Quality & Regulatory

We are committed to achieving and maintaining a high standard of quality and service in all aspects of our laboratory testing. This commitment is underpinned by the support of our management team to provide a highly professional and confidential service in our secure facilities to all of our customers.

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

Nelipak Healthcare Packaging extensive product offering and 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 and ISO 13485:2016. 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

Risk-free Supply Initiatives

Nelipak Healthcare Packaging works toward all aspects of risk-free supply. Our ongoing plan includes:

Contingency and continuity strategies
Secure, redundant manufacturing capabilities
Standardisation of product specifications

Lean Methodologies

Nelipak Healthcare Packaging dedicated Process Improvement Group strives for a culture of continuous improvement throughout the organisation. Using Six Sigma tools, lean methodology and other approaches, our engineers constantly seek to minimise variation and maximise efficiency. An active internal auditing program and customer feedback help us continually adapt our process control methods to meet market demands.

Cleanroom Converting

Cleanroom certification is part of our ongoing continuous improvement plan focused on risk reduction for our customers. Many of our plants produce converted product in certified cleanrooms:

Derry, Northern Ireland
Clara, Ireland

Global ISO 13485 Certification

Both our Clara and Derry facilities are ISO 13485:2016 registered and operate in compliance with relevant FDA cGMP standards.

Our Elsham facility is 9001:2015 registered.

ISO 11607

Extensive product data is available for Nelipak Healthcare Packaging 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.

Global Harmonisation

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

We work to the highest standards

Download our Certifications here:

See our Certifications here

Markets We Serve

Our business partnerships is built upon helping our clients successfully build brands, sell products and deliver their products successfully to market. Our team of experts offers decades of industry experience and understand the unique challenges within each specific market we serve.