Extended quality control – before, during and after

Before a single component enters the cleanroom, a rigorous quality control process must be in place. This preemptive approach to quality control acts as the first line of defense against potential issues. By implementing advanced strategies for quality assurance, we ensure that only components meeting the highest standards make it to the assembly phase.

Each component is delivered double-bagged, an essential part of maintaining cleanliness and integrity from the supplier to the cleanroom. This double-bagging method is a critical barrier against contamination, ensuring that the components remain pristine throughout their journey.

Upon arrival, each component undergoes a thorough visual inspection for particles. This inspection is not a cursory glance; it's a detailed examination to identify any potential contaminants that could compromise the quality of the product. The outer layer of the packaging plays a crucial role in this process. It is first opened in the Material Air Lock (MAL), a controlled environment that acts as a buffer zone between the outside world and the cleanroom. This step is vital in preventing any external contaminants from entering the cleanroom.

The inner layer of the packaging, which encloses the component, is only removed once it is safely within the cleanroom. This practice ensures that the component is exposed to the controlled environment of the cleanroom at the last possible stage, minimizing the risk of contamination.

After the production process, the completed assembly is double bagged, mirroring the process used for incoming components. This double-bagging is more than just a packaging procedure; it's a critical step in maintaining the purity of the product until it reaches the end user.

Thourough quality control

The journey of a product in a cleanroom doesn't end with packing; it enters the critical phase of post-packing quality control. This stage is where the assembled products undergo final checks, ensuring that every item meets the stringent quality criteria set forth. This step is crucial in maintaining the trust and reliability that customers place in us and our products.

Furthermore, the final inspection of these assemblies includes an examination over a light table. This inspection method allows for a meticulous review of the product, ensuring that even the smallest imperfections or contaminants are detected. The light table illuminates the assembly from all angles, providing a comprehensive view and allowing for a thorough quality assessment.

The post-production inspection is not performed by the individual who carried out the production and packing; instead, it is conducted by a different, equally qualified person. This protocol ensures an unbiased and thorough review of the finished product, reinforcing the integrity of the quality control process.

The individual responsible for this final inspection brings a fresh perspective, meticulously scrutinizing every aspect of the product and its packaging. This step is crucial in identifying any potential issues that might have been overlooked during the initial stages of production and packing. It's a process that underscores the commitment to leaving no stone unturned in the pursuit of quality.

Only after this comprehensive post-production control has been successfully completed, are the certificates for the products issued by the QA department. These certificates serve as a guarantee to the customers, affirming that every product has undergone and passed stringent quality checks. They are a testament to our dedication to delivering products that meet the highest standards of quality and reliability.

By involving a separate individual for the final inspection and linking the issuance of certificates to the successful completion of this inspection, we ensure that the products we deliver are not only compliant with industry standards but also meet our own stringent criteria for excellence.

Commitment to quality

In conclusion, the quality-control process for incoming components at Alflow is a testament to our commitment to quality. From the double-bagging of components to the meticulous inspections in the MAL and cleanroom, every step is designed to uphold the highest standards of quality and ensure that the final products meet the rigorous demands of the life-science industry.

In the realm of cleanroom operations, especially for companies like Alflow, quality control extends far beyond the basics. It's an ongoing, comprehensive process that scrutinizes every aspect of the operation, from the integrity of raw materials to the final assembly. Extended quality control involves advanced techniques like particle monitoring, sterility testing, and bioburden analysis. These methods ensure that the products not only meet but exceed the stringent standards expected in the life-science industry, reflecting a commitment to superior quality and safety.

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Contact us if you want to know more about our cleanroom and single-use solutions.
Lasse Domar Nielsen
Product Manager SU & Cleanroom Team Lead
Silvia Roma Bentin
Internal Technical Sales
Peter Andersen
Internal Technical Sales
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