Medical grade TPE direct contact with medications

Medical grade TPE for direct contact with medications

5:55 AM, 22nd January 2018
Medical grade TPE for direct contact with medications
Abu Dhabi Medical Devices Company puts its trust in THERMOLAST® M products of KRAIBURG TPE. The medical grade TPE is used in innovative auto-disable single-use syringes.

By Josef Neuer

A new ophthalmic squeeze dispenser (OSD) from Aptar Pharma, a leader in drug delivery systems, incorporates several functional components manufactured using a newly developed grade in the THERMOLAST® M family of thermoplastic elastomers (TPE) for medical applications from KRAIBURG TPE. Both companies are headquartered in Germany and have multiple manufacturing locations around the world.

The TPE components come into direct contact with the medical eye drop formulation. Because of this, Aptar Pharma requires the use of materials classified as medical grade plastics 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, and even 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 has been in widespread use as a dispenser for eye drops that contain no preservatives for several years.

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. Stefan Ritsche, president, global market development at Aptar Pharma, has said that in close cooperation with KRAIBURG TPE, his company was able to further improve the exemplary safety and integrity of the OSD, without compromising its intuitive and convenient use.

Guaranteed integrity

Aptar Pharma’s OSD is the only repeated-use dosing system in the world 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 KRAIBURG TPE to contribute its full range of know-how and experience and to offer the customer a TPE solution that fulfils all requirements, including the specified sterilisation. THERMOLAST® M compounds are sterilizable with EtO gas, superheated steam (134°C) or gamma ray treatment (2 x 35 kGy).

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 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.

More applications with THERMOLAST® M

The Aptar Pharma OSD is just one of numerous high-quality pharmaceutical dispensing products that benefit from the use of TPEs approved for medical applications from KRAIBURG. The company is also providing grades of THERMOLAST® M for syringes, for example.

Especially in developing countries, syringes that are contaminated through unauthorized reuse cause innumerable infections, often with life-threatening consequences. In response to this problem, Abu Dhabi Medical Devices Company (ADMD) has developed an Auto-Disable syringe (AD syringe), which activates at zero seconds and cannot be refilled and reused. The key to this technology is in the small TPE seals manufactured from THERMOLAST® M: the suction from filling the syringe with liquid activates an integrated one-way valve. After the medicine is injected, a plastic pin in a TPE seal closes the opening to the needle, sealing it reliably. The needle is blocked, preventing reuse of the syringe. This Auto-Disable (AD) mechanism effectively eliminates the risk of transmitting infections from one patient to another by pathogens carried by the blood, such as HIV or hepatitis B. Global health organizations such as WHO, UNICEF, PAHO and UNRWA acclaim these syringes and use them in their vaccination programs around the world.

ADMD has also launched a one-of-a-kind and patented AD Needle, with the same technology as the AD Syringe. The AD Needle can be mounted on single-use standard syringes or prefilled syringe, transforming them into auto-disable syringes.

“We chose KRAIBURG TPE as our development partner in this ambitious project because THERMOLAST® M has all the relevant ISO10993 certifications and provides a reliable seal for our system in contact with media,” said Mounir Haddad, General Manager of ADMD. “In combination with extensive support offered by the company with its medical service package, we can be certain of maintaining our high-quality requirements and product safety in the future, as well. The cooperation between the two companies extends to two syringe types of different sizes.

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.

Ophthalmic squeeze dispenser (OSD) from Aptar Pharma with components made of medical grade thermoplastic elastomers of the product group THERMOLAST® M from KRAIBURG TPE for direct contact with medications.

Abu Dhabi Medical Devices Company puts its trust in THERMOLAST® M products of KRAIBURG TPE. The medical grade TPE is used in innovative auto-disable single-use syringes.

Author: Josef Neuer is from Product Management, EMEA at KRAIBURG TPE.

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