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Trusted containment for sterile workflows
A complete containment portfolio—from sampling to bulk storage
Fluid containment should work easily within your process—without compromising integrity or compliance. Our trusted, validated systems support process integrity, compliance, and supply assurance from development through commercial manufacturing. Engineered for leakproof performance, low particulates, and backed by robust regulatory documentation, our single-use and reusable solutions help reduce contamination risk, facilitate consistent quality, and strengthen supply chain resilience across the bioprocessing workflow.
Featured products
Select containment based on where you are in your workflow
Clean. Ready-to-use.
Documentation and traceability to support qualification in regulated workflows.
ISO compliant cleanroom manufacturing
Brochure: Building a robust manufacturing network: The way forward in single-use supply assurance
USP <788> CGMP
Compliance with <788> CGMP compliance
Sterilization validated
Each batch is tested and validated
How clean is clean?
Choose the level of clean required for your application.
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Product qualities |
Application examples |
Container materials |
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PETG |
PC |
HDPE |
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Standard |
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✔ |
✔ |
Low particulate |
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✔ |
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N/A |
Ultra-low particulate |
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✔ |
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✔
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* Our guarantee for a leakproof seal is subject to our standard product warranty, as set forth in the Thermo Fisher Scientific Terms and Conditions of Sale. Our products are leakproof under use with our required specifications at ambient temperature and pressure when used with their corresponding closures, when handled properly and secured by the user properly. However, to facilitate safe usage, customers are advised to test our containers and closures under conditions of their planned application.
** Not all Platinum Certified Clean products require WFI wash to meet particulate claims.
Customer-favorite configurations for common bioprocess applications
Controlled manufacturing for clean, consistent performance
Even trace particulates can compromise product quality in bioprocessing. That’s why Nalgene containers are manufactured, assembled, and packaged in ISO-classified cleanroom environments under validated process controls.
From resin selection through final packaging, each step is designed to support USP <788> particulate standards, endotoxin limits, and cGMP expectations. Controlled cleanroom environments, validated washing processes, and documented batch traceability help ensure consistent performance from development through commercial manufacturing.
For applications requiring enhanced particulate control, optional low-particulate washing services are available to further minimize contamination risk
Resources and insights
Frequently asked questions
Bottles and carboys are both single-use containment solutions designed to securely store and transport liquids in bioprocessing applications.
- Bottles are generally smaller-volume containers suitable for media, buffer storage, sampling, and transport of intermediate volumes.
- Carboys are larger-capacity containers designed for bulk storage and handling of larger volumes of liquids such as drug substance, buffers, or media.
Both types offer leakproof containment and are built from high-quality resins suitable for sensitive bioprocess liquids, but carboys support larger process volumes than typical bottles.
We offer multiple cleanliness tiers to match process requirements:
- Standard containers provide general-purpose containment without special particulate control.
- Low particulate containers are cleaned and tested to meet <USP 788> particulate limits, reducing the risk of particulate contamination in sensitive applications.
- Ultralow particulate containers are further certified to one-third of the allowable USP 788 limits for even stricter control.
Choosing between these depends on how critical particulate levels are for your process. Ultralow is ideal for highly sensitive biological drug substances or critical pharmaceutical intermediates.
Yes. Bioprocess bottles and carboys are available in both sterile and nonsterile formats. Sterile containers are gamma-irradiated (when supplied as assembly systems) and packaged to maintain cleanliness until use, while nonsterile versions are suitable when in-house sterilization or cleaning is planned.
These bottles and carboys come in a wide range of volumes, supporting laboratory through bulk bioprocess needs. They are available from very small sizes (milliliter scale) up to 50 L for larger carboys, covering most storage and handling requirements.
We provide extensive regulatory documentation for Nalgene containers, including compliance details and specifications, which help support regulated bioprocess environments. This documentation can be downloaded or obtained through a Thermo Fisher representative.
Yes. Thermo Scientific Nalgene bottles and carboys are designed with leakproof closures. They meet defined leakproof criteria at ambient temperature and pressure when used with the corresponding closures. However, customers are advised to validate performance under their specific process conditions.
Yes. In addition to standard configurations, we offer custom bottle and carboy assembly systems with fluid transfer components tailored to your application. These can include specific closure ports and assemblies with the BioTitan Retention Device, supporting easier system integration and validation.
To choose the right container, consider the required volume, particulate cleanliness level, sterility, material compatibility (resin type), and whether the container will integrate with fluid transfer assemblies. Thermo Fisher’s selection guides and technical documentation can help match product features to your application. You can also contact a Thermo Fisher specialist to discuss needs and request samples for evaluation.
Related resources
Additional bioprocessing resources
Bioprocessing resources
For research use or further manufacturing. Not for diagnostic use or direct administration into humans or animals.