At ILC Dover, we are always "creating what’s next" by listening carefully to our customers. In response to customer input and emerging regulations, we've developed a robust new film to support our DoverPac® Containment Solutions line. This revolutionary product, ArmorFlex® 110, delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact.
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
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
Flexible Containment Isolators provide containment standards better than can be achieved with Downflow Booth technology, and often compare favorably with a Rigid Isolator system.
Downflow Containment Booths are used extensively in the pharmaceutical industry to safeguard operators against harmful dusts generated during many manual powder handling operations. Clean air from the ceiling plenum is distributed evenly across the whole of the work area pushing any respirable dust downwards and away from the operators breathing zone.
Cross-contamination can happen in tablet presses, capsule filling, milling, and polishing machines, pill de-dusters, and other equipment associated with pharmaceutical drug development and/or chemical production. As powders, debris, and potent compounds within the environment threaten employee health and safety, they also threaten product purity. If you add the threat of combustible dust into the mix, you could potentially face something much worse.
All Isolation Systems, Inc. isolators are designed, engineered and manufactured to the highest standards, fully utilizing state of the art design and manufacturing processes. Complete as built drawings are submitted to our customers for their approval prior to manufacturing to assure total compliance with their requirements and specifications. Upon completion each isolator is fully tested for seal integrity and performance. A complete installation, operation and maintenance manual is provided including all test and certification reports, electrical and control schematics, certified final drawings, replacement parts lists, and component specification sheets, sufficient to compile your IQ’S , OQ’S and SOP’S. Isolator testing and validation protocols and procedures are available for your review upon request.
Isolation System, Inc. has designed and engineered the PTC System, with careful attention to user needs. This system has been developed to ensure effective material and product transfer between clean areas and process stations. Its rugged solid stainless steel construction protects against wear in high-traffic applications and provides long-lasting aesthetic appeal. This system can be supplied to operate under either positive or negative pressure conditions, recirculating or single pass air flows and returns. Adjustable shelves allows for multi-product and con-tainer size applications. Coved interior corners provides for easy cleaning and decontamination between uses. System can be operated under DC power or AC . DC power source is completely rechargeable . This product may be easily customized to fit your specific needs and process transfer requirements.
Isolation Systems, Inc. has designed and engineered the ASCE System, with careful attention to user needs. This system has been developed to ensure effective bulk material decontamination blow off prior to transfer into clean areas. Its rugged solid stainless steel construction protects against wear in high-traffic applications and provides long-lasting aesthetic appeal. Sensor activated cycle automatically washes product with high-velocity air prior to material introduction into clean area. Low wall air returns effectively capture dislodged contaminants through both pre- and final-filtration banks. This product may be easily customized to fit your specific needs and process requirements.
Isolation Systems, Inc’s premiere flexible enclosure system has been developed specifically for environmental separation. This system can be utilized to create any class of clean area from class 100,000 to class 10. The versatility of this partition system is such that its use within your clean area is only limited by imagination. Offered as our standard enclosure barrier on our soft wall systems, this product can also be configured to create hood enclosures, process separators, bench shrouds and to establish multi-class environments within the shared room area. Its unique anodized aluminum mounting track system is offered in three configurations- flat wall, in-jam and ceiling grid clip attachment, adding further to its versatility as well as its aesthetic appeal. Our standard system is offered in 40 mil polished and antistatic treated material. Optional thicknesses of up to 120 mil are also available. This extremely adaptable enclosure system will be custom tailored to your specifications. We assure your satisfaction with this unique product.
