- Production laboratory, pilot plant, and cell culture production.
- Biotech, diagnostic, pharmaceutical, CRO, and CMO applications.
- Designed for manufacturing of pharmaceutical products, storage of bulk drug intermediates and ingredients, as well as transportation of APIs.
- 20-20,000mL sizes available in amber, clear, narrow, and wide-mouth openings.
DURAN® PURE
Frequently Asked Questions
- Enhanced Quality Control: Every DURAN® PURE bottle is 100% visually inspected.
- Lot Traceability: PURE bottles guarantee single-lot integrity in addition to retrace codes for tighter traceability.
- Cleanliness and Handling: PURE bottles are handled with pharmaceutical care: after forming, they are immediately closed with a dust cover. Workers use protective clothing when handling PURE products, and the bottles are packed with extra safeguards.
- Documentation and Change Control: Each PURE bottle lot is received with a Certificate of Analysis and a comprehensive documentation pack (e.g. statements of USP <660> compliance, heavy metal content, BSE/TSE declarations). In addition, DWK operates a formal change notification system for PURE.
- Regulatory Support: DWK has filed Drug Master Files (DMF) and similar dossiers for the PURE line. This makes it easier for pharma customers to reference the bottles in regulatory submissions.
- Single-lot ordering. If bottles from the same manufacturing lot are needed (for consistency in validation), DWK can often support this on request.
PURE bottles are supplied with a temporary dust cover instead of a functional screw cap, so compatible caps will need to be ordered separately.
DURAN® PURE products are not sterile by default; you should plan to sterilize them (e.g. by autoclaving) if your application is aseptic or requires sterility.
The usual method is moist-heat (steam) sterilization (autoclaving at 121 °C for 15–20 min is very effective and is within the product’s capabilities). Both the glass and the caps can handle standard autoclave cycles easily. If your process needs it, they can also tolerate higher heat (see next FAQ) or other sterilization methods like dry heat , but verify compatibility of caps for those methods (the liner-less caps are fine up to 260 °C dry heat; the lined caps are limited by the silicone to 200 °C).
They are not additionally washed by DWK after manufacturing.
Caps are manufactured and packaged in a cleanroom environment (ISO Class 7). Glass bottles are not formed in a cleanroom. However, the bottles are handled in a controlled manner immediately after production. Workers on the PURE line follow clean protocols (gloves, special attire), and immediately apply a dust cover and segregate PURE bottles from open exposure.
Whilst DURAN® PURE Bottles are supplied closed with a protective cover to prevent contamination, they are not certified as particle free, sterile, or ready to use. However, through DWK’s Custom Solutions service, we can tailor the product to meet your specific requirements - including options for particulate cleaning, depyrogenation, sterilization and secondary packaging. We’d be happy to explore a customised solution that aligns with your application needs.
DWK assigns a formal 5-year shelf life to DURAN® PURE bottles, and an expiration date is printed on each PURE bottle’s label and Certificate of Analysis. Glass itself doesn’t “expire,” but this dating is in place to meet GMP / pharma regulatory expectations.
Each lot of DURAN® PURE bottles has a Certificate of Analysis (CoA) that includes actual test results for that lot, and DWK can provide a comprehensive validation dossier on request. The documentation typically include:
- Certificate of Analysis (CoA): Lists the lot number, confirms the glass meets Type I specifications (e.g. hydrolytic resistance test results, arsenic content <0.1 ppm, etc.), and often shows any tests like dimensional checks or visual inspection pass. It is signed by the Quality department and includes the product’s expiry date.
- Product Specifications
- Product Drawings
- Certificate of Conformity/Compliance: Sometimes included to state compliance with standards (USP, EP, ISO 4796, etc.), if not already in the CoA.
- Supporting Statements: DWK has readily available letters for things like BSE/TSE-free status of materials, heavy metals content (confirmation that it meets packaging heavy metal limits), and adherence to regulations like REACH or RoHS. These can be downloaded or requested; often they are part of a “validation package” PDF.
- Validation / Qualification File: On the website or by request, you can get a full validation guide which includes: glass technical specification sheets (chemical composition, physical properties), extractables data if any, statements about compliance with Food Contact and USP <661>, information on DWK’s change control process, and reference to any Drug Master Files. For instance, they’ll confirm if a Type III DMF with FDA is available (DWK has a Type III DMF for their glass under #28042 and the Chinese DMF as mentioned).
- Lot Traceability Info: The retrace code on each bottle can be entered into DWK’s online certificate portal (https://cert.dwk.com). That will retrieve the CoA and sometimes additional lot info.
- Drug Master File Access: DWK can provide a DMF authorization letter on request.
DWK Life Sciences has filed Drug Master Files to support DURAN® PURE.
We have registered the PURE products with regulatory agencies in the US (FDA) and China (CDE)
| Product range | DURAN® PURE bottles | DURAN® PURE caps |
|---|---|---|
| FDA Type III Packaging Material DMF | #28042 | #28044 #31063 |
| China Center for Drug Evaluation CDE NMPA registration number | B20220000306 | B20220000817 |