Woman doing visual quality checks on pharmaceutical vials

SCHOTT Type I plus® Pharmaceutical glass vials for highly sensitive drugs

Name: SCHOTT Type I plus®
Brand: SCHOTT Pharma

Overview

SCHOTT Type I plus® vials are the ideal containers for sensitive drug formulations

For highly sensitive drugs, leachables from packaging can affect stability, while protein adsorption can cause denaturation, aggregation, and loss of effectiveness. As a solution for highly sensitive drugs, SCHOTT Type I plus® vials feature a silicon dioxide barrier coating created using plasma impulse chemical vapor deposition (PICVD) technology that results in covalent bonding.

This silicon dioxide coating minimizes glass leachables in the neutral and acidic pH range, minimizing pH-shift. This can be particularly beneficial when reconstituting drugs using diluents such as water for injection (WFI). In addition, protein adsorption is reduced, enhancing drug stability and effectiveness.

Based on Type I Borosilicate Glass and available in TopLine quality, the additional ion barrier ensures your sensitive drug formulations are safely stored in low-to-medium pH ranges.

Properties

Superior drug stability and integrity

The silicon dioxide inner coating of SCHOTT Type I plus® vials acts as an ion barrier, providing stability for sensitive drugs in the acidic and neutral pH range. The resulting avoidance of pH-shift also helps to keep diluents such as WFI stable, while minimizing protein adsorption.

Strong stability for sensitive drugs

High stability for drugs that are sensitive to leachables

Reduced protein adsorption

The silicon dioxide inner coating helps to reduce protein adsorption

Minimised pH-shift

Reducing pH-shift helps to maintain drug stability as well as diluents such as WFI and sodium chloride

Layer stability

Long-term layer stability ensures durable protection against ion leaching

Application

Reliable storage solution for complex proteins, radiopharmaceuticals, and diluents

SCHOTT Type I plus® vials are suitable for a wide range of applications. Thanks to their low level of leachables, they are ideal for storing complex proteins, radiopharmaceuticals, and diluents.

Reduced levels of leached aluminum also enable the storage of drugs that contain amino acids, such as parenteral nutrition.

Available in pre-washed, pre-sterilized ready-to-use (RTU) configurations, SCHOTT Type I plus® vials are compatible with a wide range of fill-and-finish lines and can remain nested throughout the process (including freeze-drying).

Specifications


Product Name	Product Name SCHOTT Type I plus®	Product Name EVERIC® pure	Product Name EVERIC® care	Product Name EVERIC® freeze	Product Name EVERIC® strong & smooth	Product Name EVERIC® smart	Product Name SCHOTT TopLyo®	Product Name adaptiQ®	Product Name Core Vials
Applications	Applications Leachable-sensitive drugs in neutral and acidic pH range	Applications Default solution for biologics, diluents, low-filled and high-value drugs	Applications Drugs in high alkaline pH range	Applications Drugs that need deep-cold storage down to -80°	Applications Improved bulk fill-and-finish	Applications Track and trace solution	Applications Drugs that need lyophilization	Applications Pre-washed and pre-sterilized for leaner fill-and-finish	Applications Default solution for generics, chemicals
Tubing/Container Material	Tubing/Container Material FIOLAX®	Tubing/Container Material FIOLAX® CHR (controlled hydrolytic resistance)	Tubing/Container Material FIOLAX® CHR (controlled hydrolytic resistance)	Tubing/Container Material FIOLAX® OS (optimized strength)	Tubing/Container Material FIOLAX® OS (optimized strength)	Tubing/Container Material FIOLAX®	Tubing/Container Material FIOLAX®	Tubing/Container Material Depending on bulk vial used	Tubing/Container Material FIOLAX®
Format	Format 2-50R	Format 2-50R	Format 2R, 6R, 10R	Format 2-30R	Format 2-30R	Format 2-30R	Format 2-50R	Format 2-50R	Format 2-100R
Quality Level	Quality Level TopLine	Quality Level TopLine	Quality Level TopLine	Quality Level TopLine	Quality Level TopLine	Quality Level TopLine	Quality Level TopLine	Quality Level TopLine	Quality Level StandardLine, TopLine
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	Closure Systems Stopper + seal	Closure Systems Stopper + seal or press-fit cap	Closure Systems Stopper + seal
Pre-washed Pre-sterilized	Pre-washed Pre-sterilized Non-sterile and sterile (adaptiQ®) available	Pre-washed Pre-sterilized Non-sterile and sterile (adaptiQ®) available	Pre-washed Pre-sterilized Non-sterile and sterile (adaptiQ®) available	Pre-washed Pre-sterilized Non-sterile available	Pre-washed Pre-sterilized Non-sterile available	Pre-washed Pre-sterilized Non-sterile and sterile (adaptiQ®) available	Pre-washed Pre-sterilized Non-sterile and sterile (adaptiQ®) available	Pre-washed Pre-sterilized Sterile packaging	Pre-washed Pre-sterilized Non-sterile and sterile (only TopLine in adaptiQ®) available
Packaging	Packaging Bulk tray, adaptiQ® solution (tray, cup nest) DATASHEET	Packaging Bulk tray, adaptiQ® solution (tray, cup nest) DATASHEET	Packaging Bulk tray, adaptiQ® solution (tray, cup nest) DATASHEET	Packaging Bulk tray DATASHEET	Packaging Bulk tray DATASHEET	Packaging Bulk tray, adaptiQ® solution (tray, cup nest) DATASHEET	Packaging Bulk tray, adaptiQ® solution (tray, cup nest) DATASHEET	Packaging Pre-sterilized vials tray or cup nest CUP TRAY	Packaging Bulk tray, adaptiQ® solution (tray, cup nest) STANDARDLINE TOPLINE
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Vial coating process

Vial coating process
Vial production process

How to ensure the integrity of highly sensitive drug formulations

Sensitive drugs are at risk from leachables and protein adsorption, compromising stability and effectiveness. Learn how SCHOTT Type I plus® vials that feature an advanced ion barrier coating, reduce these risks and ensure long-term drug protection.

How to store highly sensitive drugs - Next.PNG

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Diana Löber

Global Product Manager Specialty Vials & adaptiQ®

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