Sterility Test I Aseptic Isolator
The Sterility Test Isolator/Aseptic Isolator offered by BLOCK Technology is a cutting-edge solution designed to provide a highly reliable and secure environment for conducting sterility testing. This advanced isolator ensures aseptic conditions, guaranteeing the utmost protection and integrity of final products during the critical testing process.
The Sterility Test Isolator meets the stringent standards of quality and safety in the pharmaceutical industry.
Sterility Test Isolator l Aseptic Isolator
BLOCK’s Sterility Test Isolator is a reliable and safe isolator for sterility testing and product protection. This isolator provides a high degree of product protection by handling the materials in aseptic conditions. The primary function takes place within the working chamber, where the sterility testing of final products is conducted.
Advanced Sterility Test Isolator Design for Enhanced Safety and Operator Protection
The single-chamber isolator is designed for sterility testing and includes four sleeves for working with sterile materials. An airlock facilitates easy material loading and features an option for sterilising with H2O2. A Leak tightness class 3, according to ISO 10648-2, ensures the containment of hazardous materials. Moreover, the isolator meets the “A” class cleanliness standard of EU GMP and is “Audit Trail” compliant, offering complete process traceability.
The isolator comes equipped with a Rotronic temperature and humidity sensor for critical parameter monitoring and decontamination control, resistant to hydrogen peroxide vapors. It also includes built-in LED lights, ensuring workspace illumination levels of at least 500 lux. Safety features such as pressure fuse and tempered safety glass for front windows and ports further enhance operator protection. The glove/sleeve flanges are designed for safe glove replacement.
Located above the K1 working chamber, a beacon light and acoustic alarm offer a prompt and clear indication of operational status and any potential failures for the user. The combined audible and visual signals provide efficient feedback, ensuring swift awareness of the isolator’s condition during use.
Laminar Flow System Ensures a Controlled and Sterile Environment
The Sterility Test Isolator employs laminar flow to achieve “A” class cleanliness, ensuring unidirectional airflow in a vertical orientation. The laminar flow is directed by a specialised, finely perforated fabric laminar frame. The technology maintains a laminar flow velocity of 0.45 m/s ±20%. HEPA filters (H14) with a 99.995% efficiency are utilised for filtering both incoming and outgoing air. Additionally, this system is commonly integrated with air re-circulation within the chamber.
Benefitting from the laminar flow system the Sterility Test Isolator provides a controlled, clean, and sterile environment necessary for conducting accurate and reliable sterility testing. It safeguards the products from contamination, protects sensitive materials, and ensures compliance with stringent quality and safety standards in the pharma industry.
Positive Pressure Mode Safeguards Product Integrity
The positive pressure feature in the HVAC system offers crucial benefits by ensuring product integrity and preventing damage to the sterility test isolator and its sensitive components. The HVAC system facilitates the generation of positive pressure within the isolator’s interior. This feature is primarily employed as a protective measure in the event of a failure, such as compromised leak tightness, to safeguard products. To prevent equipment damage caused by inadequate pressure, a pneumatic valve is utilised. This protective function ensures that the pressure does not drop further, effectively shielding the technology from potential harm.
Made from High-quality Stainless Steel Materials for Durability and Easy Maintenance
BLOCK Technology uses the highest-quality stainless steel materials for the construction of its devices. Crafted with precision, the sterility test isolator’s jacket material is made of stainless steel AISI 304, while the chamber material is AISI 316L with a thickness of 3.00 mm. The polished surface finish boasts Ra<0.6 µm, ensuring easy cleaning of inner and outer surfaces, as well as high corrosion resistance.
Cutting-edge Electronic Control System by Siemens Enhances Workflow Efficiency
The Sterility Test Isolator’s control system utilises a Siemens colour touch screen, providing an intuitive and user-friendly interface. Together with a foot-operated switch, the Simatic control system from Siemens ensures a seamless user experience. The screen prominently displays real-time environmental parameters and continuously monitors emergency statuses. Additionally, the system offers remote access, allowing efficient customer service support. Furthermore, it is adaptable to connect with an external device for production data storage and export.
The Sterility Test Isolator from BLOCK Technology is a reliable, secure, and user-friendly device that meets the highest standards of quality and safety in the pharma industry. To learn more please complete the contact form or visit:
