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[complaincepackaging-blog]

Compliance Packaging Medications

When the number of medications you take becomes confusing, or perhaps you are just one of those people who has a hard time remembering to take your medication, we have the answer!  We offer compliance packaging services free of charge.  

We have 2 options for compliance packaging:

Traditional Blister Pack

1 week cards with the days of the week down the side and 4 times-slots across the top for your medications. Each weekly pack can fit up to 15 medications!  For those with more than 15 medications, 2 cards would be used for each week.

Labels include descriptions and color pictures of all your medications for easy identification

Can be done in 1 week, 2 week or 4 week cycles, depending on your needs and prescription changes

Are done on a schedule and rotation, and can be set up for automatic delivery so you don’t have to remember to call and ask for your medications

Medication Strip Packaging

Medications are packaged in a strip with dates and times on each package so you know when to take them

No limit on the number of medications that can go in these and each dose time can be separated from the strip and easily taken with you for when you are going to be out

Descriptions of the drugs on each packet

Can be done in 1 week, 2 week or 4 week cycles, depending on your needs and prescription changes

Are done on a schedule and rotation, and can be set up for automatic delivery so you don’t have to remember to call and ask for your medications

[childresistantpackaging-blog]

child resistant packaging,closures, and tactile warning devices

Overall, the requirements for  child resistant packaging used for hazardous chemical products are straightforward. In short, such package should:

prevent escape of the chemical;

not be adversely affected by the chemical; and

be strong enough to withstand normal handling.

In addition, if the package has a replaceable closure this must continue to prevent escape even after repeated use.

The packaging for some chemicals must not have a shape or designation likely to attract the active curiosity of children or mislead consumers. This applies regardless of whether the packaging is re-closeable or not.

Child resistant closures and tactile warning devices

‘Child resistant’  packaging  closures/fastenings and/or ‘tactile warnings’ (raised-profile warnings that can be understood by those with impaired vision) are also required in some cases.

The requirements to include such elements as part of packaging are triggered by either classification under a certain hazard class/category, or by certain substances at specified concentrations. The details appear in the CLP Regulation, Annex II.

[childresistantpackaging-blog]

Child Resistant Packaging New Upadte

Most poisoning accidents involve medicines, household products and cosmetics. According to the World Health Organization (WHO), child-resistant packaging is one of the best-documented successes in preventing the unintentional poisoning of children. It also observed that medicinal drugs are the leading cause of non-fatal poisoning in children in middle and high income countries and in the USA.

Child-resistant  packaging is used to reduce the risk of poisoning in children via the ingestion of potentially hazardous items including certain prescription and over-the-counter (OTC) medications, pesticides, and household chemicals. According to the US Poison Prevention Packaging Act (PPPA), the term “Child-resistant” means that packaging is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly.

It doesn’t mean that children from this category cannot open a Child Resistant Packaging-packaging within a reasonable time. The Child Resistant Packaging is intended to be a last line of defence with safe and appropriate storage of medicines being the primary preventative measure in harm reduction.

In the early 1970s when the first Child Resistant Packaging appeared on the market after the PPPA had published its direction, there only was one packaging format (the bottle or jar) used in this market segment. For pharmaceutical and medicinal products blister packs or original pack dispensing (OPD) packs were uncommon, and consequently we saw the transformation of the bottle cap into a child-resistant closure (CR) as the singular approach to this problem.

But today we have a much more diversified market for medicines as now more than 50% of prescription drugs are dispensed in blister packs and potentially hazardous household products often are packaged in aerosols or spray bottles, representing a potential danger of child poisoning.

The blister pack is an excellent packaging format for medicines and a range of other products, as it incorporates a perfect seal, preventing contact either with the atmosphere or other products and permits dispensing with no risk of contamination at the retail level. Similar arguments can be used to describe the popularity of aerosols and spray bottles in the household market, and also here, thus far, the relevant consumer goods companies have only toyed with CR-blisters and CR-sprayers. The prescription drugs market as well as the household chemicals market is often exclusively serviced with containers (bottles and jars) with the traditional and trusted CR-cap closure.

