Cytiva, UP1F10-0000-0005, Newform medical grade LDPE bags, inner bag size (W x L) 600 mm x 800 mm (31.5 in x 23.6 in), double packed per 100

Name: Newform medical grade LDPE bags, inner bag size (W x L) 600 mm x 800 mm (31.5 in x 23.6 in), double packed per 100
Brand: Cytiva
SKU: UP1F10-0000-0005

Low-density-polyethylene (LDPE) cleanroom bags for packaging and gamma irradiation.

Catalog Number: UP1F10-0000-0005

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Category

Biohazard Bags

TagsFluid Management Sterilizable packaging

CollectionsCytiva Fluid Management Solutions for Secure & Sterile Liquid Transfer Cytiva Protein Analysis Equipment & Supplies Collection

Description

In the biopharmaceutical and medical industries, visible and subvisible contaminants from packaging materials not only reduce process efficiency by generating unacceptable waste percentages, but they can also constitute real chemical and biological hazards when delivering parenteral drugs to patients. Low particle levels should be guaranteed by the product supplier, and product integrity must be 100% guaranteed by the packaging itself. Newform Bags are medical-grade, low-density-polyethylene (LDPE) bags, ideal for packaging and gamma irradiation of powders, products and components. Features In-house extrusion of LDPE film using certified and virgin resin without any additives Blown-film extrusion of LDPE film, conversion and packaging in certified ISO Class 5 cleanrooms Flexibility in customizing sizes, thicknesses and shapes (bags, tubing, sheets, film,..) Dye-penetration test (methylene blue) to show packaging integrity cGMP focused manufacturing Material Drug Master File on resin is registered with FDA Benefits Low visible and subvisible contaminant level Low bioburden and endotoxin level Low leachables and extractables level Certified cleanliness Improved process efficiency Gamma sterilizable up to 50 kGy Pre-sterilized bags available upon request (gamma irradiated at 25 kGy, certified) Quality Cleanliness level 100 according to IEST-STD-CC1246D standard LDPE film is Animal-Derived-Component-Free (ADCF) Compliant to: FDA Title 21 CFR 177.1520 ‘Olefin Polymers’ EU Commission Directive 10/2011 (food contact approval) USP<87> Biological Reactivity test in vitro USP <88> Biological Reactivity test in vivo, class VI USP <661> Physicochemical test – plastics EP monograph 3.1.3 ‘Polyolefins’ EP monograph 3.1.4 ‘Polyethylene without additives for containers for parenteral and ophthalmic preparation’ EP monograph 3.2.2 ‘Plastic containers and closures for pharmaceutical use’ Applications Packaging and/or Gamma sterilization of: Stoppers, caps and closures Vials and containers API, medical powders, buffers, media Filters Medical devices Cleanroom garments Syringe components

FAQs

Question: What are the internal dimensions and film thickness of the Newform bags?

Answer:The inner dimensions are 600 × 800 mm, with a 600 mm opening width and 100 µm LDPE film thickness.

Question: How many Newform bags are supplied in the large-format pack?

Answer:The 600 × 800 mm version is double-packed in quantities of 50 bags.

Question: Are Newform LDPE packaging bags supplied gamma-sterilized?

Answer:The film can undergo gamma sterilization; pre-sterilized bags are available by specific arrangement rather than automatically included.

Application Note

Cytiva Newform medical-grade LDPE bags provide a clean packaging barrier for biopharmaceutical and medical components. The 600 × 800 mm inner bag has a 100 µm film thickness and is manufactured from virgin, additive-free low-density polyethylene. The 600 mm dimension is the bag opening width. These bags are suitable for packaging closures, filters, cleanroom garments, medical components, and powders before controlled handling or a separately specified sterilization step. The LDPE film is free of animal-derived components and is compatible with gamma sterilization. Pre-sterilized supply is available as an option rather than an inherent feature of this standard packaging item. The large-format version is double-packed in units of 50 bags.

Ordering

Notice

Unless otherwise stated, the minimum order amount is USD 1,000.
For orders below USD 1,000, an additional handling fee may apply, or we may arrange local delivery / local handover where available.
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