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Poison prevention packaging requirements; exemption of hormone replacement therapy products. Final rule.

The Commission is amending its child-resistant packaging requirements to exempt hormone replacement therapy ("HRT") products containing one or more progestogen or estrogen substances. Current exemptions cover some HRT products, but not others. This rule would uniformly exempt from child resistant packaging requirements all HRT products that rely solely on the activity of one or more progestogen or estrogen substances.

Child↗

[Packaging: the guarantee of medicinal quality].

Primary packaging guarantees the pharmaceutical quality of the medicinal preparation received by the patient. Glass bottles containing parenteral solutions for example ensure that sterility, quality and optimal stability are preserved until administration. Recent innovations in materials research has lead to improvements in parenteral infusions. Multicompartmental bags, allowing extemporaneous mixtures without opening the container, constitute an extremely beneficial advance for the patient, allowing administration of mixtures with solutions and emulsions which would be unstable if stored. Metered dose pressurized inhalers are an excellent example of drug administration devices designed specifically to ensure quality and bioavailability. These examples illustrate the important role of primary packaging and demonstrate the usefulness of research and development in this area.

Drug Combinations↗

[Polyethylene terephthalate (PET)--health aspects and food packaging application].

Polyethylene terephthalate (PET) due to its physicochemical properties, especially regidity and glass-like transparency is widely used as food packaging material. The relevant legislation states that substances may not migrate from food contacting materials in quantities that may cause undesirable changes in organoleptic properties of food coming into contact with such material. The lists of substances authorized for food contact plastic materials and requirements for the final product were established. The requirements concern global migration limits (60 mg/kg or 10 mg/dm2) and specific migration limits (SML) set for substances which, when migrate into food in grater quantities may cause risk for human health. For the products manufactured from PET the specific migration limits were set for terephthalic acid (7.5 mg/kg), for isophthalic acid (5 mg/kg), for isophthalic acid dimethyl ester (0.05 mg/kg) and for ethylene and diethylene glycol (30 mg/kg). PET may undergo thermal degradation resulting in formation of acetaldehyde, which may influence organoleptic characteristics of packaged foods changing taste and smell.

Ethylene Glycol↗

Sterility of packaged implant components.

Several implant components in their original glass vial and peel-back packages were subjected to sterility testing to determine whether the contents remained sterile after the expiration date marked on the package had passed. The results from a university microbiology laboratory showed that the contents remained sterile for 6 to 11 years after the expiration dates.

Dental Implants↗

[Historical study of the moth repellent, "Fujisawa Camphor" (7) - selling price and packaging.].

The selling price of "Fujisawa Camphor" has increased 1,000-fold in the 100 years since it first went on sale. This 1,000-fold increase is not high at all. The price of "Fujisawa Camphor" was not low in the 1980s, one of grounds for setting the price was the damage caused by moths to expensive Japanese clothes and curios. For packaging in the Edo era, being wrapped in paper was the mainstream form, but modern-age packaging shifted to a cardboard box. As for "Fujisawa Camphor", a beautiful design was created for the cardboard.

Animals↗

Packaging issues: avoiding delamination.

Manufacturers can minimise delamination occurrence by applying the appropriate packaging design and process features. The end user can minimise the impact of fibre tear and reduce subsequent delamination by careful package opening. The occasional inconvenient delamination is a small price to pay for the high level of sterility assurance that comes with the use of Tyvek.

Biocompatible Materials↗

[Identification of glial cell line-derived neurotrophic factor recombinant retroviral vector and establishment of its packaging cell line PA317].

OBJECTIVE: To identify glial cell line-derived neurotrophic factor (GDNF) recombinant retroviral vector and to establish its packaging cell line PA317. METHODS: PA317 cells were transfected with recombinant retroviral vector pLXSN-GDNF using liposomes. The recombinant retroviral particles were then harvested from culture media of G418 resistant transfected cells and analyzed using RT-PCR. Virus titers in supernatants were investigated. RESULTS: Sequencing date indicated that GDNF gene was exactly identical to the sequence in the GeneBank. PA317 cells were transfected with recombinant retroviral vector pLXSN-GDNF using liposomes, and virus titers in supernatants harvested from culture media of (G418 resistant transfected cells were 10(4)10(5) CFU/ml. CONCLUSION: Packaging cell line PA317/pLXSN-GDNF was established.

