SaniSure has introduced PETG PharmaTainer, a bioprocessing bottle and carboy line made with medical-grade Eastman Eastar PETG 6763 resin and the company’s production process and automated manufacturing systems.
The addition broadens the existing PharmaTainer portfolio, which already includes polyethylene terephthalate (PET) and polycarbonate (PC), by bringing in PETG as another material option.
The range will be offered in sizes from 10ml stability vials up to 10l carboys, with sterile gamma-irradiated and non-irradiated versions.
The products are intended for use across bioprocessing stages.
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.
The PETG PharmaTainer line carries the same cleanliness and compliance characteristics as its PET and PC bottle products.
These include particle levels certified at less than 5% of USP <788> limits for sub-visible particulates, with testing carried out at lot release and no post-wash step required.
It also reported endotoxin results 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 sterilised to SAL 10⁻⁶.
This reduces the washing, depyrogenation and sterilisation steps often needed for comparable products.
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.
PETG products are designed as a direct replacement for legacy PETG bioprocessing bottles, with matching volume and format specifications.
The company added that a comparability guide and technical support will be available.
SaniSure CEO Steven Chevillotte said: “With PETG PharmaTainer, we are shifting cleanliness from a post-processing step to a fully automated, built-in standard - enabling us to confidently deliver the cleanest bioprocessing containers on the market for our customers’ most critical applications.
"Our bottles provide the lowest possible levels of particulates, endotoxins and RNase/DNase - by design - while minimising adoption timelines.”
