On 25^nd of August 2023, a year after its publication, Annex 1 to the Guidelines for Good Manufacturing Practice for medicinal products came into force. This new addition to the regulatory framework governs the manufacturing of sterile products and includes regulations on operating isolators in cleanroom environments. To stay abreast of current GxP rules, VelaLabs is upgrading its device fleet with a new aseptic isolator, able to disinfect its internal environment as well as the samples using hydrogen peroxide gas (H₂O₂). That guarantees a more thorough sterilization which ensures a precise analytical outcome. The device can be used for working with different matrices such as gels, liquids, and solids. Analytical methods such as membrane filtration or the direct loading method are used for this purpose.

Besides the H₂O₂ sterilization method, the new isolator also comes with more exciting features. There are integrated alarm systems in place which give off an audiovisual signal if any monitored system parameters are out of bounds. The device can also create a detailed report of all relevant parameters like pressure in the material lock, particle count, successful sterilization process count, relative humidity, airflow velocity and temperature. Therefore, this device complies with the high GxP demands of the industry and allows VelaLabs to meet all customer needs.

Due to the special requirements VelaLabs places to serve its global customer base, this tailored to, and custom-built Grade A device will be qualified and validated to match a comprehensive specification. After installation, the Grade D cleanroom will be qualified anew along with isolator to complete the audit trail.

Interested in working with the highest purity standards? Send us an e-mail to velabd@vela-labs.at with your enquiry, we look forward to hearing from you!