An entire production batch often depends on a negative sterility result (no growth) and if this batch fails, it can lead to significant treatment delays for the patient and potentially a serious deterioration in health due to the absence or delayed treatment of important medications. This is particularly critical in the development and application of innovative therapies such as CAR-T cell therapy, autologous therapy, and gene and cell therapy. Because these ATMP products cannot be terminally sterilized, it is that much more important to adhere to the highest sterility standards as they are tailored directly to the patient and often derived in precious small amounts from the patient's own body.
Therefore, it is essential to ensure an appropriate environment for all cleanroom procedures. This includes quality assurance measures, training, materials, quality controls, and of course the direct environment of sample processing. A modern cleanroom not only provides an indispensable environment for easier and thus safer processing by the analyst but also the conditions for a microbiologically controllable environment. All influences of the cleanroom are aimed at minimizing contamination sources as much as possible. This includes easy-to-clean and disinfect surfaces, 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. Often, the outer packaging is exposed to contamination sources through transport, storage, and handling. Multiple packaging layers, which are removed according to the Cleanroom Class, can counteract a significant portion of this microbiological burden. Similarly, adequate disinfection treatment before introducing into the various Cleanroom Classes is essential.
To meet all these requirements and to provide our customers with the highest level of safety regarding sterility testing, VelaLabs GmbH has made a significant improvement step towards cleanroom quality by incorporating gassed isolator technology as Cleanroom A into the cleanroom concept. This technology enables seamless disinfection of all materials and samples that can be gassed with H2O2. All surfaces, including difficult-to-access parts of primary packaging, can thus be made microbiologically safe. All safety parameters are remotely monitored and locked ensuring continuous quality control and audit trail. Combined with analytical capabilities such as bacterial endotoxins (BET), total organic carbon (TOC) and germ identification, this Isolator additionally strengthens VelaLabs’ already comprehensive safety testing portfolio.
Therefore, it is essential to ensure an appropriate environment for all cleanroom procedures. This includes quality assurance measures, training, materials, quality controls, and of course the direct environment of sample processing. A modern cleanroom not only provides an indispensable environment for easier and thus safer processing by the analyst but also the conditions for a microbiologically controllable environment. All influences of the cleanroom are aimed at minimizing contamination sources as much as possible. This includes easy-to-clean and disinfect surfaces, 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. Often, the outer packaging is exposed to contamination sources through transport, storage, and handling. Multiple packaging layers, which are removed according to the Cleanroom Class, can counteract a significant portion of this microbiological burden. Similarly, adequate disinfection treatment before introducing into the various Cleanroom Classes is essential.
To meet all these requirements and to provide our customers with the highest level of safety regarding sterility testing, VelaLabs GmbH has made a significant improvement step towards cleanroom quality by incorporating gassed isolator technology as Cleanroom A into the cleanroom concept. This technology enables seamless disinfection of all materials and samples that can be gassed with H2O2. All surfaces, including difficult-to-access parts of primary packaging, can thus be made microbiologically safe. All safety parameters are remotely monitored and locked ensuring continuous quality control and audit trail. Combined with analytical capabilities such as bacterial endotoxins (BET), total organic carbon (TOC) and germ identification, this Isolator additionally strengthens VelaLabs’ already comprehensive safety testing portfolio.
