9 Nov 2017
Reliable seals with THERMOLAST® M
Aptar Pharma relies on medical grade TPE for eye drop packaging
With several functional components manufactured using a newly developed, medical grade TPE from KRAIBURG TPE, Aptar Pharma launched its ophthalmic squeeze dispenser (OSD). The Thermoplastic Elastomer components come into direct contact with the medical eye drop formulation. Aptar Pharma requires classification as a medical grade plastic in compliance with the stringent regulations for the primary packaging of sensitive medications.
Dry eyes can be caused by various medical conditions, such as diabetes, rheumatism and thyroid disorders, and also by draughts or contact lenses, or by prolonged exposure to computer monitors. Moisturising eye drops are a time-proven remedy. However, they seldom contain preservatives, which cause allergic reactions in many people. Due to its microbiological safety as well as easy and precise dosing capabilities, the ophthalmic squeeze dispenser (OSD) from Aptar Pharma is in widespread use as dispenser for eye drops that contain no preservatives.
To further optimise the product, the manufacturer sought a thermoplastic processable material that allows direct contact with medications. KRAIBURG TPE supported Aptar Pharma in choosing the material through to series production with a comprehensive medical technology service package. The result is a new component manufactured from a new THERMOLAST® M material developed by KRAIBURG TPE for the medical and pharmaceutical market. “In close cooperation with KRAIBURG TPE we were able to further improve the exemplary safety and integrity of the ophthalmic squeeze dispenser from Aptar Pharma, without compromising its intuitive and convenient use,” says Stefan Ritsche, President Global Market Development at Aptar Pharma.
Maximum purity and conformity
Purity, tolerance, quality, continuous availability and safety of the materials used are top priorities in medical technology and are subject to stringent regulations. THERMOLAST® M compounds from KRAIBURG TPE are tested in accordance with relevant standards such as USP Class VI, ISO 10993-4 (haemolysis), ISO 10993-5 (cytotoxicity), ISO 10993-10 (intracutaneous irritations) and ISO 10993-11 (acute system toxicity). In addition, a drug master file (DMF) for the materials is on file with the US Food and Drug Administration (FDA). KRAIBURG TPE is therefore committed to consistent adherence to the specified formulation and manufacturing process. Any necessary changes are announced and implemented in accordance with a defined change control process. After announcement of a change, KRAIBURG TPE guarantees delivery for a period of 24 months and also has the purity of the raw materials guaranteed by its suppliers.
Compounds for medical technology or medical applications are manufactured at KRAIBURG TPE only on special equipment reserved for these products. The company offers its customers in the medical and pharmaceutical sector an extensive service package that ensures maximum control with respect to quality, safety and reliability.
The ophthalmic squeeze dispenser from Aptar Pharma is the only repeated-use dosing system thus far approved by the FDA for liquid medications that do not contain preservatives. The design contains no metal parts whatsoever in the drug flux and is therefore also suitable for very sensitive formulations. The purely mechanical functioning principle of the seal membrane and spring unit eliminates the possibility of microbiological contamination of the liquid.
KRAIBURG TPE has been working in cooperation with Aptar Pharma for a number of years. “Early integration in the project allowed us to contribute our full range of know-how and experience and to offer our customer a TPE solution that fulfils all requirements, including the specified sterilisation”, says Oliver Kluge, Medical Product Consultant at KRAIBURG TPE.
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Notes for editors
About KRAIBURG TPE
KRAIBURG TPE (www.kraiburg-tpe.com) is a global manufacturer of thermoplastic elastomers. From its beginning in 2001 as subsidiary of the historical KRAIBURG Group founded in 1947, KRAIBURG TPE has pioneered in TPE compounds, today being the competence leader in this industry. With production sites in Germany, the US, and Malaysia the company offers a broad range of compounds for applications in the automotive, industrial, consumer, and for the strictly regulated medical sectors. The established THERMOLAST®, COPEC®, HIPEX®, and For Tec E® product lines are processed by injection molding or extrusion and provide numerous processing and product design advantages to manufacturers. KRAIBURG TPE features innovative capabilities as well as true global customer orientation, customized product solutions and reliable service. The company is certified to ISO 50001 at its headquarters in Germany as well as in Malaysia and holds ISO 9001 and ISO 14001 certifications at all global sites. In 2016, KRAIBURG TPE, with over 550 worldwide employees, generated sales of 167 million euros.
About Aptar Pharma
Aptar Pharma is part of the AptarGroup, Inc (NYSE: ATR), which is a worldwide market leader with a broad spectrum of innovative dosing systems for cosmetic and personal hygiene articles, as well as medications, foodstuffs and beverages. Aptar Pharma has been setting standards for decades when it comes to spray and dosing systems in medical technology, including nose spray pumps, inhalers, drop dispensers and injectors. The group of companies, with headquarters in Crystal Lake, Illinois (USA), has production plants in North and South America, Europe and Asia. For more information, please visit www.aptar.com.