The Technical Vault
By SOSCleanroom
DURAN PURE 891169109
GLS 80 Wide Mouth
White Cap
Current DWK: PPSU
PTFE-Coated Silicone
88 x 40 mm
Autoclavable
CoA-Supported
5 Caps / Pack
Exact-SKU Technical Overview
DURAN® PURE 891169109 is a white GLS 80® screw cap with an installed PTFE-coated silicone liner, manufactured for compatible DURAN PURE wide-mouth bottle systems. The current DWK online specification identifies the cap body as PPSU (polyphenylsulfone). It is supplied five caps per pack, and DWK lists the cap as autoclavable.
The manufacturer lists 88 mm outer cap diameter, 40 mm cap height, and GLS 80 thread. These measurements are for the closure; they must not be confused with bottle diameter, bottle height, or internal mouth clearance. Five lined caps, not five bottles, are the confirmed current sales unit.
The DURAN PURE line is designed for pharmaceutical and biotech applications requiring lot traceability, CoAs, inspection, and change-control support. DWK offers an extractables report and identifies USP <88> Class VI pharmaceutical-grade material testing. The cap is a functional closure, but actual liquid-tightness, chemical compatibility, and sterilization performance depend on the full assembly and process.
Ordering configuration: 891169109 = white GLS 80 lined screw cap, current DWK-listed PPSU body, PTFE-coated silicone seal, 88 x 40 mm, 5 caps/pack. No bottle, pouring ring, or additional replacement seal included. Autoclavable but non-sterile on delivery. Historical DWK sources call the cap PSU and require reconciliation when resin identity matters.
Exact Manufacturer Specifications
| Specification | Current DWK value / qualification |
|---|
| Manufacturer | DWK Life Sciences |
| Product family | DURAN PURE |
| Manufacturer SKU | 891169109 |
| Product | GLS 80 premium screw cap with installed liner |
| Thread | GLS 80; not GL 25 or GL 45 |
| Current cap-body material | PPSU (polyphenylsulfone), per current manufacturer web listing |
| Historical cap-body wording | PSU (polysulfone) in older DWK brochures and 2025 certificate description |
| Seal | PTFE-coated silicone, included in cap assembly |
| Color | White |
| Cap outer diameter | 88 mm |
| Cap height | 40 mm |
| Commercial quantity | 5 caps per pack |
| Container bottles included | No; sold separately |
| Additional replacement seals included | No; one installed seal per cap |
| Pouring ring included | No |
| Autoclavable | Yes |
| Current exact-page complete-cap maximum temperature | Not published |
| Historical lot-specific cap material temperature | +180°C in an accessible 2025 DWK CoA |
| Historical lot-specific silicone and PTFE temperature | +200°C for each material in the same 2025 CoA |
| Sterile on delivery | No, standard DURAN PURE supply |
| Cleanroom manufacture | DURAN PURE family FAQ states ISO Class 7 for caps |
| Visual / dimensional inspection | Manufacturer inspection program; exact lot CoA contains sampling results |
| Lot presentation | Single-lot delivery |
| CoA / manufacturing traceability | Available; DWK states 100% process traceability |
| Change control | Manufacturer-managed change notification |
| Extractables report | Available from DWK on request |
| Material reference | USP <88> Class VI |
| US regulatory reference | FDA Type III Packaging Material DMF #28044 (PURE caps) |
| China regulatory reference | CDE/NMPA B20220000817 (PURE caps) |
| Replacement gasket | 292489102, PTFE-coated silicone, 10/pack, separate |
| Matching amber 1 L bottle | 818665405, GLS 80, separate |
| Matching amber 2 L bottle | 818666307, GLS 80, separate |
| Cap torque / cycle-life limit | Not established on current SKU page |
| Finished-system leak, vapor, pressure or vacuum rating | Not established |
| Current cap shelf life / minimum life on receipt | Not confirmed; obtain lot-specific documentation |
| Individual bagging and current resin declaration | Confirm against actual supplied lot / order unit |
Dimensional note: 88 mm is the present catalog outside-diameter figure and 40 mm is catalog cap height. Historic lot certificates can contain more detailed nominal dimensions and tolerances that are not automatically current universal acceptance specifications.
