Contamination control

We have an extremely careful approach when it comes to prevent cross-contamination. By handling each IVD/ASR product separately in dedicated rooms under laminar air-flow in every step and never expose these products to an uncontrolled environment, we can guarantee non-contaminated products. This approach is obviously time consuming but is of utmost importance in order to secure the correct performance of our products in diagnostic assays.

Environment

A clean indoor environment is of utmost importance to us. Our concern is to isolate each product, in order to protect it from both other products and an uncontrolled environment. Such exposures can namely be devastating to your products as it may influence its ability to target detection.

To be able to achieve this isolation, we handle each product separately under laminar air-flow in a dedicated clean room. This approach involves frequent cleaning, but also requires a large number of clean rooms. Today, we have 21 clean rooms (ISO class 8) that are managed by three separate ventilation systems. The laminar air-flow cabinets are regularly tested and approved.

We actively work to restrict the number of particles in our production facility, and regularly count particles and perform microbiological tests. We have implemented a number of procedures in order to limit the number of particles surrounding the products, such as special clothing for people working in the production, strict routines regarding health and hygiene and, of course, specific actions with regards to the facility itself.

Dedicated HPLC columns

It is our experience that the HPLC column constitutes the largest risk of carry-over of one oligonucleotide to another. This fact is easy to accept when you consider that the active stationary phase of the HPLC column corresponds to a huge surface. This means that no matter how ever extensive washing methods are used, there will be residues of oligonucleotides present on this complex surface, inaccessible to washing efforts. Therefore, we use dedicated HPLC columns for IVD/ASR products. A column can be dedicated to one oligonucleotide or to a group of oligonucleotides, for example primer pairs that are going to be mixed later on in your process. A dedicated HPLC column needs to be purchased only once and will be stored at SGS DNA to accommodate future orders.

We manufacture our own HPLC columns. This, naturally, gives a better price, but even more important, it facilitates up-scaling. We use the same type of media for the manufacture of small scale columns as well as large scale columns, which eliminates one significant source of diversity when scaling-up. This is not easily obtained by any commercial column manufacturers.