Philadelphia, PA March 13, 2018 –
Leveraging on more than 10 years of utilizing dedicated, disposable, soft wall, negative pressure isolators (NPIs), Lyophilization Technology Inc. (LTI) incorporates advanced design features into the next generation isolators. The new design will be based on the extensive experience in conducting both development studies and clinical material batches of sterile product.
NPIs are utilized as a full barrier technology between the operator and the product to meet the needs of potentially hazardous or highly potent pharmaceutical compounds, requiring both containment and aseptic manipulations. Such compounds include
Biological Safety Level (BSL) 2 and Control Band (CB) 2 and 3 materials. This provides for safe handling of a wide variety of products, including antibody drug conjugates (ADC), cytotoxic compounds, steroids, hormones, vaccines, and virus-like particles (VLP). LTI employs the use of soft-walled, product dedicated, disposable NPIs. These unique NPIs provide many benefits including safety in the design and during processing, sterility assurance, as well as, flexibility in configuration and use.
The unique LTI NPIs are custom fabricated, comprised of two separate sections constructed of vinyl sheets using lap seam sealing to provide optimal seal integrity. The main processing area connects to an in-feed vestibule with a transfer pass-through unit fitted with additional gloves. The isolator mounts on a rigid frame and has a suction blower fitted with a HEPA filter to create the reduced pressure within the isolator. The negative pressure is created when the air is extracted through these additional filters, creating a lower pressure inside the chamber relative to the surrounding room. The main processing area maintains air quality levels in accordance with Grade 'A' EU GMP (Class 100) supplied via a HEPA intake filter. For preparation of sterile product, the entire isolator is situated inside an ISO 4.8 area providing unidirectional airflow. A high air change rate allows for rapid removal of any potential airborne contamination for safe aseptic transfers and rapid evaporation of disinfecting agents. Audible alarms with a clear and informative display ensure proper monitoring of the negative pressure working conditions throughout processing. High air change rates are achieved in both work area and transfer pass through. Nitrile textured fingertip gloves on flexible sleeves allow for relative ease of access and manipulation. The sleeves provide a full extension to reduce operator stress and fatigue.
When required for high-level containment in preparation of clinical material, two separate soft wall isolators are fitted into the ISO 4.8 area. This allows segregating bulk solution compounding, with the transfer of the bulk solution to a second isolator during sterile filtration. A second isolator houses dispensing, inserting stoppers, and loading of a pilot-sized lyophilizer. The soft wall isolators are interconnected, with the filling isolator interfaced directly to the lyophilizer. This flexibility allows processes ranging from weighing, dispensing, and compounding to filtration, filling, loading and unloading of the lyophilizer, and decontamination of the outer container.
For over ten years, safe and effective processes have been aided by the use of NPIs. The units were designed, tested, and proven to assure operator safety during the handling of potentially hazardous and highly potent compounds. The units have been extensively used in Aseptic Process Simulations (APSs), removing the operator from the product interface, resulting in a high level of sterility assurance, vital when processing sterile parenteral products. As an added benefit, when processing Phase I and Phase II Clinical Material, the NPIs are product dedicated, allowing even greater flexibility and no risk of product contamination by other products in a multi-product facility.
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