Access control is already one of the underpinnings of FDAs current Good Manufacturing Practices (cGMP), and 21 CFR Part 11. Open control and the use of convenient Web-based interfaces has made security more of a priority for drug manufacturers. Sarbanes-Oxley (see "Making Sense of Sarbanes-Oxley," May 2005) also promises to heighten interest in access control, and drive the use of more advanced technologies.At more drug manufacturing facilities, barcoding and RFID are starting to replace the use of password-protected access. Some facilities have taken the next step and are using biometrics, such as fingerprint identification, either in smart cards featuring embedded biometrics or in devices that record fingerprints. The future will likely see greater use of retinal systems for ultraclean processing environments, where operators must wear gloves.Purdue Universitys Biometrics and Manufacturing Security Initiative (www.tech.purdue.edu/it/resources/biometrics/manufacturing.html) has already demonstrated how all of these technologies could apply to drug manufacturing. High-tech access control will be particularly important to drug R&D operations, Purdue researchers say, since these are vulnerable to information theft.Process control system vendors including Rockwell, Emerson and GE Fanuc are already incorporating many of these technologies into their process control systems. A number of companies have partnered with biometrics specialists. Honeywell, for example, has partnered with Cansec Systems Ltd. (Mississauga, Ont.) on systems using smart cards that incorporate biometrics into its physical access control systems. Johnson Controls has installed Bioscrypts V-Pass biometric readers at a number of drug manufacturing facilities, Emerson has worked with SAFLINK (Bellevue, Wash.), as has Iconics (Foxborough, Mass), which is also using the companys biometric identity assurance management software in its Genesis32 automation suite. Rockwell has also worked with SAFLINK and recently demonstrated a biometric interface with RSView and ControlLogix.This trend only promises to continue. Here, we profile two of the latest offerings that incorporate biometrics into an operator interface.Interface Offers A Choice:
Biometrics, RFID, or Both?Next month, Red Lion Controls (York, Pa.) is expected to introduce a new stand-alone operator interface terminal that would allow users to comply with 21 CFR Part 11 without an external server or specific coding. The new G310CFR uses a tag-based security system that automatically prompts the operator for user name and password confirmation every time a user action results in a change of a data tag. Users can override this feature, temporarily, during maintenance and commissioning.A key feature of the new system is its availability with an optional biometric or RFID reader. The biometric fingerprint reader can store up to 30 users locally, or allow an unlimited number of users to be stored within an external server. The RFID alternative, which offers similar capabilities, could be used by gloved operators, allowing them to log in with devices such as badges, ID cards or key fobs. Both methods would provide convenient information storage as well as a fast, secure alternative to username and password entry.The interface was designed to store a complete history of changes, as well as the time, date and operator who made the changes. This data is stored in CSV files, written to standard CompactFlash cards. For more information, contact Jesse Benefiel, interface and control product manager at [email protected].U.K. Engineering Companies Offer
Out of the Box Biometric HMI SolutionTwo U.K. engineering companies, AJM Automation Ltd. (Derby) and Ultima Control Systems (Leicester), have recently introduced an HMI that incorporates fingerprint recognition technology. The system uses CTC Parker Hannifin Automations HPX PowerStation and Ultima Controls Datatrak software to help users achieve compliance and fingerprint authentication.The fingerprint sensor used in the device was developed by Authentec (Melbourne, Fla). Called TruePrint, it was designed to read below the surface layer of skin so that readings arent distorted by cuts or irregularities. For more information, contact AJM director Andy Markgraf at 011-44-0-1283-734388.
Biometrics, RFID, or Both?Next month, Red Lion Controls (York, Pa.) is expected to introduce a new stand-alone operator interface terminal that would allow users to comply with 21 CFR Part 11 without an external server or specific coding. The new G310CFR uses a tag-based security system that automatically prompts the operator for user name and password confirmation every time a user action results in a change of a data tag. Users can override this feature, temporarily, during maintenance and commissioning.A key feature of the new system is its availability with an optional biometric or RFID reader. The biometric fingerprint reader can store up to 30 users locally, or allow an unlimited number of users to be stored within an external server. The RFID alternative, which offers similar capabilities, could be used by gloved operators, allowing them to log in with devices such as badges, ID cards or key fobs. Both methods would provide convenient information storage as well as a fast, secure alternative to username and password entry.The interface was designed to store a complete history of changes, as well as the time, date and operator who made the changes. This data is stored in CSV files, written to standard CompactFlash cards. For more information, contact Jesse Benefiel, interface and control product manager at [email protected].U.K. Engineering Companies Offer
Out of the Box Biometric HMI SolutionTwo U.K. engineering companies, AJM Automation Ltd. (Derby) and Ultima Control Systems (Leicester), have recently introduced an HMI that incorporates fingerprint recognition technology. The system uses CTC Parker Hannifin Automations HPX PowerStation and Ultima Controls Datatrak software to help users achieve compliance and fingerprint authentication.The fingerprint sensor used in the device was developed by Authentec (Melbourne, Fla). Called TruePrint, it was designed to read below the surface layer of skin so that readings arent distorted by cuts or irregularities. For more information, contact AJM director Andy Markgraf at 011-44-0-1283-734388.
