Frequently Asked Questions (FAQ)

About Purillex® PETG Bottles

Where are Purillex PETG bottles manufactured? 

Purillex® PETG bottles are manufactured 100% in the United States in Savillex’s ISO Class 7 cleanroom facilities. Domestic manufacturing enables tight process control, consistent quality, reliable supply, and responsive technical support throughout the product lifecycle. 

What types of applications are Purillex PETG bottles designed for?

Purillex PETG bottles are designed for purity critical life science and bioprocessing workflows, including: 

• Media and buffer storage 

• Reagent preparation and transport 

• Freeze/thaw and cold chain operations 

• Process intermediates 

• QC and analytical sampling 

They are engineered to function as process components, not just general-purpose lab consumables. 

Materials & Performance

What material(s) are Purillex PETG bottles made from? 

Purillex bottles are molded from USP Class VI–compliant PETG (polyethylene terephthalate glycol) resin. The material is nonpyrogenic, noncytotoxic, optically clear, and selected for low leachables and extractables suitable for sensitive applications.  

Bottles come with either 38-430 or 53B HDPE closures, molded graduations, and are available sterile, sterile tamper evident, and non-sterile. 

tamper-evidentare the benefits of PETG compared to standard PET? 

PETG is a glycol-modified version of PET that offers: 

• Improved impact resistance 

• Better performance during freeze/thaw workflows 

• Enhanced temperature tolerance 

• Favorable CO₂ and O₂ barrier properties 

• Higher clarity 

These characteristics make PETG better suited for bioprocessing and pharmaceutical applications, particularly where freezing, handling, and long hold times are expected. 

Are Purillex PETG bottles tested for particulates and endotoxin? 

Yes. Sterile Purillex PETG bottles are tested to support contamination sensitive use, including: 

• USP <788> particulate testing 

• USP <85> endotoxin testing 

All of our bottles are regularly evaluated using USP<788> testing to help support consistent performance in regulated environments. 

Temperature & Freeze/Thaw Use

What temperature range can Purillex PETG bottles withstand? 

Purillex PETG bottles are designed for a wide operating range: 

• Working temperature: –85 °C to 70 °C 

• Recommended storage: 15 °C to 25 °C 

They are suitable for frozen storage, freeze/thaw workflows, and cold chain handling. 

Are Purillex PETG bottles validated for freeze/thaw applications? 

Yes. Purillex PETG bottles have been evaluated through freeze/thaw qualification testing, including repeated cycles to –85 °C followed by pressure-based integrity testing. Bottles demonstrated reliable structural and sealing performance under these conditions. 

Closures & Handling

What type of closure is supplied with Purillex PETG bottles? 

Purillex PETG bottles are supplied with HDPE lugged closures engineered for consistent torque application and reliable sealing without secondary liners or inserts. 

This design helps minimize leakage risk during handling, transport, and freeze/thaw operations. 

Do the bottles support visual inspection and ease of handling? 

Yes. Purillex PETG bottles feature: 

• Crystal clear optical clarity for visual inspection 

• Raised volumetric graduations for readability, even when frosted 

• Sloped sidewalls that support controlled pouring and handling 

These features help improve usability without compromising purity. 

Sterility & Packaging

Are Purillex PETG bottles available sterile? 

Yes. Purillex PETG bottles are available in both sterile and nonsterile configurations. Our sterile bottle avaialbe as lab pack with tamper evident seals. 

Sterile bottles are terminally sterilized by gamma irradiation and validated to a Sterility Assurance Level (SAL) of 10⁻⁶. 

What is the shelf life of sterile Purillex PETG bottles? 

Sterile Purillex PETG bottles have a validated shelf life of 5 years from the date of manufacture when stored under recommended conditions. 

How are Purillex PETG bottles packaged? 

Packaging is designed to support cleanroom transfer and contamination control: 

• Bottles are nested on shrink wrapped trays 

• Trays are stacked and double bagged 

• Double bagged trays are placed in labeled, recyclable corrugated cartons 

Each packaging layer is labeled to support traceability and inventory control. 

Documentation & Support 

What documentation is provided with Purillex PETG bottles? 

Every shipment includes a Certificate of Conformance (CoC). 

Sterile lots additionally include a Certificate of Processing (CoP). Validation summaries and supporting documentation are available upon request. 

How does Savillex support customers using Purillex PETG bottles? 

Savillex provides: 

• U.S. based responsive technical and applications support 

• Guidance on bottle selection and configuration 

• Assistance with qualification and documentation 

• Custom component and assembly capabilities when required 

• Global sales team and distributor network 

Our team partners with customers to help reduce container related risk and improve confidence across workflows. 

Key Takeaway 

A bottle is not just a bottle. 
Purillex® PETG bottles are engineered to reduce risk, protect high-value materials, and support reliable performance in purity-critical environments, from discovery through scale-up and commercial manufacturing. 

Click here to view and shop Purillex PETG Bottles on our website!