tolerability of tin added as tin(II) chloride at concentrations of <0.5, 161, 264 and 529 mg/kg in 250 ml tomato juice in 20 volunteers (Study 1) and tin migrated from packaging at concentrations of <0.5, 201 and 267 mg/kg in 250 ml tomato soup in 24 volunteers (Study 2) were carried out. Distribution studies were conducted to get insight in the acute AEs of low molecular weight (<1000 Da) tin species in the soluble fraction of food products. Results show that the chemical form of tin and not the elemental concentration per se determines the severity of AEs. A clear dose-response relationship was only observed when tin was added as tin(II) chloride in tomato juice. No clinically significant AEs were reported in Study 2 and comparison of the incidence of tin-related AEs showed no difference between the dose levels (including control). Tin species of low molecular weight in supernatant represented 31-32% of total tin in canned tomato soup versus 56-61% in juice freshly spiked with tin(II) chloride. Differences in the incidence of AEs following administration of tomato juice with 161 and 264 mg of tin per kg and tomato soup with 201 and 267 mg of tin per kg likely results from differences in the concentration of low molecular weight tin species and in the nature of tin complexes formed. The results of this work demonstrate that tin levels up to 267 mg/kg in canned food cause no AEs in healthy adults and support the currently proposed tin levels of 200 mg/kg and 250 mg/kg for canned beverages and canned foods, respectively, as safe levels for adults in the general population.

Adolescent↗

PubMed1990

A recruitment-of-praise package to increase productivity levels of developmentally handicapped workers.

This research examined the effectiveness of a recruitment package to increase production rates of three developmentally handicapped adults in a sheltered workshop. A baseline phase measured production rates of a paper-folding task under "typical" supervisory conditions. The recruitment package, introduced in a multiple-baseline design across subjects, involved goal setting by the experimenter, and self-monitoring, recruitment of praise, and self-delivery of a "happy face" by the worker. The recruitment package increased the production rates for two subjects, but decreased production rates for the third subject. Social validity data indicated that all subjects preferred the recruitment package, and staff continued to employ the recruitment package for two subjects when the formal research was terminated.

Achievement↗

PubMed1989

Ingestion of prescription drugs by children: an epidemiologic study.

Although the Poison Prevention Packaging Act of 1970 has resulted in a 65% decline in ingestion of products packaged in child-resistant containers, ingestion of prescription drugs by children has declined by only 36%. Since ingestion of solid prescription drugs remains an important cause of ingestion-related morbidity in children, this descriptive epidemiologic study of cases reported to a poison control center was done with the hope of identifying factors responsible for this continuing problem. The study provides an epidemiologic perspective of this unnecessary risk to child health, and also proposes interventions targeted to high-risk caregivers.

Age Factors↗

PubMed2005

Look-alike, sound-alike drugs review: include look-alike packaging as an additional safety check.

BACKGROUND: Confusion resulting from look-alike and sound-alike drug names and look-alike product packaging can result in potentially harmful medication errors. CASE STUDY: A 69-year-old woman admitted to the oncology unit at a 670-bed teaching facility for correction of electrolyte imbalances was mistakenly administered Primacor instead of potassium chloride, reflecting a look-alike packaging medication error. ACTIONS TAKEN: The medical center developed and implemented process changes, including moving and reorganizing shelf storage bins, enhancing labeling for intravenous medications with similar packaging, tracking and responding to automated dispensing cabinet-filling errors, and revising processes for selecting and maintaining the list of look-alike, sound-alike medications to include the "real time" review of new medications added to the formulary and changes in packaging resulting fron contract changes or drug shortages. DISCUSSION: The Joint Commission National Patient Safety Goals for 2005 require organizations to identify and, at a minimum, annually review a list of look-alike sound-alike drugs and to proactively implement safety strategies to help prevent medication errors involving these drug combinations. Proactive assessment of potential for medication errors should include evaluation of potential look-alike packaging problems in addition to the drug names.

Aged↗

PubMed2026

E-cigarette product characteristics and packaging features and interest in e-cigarette use: Results from a randomized within-person trial nested in three prospective cohorts.

BACKGROUND: Product characteristics and packaging may be key targets for regulation to reduce e-cigarette use among youth, but existing data are limited. METHODS: Data are from an experimental study (2018-2020) nested within three prospective cohorts (age 14-26) in southern California (N = 3565). Participants were shown five e-cigarette (e-liquid) packages in a random order that varied in flavor (sweet vs. tobacco), flavor name (descriptive ["blueberry cheesecake"] vs. concept ["smurf cake"] vs. none [number only]), and cartoon image on package (yes/no). For each stimuli, survey items assessed the following outcomes: product appeal (self-enjoyment, others' enjoyment; Likert scale [1-5]), susceptibility to use (use if friends offered, curiosity; 4 ordered responses [definitely not-definitely yes]), peer acceptability (definitely not-definitely yes), and perceived harm (definitely not-definitely yes). Mixed effects proportional odds models evaluated within-person effects of each factor (flavor, flavor name, cartoon) with each outcome. RESULTS: Participants reported greater appeal, susceptibility, and peer acceptability (OR range=3.7-16.9; ps<0.05), and lower perceived harm (OR=0.61; 95%CI=0.53, 0.70) for sweet (vs. tobacco-flavored) e-cigarettes; effects were progressively stronger for younger cohorts. The descriptive flavor name rated higher than the concept flavor (OR range=1.13-2.02; ps<0.05) or number only (OR range=1.18-1.69; ps<0.05) for appeal and susceptibility measures; no differences for concept vs. number were found. The cartoon image rated higher for appeal, curiosity, and peer acceptability (OR range=1.24-1.51; ps<0.05). CONCLUSIONS: Sweet flavors, descriptive flavor names, and cartoon images may increase the appeal of e-cigarettes among youth and young adults with no history of e-cigarette use, and are key targets for regulation.

