Perfecseal | Quality

Low-Risk, Six-Sigma Quality Supply and ISO 11607 Support

Perfecseal’s extensive product offering and global manufacturing facilities manage risk and assure reliable supply for your medical packaging and pharmaceutical packaging.

We are committed to the support of global medical product quality standards and practices, such as ISO 11607, ISO 13485 and ISO 9001.

You can count on:

Documented, defined, repeatable test methods
Full product traceability
Data-driven, statistical decision-making
Specification controls to customer requirement
Certifiable, detailed product documentation

Global ISO 9001:13485 Certification

All Perfecseal facilities are either ISO 13485 or 9001 registered and operate in compliance under FDA cGMP standards.

Lean Methodologies for Continuous Improvement

Perfecseal’s dedicated Process Improvement group strives for a culture of continuous improvement throughout the organization. Using Six Sigma tools, Lean methodology, and other approaches, our engineers constantly seek to minimize variation and maximize efficiency. An active internal auditing program and customer feedback help us continually adapt our process control methods to meet market demands.

Quality Certifications

North America

Perfecseal Mankato	ISO 13485-2003
Perfecseal New London	ISO 13485-2003
Perfecseal Oshkosh	ISO 13485-2003
Perfecseal Philadelphia	ISO 13485 2003
Perfecseal Puerto Rico	ISO 13485:2003

Europe

Perfecseal Europe

ISO 13485:2003

Asia

Bemis Asia-Pacific	ISO 9001-2008
Bemis Suzhou	ISO 9001-2008

ISO 11607

Extensive product data is available for Perfecseal products, including accelerated aging studies, barrier testing, porosity, biocompatibility, cytotoxicity and other information to support ISO 11607 requirements as well as verify the suitability of our materials to your application.

Risk-Free Supply Initiatives

Perfecseal works toward all aspects of risk-free supply. Our on going plan includes contingency and continuity strategies, security, redundant manufacturing capabilities and standardization of global product specifications.

Global Harmonization

Harmonization of best practices, processes and material specifications ensures one controlled standard of compliance, no matter where we produce your medical packaging.