Materials and Manufacturing Change Notices

Adherent Bell ("AC") Bag Label Change Notification.pdf

Product Codes Affected:

All VueLife^TM Adherent Cell (AC) bag product codes: Current Standard products: 32-AC, 45-AC, 72AC, 118-AC, 197-AC, 290-AC, 750-AC, and any other product codes, or special item products using Afc film for adherent cell bags

Date of Initial Change in Shelf Life: 

All AC bags manufactured after September 30, 2011, and from lot # 237103, going forward

Type of Change:

Shelf life reduced from three (3) years to one year (1) year, with Afc performing studies over the next 24-36 months to see if shelf life can be extended beyond one year.  Change made to conservatively assure that bag seals strength does not fall below Afc specification over long-term storage.

Effect of the Change;

NO effect on product quality or handling.  This is a conservative change in labeling only, not to the product form, fit or function.  Past lots of AC bags are not affected by this label change.

Handling of the AC bags:

Handling is as per Afc instructions, noted on the website and as stated below:

"with proper support, the bags may be used for centrifugation"

The web site also has photos and a procedure for centrifugation of all Afc bags, and as more specific information is developed by Afc or centrifuge manufacturers, Afc will post this on our web site.

Spike Port Change Notice 14Sept2011.pdf

Dear Purchasing Agent:

In response to technical complaints regarding the difficult removal of the spike port cover, Afc has replaced the spike port andspike port cover (bowl connector, figure 1) with a white cap spike port cover and new style spike port (figure 2). The new whitecap is easily removed by simply applying a slight twist and pulling the cap straight off.

Replacement affects the following part numbers produced after August 2011:

2PF-0072-H-SPBC
2PF-0118-H-SPBC
2PF-197-SPS
3PF-0290
3PF-0500
3PF-0510-H-SP
3PF-0730
3PF-1000
3PF-2000

Materials Change Notice:  2P to 2PF ports

AMERICAN FLUOROSEAL CORPORATION has upgraded the material used in the luer fittings on AFC bags from this date forward.  The change will be indicated by the denotation of 2PF in the catalog number.  From this date forward, bags ordered under catalog numbers with “2P” may be shipped with the “2PF” upgrade without other notice. 

The luer fittings on “PF” bags are made from FEP FluoroEthylene Propylene.  In the past the luer fittings on AFC bags were made from PolyVinylDiene Fluoride (PVDF).   AFC is making this change to produce a bag comprised of only one material (FEP).  This change will remove the PVDF luer fitting and replace it with an FEP fitting.  The FEP fitting is the same material as the bag itself.

In the new (2PF-) configuration, FEP luer fittings are bonded directly to the body of the bag to eliminate opportunity for failures at the junction between dissimilar materials.  In the older (2P-) configuration, the PVDF fitting was attached by a friction connection rather than a bonded connection.

The FEP Luer fittings are dimensionally identical to other luer fittings.   Elimination of an intermediate FEP bushing results in a slightly shorter overall bag height.   Otherwise the form, fit and function of the containers and connector will not be affected.  There will be no change in the use of the bags or fittings.  

The catalog number will be changed from “2P-…” to 2PF-… to indicate FEP fitting. For a limited time, the previous PVDF fittings will be available under the previous “2P-…” catalog number.  The price will remain the same.

Materials Change Notice:  Upgrade in the material used in the luer fittings

AMERICAN FLUOROSEAL CORPORATION has upgraded the material used in the luer fittings on the bags in this shipment.  The luer fittings on these bags are made from FEP FluoroEthylene Propylene.  In the past AFC containers (bags) included luer fittings made from PolyVinyliDene Fluoride (PVDF).  

AFC is making this change to produce a bag comprised of only one material (FEP).  This change will remove the PVDF luer fitting and replace it with an FEP fitting.  The FEP fitting is the same material as the bag itself.

In the new (2PF-) configuration, FEP luer fittings are bonded directly to the body of the bag to eliminate opportunity for failures at the junction between dissimilar materials.  In the older (2P-) configuration, the PVDF fitting was attached by a friction connection rather than a bonded connection.

The FEP Luer fittings are dimensionally identical to other luer fittings.   Elimination of an intermediate FEP bushing results in a slightly smaller overall bag height.   Otherwise the form, fit and function of the containers and connector will not be affected.  There will be no change in the use of the bags or fittings.  

The catalog number will be changed from “2P-…” to 2PF-… to indicate FEP fitting. For a limited time, the previous PVDF fittings will be available under the previous “2P-…” catalog number.  The price will remain the same.