Cleanroom - State-of-the-art cleanroom for scalability and flexibility

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What does our cleanroom mean to you?

Our cleanroom enables us to be a "rapid-response center" and quickly produce single-use assemblies, prototypes and "proof-of-concept" designs for our customers, as well as repackage single-use components in the cleanroom.

With our local presence in the Nordic countries, our "open-architect" approach to the design phase and our comprehensive process understanding, we make it easy for our customers to incorporate the benefits of single-use solutions into their processes.

In cooperation with the customers, we also have the opportunity to adapt the solutions to their specific needs.

Quality & certificates

At Alflow, we assemble, pack and inspect our single-use assemblies in the cleanroom. The entire process is carried out in an environment that significantly reduces the risk of contamination, ensuring that the products meet the high standards required for pharmaceutical and biopharmaceutical applications. This careful approach to assembly and packaging in a controlled environment highlights our commitment to quality and patient safety.

From drawing to complete solution

Through close cooperation with our customers, we determine the precise goals and ensure that the solution exceeds the customer's expectations.

Our team creates unique designs that require customer approval before they are sent on to production.

After approval, our specialists validate the design to ensure high quality.

Throughout the entire process, strict quality control is carried out and we provide detailed documentation, ensuring transparency and the highest standards.

The final product is delivered after our extensive quality assurance process.

GMP Annex 1 Compliant - ISO Class 7

To understand the quality and safety measures that we adhere to, it is crucial to first understand the standards of GMP Annex 1 and ISO Class 7. GMP Annex 1 outlines the guidelines for the manufacture of medicinal products and the equipment used in our production, with a focus on minimizing the risk of contamination. ISO Class 7 refers to the air cleanliness in cleanrooms, which is critical to maintaining a contamination-free environment. Our commitment to these standards is a testament to our dedication to excellence.

State-of-the-art cleanroom for scalability and flexibility in single-use production

Cleanroom

In a world where pharmaceutical and biotechnology innovation is essential, cleanrooms play a key role in the production of single-use products. At Alflow Scandinavia, we are proud to introduce our state-of-the-art cleanroom, designed to meet the industry's highest standards. The cleanroom marks a significant step forward in our mission to deliver exceptional value to our customers in the production of insulin, mAb, vaccines, cancer drugs and cell & gene therapies.

Our new clean room is equipped with advanced technology that ensures a high level of cleanliness and safety throughout the production process, so that our products are free from contamination, which is essential for both manufacturers and end users. The cleanroom is part of our ongoing commitment to improving our quality systems and processes. We are committed to maintaining the highest standards of documentation and traceability, ensuring that all our products meet the strict requirements of our customers and regulatory authorities.

Scalability and flexibility

With the introduction of our new cleanroom, we now offer even greater scalability and flexibility in production. This means that we can quickly adapt to changing customer requirements and market conditions without compromising on quality. Our customers can expect a more efficient and adapted production that meets their specific needs.

Technical expertise and advice

Our team of experienced engineers are available for technical assistance and advice. With access to our state-of-the-art cleanrooms, our experts can now provide even better support in the development of tailored solutions that maximize the efficiency and productivity of our customers' single-use processes.

Contact a specialist for more information

Contact us, if uou need help, advice or wishes to hear more about our cleanroom and products for the single-use industry.

Contact a specialist for further information

Lasse Domar Nielsen

Product Manager SU & Cleanroom Team Lead

T:+45 2155 5554

M:ldn@alflow.dk

Silvia Roma Bentin

Internal Technical Sales

T:+45 7696 2133

M:sb@alflow.dk

Peter Andersen