Filler Facilitates 21 CFR Part 11 Compliance

Aug. 2, 2006
Web-enabled and Ethernet-ready, this liquid filler makes it easier for drug makers to generate FDA-recommended electronic record-keeping.

We needed built-in Ethernet and Web communications.� That�s how Rod Baker of Intellitech ( descr-ibes some of the performance characteristics he and his team wanted to incorporate as they designed the intelliFiller Model AFS liquid filler. The machine is used largely by drug makers, for both clinical trials and full-scale production and packaging. These days, drug makers are keenly interested in packaging machinery that will facilitate the kind of electronic record-keeping spelled out in the FDA�s 21 CFR Part 11 requirements. Built-in Ether-net and Web enablement can both be useful tools where electronic record-keeping is concerned. Both these characteristics are successfully incorporated in the Model AFS thanks in part to the Rockwell Automation ( Micrologix controller that�s on board. It�s small enough to meet Intellitech�s footprint requirements, yet it has a built-in Ethernet/IP port and a Web interface.

With Ethernet connectivity, says Baker, any change an operator wants to make to the machine gets recorded and time-stamped, and reflected in that record is the operator�s e-signature and user password. This data is then stored to a secured database. That provides the electronic audit trail documenting any modifications made, so it offers the customer an opportunity to become 21 CFR Part 11-compliant.

In addition, because the Model AFS liquid filler is Web-enabled, the secured database can be accessed remotely. That becomes useful if a manager in some location other than the plant in which the filler is located needs to access the database.

Also making a contribution to the liquid filler�s controls and integration capabilities is Rockwell�s RSView 32 HMI software.

�With it we created screens and entry fields and let the operator make modifications and keep track of alarms and so forth,� says Baker. �And because the software runs on a conventional desktop PC, it ties into the end-user�s office network, so they can actually tie it into any of our machines running in their plant. It gives them the ability to view all the logs, to dig down into specific ones if they have a certain day or time frame in mind. They can see exactly what happened during that time.�

Judging by what he sees and hears as he makes the rounds at exhibition booths, says Baker, these functionalities�Web-enabled monitoring and data downloading�set the Model AFS liquid filler apart from the competition.