Fluid Handling FAQ

Information applicable to use of Pall single-use technologies to support their suitability for biotechnology and pharmaceutical applications.


What is the difference between Allegro™ TK8 film and Allegro film validation guide?

The validation strategy for Allegro™ products is different to the approach taken for Allegro™ TK8 systems. Pall developed validation guides, datasheets and Instructions for Use (IFU) specifically for each Allegro™ technology, including biocontainers, mixers and bioreactors. The approach taken for Allegro™ TK8 film was for a single validation guide for the film only. This document is applicable to all products that utilize the Allegro™ TK8 film. 


As part of the Allegro™ TK8 film replacement process, Pall has created a validation document that compares the single-use systems and the manufacturing processes for original Allegro™ TK8 file and replacement Allegro™ films.

What are the volume tolerances of Allegro™ 2D and 3D biocontainers?

The 2D and 3D Allegro™ biocontainers were qualified using devices filled at their nominal volume inside their respective Allegro totes or trays. 

Our R&D team performed a limited quantity of tests to verify that the biocontainer resists an overfilling of 10% of the nominal volume. These tests were performed to ensure that the biocontainers were not at a critical limit when filled at nominal filling volume. Due to the limited number of samples used, this testing does not provide a validated guarantee that Allegro™ biocontainers can be routinely overfilled at 10% of the nominal volume.

The Allegro™ 2D biocontainers were qualified in a horizontal position. If stored in the vertical position, a volume of 10 L should not be exceeded for the 20 L and 50 L Allegro™ biocontainers.

It is the responsibility of the end user to qualify the use of biocontainers outside of the product specifications. Pall Corporation will not accept liability for any damage or product loss as a result of filling Allegro™ biocontainers with fluid volume above the specified nominal volume.


Do you have an Allegro film validation guide?

Validation guides for the Allegro™ biocontainers, mixers and bioreactors are available in the Accelerator Documentation Center.


Why can I only use Pall Emflon® II V002 filter capsules as a gas filter in my Pall Allegro™ single-use system design?

Pall manufactures different membrane filters for gas filtration. We use either Polytetrafluoroethylene (PTFE) filter membrane or Polyvinylidene Fluoride (PVDF) modified, for such a purpose.

In our Pall Allegro™ single-use systems, the method to sterilize these systems is by gamma irradiation.

The Polytetrafluoroethylene (PTFE) filter membrane, is incompatible with gamma irradiation, so it could not be used as a gas filter in our Single-Use Systems.

The Polyvinylidene Fluoride (PVDF) modified is compatible with gamma irradiation and for this reason is the device to be used with our Single-Use-Systems.

Pall Emflon II V002 sterilizing grade filters uses a filter membrane made of polyvinylidene difluoride (PVDF).

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