Man looking at a pharmaceutical cartridge taken out of a RTU nest

cartriQ® BioPure

Name: cartriQ® BioPure
Brand: SCHOTT Pharma

Pharmaceutical ready-to-use glass cartridges with a homogenous inner surface for superior drug stability

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Overview

cartriQ® BioPure: Your first choice for pharmaceutical ready-to-use glass cartridges

Biotech pipelines are increasingly defined by complex molecules, peptides, and next‑generation modalities that demand reliable, low‑risk primary packaging. Conventional ready‑to‑use glass cartridges can fall short, leading to elevated leachable levels, pH shifts, and increased aggregation risk.

SCHOTT Pharma’s cartriQ® BioPure is designed to address these challenges. Combining FIOLAX® Pro Type I Borosilicate Glass with the latest cartridge manufacturing technology and steam‑sterilization process, this glass cartridge offers a highly uniform inner surface with enhanced hydrolytic resistance and significantly reduced leachable values. For the first time, this superior packaging solution is paired with strict release criteria for sodium and aluminum content.

Part of the SCHOTT iQ® platform, cartriQ® BioPure cartridges are delivered in an industry‑standard nest‑and‑tub configuration, simplifying fill‑and‑finish operations and reducing process complexity. Combined with high‑performance coated and uncoated elastomers from SCHOTT Pharma’s broad partner network, the system allows innovators to focus on the molecule rather than the container and to evaluate multiple device and elastomer options without changing the core container.

Benefits

Reliable choice from the start

Made from FIOLAX® Pro Type I Borosilicate Glass, with its exceptionally high hydrolytic resistance and aluminum levels matching the current USP<660> draft guidance, cartriQ® BioPure is the gold standard for patient safety. It provides long‑term stability for highly sensitive biologics, enabling biotech firms to focus on future formulation adjustments and improved stability performance as complexity increases.

Every cartriQ® BioPure glass cartridge undergoes rigorous leachables testing throughout its production, helping to maintain the integrity of sensitive APIs, regardless of the fill volume. Its tight dimensional tolerances and controlled manufacturing process are engineered to interact, ensuring container closure integrity and high dosing accuracy from early development to commercial scale.

No heavy metals

No heavy metals according to ICH Q3D Class 1, 2, and 3

Ultra-low silicone levels

Quantified silicone content with ultra-low levels of free silicone based on state-of-the-art baked-on silicone

Ultimate drug stability

Proven aluminum levels and exceptional hydrolytic resistance for your pharmaceutical products

Dosing accuracy

Predictable Break-Loose and Glide Force (BLGF) behavior and tight dimensional tolerances secure accurate, device‑ready dosing

Protecting APIs

Enhanced hydrolytic resistance for long-term stability and reduced surface interaction

Component flexibility

Single container with broad elastomer compatibility, plus a variety of coated and uncoated plungers, and handheld injection devices

Sterile solution

Effective steam sterilization, free of harmful residues, providing high sterility assurance for critical assets

Applications

Quality‑by‑design glass cartridges for sensitive biologics

cartriQ® BioPure glass cartridges are engineered to meet the strict requirements of high‑value biologics. Designed according to the principles of quality‑by‑design, from raw materials to manufacturing, the optimized inner surface enhances formulation stability while minimizing the risk of time‑consuming reformulations, including those caused by known critical buffers.

The glass cartridges are ideal for the storage and self‑administration of emerging biologics and biosimilars used in handheld injection devices, such as peptides and recombinant proteins, rare and orphan drugs, emergency medicines, and high‑value formulations with limited API availability.

cartriQ® BioPure cartridges are available pre‑sterilized and delivered ready‑to‑use in an industry‑standard nest‑and‑tub configuration, enabling highly efficient fill‑and‑finish processes.

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Specifications


Product Name	Product Name cartriQ® BioPure	Product Name cartriQ®	Product Name cartriQ® Large Volume	Product Name Core Cartridges	Product Name Cartridges Break Resistant	Product Name Cartridges Double Chamber
Applications	Applications Washed and pre-sterilized for highly sensitive biologics	Applications Pre-washed and pre-sterilized for small-volume biologics	Applications Pre-washed and pre-sterilized for large-volume biologics	Applications Default solution for generics, chemicals and biologics	Applications For emergency drugs	Applications For lyophilized drugs
Tubing Container Material	Tubing Container Material FIOLAX® Pro	Tubing Container Material FIOLAX® CHR (controlled hydrolytic resistance)	Tubing Container Material FIOLAX® CHR (controlled hydrolytic resistance)	Tubing Container Material FIOLAX®	Tubing Container Material FIOLAX®	Tubing Container Material FIOLAX®
Format	Format 3 ml, 5 ml	Format 1.5 - 3 ml	Format 5 ml, 10 ml	Format 1.5 - 20 ml	Format Customized upon request	Format Customized upon request
Quality Level	Quality Level TopLine	Quality Level TopLine	Quality Level TopLine	Quality Level StandardLine, TopLine	Quality Level StandardLine	Quality Level StandardLine
Closure Systems	Closure Systems Stopper + Seal	Closure Systems Stopper + Seal	Closure Systems Stopper + Seal	Closure Systems Stopper + Seal	Closure Systems Stopper + Seal	Closure Systems Stopper + Seal
Pre-washed, Pre-sterilized	Pre-washed, Pre-sterilized Sterile available	Pre-washed, Pre-sterilized Sterile available	Pre-washed, Pre-sterilized Sterile available	Pre-washed, Pre-sterilized Non-sterile and sterile (cartriQ®) available	Pre-washed, Pre-sterilized Non-sterile available	Pre-washed, Pre-sterilized Non-sterile available
Packaging	Packaging Pre-sterilized and pre-washed cartridges in cup nest	Packaging Pre-sterilized and pre-washed cartridges in cup nest DATASHEET	Packaging Pre-sterilized and pre-washed cartridges in cup nest DATASHEET	Packaging Bulk tray, cartriQ® solution (cup nest) STANDARDLINE TOPLINE	Packaging Bulk tray	Packaging Bulk tray

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Get in touch

Florence Buscke

Head of Global Product Management Bulk & Sterile

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cartriQ® BioPure

cartriQ® BioPure: Your first choice for pharmaceutical ready-to-use glass cartridges

Reliable choice from the start

Quality‑by‑design glass cartridges for sensitive biologics

Comprehensive solutions for every pharmaceutical need

Get in touch