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Aramus Single-Use Assembly

Aramus™ Single-Use Assemblies are the only gamma-sterilizable bags made of fluoropolymer material worldwide. These fluoropolymer bags are comparable to Teflon® and are unique for their working temperature and their chemical resistances. Pre-sterilized Aramus™ single-use assemblies are mostly used in frozen applications, for example freezing of drug substance or intermediates at -85 °C.

Description

Aramus™ Single-Use Assemblies

The endotoxin level and particle contamination of the Aramus Single-Use Assemblies is much lower than in common single-use bags or other disposables. This is due to the production in a certified ISO class 5 cleanroom. Accordingly, the assemblies are being delivered very clean and also with little risk for GMP processes.

Our single-use bags are made of only one single fluoropolymer raw material. It is not a film consisting of several layers like PE, EVOH, Nylon and adhesives, like other single-use bags. Especially those different materials and also additives like plasticizers or coloring are potential sources for extractables. The leachables and extractables results of the Aramus™ single-use assemblies are excellent and also far better than of regular PE or EVA bags, since the Aramus™ bags include none of those additives. The test data following BPOG guidelines confirm this and are also available on request. Moreover, the single-use assemblies are very robust and there is no hazard by delamination. Thus, the risks of potential damages to the assembly, which may lead to a loss of product, decreased remarkably.

Besides the excellent chemical resistance, the huge range in temperature is a leading argument for Aramus Single-Use bags to be the first choice in frozen applications. The following clip shows how it still stays flexible even when dipped into liquid nitrogen.

Other materials for freezing bags would be beyond their glass transition point at these temperatures and would not be elastic anymore but imperiled to break. Since still a lot of expensive active pharmaceutical ingredients are lost in the process of freezing and transporting the final product before the filling, the Aramus™ freezing bag is a perfect solution to optimize this critical process.

Aramus Single-Use Bag Applications:

  • Downstream
  • Not only Freezing cell cultures, but also Freezing intermediate
  • Storage and transport of active ingredients
  • Freezing and also storing stem cells
  • Storing and transporting aggressive media
  • Storage and transportation of binding media
  • Filling
  • Critical sampling

Measurements of the Bags

(20ml and 50L Aramus ™ Bags available on request)

50ml 100ml 250ml 500ml 1l 2l 5l 10l 20l
Length 120 mm (4.7″) 160 mm (6.3″) 240 mm (9.4″) 210 mm (8.3″) 285 mm (11.2″) 354 mm (13.9″) 470 mm (18.5″) 570 mm (22.4″) 718 mm (28.3″)
Width 100 mm (3.9″) 100 mm (3.9″) 100 mm (3.9″) 158 mm (6.2″) 178 mm (7.0″) 254 mm (10″) 323 mm (12.7″) 383 mm (15.1″) 483 mm (19.0″)

Bag-Assembly Selections

50ml – 250ml Bag Assemblies:

500ml – 20L Bag Assemblies:

Bags without tubings (non sterile)

Further sizes and types of Assemblies are available on request.

Aramus™ Bags are compliant to:

  • USP Class VI
  • USP <87>
  • USP <88>
  • USP <85> and EP 2.6.14 – <0,125 EU/ml
  • ISO 10993-4 (non-hemolytic)
  • USP <661> (Extractables)
  • USP <788> and EP 2.9.19 (Particle)
  • BST/TSE conformity
  • Working temperature from -85°Cto 40°C
  • Sterilizable
  • Cleanroom class 5 production
  • Monolayer coating
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