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  6. Thermo Scientific™ Nalgene™ PETG Ultra-Low Particulate Vials

Thermo Scientific™ Nalgene™ PETG Ultra-Low Particulate Vials
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Catalog No. 14388031
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Capacity (Metric):
5 mL
20 mL
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Catalog No. Capacity (Metric)
14388031 20 mL
14388030 5 mL
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Catalog No. 14388031 Supplier Thermo Scientific™ Supplier No. CEN20350020

Please call Customer Service at 1-800-234-7437 or send an email to help@thermofisher.com for assistance.

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
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