The Child Resistant -closure for bottles and jars is well known, so I made a selection of recent developments in CR-packaging outside the bottle and jar sphere. I have 3 CR-designs for aerosols and/or spray bottles, 2 recent launches of CR-folding cartons with blisters, a CR-solution for flexible (stand-up) pouches and a CR-blister lidding option.

It will be a long story, so the 3 CR-designs for aerosols go to the next article. In this one the folding cartons, the stand-up pouch and the blister lidding.

Before I start detailing the designs, be aware of the following: The international standard ISO8317: 2003 describes the tests of resistance to child opening and ease of opening by adults. Children, 80% of a panel aged 42-51 months, must be unable to open the packaging in ten minutes, even after a demonstration, and 90% of a panel of 50-70 year old adults have to open and properly reclose the packaging in one minute. PPPA in the USA has similar directions.

In short we can say that a child resistant packaging usually requires a special ‘trick’ to open it. Something too complicated for most young children to work out, but easy to handle by seniors.

CR-slider for flexible packaging Presto Products Company’s launch of a child-resistant flexible pouch opens up new opportunities for flexible packaging in markets where regulated products were previously only available in rigid packaging.

The Child-Guard technology leverages flexible packaging as a format meeting child-resistant mandates. The flexible pouch is child-resistant on the initial opening and subsequent re-openings using the Press-To-Engage (PTE) resealable slider.

The slider is challenging for children under five years old, but simple for adult consumers, including seniors, noted the company. The technology allows brand owners to choose a flexible-packaging format as a lighter-weight alternative to rigid packaging and still meet child-resistant mandates.

The Child-Guard slider meets Title 16 CFR 1700 of the Poison Prevention Packaging Act (PPPA) with ASTM D3475 classification from ASTM International.

The CR method is simple, effective and ingenious: As shown in the illustration, the slider opens with an easy “point, press and pull” motion. Users align the slider tongue with the groove, press down lightly on the slider’s top side and pull the slider across the zipper track for a smooth opening experience. The company claims that adult consumers, including seniors, will find the zipper simple to open, but it will be extremely challenging for children aged five and under addressed by the PPPA regulation.

[compartordrug-blog]

Comparator Dug By Bilcare

It’s good to see drug developers addressing the issue of comparator drug sourcing and working hard to change the way they manage comparator products in clinical trials. Getting comparator sourcing right is crucial because there is increasing pressure from patients and payers to develop drugs that are substantially better than existing treatments. But managing comparator drugs has grown vastly more complex in today’s environment; where clinical studies are conducted in remote locations and biologics development demands sophisticated cold chain supply capabilities.

One of the most pressing challenges they identified was a lack of fully robust supply chain management practices. After working extensively with clinical teams on comparator drug sourcing for the past several years, I agree. A major reason for this supply chain weakness is that companies are so shocked at the high cost of purchasing comparator that they become overly distracted by this line item rather than looking how they could save money and mitigate risks overall by taking a more strategic approach. We address the importance of thinking strategically and avoiding a procurement-driven mindset in a new e-book on the subject.

When it comes to comparator drug sourcing for clinical trials, there are four essential elements to make the process as painless as possible.

 An unmatched geographic footprint with the capabilities and capacity for central and      local sourcing, regulatory support and transportation management in Asia,Latin America and Eastern Europe, as well as the United States and  European Union;

 An established  sourcing network of trusted industry relationships that enables us to      acquire comparator products directly from innovator companies or from  qualified wholesalers at favorable pricing thereby reducing both the costs and risks of counterfeit drugs;

 The financial  strength necessary to support procurement activities in an efficient way that limits financial risk.

Advanced planning, a thorough analysis of the clinical protocol, strategic thinking and an integrated supply partner. All of these considerations will go a long way toward making comparator trials less costly and frustrating.

