New 552 MED Validatable Medical Band Sealer with UDI Printer
Medical Band Sealer with a self-contained, UDI compliant print module.
Designed for sealing medical devices in bags and pouches, this advanced band sealer facilitates complex labeling requirements for regulated medical and life science applications.
San Rafael, CA (February 04, 2016) – PAC Machinery, a leader in the bag sealing and flexible packaging industry, announced today that it will offer its popular Packaging Aids 552 Medical Band Sealer with a self-contained, UDI compliant print module. Now required by the FDA, UDI is a unique identification code assigned to medical devices by the manufacturer of the device and will replace the use of NHRICs and NDCs for medical device bag and pouch serialization. “The integration of the new UDI printer ensures that our model 552 Med Validatable Band Sealer users will be in full compliance with the current FDA labeling rules”, said Mr. Brian Jobson, Product Line Manager at PAC Machinery. “ Our printer solution is designed to address the complex pouch and bag labeling requirements of highly regulated medical and life science applications”, Mr. Jobson continued. The Packaging Aids 552 Med Validatable Band Sealer will be shown in action at the WestPack 2016 packaging symposium (Feb. 9-11) in Anaheim California, booth #5039.
Packaging Aids 552 Med for medical bag and pouch sealing featuring UDI compliant printer
Working in conjunction with a major print hardware and coding manufacturer, PAC Machinery has configured an efficient, reliable band sealer to help companies who are sealing products in pouches and bags to manage UDI submissions and gain compliance, while ensuring the ability to meet future FDA or other global serialization requirements. “Our venerable model 552 Band Sealer features a new UDI printing system which is fully self-contained and requires no additional hardware to connect with an ERP server”, adds Mr. Jobson. The Packaging Aids 552 Med is a validatable medical band sealer that is designed to comply with ISO 11607 standards. External ports facilitate verification and calibration of internal controllers for ease of IQ/OQ process. The 552 Med pouch and bag sealer features PAC’s real-time monitoring system with alarmed lock-out function to prevent operation should the sealer deviate from predetermined operational settings. Originally developed in conjunction with a respected Fortune 500 healthcare products firm, the Packaging Aids 552 Med – now available with integrated UDI compliant print module – is an excellent choice for high speed medical bag and pouch sealing applications requiring seal parameter validation.