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Thermo Scientific™ Nalgene™ Polypropylene with Silicone Liner, Ported Biotainer Bottle and Carboy Closure
Descripción
Designed to aseptically handle solutions in biopharmaceutical, biotechnology and laboratory liquid transfer applications, these two- and three-ported closures are designed for Thermo Scientific™ Nalgene™ Biotainer™ bottles and carboys. With Animal Derived Component-Free (ADCF) components, including seals that are sonically-welded to the cap, and leak-proof closures, security of high value contents are guaranteed during fluid transfer. With ADCF components, including seals that are sonically welded to the cap, and leak-proof† closures, security of high value contents are guaranteed during fluid transfer.
- Made with USP Class VI resins that are non-cytotoxic, non-pyrogenic, non-mutagenic and Animal Derived Component-Free (ADCF) to assure stored material integrity
- Manufactured in ISO 14644-1 Class 7 clean room and bagged in ISO Class 4 cleanroom
- Double bagged in heat sealed bags so caps are ready to use in your clean room entry workflow
- Leak-proof closure with virtually stripproof threading mean no risk of lost sample during handling, storage or transport
- Ultrasonically-welded liners ensure they will stay in place and not risk contained product contamination
- Made with the same materials as our Biotainer bottles and carboy closures to enable easier validation in fluid transfer processes and use down to -40°C
- Fits 1L to 20L Biotainer bottle and carboys in PC and PETG
- Change notifications: Compliance with ISO 13485:2003 and cGMP requirements mean that changes to manufacturing procedures, packaging and product specifications are all documented and traceable. Ensure you receive notifications of any changes, register at www.thermoscientific.com/notifications
- Certificates: Resins are Drug Master File (DMF) registered to meet a number of regulatory specifications and Certificates of Compliance (CoC) are available on www.thermoscientific.com/certificates
- Validation support: Extensive information is available by contacting us at rocregsupport@thermoscientific.com
Especificaciones
Especificaciones
| Certifications/Compliance | FDA 21 CFR 177.1315; USP<661> Biological and Physiochemical Test for Plastic Containers; EP 2.6.9 Modified Abnormal Toxicity Test; EP 3.1.5 PE for Parenterals and Opthalmics; EP 3.1.9 Silicone Elastomer for Tubing and Closures |
| Closure Size | 48 mm |
| Description | Ported Biotainer Bottle and Carboy Closures, 3 ports |
| Dimensions (L x W) | 2 x 1/4 in. (6.36 mm) and 1 x 3/16 in. (4.76 mm) Port I.D. |
| For Use With (Equipment) | 1L to 20L Biotainer bottle and carboys in PC and PETG |
| Material | Polypropylene, Silicone |
| No. per Case | 4/Cs. |
| No. per Pack | 4 Pk. |
| Product Type | Closure |
Note: †The term leakproof applies to Thermo Scientific Nalgene products that meet the following criteria: a) Bottle/flask/funnel closure systems with closures smaller than 100mm, after they are filled with water, inverted, withstand air pressure of 2psig for 2 minutes, and no water escapes;. b) Bottle/funnel/flask closure systems of larger than 100mm after they are filled with water, inverted for 15 minutes, and no water escapes. Note: these tests, using other liquids, may not yield the same results. To ensure safe usage, customers are advised to test Thermo Scientific Nalgene bottles and closures under conditions of their planned applications. Thermo Scientific Nalgene products are leakproof at ambient temperature and pressure when used with their Nalgene closures.
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