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Thermo Scientific™ Nalgene™ PETG Ultra-Low Particulate Vials
Designed for the most critical applications, Nalgene PETG Ultra-Low Particulate Vials are platinum certified to contain less than one-third of the USP <788> particulate limits. With exceptionally low particulates and endotoxins, they set the standard for biological and pharmaceutical manufacturing downstream applications.
Supplier: Thermo Scientific™ CEN20350005
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
| 5 mL | |
| 416/Cs. | |
| 5 mL | |
| -70°C to 70°C | |
| ISO 13485:2003, 21 CFR 177.1520, USP Class VI | |
| Downstream validation, downstream intermediate storage and transport. Bulk drug product/substance transportation |
| Media/Buffer Preparation â, Media/Buffer Storage, Sampling, Storage, Transportation â, Validation Testing, Drug Substance, Drug Product | |
| 52/Pk. | |
| Sterile | |
| <1/3 USP <788> (Ultralow particulate) | |
| Media Bottle |