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LDPE grades for Blow Fill Seal applications in pharmaceutical packaging

The healthcare industry is increasingly moving towards home based monitoring and treatment. This trend is challenging the healthcare packaging industry to develop resin grades which measure up to the highest healthcare standards and enable packaging design which is user-friendly though childproof. Responding to this shift, SABIC® PCG offers converters tailored healthcare solutions that allow smart packaging without the risk of leakage and a safe disposal of healthcare products.It consists of a wide range of Polyethylene (PE) and Polypropylene (PP) solutions for Blow Fill Seal, Blow Molding and Injection Molding technologies. These grades support a broad spectrum of healthcare applications, varying from containers, bottles, closures and bags to ampoules and connectors. They have a Drug Master File (DMF) number and comply with the relevant monographs of the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP VI). LDPE grades for healthcare are produced under controlled conditions resulting in high product quality, consistency and a high level of purity. LDPE PCG00 is an additive free grade, which can be used for healthcare packaging and can typically be converted by Blow Fill Seal, Blow Molding and Blown Film to produce ampoules, bottles and tubes. It has a low MFR and a high density to give excellent mechanical properties and higher temperature resistance. These grades are additive-free (PCG grades do not contain antioxidant, antiblock or slip agent).
A new low density polyethylene (LDPE) grade for use in pharmaceutical packaging has been launched by LyondellBasell Industries. Purell PE 3420F has a density of 0.933 g/cm3, processes easily and has a wide range of best-in-class mechanical properties. Compared to standard LDPE, the grade has higher sterilization temperature resistance and provides significant wall-thickness reduction potential, which offers various cost-saving capabilities for customers using blow-fill-seal (BFS) technology to produce applications such as infusion bottles. If sterilization is needed, certain regulations require infusion solutions to be sterilized at 121°C for 15 minutes, even when filled under aseptic BFS processing conditions. However, LDPE typically cannot be sterilized at this temperature due to its melting point which is lower than 121°C. Regulatory authorities accept lower sterilization temperatures, if the treatment time is increased in parallel (equivalence method). Sterilization time for a standard LDPE used in this process may range from 130-195 minutes, and by using Purell PE3420F resins this time can be reduced to approximately 30-50 minutes. Additional benefits of it’s high density and excellent melt strength include the potential for wall thickness reduction while maintaining a high water vapor barrier. Shelf life can be extended while maintaining wall thickness at previous levels. The high melt flow leads to excellent processing and high design versatility. The new grade has the potential to be well suited for intravenous bottle production due to its intrinsically high purity; it is produced without additives and thus has a very low leachables/extractables profile.
To address specific challenges facing the healthcare value chain, The Dow Chemical Company (Dow) introduced HEALTH+ Polymers to the European industry. HEALTH+ contains a portfolio of high performance polyolefins that includes a strong commitment to service, production quality and regulatory compliance. Products in the portfolio in Europe include specific grades of Low Density Polyethylene for medical industry and pharmaceutical packaging. High-performance polyolefin grades specifically designed for blow-fill-seal applications include LDPE 91003 HEALTH+ and LDPE 91020 HEALTH+ Polymer. The product range offers great processability, clarity, squeezability/collapsibility and sterilizeability.
Ineos Polyolefins hopes that its new Eltex MED low-density polythene (LDPE) packaging line will provide pharmaceutical manufacturing firms with a means of meeting the demands of long term storage. The range, which will be manufactured at its' existing LDPE facility in Bramble, Norway, was developed to cater for blow-fill-seal applications in the drug production industry. Such applications typically include use in the production of intraveneous fluid bottles and single dose ampoules for the packaging of respiratory and ophthalmic drugs that require steam sterilisation at temperatures of up to 110°C. The technology is also compliant with the requirements of the injection moulded pharmaceutical packaging market in that it is capable of withstanding both ethylene oxide gas treatment and radiation-based sterilization of up to 35 kiloGreys. The LDPE grades have been developed to be contamination-free and compliant with current European and US Pharmacopoeia class VI criteria. The range consists of four products: Eltex MED PH22D630; Eltex MED PH23T630; Eltex MED PH27D630; and Eltex MED PH30D630, each of which is being aimed at a particular sector of the drug packaging market. Eltex MED PH22D630 is designed to be used can be used in pharmaceutical products manufactured using conversion techniques such as injection moulding and film blowing. In contrast, Eltex MED PH23T630 is intended for use in the manufacture of flexible lids, caps and closures and diagnostic packaging. Eltex MED PH27D630 will withstand heating up to 110°C, while Eltex MED PH30D630 which is intended for blow moulding of soft and flexible packages for pharmaceutical products. Eltex®MED LDPE is a leading brand for the Blow-Fill-Seal technology used in pharmaceutical liquid packaging. Primary Blow-Fill-Seal applications are IV fluid bottles and single dose ampoules for packaging of respiratory and ophthalmic treatment solutions. Borealis’ Bormed LE6609-PH is a LDPE produced in a high-pressure process intended for blow molding of soft and flexible packages for pharmaceutical products. It can be used in "blow-fill and seal" machines for the production of ampoules and bottles. The product can also be used for pharmaceutical products manufactured with other conversion techniques such as injection molding and film blowing. LE6609-PH will withstand heating up to 110°C and therefore units made from this product may be steam treated to max 110°C. This transparent, Blow Fill and Seal (BFS) low density polyethylene offers a high density level and therefore a high melting point. The resulting high steam sterilisation temperature allows converters to reduce autoclave residence time by up to 1.5 hours, speeding up their production cycle, lowering energy use and improving efficiency. In addition, it’s high density and optimised molecular weight distribution (MWD) offers the potential for material and weight reduction of up to 5-7%. Converters and brand owners can make more products of a lighter weight using the same material volume, while the resulting energy savings benefit both manufacturing costs and the environment. Bormed materials are European Pharmacopeia (EP) and US Pharmacopeia compliant and are Drug Master File registered. In addition, most of the Bormed grades comply with biocompatibility standards as specified in ISO 10993.
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