Humans↗

PubMed2000

Evaluation of the impact of short-term temperature abuse on the microbiology and shelf life of a model ready-to-use vegetable combination product.

The growth dynamics of indigenous aerobic mesophilic populations (AMP), lactic acid bacteria (LAB) and inoculated (Listeria spp.) microbial populations on cooked and fresh vegetable products, packaged as separate entities and in combination, subjected to temperature fluctuation, were assessed. Microbial proliferation was temperature and product dependent, being most pronounced at 12 degrees C in all products with maximum growth rates of 0.140, 0.175 and 0.126 log10 CFU/g per h being identified for Listeria, aerobic mesophilic and LAB populations, respectively. Listeria spp. and AMP generally demonstrated higher rates of growth within products containing cooked vegetables. Prolonged storage at 3 degrees C resulted in a reduced ability by AMP and Listeria spp. to proliferate upon exposure to growth temperatures; this was not the case with LAB populations. Comparison of Listeria population estimates made using selective (Oxford) and non-selective (nutrient agar) identified reduced recovery on the former. The magnitude of the deviation increased with the duration of exposure of Listeria populations to 3 degrees C with recoveries on selective systems being reduced by 6.3% immediately after inoculation and 82.3% after 168 h at 3 degrees C, respectively. Growth of populations associated with exposure to abuse temperatures was not accompanied by significant changes in product colour (P < 0.05).

Animals↗

PubMed1993

In vitro evaluation of carbamazepine 200 mg tablets.

A comparative in-vitro performance of carbamazepine 200mg tablet products available on the Kenyan market was evaluated. The products which include the innovator product, Tegretol, have similar quality consonant with pharmacopoeial specifications. A batch of one of the products had a carbamazepine content of 106.6% label claim which was outside the upper limits of 105%. One product packaged in multiple-unit containers of a 1000, had an unacceptable high friability of 6.82% loss in weight. All products had good dissolution profiles and released at least 70% of the dose within 45 minutes. Drug dissolution from tablets was found to vary between batches for one product. At each sampling time, most generics had wide variations in amount of dissolved drug. The effect of such variations on tablet efficacy cannot be ascertained in the absence of bioavailability data.

Carbamazepine↗

PubMed2002

The twisting force of aged consumers when opening a jar.

Many people experience difficulty when opening a vacuum-sealed jar. Yet solutions to the problem continue to be tool-based rather than exploring the possibility of innovative changes in product packaging. Improvement depends on gaining knowledge of the capabilities of users, and of using that knowledge as a base for product innovation. To establish such a base we took a sample of 750 subjects and asked them two questions about how they opened jars at home. We then carried out torque measurements using a force transducer shaped like a jam jar. We reached the conclusion that if opening torque was reduced to 2 N m then 97.6% of users between 50 and 94 years of age and 100% of 20-30 year old users would have no difficulty opening a jar.

Adult↗

PubMed1991

[Effect of packing material and temperature of storage on the quality of maize tortilla].

Three packaging materials (tortilla-packing paper, low-density polyethylene and high density polyethylene) were used to evaluate tortilla shelf-life at two different temperatures (-10 degrees C and 5 degrees C). Tortilla quality changes upon storage were evaluated by measuring pH, total moisture, texture (puncture and cutting resistance) and sensory characteristics. Results were analyzed by means of covariance analysis and slope contrast between treatments with a 0.05 level of significance. At -10 degrees C, the quality of tortillas did not change significantly during 11 days of storage, and the influence of the packaging material was negligible. Tortilla kept at 5 degrees C in high or low-density polyethylenes, had significantly better quality than the paper-packaged product. Textural changes were best shown by the Instron puncture resistance test than by the cutting resistance test. At 5 degrees C, packaged tortillas had a microbiologically stable level for up to seven days, while that at -10 degrees C significantly improved over the storage period.

Analysis of Variance↗

PubMed1993

Growth of Listeria monocytogenes and Clostridium sporogenes in cottage cheese in modified atmosphere packaging.

Low fat cottage cheese (pH 5.14) was inoculated with three strains of Listeria monocytogenes, serotypes 1a and 4b, an isolate from a dairy processing plant, and Clostridium sporogenes ATCC 3584. The cheese was packaged with or without added dissolved CO2 in polystyrene tubs overwrapped with or without high barrier heat shrink film and stored at 4, 7, and 21 degrees C for up to 63 d. The concentration of CO2 in the container headspace was 35% (vol/vol). The CO2 concentration in that headspace declined by one-third over the 63 d of storage at 4 degrees C. Clostridium sporogenes failed to grow under any condition applied in this study. In the conventionally packaged cottage cheese, L. monocytogenes increased from 10(4) to 10(7) cfu/g after lag phases of 28 and 7 d at 4 and 7 degrees C, respectively. In contrast, L. monocytogenes failed to grow in cottage cheese packaged with CO2 and stored at 4 degrees C up to 63 d and increased from 10(4) to 10(5) cfu/g in products packaged with CO2 at 7 degrees C. These data suggest that the addition of CO2 to cottage cheese to extend shelf-life does not represent an increased Listeria or botulism hazard but that cottage cheese could be a vehicle for listeriosis.

Carbon Dioxide↗