Thermo Scientific™ Nalgene™ PETG Ultra-Low Particulate Vials

Product Code.	Capacity (Metric)	unitSize
16460611	20 mL	Pack of 504
16450611	5 mL	Pack of 416

Product Code. 16460611

Brand: Thermo Scientific™ CEN20350020

Description

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.

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

• Capacity (Metric): 20 mL
• For Use With (Application): Media/Buffer Preparation ​, Media/Buffer Storage, Sampling, Storage, Transportation ​, Validation Testing, Drug Substance, Drug Product
• No. per Case: 504/Cs.
• No. per Pack: 84/Pk.
• Quantity: Case of 504
• 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
• Workflow Step: Downstream validation, downstream intermediate storage and transport. Bulk drug product/substance transportation