The Role of our Quality Team at ESI Ultrapure

At ESI Ultrapure, quality is at the core of everything we do. Our commitment to customer satisfaction drives us to focus on customer requirements and develop long-term partnerships by providing quality, innovative products, solutions, and services. Central to this commitment is our dedicated Quality Department, whose expertise ensures that we consistently deliver excellence. Here’s an in-depth look at the vital role our Quality Department plays in maintaining our high standards.

Quality Certification & Scope

Cleanroom operatives working on single use assemblies - ESI Ultrapaure

Operating in a highly regulated marketplace, ESI Ultrapure places significant emphasis on obtaining the most reputable product and system certifications. We work closely with internationally recognised certification bodies to ensure our processes meet the highest standards. Our Quality Management System (QMS) is accredited by NQA to ISO 9001:2015, encompassing all our operations in both Ireland and the UK. This certification underscores our dedication to maintaining rigorous quality standards across all facets of our business.

Ensuring Full Traceability

Traceability is a cornerstone of our quality assurance processes. Supported by our industry-leading supplier base, we provide full product and component traceability for all customers requiring it. This capability ensures that every product can be tracked through its entire lifecycle, guaranteeing transparency and accountability.

Proactive Change Control

Change is inevitable, but managing it effectively is crucial. ESI Ultrapure operates a proactive and comprehensive change management process in compliance with relevant industry and customer-specific protocols. All suppliers are made aware of their responsibilities regarding change management and are required to notify us in advance of any potential changes to their products, procedures, or services related to ESI. We meticulously review, risk-assess, document and communicate all internal changes and external change notifications, ensuring all such changes are effectively controlled, and that our customers are always informed and prepared for any adjustments.

Commitment to Our Quality PolicyQuality at ESI Ultrapure

Our Quality Policy, reviewed annually as part of our Management Review, sets the framework for our QMS. Certified to ISO 9001:2015, our QMS aims to deliver high-quality products and services that are competitively priced and backed by technical innovation. Our top management is focused on integrating the QMS requirements into broader business processes, with a commitment to continuous improvement, risk-based thinking, and a process-based approach. Indutrade, our ultimate owners, fully support our Quality Policy and Quality Objectives.

Continuous Improvement

Continuous improvement is integral to our Quality Management System. Targets, objectives, and key performance indicators are agreed upon and reviewed during our Management Review process. These measures drive the continuous enhancement of our QMS, associated processes, products, and services. Individual employee and companywide targets and objectives align with our overall company strategy and corporate vision.

Comprehensive Quality and Certification Systems

ESI Ultrapure’s quality and certification systems include:

  • ISO 9001:2015 Certification: Our QMS is certified to the internationally recognized standard, ensuring robust quality management practices.
  • ISO Class 7 Cleanrooms Certification: Our two cleanrooms are both independently certified to ISO Class 7, and in full compliance with ISO 14644.
  • Provision of Sterile-Certified Single-Use Assemblies: In full alignment with ISO 11137, and supported by similarly aligned irradiation dose mapping validations.
  • Batch Registration: We maintain meticulous batch records for traceability and quality control.
  • Training Records: Comprehensive training records, supported by an internal on-line training portal, ensure our team is well-equipped to maintain high standards.
  • Supplier Qualification: We rigorously qualify our suppliers to ensure they meet our stringent quality requirements, as well as our expectations around ethical working, environmental management and sustainability.
  • Complaint/Change Notification Process: We have a robust system for managing complaints and change notifications, ensuring any issues are promptly addressed.
  • CoC Registration: Certificates of Conformance are maintained to verify product quality.
  • Quality Control/Production Records: Detailed records ensure consistent quality throughout our production processes.

At ESI Ultrapure, our Quality Department is more than just a function; it is the bedrock of our commitment to excellence. Through stringent certification, comprehensive traceability, proactive change control, and a relentless focus on continuous improvement, our Quality Department ensures we deliver the best to our customers, every time.

Latest News & Updates from ESI

Single Use Assemblies in Bioprocessing

A single use assembly / single use bag assembly is a combination of different components (ie tubing, bags, fittings) which are assembled together based on a customer’s requirements.

What is a Single Use Assembly?

We have seen many Bioprocessing end users carry out in-house assembling of their single use systems. Often this can lead to production delays if connections between the various components aren’t made correctly resulting in cross contamination and leakage.


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