Nalgene™ PETG Ultra-Low Particulate Vials
Nalgene™ PETG Ultra-Low Particulate Vials
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.
製品番号(カタログ番号)容量(メートル法)
CE-N2035-00055 mL
CE-N2035-002020 mL
製品番号(カタログ番号) CE-N2035-0005
価格(JPY)
1,112,000
Case of 416
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容量(メートル法):
5 mL

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
仕様
使用対象(アプリケーション)Media/Buffer Preparation ​, Media/Buffer Storage, Sampling, Storage, Transportation ​, Validation Testing, Drug Substance, Drug Product
微粒子<1/3 USP <788> (Ultralow particulate)
箱あたりの入数416/Cs.
パックあたり入数52/Pk.
数量5 mL
温度範囲(摂氏)-70°C to 70°C
ワークフローステップDownstream validation, downstream intermediate storage and transport. Bulk drug product/substance transportation
容量(メートル法)5 mL
認証/コンプライアンスISO 13485:2003, 21 CFR 177.1520, USP Class VI
製品タイプMedia Bottle
無菌性Sterile
Unit SizeCase of 416