The validation strategy for Allegro™ products (Pall™ Life Sciences products) is different to the approach taken for Allegro™ TK8 systems. We have 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, we have created a validation document that compares the single-use systems and the manufacturing processes for original Allegro™ TK8 file and replacement Allegro™ films.
The 2D and 3D Allegro™ biocontainers (Pall™ Life Sciences products) 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. Cytiva will not accept liability for any damage or product loss because of filling Allegro™ biocontainers with fluid volume above the specified nominal volume.
Yes, validation guides for the Allegro™ biocontainers, mixers, and bioreactors are available at Cytiva regulatory support.
Validation guides for the Allegro™ biocontainers, mixers, and bioreactors (Pall™ Life Sciences products) are available at Cytiva regulatory support.
We manufacture different membrane filters for gas filtration. We use either Polytetrafluoroethylene (PTFE) filter membrane or Polyvinylidene Fluoride (PVDF) modified, for such a purpose.
In our 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 used with our single-use systems.
Emflon™ II V002 sterilizing grade filters uses a filter membrane made of polyvinylidene difluoride (PVDF).
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