At Sterillab, quality is the essens of our operation. Our facility is engineered to provide small and medium-sized pharmaceutical and medical enterprises with the same level of compliance and security found in large-scale manufacturing operations. We bridge the gap between niche flexibility and rigorous manufacturing standards.
We operate a fully integrated Quality Management System (QMS) that ensures traceability, consistency, and risk mitigation in every batch we process.
This specialized certification is our promise to you. It applies the requirements of ISO 9001 together with Good Manufacturing Practice (GMP) for the design, manufacture, and supply of primary packaging for pharmaceuticals. It ensures that our handling of glassware, vials, and pipettes meets the specific safety requirements for medicinal use.
Our ISO 9001 certification ensures that our internal processes are optimized for efficiency and customer satisfaction, providing a robust framework for continuous improvement.
The integrity of sterile medical products depends on the environment in which they are processed. Following our 2024 facility upgrade, Sterillab operates with state-of-the-art cleanrooms designed to meet the most demanding requirements.
We operate in Grade A and B environments, with a continuous monitoring of the critical air quality and pressure differentials required to meet the highest standard of sterilization and aseptic handling.
Our state-of-the-art ventilation and HEPA-filtration systems ensure an exceptionally low particle pressure. Constant monitoring of environmental parameters guarantees that our sterilization rooms remain well within the limits defined for pharmaceutical production.
Our processes are built on the principles of Good Manufacturing Practice (GMP). We understand that our clients rely on our documentation for their own regulatory approvals.
All sterilization cycles—whether Steam or Dry Heat—are fully validated according to industry standards (ISO 15378).
For injectable-grade primary packaging, our depyrogenation processes are validated to ensure a minimum 3-log reduction in bacterial endotoxins.
Every batch is accompanied by comprehensive documentation, including cycle logs and certificates of conformity, ensuring full traceability from arrival at our facility to final delivery.
We offer a direct line of communication for technical consultation. We assist our partners in Denmark, and across Europe in navigating the regulatory landscape for niche production and small-batch sterilization.
"We don’t just provide a service; we provide the documented security that your medicinal products deserve.", says Claus Bardram, CEO
Sterillab’s management holds the overall responsibility for ensuring that the organization continuously adheres to the quality policy. Management shall, in consultation with Quality Assurance (QA), ensure that all established objectives are achieved.
Every member of the Sterillab staff is responsible for complying with the Quality Policy and must strive to meet the defined quality goals.
To ensure that Sterillab continues to meet the requirements set by our customers, the industry, and current legislation, the following Quality Policy has been formulated to guarantee compliance.
To support this policy, specific quality objectives have been developed. These objectives are evaluated and revised annually in conjunction with the management review.
Sterillab sets high standards for ourselves to deliver a professional high-quality product, ensuring that customers receive the service agreed upon in the contract or partnership agreement.
The perception of quality must be evident in all aspects of the interaction between the customer and the company – both during physical meetings and any subsequent follow-up visits.
We aim to attract and retain qualified and dedicated employees who are committed to adhering to our quality policy and objectives.
All employees must undergo an induction process to ensure they are well-informed about all company activities. Furthermore, ongoing training activities will be established based on legal and professional requirements, as well as the individual employee’s competencies, job profile, and needs.
Our services are based on customer needs and relevant legislation.
The customer must experience receiving services that align with the agreed foundation regarding quantity, time, and price.
All other service experiences a customer encounters when interacting with Sterillab must comply with our values, policies, and objectives defined for the area.
Copyright © 2026 All Rights Reserved
