Description
Thermo Scientific Nalgene HDPE Platinum Certified Clean Bottles and Carboys are certified platinum clean and include particulate certifications to under 1/3 the allowable limits according to USP<788> and lower endotoxin levels of 0.25 EU/mL, to help mitigate potential sources of unwanted impurities.
Our single-use products, including Thermo Scientific Nalgene HDPE Platinum Certified Clean Bottles and Carboys, help reduce the potential for carry-over contamination. Our new certified platinum clean products include particulate certifications to under 1/3 the allowable limits according to USP<788> and lower endotoxin levels of 0.25 EU/mL, to help mitigate potential sources of unwanted impurities.
- Products are washed with USP Water for Injection and handled post-washing in Class 5 clean rooms with Class 4 packaging/inspection hoods to produce these very low particulate products
- Certified and lot-to-lot tested to contain less than 1/3 the particulates allowable according to USP <788> to limit potential particulate contamination
- Certified low endotoxin (0.25 EU/mL) according to USP <85> to reduce pyrogens
- Sterile, ready-to-use products with a Sterility Assurance Level of 10-6 inside the container/closure, including 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
- All container/closure systems are certified leakproof* to protect valuable contents
- Robust, HDPE can be used from -100°C to 120°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
- 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
| Capacity (Metric) | 250 mL |
| Capacity (English) | 8.5 oz. |
| Color | Colorless |
| Description | Nalgene Certified Platinum Clean HDPE Bottle |
| For Use With (Application) | Media/Buffer Preparation , Media/Buffer Storage, Sampling, Storage, Transportation , Validation Testing, Drug Substance, Drug Product |
| Material | HDPE |
| No. per Case | 72/Cs. |
| No. per Pack | 12/Pk. |
| Sterility | Sterile |
| Temperature Range (Metric) | -100°C to 120°C |
| Low Particulate | <1/3 USP <788> (Ultralow particulate) |
| Certifications/Compliance | < 1/3 particulates allowed according to USP <778>, USP Class VI, non-cytotoxic, USP 30 <661>-compliant, non-pyrogenic, FDA 21 CFR 177.1315 |
| Closure Included | Yes |
| Autoclavable | Not Autoclavable |
| Mouth | Narrow |
| Shape | Round |
| Height (Metric) | 133 mm |
| Product Type | Media Storage Bottle |
| Height (English) | 5.2 in. |
| Closure Material | Polypropylene |
| Closure Size | 24 mm |
| Diameter (Metric) | 61 mm |
| Show More Show Less |
