Purillex® PETG Bottles
Purity. Reliability. Engineered for Bioprocessing.
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Engineered for Bioprocessing - Not Adapted from LabwareMany PETG bottles available today were originally developed for general laboratory storage. Modern bioprocess environments require containers engineered to function as part of the purity fluid handling process. Bioprocess containers must support:
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Purillex Bottles are engineered with these requirements as primary design inputs rather than adaptations from general laboratory products. |
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Purity That Supports Process Performance
Purity in bioprocessing extends beyond sterility. Containers must also minimize particulates, extractables, and variability that may affect sensitive biological processes.
Purillex bottles support purity (contamination control) through:
- High-purity PETG resin selection
- Gamma sterilization
- Controlled manufacturing environments
- USP <788> particulate characterization
- USP <661> physicochemical plastics testing
- USP <85> — Bacterial Endotoxins Test
- Extractables and Leachables material assessment
- Lot-to-lot consistency monitoring
- High optical clarity for inspection
- ISO-compliant documentation
Why Purity Matters
Purity-focused container design helps support:
- Consistent cell growth performance
- Reduced filter fouling risk
- Stable buffer performance
- Reliable analytical testing
- Reduced investigation burden
Reliability Engineered for Bioprocess Performance
Container reliability directly impacts process continuity. Purillex PETG bottles are engineered to support consistent performance across handling, storage, and process integration.
Reliability engineering (process performance and material safety) includes:
- Cold storage durability to –85 °C
- Precision molded threads
- Leak-resistant closure systems
- Torque retention testing
- Tamper-evident options
- Dimensional repeatability
- Impact-resistant PETG construction
- USP <88> — Class VI Biological Reactivity
- USP <87> — Cytotoxicity Testing
- QC inspection checkpoints
- Lot-to-lot consistency
Why Reliability Matters
Reliable containers help reduce:
- Container-related deviations
- Workflow interruptions
- Product loss
- Process variability
- Manufacturing disruption
Designed For Ultra-Low Temperature Bioprocess Applications
Purillex PETG bottles are engineered to withstand storage down to –85 °C, supporting advanced therapy workflows requiring frozen storage. These include:
- Viral vector manufacturing
- Cell therapy processes
- Frozen media staging
- Process intermediates
- Cold chain workflows
Many general laboratory PETG bottles are not engineered for these ultra-low temperature environments.
Quality and Compliance Attributes
Purillex PETG bottles are supported by material characterization and testing aligned with recognized USP standards.
USP-aligned testing and evaluations
- Endotoxin evaluation aligned with USP <85>
- Cytotoxicity testing aligned with USP <87>
- Class VI biological reactivity testing aligned with USP <88>
- Physicochemical plastics testing aligned with USP <661>
- Particulate characterization aligned with USP <788>
These controls support use in:
- GMP manufacturing
- Biologics production
- Advanced therapies
- CDMO operations
Built for High-Value Life Sciences Workflows
Bioprocessing
- Media preparation
- Buffer storage
- Intermediate storage
- Sampling workflows
Advanced Therapies
- Cell and gene therapy
- Viral vector manufacturing
- mRNA production
Pharmaceutical Manufacturing
- GMP production
- Fill-finish preparation
- CDMO operations
Quality Laboratories
- QC reagent storage
- Stability programs
- Analytical preparation
Additional Markets
- Veterinary biologics
- Process development labs
- OEM integration
- Scale-up manufacturing
Packaging Designed for GMP Operations
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Packaging designed for cleanroom use:
Available documentation:
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Container Performance Matters More Than Unit Cost
In sterile bioprocess manufacturing, container selection is typically driven by process reliability rather than unit price.
Industry analyses indicate biologics batch failures associated with contamination or process deviations may result in losses exceeding $500K–$2M per batch, depending on scale and production stage.
Because of this, experienced bioprocess teams prioritize:
- Process compatibility
- Supplier reliability
- Documentation
- Consistency
- Risk reduction
before considering price.
Technical Specifications
Volumes
- 125 mL
- 250 mL
- 500 mL
- 1 L
- 2 L
Material
Polyethylene terephthalate glycol (PETG)
Sterility Options
- Non-sterile
- Gamma sterilized SAL 10⁻⁶
Temperature Capability
Storage to –85 °C
Documentation
- Material declarations
- Dimensional drawings
- Sterility validation summaries
- Certificates of Conformance
- Certificates of Processing
- Lot traceability
Product Highlights
- Gamma sterilized SAL 10⁻⁶
- Ultra-low temperature durability to –85 °C
- 3.5 turn precision-molded threads
- USP <788> ultra-low particulate characterization 100% inspected
- USP <85> endotoxin evaluation
- USP <87> cytotoxicity testing
- USP <88> Class VI testing
- USP <661> plastics testing
- Tamper-evident sterile packaging
- High clarity PETG
- Lot traceability
When Sterile Alone Isn't Enough
Purillex bottles are not commodity sterile containers.
They are engineered for teams needing:
- More purity
- More reliability
- More consistency
- More process confidence
Because in bioprocessing:
Containers are part of the process.
Reduce Container Risk in Critical Workflows
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