Animals↗

Unit dose calendar packaging and elderly patient compliance.

A controlled trial of the effect of a unit dose system of tablet/capsule calendar packaging (Webster-Pak) on the rate of successful self medication both in hospital and after discharge to the community has been completed in a geriatric assessment and rehabilitation unit. Eighty-four elderly patients, 45 using calendar packs (study), and 39 using conventional bottles or packs (control), were followed for three months after discharge. There was a significant improvement in patient compliance in the study group over controls on discharge (86.7% vs 66.7%), 10 days (68.8% vs 41.0%), one month (64.4% vs 38.5%) and three months (48.9% vs 23.1%) after discharge. Unit dose packaging is a cost effective method of improving the delivery of medicine in elderly patients, and should be available as part of the health budget.

Aged↗

Prediction of water vapor transport rates across polyvinylchloride packaging systems using a novel radiotracer method.

A radiotracer method is used to study the transport properties of water vapor in polyvinylchloride (PVC), a plastic commonly used in the packaging of parenteral solutions. Water vapor transport across a PVC film appears to be Fickian in nature. Using the steady-state solution of Fick's second law and the permeability coefficient of water vapor across the PVC film obtained using the described method, the predicted water vapor transport rate (WVTR) for a parenteral solution packaged in PVC is in reasonable agreement with actual WVTR as determined by weight loss under precisely controlled conditions.

Deuterium↗

[Total parenteral nutrition in packages. Methods of application in a general surgery department].

In the period June 1987-March 1988, 80 patients classifiable according to ASPEN criteria were submitted to Total Parenteral Nutrition (TPN) using a single package nutrient mixing technique. The problems relating to the compatibility and stability of the solution are analysed and a protocol is proposed for the preparation of packages and the management of the central venous catheter compatible with the needs of a general surgery department. Personal experience has enabled us to observe the undoubted advantages of this technique: reduction of the time necessary for nursing the TPN patient, greater reliability in controlling speed of infusion and infectious complications, greater comfort for the patient.

Drug Packaging↗

Effect of safety packaging on aspirin ingestion by children.

The effectiveness of child-resistant closures, required under the Poison Prevention Packaging Act of 1970, in reducing the incidence of accidental ingestion of aspirin and aspirin-containing products among children less than 5 years of age has been investigated. Data from Poison Control Centers and the National Center for Health Statistics were analyzed to determine the ingestion level before and two to three years after safety closures were required. Baby aspirin and nonbaby aspirin products were analyzed separately. For baby aspirin. It is estimated that safety packaging has reduced the incidence of ingestions 45% to 55%. For nonbaby aspirin products, the reduction has been 40% to 45%.

Aspirin↗

[Sterilization of packages using radiation. I. Microbiological studies].

Utilization of ionizing radiation for the sterilization purposes enables the sterilization of dressing materials in packed form together with the protecting packages. This procedure secures advantageous conditions for prolongation of storage time of manufactured articles in the sterile state. In this work the results of six years investigations dealing with the sterility of dressings sterilized by 60Co gamma-irradiation and packed in one--and multilayer packaging materials were shown. After sterilization those materials were storaged in various temperature conditions.

Aluminum↗

Modern concepts of packaging surgical needles and suture.

A new, innovative packaging system for surgical needles and sutures has been developed that meets the special needs of surgical technologists. This packaging system consists of an overwrap, or breather pouch, as well as an innerwrap containing the suture swaged to a surgical needle. The flaps of the overwrap are offset and serrated to facilitate the opening and sterile transfer of the inner packet to the sterile field. The inner packet contains either a plastic labyrinth, or craft board that maintains the suture as straight as possible until knot construction. The needle swaged to a suture is 'parked' in foam to protect its sharp cutting edges and point.

Drug Packaging↗

Effectiveness of child-resistant packaging on toxin procurement in young poisoning victims.

