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Thermo Scientific™ Nalgene™ Square PETG Platinum Certified Clean Media Bottle
Description
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. 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.
- Sterile to 10-6 SAL
- Non-pyrogenic and non-cytotoxic
- Leakproof High Density Polyethylene (HDPE) closures
- Serum Vials are packed in shrink-wrapped trays with closures attached
- Manufactured in compliance with ISO 13485:2003 quality requirements
Specifications
Specifications
| For Use With (Application) | Media/Buffer Preparation , Media/Buffer Storage, Sampling, Storage, Transportation , Validation Testing, Drug Substance, Drug Product |
| No. per Case | 416/Cs. |
| No. per Pack | 52/Pk. |
| Sterility | Sterile |
| Temperature Range (Metric) | -70°C to 70°C |
| Low Particulate | <1/3 USP <788> (Ultralow particulate) |
| Certifications/Compliance | ISO 13485:2003, 21 CFR 177.1520, USP Class VI |
| Product Type | Media Bottle |
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