SaniSure Launches PETG PharmaTainer™: Cleaner by Design, Bioprocessing Bottles & Carboys
SaniSure® today announced the launch of PETG PharmaTainer™, a new line of bioprocessing bottles and carboys built on the trusted medical-grade Eastman Eastar® PETG 6763 resin (DMF#9987) and manufactured via Injection Stretch Blow Molding (ISBM) under restricted-access ISO 5 conditions using sterile-filtered air. Every bottle exits the RABS robotically capped, yielding a container that is clean by design — no post-manufacture washing, no extra processing steps, no compromise on quality.
Available in volumes from 10 mL stability vials to 10 L carboys — in sterile (gamma-irradiated) and non-irradiated configurations — PETG PharmaTainer supports the full bioprocessing workflow. Standard and fully custom assemblies with Cap2V8® closures and Cellgyn™ TPE tubing are available for both open and closed operations. Start with PharmaTainer in early-stage R&D and carry the same platform through clinical and commercial phases — no requalification required when scaling.
For part numbers, ordering information, and technical specifications, visit sanisure.com or contact your SaniSure representative.
Steven Chevillotte, CEO of SaniSure®, said:
Today, we’re proud to officially launch PETG PharmaTainer™, a major milestone for SaniSure and a powerful new tool for you in the field. This is not just another PETG bottle. This is the cleanest bioprocessing container available — by design and by process.
Cleaner by Design: What Sets PETG PharmaTainer™ Apart
PETG PharmaTainer delivers a validated suite of cleanliness and compliance attributes:
• Ultra-Low Particle Levels: Certified to less than 5% of USP <788> limits for sub-visible particulates, tested multiple times per shift and at lot release — no post-wash required.
• Exceptional Endotoxin Control: Endotoxin results consistently below 0.001 EU/mL per USP <85>, validated using a 5% rinse volume test — achieved by design, not by washing.
• RNase/DNase-Free Certified: Validated for nucleic acid-based therapies including mRNA, oligonucleotides, and gene therapy applications requiring contamination-critical containers.
• Ready-to-Use — Sterile and Endotoxin-Free: Gamma-sterilized to SAL 10⁻⁶, eliminating the 2–3 days of washing, depyrogenation, and sterilization typically required with competitive products, reducing labor and contamination risk.
• Freeze-Thaw Validated to −80°C: Suited for bulk drug substance cold chain, stability studies, and frozen intermediates, extending operational flexibility across the full temperature range.
• Drop-In PETG Replacement: One-to-one volume and format compatibility with incumbent PETG bioprocessing bottles, supported by a comparability guide and dedicated technical support to minimize change-control burden.
• Comprehensive Validation Package: Medical-grade resin with DMF#9987, USP <665> high-risk extractables profile, USP <87>/<88> Class VI, ISO 10993 biocompatibility, and lot-level certificates of compliance.
