SaniSure adds PETG PharmaTainer bottles, carboys with freeze-thaw validation down to -80°C

LUXEMBOURG – SaniSure has introduced PETG PharmaTainer, a bioprocessing bottle and carboy line made with medical-grade Eastman Eastar PETG 6763 resin, offered in sizes from 10ml stability vials to 10L carboys with sterile gamma-irradiated and non-irradiated versions validated for freeze-thaw use down to -80°C.

The addition broadens the existing PharmaTainer portfolio, which already includes PET and polycarbonate, by bringing in PETG as another material option. 

Standard and custom assemblies using Cap2V8 closures and Cellgyn TPE tubing will be available for open and closed operations. 

The same platform can be used from early research and development through clinical and commercial stages, avoiding requalification during scaling.

Cleanliness by Design, Not by Rework

The PETG PharmaTainer line carries the same cleanliness and compliance characteristics as its PET and PC bottle products. 

Particle levels are certified at less than 5 percent of USP <788> limits for sub-visible particulates, with testing carried out at lot release and no post-wash step required. 

Endotoxin results are below the 0.001 EU/ml detection limit under USP <85>, along with RNase/DNase-free certification for use in nucleic acid-based therapies such as mRNA, oligonucleotides, and gene therapy.

According to SaniSure, sterile products in the range are gamma sterilized to SAL 10⁻⁶, reducing the washing, depyrogenation, and sterilization steps often needed for comparable products.

Direct Replacement for Legacy Bottles

PETG products are designed as a direct replacement for legacy PETG bioprocessing bottles, with matching volume and format specifications. 

The line has been validated for freeze-thaw use down to -80°C for applications including bulk drug substance cold chain, stability studies, and frozen intermediates. 

For bioprocessing customers, this means switching to SaniSure’s PETG bottles requires no changes to filling lines, storage racks, or freezer configurations.

A Built-In Standard for Cleanliness

Steven Chevillotte, SaniSure CEO, explained that with PETG PharmaTainer, the company is shifting cleanliness from a post-processing step to a fully automated, built-in standard, enabling SaniSure to confidently deliver the cleanest bioprocessing containers on the market for customers’ most critical applications. 

He noted that the bottles provide the lowest possible levels of particulates, endotoxins, and RNase/DNase, by design, while minimizing adoption timelines.

When Packaging Defines the Process

A bottle that requires post-wash steps is a bottleneck. One that arrives sterile, validated, and ready for -80°C storage is an enabler. 

SaniSure’s PETG PharmaTainer line shifts cleanliness from quality control to quality by design, and lets bioprocessors focus on the drug, not the container.

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