VelaLabs modernizes its equipment with an aseptic isolator

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

VelaLabs equips its facilities with a modern aseptic isolator from Block® for sterility testing. This continues to ensure analytical services are performed to the highest standards.

On August 25, 2023, one year after its publication, Annex 1 to the Good Manufacturing Practice guidelines for pharmaceuticals came into force. This new addition to the regulatory framework governs the manufacturing of sterile products and includes regulations for the operation of isolators in cleanroom environments. To keep pace with current GxP regulations, VelaLabs is upgrading its equipment with a new aseptic isolator capable of disinfecting its internal environment and samples with hydrogen peroxide gas (H2O2). This guarantees a more thorough sterilization, ensuring precise analytical results. The device can be used for work with various matrices such as gels, liquids, and solids. Analytical methods such as membrane filtration or direct load methods can be performed in this way.

In addition to the H2O2 sterilization method, the new isolator also offers other exciting features – it is equipped with state-of-the-art alarm systems that emit an audiovisual signal when monitored system parameters are outside the set limits. Furthermore, the device can generate a detailed report on all relevant parameters such as pressure in the material lock, particle count, number of successful sterilization processes, relative humidity, airflow velocity, and temperature. Therefore, this device meets the high GxP requirements of the industry and enables VelaLabs to fulfill all customer needs.

Due to the special requirements VelaLabs imposes to serve its global customer base, this device is tailored to Class A quality, manufactured according to a comprehensive specification, and subsequently qualified and validated. After installation, the Class D cleanroom is re-qualified to complete the audit routine.