Manufacturer Source Reconciliation: PPSU, PSU, and Packaging
DWK sources for the exact catalog number are not completely consistent. The current web listing should be used for the commercial unit and current descriptive name, but the older manufacturer documents should be flagged when they may affect controlled purchasing.
| Source | Material | Pack information | Interpretation |
|---|
| Current DWK SKU 891169109 product page | PPSU with PTFE-coated silicone | 5 per pack | Current public catalog baseline |
| Older DWK PURE GLS 80 technical flyer | PSU with PTFE-coated silicone | 1 cap per PE bag | Historic technical/packaging description, not current sales unit |
| Older DWK GLS 80 cap/accessory guide | PSU with PTFE-coated silicone | 5 per pack | Historic guide supports five-cap order unit |
| Publicly available DWK CoA for a 2025 lot | Description says PSU; resin field describes a high-temperature amorphous thermoplastic | 5 units per bag | Historical lot-specific documentation; not an assertion about a future lot |
Current public-facing terminology: The exact-SKU page says PPSU and 5/pack. Do not state that PPSU and PSU are chemically identical, or silently claim a manufacturer resin change. Obtain written clarification of the exact polymer and current inner packaging if required by the approved product specification.
Why this matters: PSU and PPSU are different polymers. Controlled pharmaceutical procurement and chemical-resistance assessment should be based on the actual resin declared for the delivered manufacturing lot, not an inferred equivalence from historical brochures.
Cap Body, Silicone Gasket, and PTFE Facing
The complete closure combines a rigid thermoplastic threaded cap body with a compliant silicone elastomer seal and a PTFE-coated contact surface. It is not a one-piece linerless closure, a molded silicone stopper, or a solid PTFE disc.
| Component | Material description | Role |
|---|
| Cap body | PPSU currently listed; historic PSU designation | Thread engagement and mechanical closure structure |
| Seal core | Silicone elastomer | Compliant gasket compression |
| Seal contact surface | PTFE coating / film | Chemically durable interface under compatible use |
| Functional assembly | Cap plus installed liner | Must be qualified with bottle and contents |
PTFE facing does not guarantee zero permeation, zero leachables, or complete isolation of silicone for every solvent or exposure. If the liner is damaged, improperly fitted, compressed inconsistently, or incompatible with the contents, closure performance can change. Review the exact formulation, concentration, temperature, processing, and duration.
Autoclavability: Distinguishing Cap vs. Seal Temperature Data
The current DWK SKU record explicitly states autoclavable: yes, but does not publish a complete cap-assembly maximum service temperature. The manufacturer's general DURAN PURE FAQ discusses a typical moist-heat sterilization example of 121°C for 15-20 minutes for compatible products. That example is not a site-validated cycle for every assembled bottle or filled formulation.
A 2025 DWK CoA for this same article number lists material temperature resistance as +180°C for the cap thermoplastic, compared with +200°C for the silicone mixture and PTFE film. These represent different materials and a specific historical lot, not a current universal maximum rating. Do not substitute the seal's 200°C limit for the complete closure.
| Temperature/processing claim | Evidence and qualification |
|---|
| Autoclavable | Yes, current exact-SKU listing |
| Typical steam example | 121°C for 15-20 minutes in general DWK PURE FAQ; site validation required |
| Historical cap thermoplastic resistance | +180°C, historical 2025 DWK CoA for 891169109 |
| Historical seal materials resistance | +200°C, same 2025 CoA for silicone and PTFE materials |
| Current exact-SKU full-assembly maximum | Not established on current product page; ask DWK |
| Maximum repeat autoclave cycles | Not established |
| Heating with caps tightly sealed | Not automatically approved; evaluate pressure buildup and venting |
| Dry heat and filled-container sterilization | Require explicit current material and process qualification |
Thermal specification decision: If a process will exceed ordinary validated moist-heat conditions, require a current DWK technical declaration for the exact supplied lot, the cap resin, and the fitted silicone/PTFE seal. Do not advertise 200°C maximum complete-cap temperature without this confirmation.
Sterility and Cleanroom Manufacture
DWK's current DURAN PURE FAQ states that caps are manufactured and packaged in an ISO Class 7 cleanroom environment. Cleanroom manufacturing is not a claim that each cap arrives sterile, sterile-barrier packaged, depyrogenated, or ready for direct aseptic filling.
The same manufacturer FAQ explicitly states that DURAN PURE bottles and caps are not sterile by default. Aseptic or pharmaceutical processes may require validated washing, sterilization, material introduction, inspection, and packaging according to the intended use.
