Sterility testing at VelaLabs – That's why it has such a high significance for us

VelaLabs GmbH Block (R) Isolator (Image: Tentamus Group GmbH)

A whole production batch often depends on a negative sterilization result (no growth), and if this batch fails, it can lead to significant treatment delays for the patient and potentially a serious deterioration of health due to the absence or late administration of important medications. This is especially critical in the development and application of innovative therapies such as CAR-T cell therapy, autologous therapy, as well as gene and cell therapy. The sterility assurance is particularly important for ATMP products, as they cannot be terminally sterilized. These advanced treatment approaches require the highest sterility standards because they are tailored directly to the patient and are often derived from the patient's own body in precious small quantities.

It is therefore essential to provide an appropriate environment to ensure the safe conduct of sterility testing. This includes, among other things, quality assurance measures, training, materials, quality controls, and of course the immediate environment of sample processing. A modern cleanroom not only provides an indispensable environment for easier and thus safer processing by the analyst but also conditions for a microbiologically controllable environment. All influences of the cleanroom are aimed at minimizing sources of contamination. These include surfaces that are easy to clean and disinfect, appropriate design specifications for an undisturbed workflow, or invisible conditions such as airflow, pressure cascades, and filtered supply air. An important aspect is the introduction of materials and samples into the cleanroom area. External packaging is often exposed to contamination sources, whether through transportation, storage, or handling. Multiple overpackaging, which is approved according to the cleanroom classes, can counteract much of this microbiological load. Likewise, sufficient disinfection treatment before introducing materials into the various cleanroom classes.

To meet all these requirements and to provide our customers with the highest level of safety regarding sterility testing, VelaLabs GmbH has achieved a major development step towards cleanroom quality by adopting the gas-sterilizable isolator technology as a cleanroom class A in the cleanroom concept. This technology enables thorough disinfection of all materials and samples that can be gas-sterilized with H2O2. All surfaces, including hard-to-reach components of primary packaging, can thus be rendered microbiologically safe. This is of crucial importance, especially in the manufacturing and processing of personalized medicines, such as those used in CAR-T cell therapy, autologous therapy, and gene and cell therapy, to ensure that these highly sensitive and patient-specific treatments can be carried out without the risk of microbiological contamination.