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Superior Quality. Regulation Compliance.

It begins and ends with Quality. Nelipak Healthcare Packaging is a quality-driven organization committed to supplying products and services to the medical device and pharmaceutical industries that meet or exceed customers’ requirements – including Regulatory Standards.

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Quality Advantage in a Complex Industry

Positioned with our commitment to customer’s Quality, Nelipak’s technologies and resources provide a competitive advantage in the market.

With the strength of 1,400 employees and 11 sites globally, Nelipak is committed to delivering superior quality, service, and customer experience through world-class cleanroom manufacturing and superior quality standards.

Assurance at Every Level

Nelipak’s extensive product offering and manufacturing facilities manage risk and assure reliable supply for your medical device 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.

Nelipak Quality covers:

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

Cleanroom Manufacturing

Nelipak manufacturing facilities operate in accordance with ISO 13485 for custom packaging solutions.

Our quality program meets the stringent standards of medical device and pharmaceutical manufacturers worldwide.

Key Features:

  • Manufacturing occurs in certified ISO 14644-1 Class 7 & 8 cleanrooms.
  • Work aligned to applicable EU and FDA GMP Directives.
  • On-line inspections that meet MDR standards.
Validation of thermoform mold tool

Process Validation & Tool Qualification

Process control for consistent, high-quality products – all for patients across the globe.

In order to achieve its high-quality products, Nelipak focuses on robust process validation programs in collaboration with our customers.

Including, but not limited to, are:

  • Design Validation
  • Installation Qualification
  • Operational Qualification
  • Process Qualifications to achieve proper process capability levels (Cpk’s and Ppk’s),
  • Test Method Validations

A Partner You Can Trust

All Nelipak facilities where products are made, are certified to ISO 13485 and /or ISO 9001 for the manufacture of custom healthcare packaging and products to customer specifications.

Quality Program

A pillar of our business operations, Quality is at the center of our work – it strengthens our safety proposition and commitment to customers. Our quality program meets the stringent standards of medical device and pharmaceutical manufacturers worldwide.

Quality Assurance

The guarantee makes all the different. Quality assurance is built into everything Nelipak does for the customer:

  • Order entry
  • Contract review, document control to training programs
  • Design control
  • Validation

Full Product Traceability

Full product traceability is available for customers, no matter the size of the project. Track all of the following:

  • Raw materials
  • Auxiliary materials
  • Inspection results
  • Production conditions
  • Employees involved

Superior Products & Services.

Speak to a Nelipak commercial sales representative about how Nelipak’s Performance Packaging solutions are right for any and all sensitive medical products.

Our business partnerships is built upon helping our clients successfully build brands, sell products and deliver their products successfully to market. We will work with your team to deliver on time and on budget – from concept to end-use, we’re with you through it all.

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