For customers requiring an exact ISO 14644 facility qualification, cap bioburden limit, particulate specification, or sterile product status, request current product-specific documentation instead of interpreting a family-level FAQ as a lot certification.
Certificate of Analysis, Inspection, and Lot Traceability
DWK describes single-lot delivery, a Certificate of Analysis, visual and dimensional inspection, and 100% manufacturing-process traceability. The CoA for the delivered lot is the appropriate source for actual batch identity, inspection findings, and any product-specific material declarations.
A publicly available 2025 DWK CoA for article 891169109 illustrates this documentation in practice, with sampled dimensional inspection for cap features and separately identified silicone/PTFE seal inspection. The figures in that certificate belong to its specified historical lot; they must not be copied as the actual test results for a newly purchased shipment.
- Confirm the exact 891169109 article number and current pack quantity.
- Record the delivered cap lot or Retrace Code.
- Obtain the corresponding DWK CoA and review material designation, inspected attributes, and acceptance criteria.
- Verify the seal type and correct installed-liner condition.
- Retain applicable manufacturer change-control and regulatory documents.
- Confirm whether a resin statement or validated sterilization data are required for the intended quality system.
USP <88> Class VI, Extractables, and Regulatory Support
DWK identifies the DURAN PURE GLS 80 cap materials with USP <88> Class VI and offers an extractables report on request. This supports materials evaluation but does not establish that the finished container assembly is sterile or acceptable for every drug contact scenario.
DWK lists FDA Type III Packaging Material DMF #28044 and China CDE/NMPA B20220000817 for DURAN PURE caps. The associated glass bottles have separate documentation, including bottle DMF #28042. The existence of a filed Drug Master File is not FDA approval of a particular finished drug product or universal permission to substitute this cap.
| Regulatory / quality reference | Appropriate interpretation |
|---|
| USP <88> Class VI | Manufacturer-identified materials testing; not finished-package approval |
| FDA cap DMF #28044 | Packaging-material regulatory filing for PURE cap family |
| China CDE/NMPA B20220000817 | Cap-family regulatory reference |
| Lot-specific CoA | Batch identity and quality evidence for the supplied lot |
| Extractables report | Manufacturer study available on request; not automatically formulation-specific leachables clearance |
| Change control | Manufacturing and product-change management documentation |
| Container-closure integrity | Requires verification for the actual bottle, cap, gasket, and application |
Regulated users should request current regulatory statements and a letter of authorization or other supporting documents when applicable. Supplier documentation complements but does not replace risk assessment, validation, and finished-product stability testing.
GLS 80 Cap vs. GL 45 and Other Closure Styles
The GLS 80 thread identifies a different neck size from GL 45 and GL 25. Product-family and brand similarity do not establish mechanical interchangeability or identical liner construction.
| Closure | Thread / design | Difference |
|---|
| 891169109 | GLS 80, white, lined PURE cap | Current DWK PPSU, PTFE-coated silicone; 5/pack |
| 891088679 | GL 45, transparent PFA PURE premium cap | Smaller thread; not interchangeable |
| 891081306 | GL 25, transparent PFA PURE premium cap | Smaller thread; not interchangeable |
| Conventional blue DURAN GLS 80 cap | GLS 80 with different resin/seal | Not the same PURE pharmaceutical documentation / material claim |
| Membrane-vented GLS 80 cap | Vented specialist closure | Different pressure-equalization function; 891169109 is not identified as vented |
| Temporary PURE bottle dust cover | Transport protection | Not a qualified functional screw cap |
The PURE 891169109 is a lined standard screw cap. No vent membrane or pressure-equalizing feature is established in the reviewed SKU specification. Do not describe it as a pressure relief cap, pierceable septum, or a complete cap-and-bottle assembly.
Matching DURAN PURE Wide-Mouth Bottles
The following bottle references use the GLS 80 neck and are separate products. Standard DURAN PURE bottles ship with protective dust covers rather than functional screw caps.
| Bottle SKU | DURAN PURE bottle configuration | Quantity |
|---|
| 818664409 | 500 mL amber, GLS 80 wide mouth | 10/case |
| 818605408 | 1,000 mL clear, GLS 80 wide mouth | 10/case |
| 818665405 | 1,000 mL amber, GLS 80 wide mouth | 10/case |
| 818606301 | 2,000 mL clear, GLS 80 wide mouth | 10/case |
| 818666307 | 2,000 mL amber, GLS 80 wide mouth | 10/case |
| 818667303 | 5,000 mL amber, GLS 80 wide mouth | 1/case |
| 818668608 | 10,000 mL amber, GLS 80 wide mouth | 1/case |
Quantity example: A case of ten 1 L or 2 L PURE GLS 80 bottles requires two five-cap packs if each bottle needs a functional cap. These are purchasing quantities, not components bundled into 891169109.
