Maik W. Jornitz, President, G-CON Manufacturing LLC
Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
With the use of catalytic aeration, M + P is able to reduce the duration of the aeration phase in isolators by about 50 %. The aeration phase is the most time consuming cycle during H2O2 decontamination. By Felix Henning, Optima Packaging Group GmbH
Barrier technology has become overwhelmingly accepted as the basis for new aseptic processing facilities in 2013. The traditional clean room facilities of the 20th century are being rapidly replaced with advanced barrier based technology filling facilities. This technological evolution is dramatically reducing the risk of product contamination and risk of infection to patients. By Sterling Kline, RA IPS
You have been tasked by senior management to look into purchasing a cleanroom environment for a possible new product line. The mandate is that the cleanroom system provider must guarantee temperature, humidity, pressurization, and classification. As with any purchase, it is always best to be an educated buyer and have researched the options available to you. Knowing what questions to ask and what the cumulative effect is to those answers will make for a sound decision process and an overall successful project. By Rick Dobson, AES Clean Technology
This case study demonstrates how a commercial manufacturing partnership between Alkermes Contract Pharma Services (Alkermes) and a large pharmaceutical company resulted in the establishment of a high volume process for Highly Potent (HP) Active Pharmaceutical Ingredients (APIs).
Achieving the desired containment of products during manufacturing is a careful combination of well-engineered equipment, expert process design, simplification of operations, and access to real-time feedback on existing procedures.
A Glovebox is a sealed enclosure that allows materials handling through long, relatively impermeable gloves secured to ports in the walls of the enclosure. The purpose is protection or isolation, which is provided by the physical barrier. Depending on the type of system, the physical barrier may be to isolate a sensitive material inside the box from environmental contamination (controlled atmosphere type) or to protect the operator from hazardous materials being manipulated inside the box (ventilated type). Most systems have a main chamber where manipulations occur and a smaller transfer or antechamber where samples, small apparatus, and supplies are introduced into the main chamber. By Gary Roepke and Bob Applequist, Labconco Corporation
Safety is the primary purpose of any filtered enclosure or ventilated fume hood. In most situations, fume hoods remain the equipment of choice for ventilating hazardous airborne chemicals from the laboratory. By Gary Roepke, Senior Project Engineer, Labconco Corporation
Safety is the primary purpose of any laboratory hood. Facility managers and laboratory planners desire fume hoods that can conserve energy without compromising safety. Exhausting less air through a hood can result in substantial energy savings.
NANOSAFE INC., an independent testing company, evaluated the XPert Nano Enclosure for its ability to contain nanoparticles.
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