02/05/2023
Weiss Pharmatechnik GmbH
Tailor-made Containment Solutions – WIBO® Safe Isolator
Weiss Pharmatechnik presents the WIBO® Safe isolator technology for the safe handling of HAPI (Highly Active Product Ingredients) at Interpack in Düsseldorf in Germany.
The containment isolator was developed specifically for the pharmaceutical industry, which demands the highest safety standards when handling potentially hazardous substances. Activities such as weighing, decanting and sampling can be performed safely in the WIBO® Safe Isolator. Weiss Pharmatechnik's containment isolators ensure an OEL Level 5 for maximum operator protection.
The isolator is hermetically sealed and complies with the tightness class according to ISO EN 14644-7 and ISO 10648-2 : 3. Even in the event of a glove rupture, the constant negative pressure prevents the working substance used from escaping to the outside.
The isolator is equipped with turbulent diagonal airflow and has an air change rate > 50. High-efficiency HEPA H14 push-push filters clean both fresh air and exhaust air. Containment double dampers ensure that airways remain closed when not in use.
Volume flow is maintained at a constant value via the regulated fan for supply air. Unlike many isolators, the volume flow is not subject to fluctuations. A defined constant flow is generated. This means that the isolator meets at least the requirements of cleanroom class C according to EU GMP.
The material lock is equipped as an active lock with HEPA filter H14 for supply air and exhaust air. An air exchange rate > 100 ensures that airborne particles are reliably discharged.
Both the airlock and the isolator booth are equipped with Wash-In-Place (WIP) system for manual cleaning using spray guns. To ensure that the cleaning water can drain off well, the floor of the interior is equipped with a slope to the drain. The interior also has minimized joints, making it easy to clean.
During the development of the WIBO Safe Isolator, great importance was attached to hygienic design. For example, the circumferential seals of the front pane and the sluice doors are equipped with a hygienic static seal. The static seal does not form a joint, allowing the water in the interior to drain more easily and keeping the interior free of residue.
Glove changes can be performed completely contamination-free in the closed containment. A flush joint-free glove ring prevents contamination of the inner glove ring when changing gloves.
An RTP with an alpha port and a mobile beta transfer container is provided for the discharge of materials or waste. The material is discharged quickly and safely in this way.
Ausstellerdatenblatt
The containment isolator was developed specifically for the pharmaceutical industry, which demands the highest safety standards when handling potentially hazardous substances. Activities such as weighing, decanting and sampling can be performed safely in the WIBO® Safe Isolator. Weiss Pharmatechnik's containment isolators ensure an OEL Level 5 for maximum operator protection.
The isolator is hermetically sealed and complies with the tightness class according to ISO EN 14644-7 and ISO 10648-2 : 3. Even in the event of a glove rupture, the constant negative pressure prevents the working substance used from escaping to the outside.
The isolator is equipped with turbulent diagonal airflow and has an air change rate > 50. High-efficiency HEPA H14 push-push filters clean both fresh air and exhaust air. Containment double dampers ensure that airways remain closed when not in use.
Volume flow is maintained at a constant value via the regulated fan for supply air. Unlike many isolators, the volume flow is not subject to fluctuations. A defined constant flow is generated. This means that the isolator meets at least the requirements of cleanroom class C according to EU GMP.
The material lock is equipped as an active lock with HEPA filter H14 for supply air and exhaust air. An air exchange rate > 100 ensures that airborne particles are reliably discharged.
Both the airlock and the isolator booth are equipped with Wash-In-Place (WIP) system for manual cleaning using spray guns. To ensure that the cleaning water can drain off well, the floor of the interior is equipped with a slope to the drain. The interior also has minimized joints, making it easy to clean.
During the development of the WIBO Safe Isolator, great importance was attached to hygienic design. For example, the circumferential seals of the front pane and the sluice doors are equipped with a hygienic static seal. The static seal does not form a joint, allowing the water in the interior to drain more easily and keeping the interior free of residue.
Glove changes can be performed completely contamination-free in the closed containment. A flush joint-free glove ring prevents contamination of the inner glove ring when changing gloves.
An RTP with an alpha port and a mobile beta transfer container is provided for the discharge of materials or waste. The material is discharged quickly and safely in this way.
Ausstellerdatenblatt