What Sterility and Cleanliness Levels Do PETG PharmaTainer Bottles Provide?

PETG PharmaTainer bottles are available sterile or non-sterile. Sterile bottles achieve a Sterility Assurance Level (SAL) of 10⁻⁶ per ISO 11137 via gamma or x-ray irradiation. Cleanliness specifications include subvisible particulates below 5% of USP limits, endotoxin levels below 0.001 EU/mL at lot release, and certified DNase/RNase-free status — the only PETG bottle in the market to carry this certification.

How Easy Is It to Convert from Existing PETG Bottles to PharmaTainer?

Converting to SaniSure PETG PharmaTainer is designed to be straightforward. The bottles use standard GMP-compatible cap and closure systems, and SaniSure provides full regulatory documentation packages to support change control and supplier qualification. The Cap2V8 assembly system is compatible with PharmaTainer bottles, enabling easy integration into existing fluid transfer and sampling setups without redesigning workflows.

PETG Bottles & Carboys for GMP

Name: PETG PharmaTainer™ Bottles and Carboys
Brand: SaniSure
SKU: PETG-PHARMATAINER
Availability: InStock

Ultra-Clean

Sterile

RNase/DNase-
Free

Ultra-Low
Particulates

Ultra-Low
Endotoxin

Drop-In
Replacement (10 mL – 10 L)

What is PETG PharmaTainer?

PETG PharmaTainer is a platform of ready-to-use, square PETG bottles and carboys that combine exceptional cleanliness, 10^-6 sterility assurance, and comprehensive regulatory documentation for sampling, shipping, storage, and processing of biomanufacturing fluids from lab through commercial manufacturing.

The PETG PharmaTainer family mirrors the standard PharmaTainer platform but is optimized for PETG applications, enabling one-to-one replacement of incumbent PETG bottles with enhanced cleanliness and validation.

Download Datasheets

Sterile Non-Irradiated

PETG PharmaTainer carboy with volume markings

Key Specifications

Volume Range

10 mL to 10 L (square bottles and carboys)

Material

Medical-grade Eastman Eastar PETG 6763

Animal Derived Component Free (ADCF)
Pass USP <661.1>
DMF 9987

Sterility

SAL 10⁻⁶ (gamma/validated per ISO 11137)

Freezing

Validated to -80°C with appropriate handling

Cleanliness

Nucleases: DNase/RNase-free

Endotoxins: <0.001 EU/mL

Particulates: <5% of the USP<788> limits

Bioreactivity

USP <87>/<88>, ISO 10993-3, 5, 6, 10 & 11

Extractable Profile According to USP <665>

Extractions at High Risk level

Scientist handling PETG PharmaTainer bottle

What is PETG PharmaTainer Designed For?

PETG PharmaTainer™ bottles are engineered for sampling, storage, shipping, and processing of biomanufacturing fluids from lab through commercial manufacturing, including the most critical applications.

Sensitive Modality Support

RNase/DNase-free certification—in the PETG bottle market—for biologics, CGT, and nucleic-acid-based applications.

Nuclease-Free White Paper ›

Cold Chain Performance

Validated for frozen storage down to −80°C with appropriate handling precautions.

Fluid Handling Flexibility

Open and closed operations with HDPE caps, ported closures, and Cap2V8^® assemblies support Annex 1 contamination control.

High Purity

Ultra-low particulate and endotoxin levels. The lowest of any bottle.

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What Biomanufacturing Applications Does PETG PharmaTainer Support?

Learn More About Applications

Upstream

Media, supplement and feed preparation, storage and transfer.

Downstream

Buffer and reagent preparation, storage and transfer. Intermediate frozen and liquid storage, processing and transfer.

Drug Substance

Frozen and liquid shipping and storage of bulk drug substance and stability samples.

Utility

In-process and utility sampling. WFI, reagent and compatible chemical storage and transfer.

How Does SaniSure Manufacture PETG PharmaTainer?

SaniSure manufactures PET PharmaTainer bottles and carboys with a proprietary process and high levels of automation to deliver DNase/RNase free containers with extra-low particulate and endotoxin levels, high clarity, and robust integrity for GMP customers requiring validated, documented, traceable containers.

Process Controls

Manufactured with a proprietary process and high levels of automation.

Inspection and primary packaging performed in ISO 7 cleanroom environments.

Injection-Stretch-Blow-Molding (ISBM) process designed to support uniform wall thickness, dimensional consistency, clarity, and cleanliness

Traceability & Documentation

Individual PharmaTainer traceability via serial number, lot number, expiration date with data matrix and recycling logo to support internal compliance and tracking requirements.

Routine bioburden, endotoxin, and particulate monitoring (USP <61>, <85>, <788>) with defined pre- and post-gamma shelf life.

Regulatory Support

Biocompatibility per USP <87>/<88> (Class VI) and ISO 10993 parts 3, 5, 6, 10, and 11.

Plastic packaging systems compliance per USP <661.1> extractables profile per USP <665>, High Risk level, and resin DMF #9987 for Eastman Eastar medical-grade PETG 6763.

What Components Are Included
in the PETG PharmaTainer System?

PETG PharmaTainer is a modular platform that scales from basic bottles to fully closed, integrated assemblies using SaniSure components.

PETG PharmaTainer bottle and carboy family

Core Components

PETG PharmaTainer Square Bottles and Carboys

125 mL, 250 mL, 500 mL, 1 L, 2 L, 5 L, and 10 L

PETG PharmaTainer Vials

10 mL and 50 mL

Standard HDPE Closed Caps, Ported Caps and Cap2V8 Integrated Assemblies

Gasket-free double-lip sealing for reliable integrity.

Assemblies & Integration

Cap2V8 Closures and Tubing Assemblies ›

Aseptic transfer, sampling, and fill operations aligned with EMA cGMP Annex 1 closed-processing practices, with standard and custom configurations available.

SaniSure Tubing ›

Mixed4Sure™ Mixing Solutions ›

Single-use, out-of-the-box bottle and carboy mixing platform that enables continuous mixing at smaller volumes with reduced shear forces and CapEx.

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Why Choose SaniSure's PETG PharmaTainer Bottles?

SaniSure's PETG PharmaTainer delivers a premium PETG bottle platform that meets the strictest cleanliness, validation, and regulatory expectations for bioprocessing. It is especially suited to customers who want to reduce contamination risk, streamline audits, and simplify change control when switching from incumbent PETG bottles.

RNase/DNase-Free Certification

Extra-Low Endotoxin Test Limits

Ultra-Low Particulate Specifications

Comprehensive Documentation

Ready to Use: No internal washing, depyrogenation, or sterilization

−80°C Validated Freeze and Handling Performance*

Seamless integration with SaniSure's Single-Use Portfolio

Consistent Branding, Specifications, Traceability

*With appropriate frozen-state handling practices.

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FAQs

Can PETG PharmaTainer Bottles Be Used for Frozen Storage and Shipping?

Yes. They are validated for freezing down to −80°C, provided bottles and assemblies are handled carefully to minimize breakage and preserve integrity. For information on shipping solutions, please contact SaniSure's technical team.

What Sterility and Cleanliness Levels Do They Provide?

Available sterile or non-sterile. Sterile bottles achieve SAL 10⁻⁶ under ISO 11137 after gamma or x-ray treatment, <5% of USP<788> subvisible particle limits, <0.001 EU/ml for lot release, and are certified DNase/RNase free.

How Easy Is It to Convert from Existing PETG Bottles?

PETG PharmaTainers mirror incumbent PETG formats (10 mL–10 L), enabling drop-in replacement with minimal process changes. PharmaTainers meet or exceed all existing PETG rigid container specifications. Comprehensive Comparability guides help map existing usage to equivalent SKUs across all technical requirements.

Since PETG PharmaTainers are manufactured with the Eastman Eastar™ 6763 Copolyester DMF#9987 — the transition is facilitated.

How Does PETG PharmaTainer Support GMP Compliance?

PharmaTainer bottles and carboys are certified DNase/RNase free and are backed by biocompatibility testing (USP <87>/<88>, ISO 10993), plastic packaging compliance (USP <661.1>), extractables data (USP <665>, High Risk level), resin DMF, and lot-specific ultra-low endotoxin and particulate testing and certificates for audits and submissions.

The PharmaTainer product line was conceived from the very start to reliably establish and maintain the highest purity and best characterized rigid container system for biopharmaceutical applications. Lot release criteria include endotoxin, particulates, leak tightness, dosimetry (sterility) and conformance to specifications. Individual PharmaTainer serial numbering enhances traceability of filled containers.

How Do PETG PharmaTainer Bottles Compare to Standard PETG Media Bottles?

PETG PharmaTainer bottles are manufactured from the same Eastman Eastar™ 6763 copolyester resin as legacy PETG media bottles and are available in equivalent sizes — making them a drop-in replacement that requires no change to your fluid-contact surface or bottle material.

Where PharmaTainer differentiates is in manufacturing environment, cleanliness specifications, and validation package. Stricter limits for particulates and endotoxin, DNase/RNase-free certification, and a comprehensive extractables and traceability documentation package make PharmaTainer the stronger choice for applications requiring tighter process control.