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Thermo Scientific™ Nalgene™ PC Low Particulate Biotainers
Beschreibung
Specifically designed for pharmaceutical and biological manufacturing, Thermo Scientific™ Nalgene™ Polycarbonate Biotainer™ Bottles and Carboys reduce the risk of carry-over contamination. Durable, translucent PC construction ensures the integrity of your sample, even frozen to -100°C. Provided sterile and ready-to-use; including certified clean products, which meet USP <788> standards and endotoxins below 0.5 EU/mL. Certified clean products include triple layer packaging, with two heat-sealed layers to facilitate ease of entry into cleanrooms.
- Certified clean products include triple layer packaging, with two heat-sealed layers to facilitate ease of entry into cleanrooms
- Sterile, ready-to-use products with a Sterility Assurance Level of 10-6 inside the bottle/closure
- Robust, PC can be used from -100°C to 100°C, allowing for both heated mixing and frozen storage or shipment. Must be tested in actual use conditions as results may vary depending upon application.
- Inspection procedures throughout manufacturing include leak testing, dimensional testing, visual inspection for particulates and release testing to ensure the product meets all specifications
- All container/closure systems are certified leakproof** to protect valuable contents
- Products can be supplied with forced extraction studies*, validation binders* and certificates
- Customer support includes our highly experienced commercial specialist teams, regulatory team, quality team and regional technical support
Additionally our certified clean products include:
- Clean room produced in ISO Class 7 to limit particulates during molding
- Two heat-sealed sterile barriers to protect product prior to use
- Heat-sealed bags include quick-tears on the top and bottom and placed in carton liner twisted and tape/tie sealed to prevent gross contamination on the inner packaging
- Certified and lot-to-lot tested to meet USP <788> low particulate requirements to limit potential particulate contamination
- Certified low endotoxin (0.50 EU/mL) according to USP <85> to reduce pyrogens
Spezifikation
Spezifikation
| Autoclavable | Not Autoclavable |
| Capacity (Metric) | 5 L |
| Capacity (English) | 169.1 oz. |
| Certifications/Compliance | USP Class VI, non-cytotoxic, USP <661>, non-pyrogenic, FDA 21 CFR 177.1315 |
| Closure Color | White |
| Color | Blue (Translucent) |
| Closure Material | Polypropylene |
| Closure Size | 48 mm |
| Diameter (Metric) Inner Neck | 48 mm |
| For Use With (Application) | Media/Buffer Preparation , Media/Buffer Storage, Sampling, Storage, Transportation , Validation Testing, Drug Substance, Drug Product, Media/Buffer Preparation , Media/Buffer Storage, Sampling, Storage, Transportation , Validation Testing, Drug Substance, Drug Product |
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*Studies are non-GMP and provided for informational purposes only. The identify and quantity of extractables may vary with routine changes made to the manufacturing process. The studies may assist you in determining whether further leachable studies are warranted to meet any applicable regulatory requirements or expectations, and are available under CDA by contacting us at rocregsupport@thermofisher.com *The term leakproof applies to Thermo Scientific Nalgene products that meet the following criteria: a) Bottle/flask/funnel closure systems with closures smaller than 100 mm, after they are filled with water, inverted, withstand air pressure of 2 psig for 2 minutes, and no water escapes. b) Bottle/funnel/flask closure systems of larger than 100 mm 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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