[childresistantpackaging-blog]

Child Resistant Packaging

Child Resistant Packaging Regulations: The Consumer Product Safety Commission (CPSC) has determined that a hazard to children is posed by the packaging of the following substances and that special packaging is required to protect children from serious personal injury or illness resulting from handling, using, or ingesting these substances:

Guidelines for child resistant packaging:

(1) Aspirin. (2) Furniture polish. Nonemulsion type liquid furniture polishes containing 10 percent or more of mineral seal oil and/or other petroleum distillates and having a viscosity of less than 100 Saybolt universal seconds at 100 °F. (3) Methyl salicylate. Liquid preparations containing more than 5 percent by weight of methyl salicylate. (4) Controlled drugs. Any preparation for human use that consists in whole or in part of any substance subject to control under the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. 801 et seq.) and that is in a dosage form intended for oral administration. (5) Sodium and/or potassium hydroxide. Household substances in dry forms such as granules, powder, and flakes, containing 10 percent or more by weight of free or chemically unneutralized sodium and/or potassium hydroxide, and all other household substances containing 2 percent or more by weight of free or chemically unneutralized sodium and/or potassium hydroxide. (6) Turpentine. Household substances in liquid form containing 10 percent or more by weight of turpentine. (7) Kindling and/or illuminating preparations. Prepackaged liquid kindling and/or illuminating preparations, such as cigarette lighter fuel, charcoal lighter fuel, camping equipment fuel, torch fuel, and fuel for decorative or functional lanterns, which contain 10 percent or more by weight of petroleum distillates and have a viscosity of less than 100 Saybolt universal seconds at 100 °F. (8) Methyl alcohol (methanol). Household substances in liquid form containing 4 percent or more by weight of methyl alcohol (methanol). (9) Sulfuric acid. Household substanes containing 10 percent or more by weight of sulfuric acid, except such substances in wet-cell storage batteries. (10) Prescription drugs. Any drug for human use that is in a dosage form intended for oral administration and that is required by Federal law to be dispensed only by or upon an oral or written prescription of a practitioner licensed by law to administer such drug. *multiple exceptions exist, see regulation for specific examples. (11) Ethylene glycol. Household substances in liquid form containing 10 percent or more by weight of ethylene glycol, except those articles exempted by 16 CFR 1500.83. (12) Iron-containing drugs. With the exception of: (i) Animal feeds used as vehicles for the administration of drugs, and (ii) those preparations in which iron is present solely as a colorant, noninjectable animal and human drugs providing iron for therapeutic or prophylactic purposes, and containing a total amount of elemental iron, from any source, in a single package, equivalent to 250 mg or more elemental iron in a concentration of 0.025 percent or more on a weight to volume basis for liquids and 0.025 percent or more on a weight to volume basis for liquids and 0.05 percent or more on a weight-to-weight basis for nonliquids. (13) Dietary supplements containing iron. Dietary supplements, as defined in § 1700.1(a)(3), that contain an equivalent of 250 mg or more of elemental iron, from any source, in a single package in concentrations of 0.025 percent or more on a weight-to-volume basis for liquids and 0.05 percent or more on a weight-to-weight basis for nonliquids. (14) Solvents for paint or other similar surface-coating material. Prepackaged liquid solvents (such as removers, thinners, brush cleaners, etc.) for paints or other similar surface-coating materials (such as varnishes and lacquers), that contain 10 percent or more by weight of benzene (also known as benzol), toluene (also known as toluol), xylene (alsoknown as xylol), petroleum distillates (such as gasoline, kerosene, mineral seal oil, mineral spirits, naphtha, and Stoddard solvent, etc.), or combinations thereof, and that have a viscosity of less than 100 Saybolt universal seconds at 100 °F. (15) Acetaminophen. Preparations for human use in a dosage form intended for oral administration and containing in a single package a total of more than one gram acetaminophen (16) Diphenhydramine. Preparations for human use in a dosage form intended for oral administration and containing more than the equivalent of 66 mg diphenhydramine base in a single package. (17) Glue removers containing acetonitrile. Household glue removers in a liquid form containing more than 500 mg of acetonitrile in a single container. (18) Permanent wave neutralizers containing sodium bromate or potassium bromate. Home permanent wave neutralizers, in a liquid form, containing in a single container more than 600 mg of sodium bromate or more than 50 mg of potassium bromate. (19) Ibuprofen. Ibuprofen preparations for human use in a dosage form intended for oral administration and containing one gram (1,000 mg) or more of ibuprofen in a single package. (20) Loperamide. Preparations for human use in a dosage form intended for oral administration and containing more than 0.045 mg of loperamide in a single package (i.e., retail unit). (21) Mouthwash. Mouthwash preparations for human use and containing 3 g or more of ethanol in a single package. Mouthwash products with nonremovable pump dispensers that contain at least 7% on a weight-to-weight basis of mint or cinnamon flavoring oils, that dispense no more than 0.03 grams of absolute ethanol per pump actuation, and that contain less than 15 grams of ethanol in a single unit are exempt from this requirement. The term ‘‘mouthwash’’ includes liquid products that are variously called mouthwashes, mouth rinses, oral antiseptics, gargles, fluoride rinses, anti-plaque rinses, and breath fresheners. It does not include throat sprays or aerosol breath fresheners. (22) Lidocaine. Products containing more than 5.0 mg of lidocaine in a single package. (23) Dibucaine. Products containing more than 0.5 mg of dibucaine in a single package. (24) Naproxen. Naproxen preparations for human use and containing the equivalent of 250 mg or more of naproxen in a single retail package. (25) Ketoprofen. Ketoprofen preparations for human use and containing more than 50 mg of ketoprofen in a single retail package. (26) Fluoride. Household substances containing more than the equivalent of 50 milligrams of elemental fluoride per package and more than the equivalent of 0.5 percent elemental fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-liquids. (27) Minoxidil. Minoxidil preparations for human use and containing more than 14 mg of minoxidil in a single retail package. (28)Methacrylic acid. Liquid household products containing more than 5 percent methacrylic acid (weight-to-volume) in a single retail package  Products applied by an absorbent material contained inside a dispenser (such as a pen-like marker) are exempt from this requirement provided that: (i) the methacrylic acid is contained by the absorbent material so that no free liquid is within the device, and (ii) under any reasonably foreseeable conditions of use the methacrylic acid will emerge only through the tip of the device. (29) Over-the-Counter Drug Products. (i) Any over-the-counter (OTC) drug product in a dosage form intended for oral administration that contains any active ingredient that was previously available for oral administration only by prescription . (30) Hazardous substances containing low-viscosity hydrocarbons. All prepackaged nonemulsion-type liquid household chemical products that are hazardous substances as defined in the Federal Hazardous Substances Act (FHSA) (15 U.S.C. 1261(f)), and that contain 10 percent or more hydrocarbons by weight and have a viscosity of less than 100 SUS at 100F. (31) Drugs and cosmetics containing low-viscosity hydrocarbons. All prepackaged nonemulsion-type liquid household chemical products that are drugs or cosmetics as defined in the Federal Food, Drug, and Cosmetics Act (FDCA) (21 U.S.C. 321(a)), and that contain 10 percent or more hydrocarbons by weight and have a viscosity of less than 100 SUS at 100F.