Replacement PTFE-Coated Silicone Seal: 292489102
The DWK DURAN PURE technical brochure identifies 292489102 as the GLS 80 PTFE-coated silicone replacement seal, with 10 seals per pack. It is a distinct part number intended for appropriate cap maintenance or replacement under an approved procedure.
Each new 891169109 screw cap already includes an installed liner. Replacement seals are not additional units included with the five-cap order. Before replacing a gasket, confirm dimensional fit, cleaning, material status, processing instructions, and reuse policy.
Chemical Compatibility and Container-Closure Integrity
The complete filled system includes glass, cap resin, PTFE coating, and silicone gasket. Compatibility depends on the actual formulation, concentration, temperature, exposure duration, headspace, cleaning chemicals, and compression or closure torque. A wide-mouth cap with a high-performance liner is not automatically chemically compatible with every laboratory chemical.
| Use scenario | Qualification requirement |
|---|
| Aqueous solutions | Review pH, buffer salts, gasket contact, and relevant cleanliness limits |
| Organic solvents | Assess PPSU/declared resin, PTFE facing, silicone, and vapor exposure |
| Light-sensitive APIs | Use a properly selected amber bottle and confirm closure compatibility and formulation stability |
| Volatile or odor-producing materials | Evaluate vapor transmission, sealing pressure, containment and ventilation |
| Long-term storage | Assess cap/gasket aging, compression, sample interaction, and test methods |
| Autoclaving | Validate venting, full assembly, temperature profile, cycle count and post-cycle integrity |
| Filled-product transport | Verify shipping configuration and applicable regulatory packaging requirements |
| Trace-level analytical use | Evaluate background contamination and extractables/leachables under method conditions |
Do not infer: A specified GLS 80 thread or PTFE-coated silicone liner does not independently certify leakproofness, vapor-tight storage, pressure/vacuum performance, sterile integrity, or universal solvent compatibility.
Receiving, Installation, and Quality-Control Checklist
- Confirm identity: DURAN PURE 891169109, white GLS 80 lined cap.
- Count the order: Current commercial sales unit is 5 caps per pack.
- Inspect components: Check cap threads, white plastic body, and installed gray PTFE-coated silicone liner.
- Review packaging: Confirm actual individual/inner bagging if controlled bag configuration is required.
- Record the lot: Capture the manufacturer's batch information for traceability.
- Retrieve the CoA: Match certificate to the lot; inspect declared resin and current quality data.
- Confirm the polymer: Resolve PPSU versus PSU if relevant to procurement or process validation.
- Check mating bottle: Verify the bottle has a compatible GLS 80 neck and clean sealing surface.
- Assess contents: Verify compatibility with the actual chemicals and anticipated storage conditions.
- Validate the process: Establish capping torque, sealing integrity, washing, and sterilization requirements.
- Retain records: Link cap and bottle lots to receiving and quality release documentation.
Limitations and Claims Not Established
- Not a bottle: This is a five-cap pack; no glass bottle included.
- Not GL 45 or GL 25: The cap thread is GLS 80.
- Not PFA: The current GLS 80 cap record lists PPSU; PFA applies to different PURE GL 25/GL 45 cap SKUs.
- Not linerless: Each cap includes PTFE-coated silicone.
- Not a solid PTFE gasket: Silicone is an essential core material.
- Not vented: The reviewed cap is not specified as a membrane-vented pressure-equalization cap.
- Historical resin inconsistency: PPSU in current listing, PSU in older DWK references.
- Historical bag-count inconsistency: Older flyer says 1/PE bag; current page says 5/pack and 2025 CoA says 5/bag.
- No current maximum whole-cap temperature confirmed: Historic cap and seal materials have different temperature limits.
- Autoclavable is not sterile on receipt: Site sterilization and process qualification may be required.
- No universal chemical compatibility: Qualify exact resin, gasket, and formulation.
- No published numeric capping torque: Use qualified application settings.
- No certified vapor-tight/leakproof or pressure rating: Test the complete assembly as needed.