The objective of this study was to determine how often and how children < 5 y-of-age involved in unintentional poisonings gained access to those poisons by opening properly secured child-resistant packages. From June 1994 through February 1995 we surveyed caretakers of children < 5 y-of-age presenting with the chief complaint of ingestion, inhalation, or ocular or dermal exposure of potential or perceived toxins. Excluded were exposures to plants, bites or stings, or patients inadvertently overdosed by a caretaker. The survey was administered to caretakers of 168 patients. Mean age was 26 mo (range 9 mo to 56.9 mo). The toxin was in its original container in 71% and transferred to another container or found outside of its container in 29% of cases; 33% involved a child-resistant closure. The child gained access by opening a properly closed child-resistant closure in 20% of the exposures and in 18.5% by opening a properly closed non-child-resistant closure. Child-resistance did not ensure child impenetrability. This suggests the need to reevaluate child-resistant closure testing protocols or retest currently used closures. Packaging misuse, including improper closure use or transferring medications or household products from the original container accounts for a large percentage of pediatric toxin exposures, thus emphasizing the importance of poison prevention education.

Child Health Services↗

[Repetitive movements of the upper limbs: results of exposure evaluation and clinical investigation in the production and packaging of ice cream].

An evaluation was made of the degree of exposure to risk and the frequency of disorders attributable to biomechanical overload of the upper limb in workers employed on packaging in an ice cream factory. The risks were first evaluated against a checklist, then subsequently an assessment was made of the tasks found to feature the highest risks, using an ergonomic analysis method. The method identified several jobs, such as placing ice cream coupes and such like in boxes, as requiring a large number of actions per minute (> 30) and considerable muscular strength. The 59 female workers performing the packaging operations were given a risk-targeted physical examination. The clinical test detected an extremely high frequency of carpal tunnel syndrome, (7.1%) epicondylitis (5.2%) and scapulo-humeral periarthritis (3.5%) in the over 35 years age group, with respect to a control population not exposed to risk. The authors conclude that the repetitiveness of the actions, the use of gloves due to prolonged contact with frozen products and the effects of the low temperatures themselves, may have favoured the spread of the disorders that appeared in this population of workers. These findings must be further supported by more in-depth epidemiological studies.

Adult↗

[Color loss evaluation of a dietary formulation in function of temperature, storage time and packaging].

Color loss of a dietetic formulae based on pumpkin (Cucurbita maxima), rice, hen and vegetable oils was evaluated. The product was under an accelerated test at temperatures of 40, 50 and 70 degrees C for a month. The kinetic reaction of color loss (quality loss indicator) was obtained with n = 1 and Ea = 11.5 Kcal/mol. The product was also stored for sixth months at temperatures of 25, 30, 35 and 40 degrees C using glass containers, laminated and composite cans (non metallic). The color was measured by a colorimetric method and by sensory evaluation under the defined conditions of time, temperature and package. The statistical analyses of the color loss measured by instrument was performed by a randomized block design with a significance level of p < 0.05. The results obtained both by the instrument and by the sensory evaluation method, showed that the temperature and storage time has significant effect (p < 0.05) on the other hand, the package does not have a significant effect. It was concluded from this study that the product could be stored for 6 months at temperatures below 35 degrees C without changes in color.

Color↗

[Twenty-years health surveillance of workers in dipterex packaging].

Data of health surveillance from 1970 to 1989 for the workers employed in dipterex packaging were collected and statistically analyzed with a microcomputer by scoring their whole blood choline esterase activities and symptoms and signs. Results showed working environment improved and air pollution and absorption of pollutants via skin decreased with technology innovation and longterm hygienic supervision, monitoring and health surveillance in the factory. Incidence of dipterex poisoning in workers employed in the department of pesticide packaging lowered significantly, from 25.26% in the early 1970's to 5.17% in late 1970's and to 1.85% during 1980's, with periodical physical examinations for them, and timely management of the patients with poisoning and the cases at high risk.

Adolescent↗

The effect of drug packaging on patients' compliance with treatment for Plasmodium vivax malaria in China.

A study conducted in 1994 showed that the use of blister packs containing antimalarial drugs significantly increased patients' compliance, compared with traditional means of dispensing drugs in a paper envelope. The present study assessed patients' compliance and compared the difference between 3-day chloroquine and 8-day primaquine courses of treatment for vivax malaria. The level of real compliance was determined by making the drugs with phenobarbital, and measuring its level in the blood following treatment. The results show that blister packaging significantly improved patients' compliance (p < 0.001) over traditional means of dispensing antimalarial drugs; there was no difference in treatment compliance between 3-day and 8-day courses when the drugs were in blister packs. However, with ordinary packaging the treatment compliance rate for an 8-day course was significantly less than for a 3-day course (P < 0.05).

Adolescent↗