| 2005N-0510 | Anti-Counterfeit Drug Initiative Workshop and Vendor Display | ||||||||||||||||||||||
| FDA Comment Number : | EC9 | ||||||||||||||||||||||
| Submitter : | Mr. Rob Faulhammer | Date & Time: | 02/27/2006 01:02:18 | ||||||||||||||||||||
| Organization : | ATS Automation Tooling Systems Inc. | ||||||||||||||||||||||
| Category : | International Industry | ||||||||||||||||||||||
| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| ATS VALIDATE Glass Marking Technology:
ATS is a global automation solutions company which has been delivering manufacturing equipment to the pharmaceutical and medical device industry for many years. Our offerings to the parenteral drug customer base include vision inspection solutions, material handling solutions, assembly systems and packaging systems. ATS has partnered with TESA AG to offer a glass marking solution for marking vials and syringes which applies an unerasable, good contrast mark which can be tailored to the application. Marks such as logos, text, 2D bar codes, lines on syringes and other information can be printed on the glass substrate, making them readable by either human eyes or bar code scanners. The mark becomes a part of the molecular structure of the glass making it unerasable. As an anti-counterfeiting solution, ATS/TESA sees the advantages as: a) as it is not erasable the VALIDATE marking solution becomes a way for the end user to verify authenticity as long as a tamper evident cap is used or the diversion of product between the manufacturing site and the consumer or pharmacy can be avoided b) as it is machine readable the mark becomes a tracking tool on production lines to support the creation of the product pedigree c) as the 2D or 1D bar code is compatible with existing reader technology, the existing ink jet infrastructure can potentially be used with minor positioning changes c) as covert security features can be buried into the mark, optical verification of authenticity at the point of use is possible d) all current thoughts on internet feedback of a bar code scanner read code on the vial or syringe are possible with this technology; material handling becomes important e) complements RF ID solutions in that a secondary level of human readable security can be added where the RFID infrastructure is not available The cost per mark, depending upon the information printed, is slightly more than an ink jet mark, but considerably less than the cost of an RF ID tag. ATS provides the production solution for the technology, integrating processing systems either directly in-line on existing filling lines, after an ATS vial or syringe inspection system or to the side of an existing filling line. Conventional paper labeling can also be integrated into the production solution. The marking speed varies with the information printed, but systems can be configured to process up to 400 vials or syringes per minute. The marking can be performed either before washing and filling or after filling and vision inspection. The machine control systems are CFR21 part 11 compliant and allow a seemless integration into the production line. Please see the attached PDF document for further information. | |||||||||||||||||||||||
|
For further information, please contact: Rob Faulhammer, Director of Business Development,; ATS Automation Tooling Systems Inc., 250 Royal Oak Road, Cambridge, Ontario, Canada, N3H 4R6; Tel: (519)653-4483 ext. 2234, E-Mail: rfaulhammer@atsautomation.com | |||
| 2005N-0510-EC9-Attach-1.PDF | |||