Flexible packaging in medical applications

Basell is introducing two new low density polyethylene grades, Purell PE 2420 F and Purell PE 3020H, that have been produced using a medical protocol tailor made to address the specialised requirements of customers in medical blown film applications. Basell’s Purell family of select polyethylene and polypropylene grades delivers advantages in terms of design, regulatory requirements and functionality that the medical and pharmaceutical markets require. The resins can be used by customers that produce flexible packaging for liquid pharmaceutical and medical preparations as well as packaging for any type of medical devices, such as syringes and diagnostics equipment.

Additive-free resins
The new products surpass the performance capabilities of conventional polyethylene, particularly when it comes to their high level of purity. Due to Basell’s medical production protocol, Purell PE 2420F and Purell PE 3020H achieve the requested properties and performance without the use of additives. This further lowers the potential for small amounts of additives migrating into the application. The key factor here is the production process. Whereas standard LDPE resins are produced by the aid of peroxide preparations, the new film grades use a peroxide-free process in their production chain, leading to good organoleptic properties of the resin.

Additives are substances that are often added to a resin which dictate the specific properties of the plastic. Typical regulatory laws strictly regulate additives and the maximum quantities of additives that are permitted to ‘migrate’ out of the plastic. Purell PE grades meet aspects given in medical regulations as they are produced without additives.

Consistent quality packaging
In addition to their high level of purity, the new grades provide good puncture and tear resistance and their mechanical behaviour has demonstrated resistance to the usual variations encountered on industrial processing lines. The use of Purell resins gives customers a way to produce medical packaging with consistent quality, which is essential in the medical sector. Basell launched the new grades in order to address market demands for high-quality PE film that can be produced at the level of the well-established Purellresins. Purell PE resins provide superior processablity, good sealability and excellent mechanical properties.

The new grades complement the existing Purell family of grades used by customers in injection and blow moulding applications, and mark the first step for Basell into PE film applications used in the medical industry. With the addition of the new grades, the Purellfamily now offers the entire density range – from 0,92g/cm3 up to 0,93g/cm3 – required by the LDPE films market.

Medical Protocol
Basell’s Purellfamily of polypropylene and polyethylene resins is designed to address demanding customer requirements for high performance, flexibility and stability. The company and its predecessors traditionally serve a huge number of companies engaged in pharmaceutical and medical applications. The Basell owned Medical Protocol has been designed for manufacturers in the medical sector with special requirements – their products must undergo an intensive validation process before they are approved for use, which can take months to complete.

The Medical Protocol includes Basell’s confirmation on the compliance of the selected Purellgrade with certification for European Medical Device Directive (MDD) and European and US pharmacopoeia and drug master file (DMF) listing, which facilitates obtaining approval by the customer. Through the Medical Protocol the customers agree to use the products only in selected and approved applications. With Purellresins, customers will be informed at least 24 months in advance of relevant changes to the formulation that might become necessary. We could not always provide this assurance of formulation consistency for a standard PE grade.

A quality audit to converters can be provided upon request. In agreement with Asset Management, Basell also provides special quality certificates. With respect to the supply chain, we may agree on plant sourcing on customers’ request (preferably with a back up source) and use only Basell approved hauliers. We continue to support medical applications with dedicated medical grades for use by customers as bottles, containers, closures, tubes, disposable laboratory or diagnostic applications, empty and disposable syringes and packaging for inhaler systems. These are packed separately and not pre-filled. The resins are currently manufactured in Europe and are available for export.

Basell is the global leader in polyolefins technology, production and marketing. It is the largest producer of polypropylene and advanced polyolefin products; a leading supplier of polyethylene and catalysts, and the industry leader in licensing polypropylene and polyethylene processes, including providing technical services for its proprietary technologies. Additional information about Basell is available at www.basell.com.

BIO
Hans-Jürgen Bach is Basell's Application Development Manager. Prior to joining Basell, he gathered professional experience in process development of emulsion polymerization scale-up and technical service in polyester rigid packaging.