Woman with glass molecule looking at ampoules in front of her

SCHOTT StandardLine Ampoules

Always in line with evolving industry standard
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Safe and stable storage from production to administration

Glass ampoules are one of the most widely used forms of pharmaceutical packaging, with health care professionals around the world using over three million every hour. Whether in a surgery, an emergency room, or an ambulance, clinicians need rapid and simple access to life-saving drugs stored in safe and stable containers.

StandardLine Ampoules are made using FIOLAX® Type I Borosilicate Glass, which offers high chemical resistance and fulfill all specifications regarding hydrolytic resistance to offer stable storage for pharmaceutical companies and to keep drug-container interaction to a minimum.

Tight tolerances ensure an efficient fill-and-finish process, while stringent camera-controlled inspections reduce the amount of rejects. All four available break systems for ampoules help to support easy-to-open usage. 

	 Line of pharmaceutical glass ampoules with different break systems and different forms
Applications

The cornerstone of the global drug storage system

Made using Type I Borosilicate Glass with high chemical resistance according to ISO 9187-1, StandardLine Ampoules have a crucial role in the safe storage of a vast range of drugs and medications around the world. These drugs include:

  • Anesthetics for local, pre-operative, and sedation for short-term procedures.

  • Emergency drugs, such as medication used to treat anaphylaxis, as well as poison antidotes and anti-seizure drugs.

  • Medications for cardiovascular, gastrointestinal, endocrine, neurological, and behavioral disorders.

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Advantages

Low reject rate, reduced particles, and an outstanding fill and finish process

SCHOTT Pharma´s StandardLine Ampoules have a wide range of advantages that benefit pharmaceutical companies, clinicians, and patients.

  • Hermetically sealed through melting, the ampoules provide intrinsic container closure integrity, and deliver an outstanding fill and finish process thanks to highly accurate dimensions and a choice of forms such as Type B.

  • High cosmetic quality provides a low reject rate and high inspectability.

  • Made of 100 % glass, StandardLine Ampoules are tamper-safe and offer high chemical resistance and excellent extractables and leachables profiles.

  • The SCHOTT Pharma´s OPC break system offers tighter and more consistent breakforces.

  • When combined with SCHOTT’s innovative ampoule opening techniques, particle loss during opening can be reduced by more than 60 %.

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Hermetically sealed for intrinsic container closure integrity

100 % tamper-safe with excellent extractables and leachables profiles

ISO dimensions ensure an outstanding fill and finish process

Particle loss during opening can be reduced by 60 %

Specifications

High quality drug containers with a wide range of options

  • Cosmetic AQLs* at least according to current Defect Evaluation List as most relevant industry standard, also aligned with current PDA Technical Report

  • A choice of glass for ampoules is offered: FIOLAX® clear, FIOLAX® amber, FIOLAX® Pro (only for China), and FIOLAX® CHR.

  • StandardLine Ampoules are available in a range of formats, from 1-30 ml.

  • Three forms are available: B, C and D.

  • We offer a choice of packaging, including polypropylene tray and lid, cellophane cover, and polyethylene shrink-wrap.

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Sterile format

High quality drug containers with a wide range of options

With the StandardLine Ampoules of SCHOTT Pharma, you have a range of sterile and non-sterile options. While open (form B and C) and closed (form D) StandardLine Ampoules are available as non-sterile containers from all our sites, form D pre-sterilized ampoules with ethylene oxide (ETO) are available from our Mexico site. 

Pre-sterilized ampoules have the advantage of being ready to fill, which saves time and resources spent on depyrogenation after purchase. Whether pre-washed and pre-sterilized or non-sterile, our StandardLine Ampoules are delivered in highly standardized secondary packaging.

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If you are looking for further information about our products, it’s just a click away! Explore our digital services portal – SCHOTT Connect – and get education, support, and services in one place. Collaborate with SCHOTT experts and get deeper insights into everything you need to know, with: Webinars and podcasts Whitepapers Datasheets and study results Project and Community Rooms

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Victoria de la Torre

Victoria de la Torre

Global Product Management Ampoules

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