CPhI Worldwide: New tamper-evident solutions meeting US requirements under the FDA

CPhI Worldwide: New tamper-evident solutions meeting US requirements under the FDA

Düsseldorf/Frankfurt, October 30, 2019 – It is often only the minor improvements that make a product ideal to use. One example is the new dropper bottle system E / F with different cap solutions – a cap where the tamper-evident (TE) ring stays attached to the bottle after opening (System E) and a sleeved cap (System F).

“Many people need to take eye drops several times a day, so it’s important that these vials work reliably right down to the last drop,” says Niels Düring, Global Executive Vice President at Gerresheimer Plastic Packaging, who, with the help of his team, will showcase an extensive portfolio of plastic primary packaging for solids and liquids to existing and potential customers at booth 111B10 at the CPhl in Frankfurt. The dropper bottles are manufactured in clean rooms.

TE ring – now firmly attached to the bottle

The U.S. Food and Drug Administration (FDA) has set out new requirements for eye-dropper bottles, which stipulate that the TE-ring has to be firmly attached to the bottle in order to protect the original contents. Gerresheimer has therefore developed a new dropper bottle system E / F with two different cap designs, which meets the new requirements and has now been FDA approved. Alongside the already well, known sleeved cap (System F), another one has been introduced, where the tamper-evident ring stays attached to the bottle after opening (System E). The tamper-evident ring consists of flexible parts that act like valve flaps and thus provide a positive-retention mechanism at the bottle neck.

Dropper bottles for all standard volumes

Gerresheimer produces the dropper bottles system E / F in the sizes of 5, 10, 15, and 30 ml under clean-room conditions. The bottle and the dropper are made from LDPE and the cap from HDPE

Gerresheimer now offering gamma-ray irradiation

Gerresheimer can now arrange for vials to be irradiated post-production with gamma rays by selected specialist partner companies for customers interested in this added-value service.

Gerresheimer at CPhI Worldwide

As a leading specialist in drug packaging and administration, Gerresheimer has been a part of CPhI Worldwide for many years. CPhI – the Convention of Pharmaceutical Ingredients – has been the most important trade fair for the development and marketing of pharmaceutical ingredients for the past 30 years. This year’s CPhI is being held in Frankfurt. Gerresheimer can be found at booth 111B10 in hall 11.2 in the InnoPack area.

More information

Plastic primary packaging for pharmaceuticals

About Gerresheimer

Gerresheimer is a leading global partner to the pharma and healthcare industry. With specialty glass and plastic products, the Company contributes to health and well-being. Gerresheimer operates worldwide and its approximately 10,000 employees manufacture products in local markets, close to its customers. With plants in Europe, North America, South America and Asia, Gerresheimer generates revenues of around EUR 1.4 bn. The comprehensive product portfolio includes pharmaceutical packaging and products for the safe, simple administration of medicines: insulin pens, inhalers, micro pumps, prefillable syringes, injection vials, ampoules, bottles, and containers for liquid and solid medicines with closure and safety systems as well as packaging for the cosmetics industry.

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