- Not a Drug Master File approval: DMF filing supports documentation but is not finished-product approval.
- No guaranteed cap shelf life: Do not transfer five-year PURE bottle dating to this cap SKU.
- No automatic ready-to-use claim: Cleanroom manufacture does not establish sterility or particle-free certification.
Technical FAQs
1. What is DURAN PURE 891169109?
A white GLS 80 screw cap with PTFE-coated silicone liner, offered in a five-cap pack.
2. What are the cap dimensions?
88 mm outside diameter and 40 mm height, per the current DWK listing.
3. What thread does it fit?
GLS 80 wide-mouth bottles; it is not interchangeable with GL 45 or GL 25.
4. Is it white or transparent?
White. Transparent PFA versions belong to different DURAN PURE cap products.
5. What is the cap-body polymer?
The current DWK exact-SKU page lists polyphenylsulfone (PPSU); older DWK documents use PSU. Obtain a current material declaration when needed.
6. Are PSU and PPSU identical?
No. They are distinct polymers. The source discrepancy should not be reconciled by assuming the terms are synonyms.
7. What kind of liner is supplied?
PTFE-coated silicone, installed in each cap.
8. Is the liner a solid PTFE disc?
No. The sealing element combines a PTFE facing with a silicone elastomer.
9. How many caps are in the current sales unit?
Five caps per pack, according to DWK's current product listing.
10. Why does an older flyer say one cap per bag?
It is older manufacturer literature. DWK's current listing specifies five per pack, and a 2025 CoA also lists five per bag. Confirm any required inner-pack specification.
11. Are DURAN PURE GLS 80 bottles included?
No. Glass bottles and pouring accessories are separate products.
12. Does the cap include the silicone/PTFE seal?
Yes. A replacement gasket is not required just to obtain a new lined cap.
13. Which replacement seal does DWK identify?
DURAN PURE 292489102, GLS 80 PTFE-coated silicone, ten replacement seals per pack.
14. Is the cap autoclavable?
Yes, per the current exact-SKU listing. The actual cycle and assembled system require qualification.
15. Is the complete cap rated to 200 degrees C?
Not established on the current product page. A historical CoA lists +180°C for cap material and +200°C for silicone/PTFE materials.
16. Is it sterile upon delivery?
No. Standard DURAN PURE caps are non-sterile.
17. Is the cap cleanroom-manufactured?
DWK's DURAN PURE family FAQ describes cap manufacture and packing in ISO Class 7 cleanrooms; request product-specific evidence if required.
18. Is a Certificate of Analysis supplied?
DWK identifies a CoA and single-lot delivery. Match the document to the actual cap lot.
19. Is an extractables report available?
Yes, DWK lists an extractables report available on request. It does not replace formulation-specific leachables testing.
20. What USP Class VI claim is made?
DWK identifies materials as USP <88> Class VI; this is not finished-drug approval.
21. What is the applicable FDA DMF?
DWK lists Type III Packaging Material DMF #28044 for DURAN PURE caps, not bottle DMF #28042.
22. What China regulatory reference is listed?
CDE/NMPA B20220000817 for DURAN PURE caps.
23. Does it fit the 1 L amber DURAN PURE GLS 80 bottle?
It is designed for the GLS 80 bottle system, including amber 818665405. Validate the exact assembly for use.
24. Does it fit the 2 L amber DURAN PURE GLS 80 bottle?
It is designed for that thread system, including amber 818666307, which is sold separately.
25. Is a five-year cap shelf life established?
No specific cap shelf life was established in the current record; the five-year statement applies to PURE bottles.
26. Is the assembled container guaranteed leakproof?
No complete-system numerical leak or vapor-tight certification was established. Qualify the bottle, liner, capping procedure, and intended contents.
27. Can it be used as a pressure vent?
No membrane-venting or pressure-relief function is specified for this screw cap.
28. How many packs cover ten separately ordered bottles?
Two packs of five caps provide ten caps, assuming one cap is needed per bottle.
Manufacturer Technical Documentation
Only manufacturer technical resources and the certificate portal are linked. No DWK catalog-shopping, product-detail, or purchasing pages appear in this Technical Vault. Historical documents can differ from current online specifications; confirm any material or process-critical conflict with DWK.
For GLS 80 caps, compatible DURAN PURE bottles, current resin confirmation, or CoA support: Contact SOSCleanroom at Sales@SOSsupply.com or (214) 340-8574.
Last updated: October 28, 2026
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