Medical device sterile packaging consulting
When medical device packaging challenges slow your progress, Nissen Technical brings specialized engineering expertise to solve difficult problems and keep your projects moving.
Technical expertise
Medical device packaging systems must protect both the device and the sterile barrier throughout sterilization, distribution, and storage, while enabling aseptic presentation at the point of use.
Nissen Technical specializes in packaging system development, performance and stability validation, and sealing process development and validation - with deep expertise in sterile barrier systems and ISO 11607.
Whether you are developing a new packaging system, evaluating a design change, or investigating a persistent problem, Nissen Technical can help you understand the options, make informed technical decisions, and implement effective solutions.
Explore ISO 11607 supportServices
Focused engineering assistance for a specific challenge, a critical project phase, or a difficult technical decision.
ISO 11607-1
Nissen Technical develops medical device packaging systems designed to protect the device, maintain sterile barrier integrity, and support aseptic presentation.
Services include material selection, sterile barrier system and protective packaging development, technical feasibility, and design evaluation.
ISO 11607-1
Get experienced support managing your packaging validation program, from strategy and test planning through laboratory coordination, data evaluation, and final documentation.
Services include packaging performance and stability evaluations, aseptic presentation, material characterization, and other specialized testing as needed.
ISO 11607-2 & ISO 11607-3
Establish robust sealing processes through structured development, characterization, and validation, with practical engineering support from initial setup through qualification.
Services include process parameter development, process characterization, IQ/OQ/PQ, and technical documentation.
TECHNICAL PROBLEM-SOLVING
When packaging design or manufacturing problems disrupt your project, focused investigation and structured analysis help identify root causes and develop practical solutions.
Services include package integrity and seal quality investigations, process variability analysis, design change evaluations, and corrective action support.
Complementary capabilities
Process optimization, equipment troubleshooting, technical transfer, and scale-up support to improve manufacturing performance.
Independent technical assessments, focused engineering assistance, and practical guidance to help project teams make informed decisions.
Comprehensive project support
From system development through validation, Nissen Technical can manage the technical details, coordinate specialized testing, and assemble the evidence your team needs to move forward with confidence.
About Brian Nissen
Brian Nissen, CPP
Founder, Nissen Technical, LLC
With over 25 years of experience across product development, manufacturing, packaging, validation, and quality, Brian brings a broad engineering perspective to medical device packaging challenges.
Brian's background spans medical device packaging development, manufacturing processes, technical investigations, and engineering leadership. His experience in both OEM and contract manufacturing environments brings a practical perspective to the challenges your team faces.
A Certified Packaging Professional, Brian has contributed to industry standards development through AAMI and ISO working groups. He also brings extensive experience in technical training, mentoring, and structured problem-solving.
As an independent, owner-operated practice, Nissen Technical provides direct access to the specialist doing the work.
Let's talk
Whether you are developing a new packaging system, navigating a validation challenge, or investigating a difficult technical problem, let's talk about how Nissen Technical can help.
Discuss Your ProjectNissen Technical, LLC
[email protected]Minnesota, USA
Start with a brief description of your challenge and the kind of support you need.
