PETG PharmaTainer Press Release
PETG PharmaTainers Cleaner by Design, Bioprocessing Bottles & Carboys
FOR IMMEDIATE RELEASE
April 1, 2026SaniSure Launches PETG PharmaTainer™:
Cleaner by Design, Bioprocessing Bottles & Carboys
Industry-standard
PETG material meets industry-leading cleanliness, compliance, and
RNase/DNase-free validation — now available for the full bioprocessing
workflow.
SaniSure Launches PETG PharmaTainer™:
Cleaner by Design, Bioprocessing Bottles & Carboys
Industry-standard
PETG material meets industry-leading cleanliness, compliance, and
RNase/DNase-free validation — now available for the full bioprocessing
workflow.
CAMARILLO, CA — SaniSure®,
a global leader in single-use bioprocessing solutions, today announced the
official launch of PETG PharmaTainer™, expanding its PharmaTainer family of
bioprocessing bottles and carboys with a dedicated PETG offering designed and
validated to meet the most demanding standards in biopharmaceutical
manufacturing.
Built on the trusted Eastman
Eastar® PETG 6763 resin (medical-grade DMF#9987) and manufactured via Injection
Stretch Blow Molding (ISBM) under restricted-access ISO 5 conditions using
sterile-filtered air, PETG PharmaTainer sets a new benchmark for cleanliness in
bioprocessing containers — requiring no post-manufacture washing, no extra
processing steps, and no compromise on quality.
“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.”
—
Elisabeth Vachette, Senior Director, Product Line Management, SaniSure®
Cleaner by Design: What Sets PETG PharmaTainer Apart
PETG PharmaTainer delivers a
comprehensive suite of validated cleanliness and compliance attributes:
•
Ultra-Low Particle Levels: Certified to contain
less than 5% of USP <788> limits for sub-visible particulates, tested via
light obscuration multiple times per shift and at lot release — no post-wash
required.
•
Exceptional Endotoxin Control: Endotoxin test
results consistently below 0.001 EU/mL detection limit per USP <85> —
achieved by design, not by washing.
•
RNase/DNase-Free Certified: The only PETG
bioprocessing bottles and carboys on the market validated as RNase/DNase-free,
making them uniquely suited for nucleic acid-based therapies including mRNA,
oligonucleotides, and gene therapy applications.
•
Ready-to-Use — Sterile and Endotoxin-Free: Gamma-sterilized
to SAL 10⁻⁶, eliminating the 2–3 days of washing, depyrogenation, and
sterilization steps typically required with competitive products.
•
Freeze-Thaw Validated to −80°C: Suited for bulk
drug substance cold chain, stability studies, and frozen intermediates 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.
•
Leak-Proof Double Neck Seal: Validated container
closure integrity torque values ensure secure containment from storage through
shipment.
•
Comprehensive Validation Package: Medical-grade
resins with DMF# (Eastman Eastar PETG 6763 — DMF#9987), USP <665>
high-risk extractables profile, USP <87>, <88> Class VI, and ISO
10993 biocompatibility, with lot-level certificates of compliance.
Availability and Configuration
PETG PharmaTainer is available
in volumes from 10 mL stability vials to 10 L carboys, in sterile
(gamma-irradiated) and non-irradiated configurations, supplied in individual or
multi-unit double-wrapped packaging. Standard bottle assemblies and fully custom
assemblies with Cap2V8® closures, Cellgyn™ TPE tubing, and filters are
available to support both open and closed operations, including EU Annex
1-driven contamination control strategies.
PETG PharmaTainer is
manufactured in SaniSure’s facility in Bascharage, Luxembourg, under an ISO
9001 certified quality management system, with individual bottle serialization
for enhanced traceability.
Designed for the Full Bioprocessing Workflow
PETG PharmaTainer supports a
broad range of applications across the biomanufacturing continuum:
•
Media, buffer, and reagent preparation and storage
across upstream and downstream processes.
•
Bulk drug substance, intermediates, process and
stability samples, and WFI storage.
•
Oligonucleotide, mRNA, and gene therapy workflows
requiring certified RNase/DNase-free containers.
•
Research and early-stage development through clinical
and commercial phases — no requalification required when scaling.
About SaniSure®
Created from the merger of six market-leading companies,
SaniSure is a global provider of single-use bioprocessing solutions, custom
assemblies, and engineered components. With operations spanning Camarillo (CA),
Twinsburg (OH), Bascharage (Luxembourg), Stapleford (UK), and Shanghai (China),
SaniSure combines unparalleled flexibility with end-to-end design,
manufacturing, and regulatory support capabilities. Learn more at sanisure.com
Media
Contact
SaniSure
[email protected]
+1
800 726 4835
sanisure.com