Poison Prevention Packaging Standards.

To protect children from serious personal injury or serious illness resulting from handling, using, or ingesting household substances, the Commission has determined that packaging designed and constructed to meet the following standards shall be regarded as ‘‘special packaging’’ (a) General requirements. The special packaging must continue to function with the effectiveness specifications set forth in paragraph (b) of this section when in actual contact with the substance contained therein. This requirement may be satisfied by appropriate scientific evaluation of the compatibility of the substance with the special packaging to determine that the chemical and physical characteristics of the substance will not compromise or interfere with the proper functioning of the special packaging. The special packaging must also continue to function with the effectiveness specifications set forth in paragraph (b) of this section for the number of openings and closings customary for its size and contents. This requirement may be satisfied by appropriate technical evaluation based on physical wear and stress factors, force required for activation, and other such relevant factors which establish that, for the duration of normal use, the effectiveness specifications of the packaging would not be expected to lessen.

Special packaging, tested by the method described in § 1700.20, shall meet the following specifications: (1) Child-resistant effectiveness of not less than 85 percent without a demonstration and not less than 80 percent after a demonstration of the proper means of opening such special packaging. In the case of unit packaging, child-resistant effectiveness of not less than 80 percent. (2) Ease of adult opening. (i) Senior- adult test shall have a senior adult use effectiveness of not less than 90% for the senior-adult panel test.