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Technology news
Filtration+Separation May 2006
Pall launches flexible containment system for handling potent compounds Protecting workers and the surrounding environment from exposure to hazardous compounds poses an increasing challenge to pharmaceutical manufacturers, as new and more potent Active Pharmaceutical Ingredients (APIs) enter the processing pipeline (such as cytotoxic – cell killing – drugs to treat cancer). Separation and purification processes potentially expose workers to harmful, biologically active, contaminating particulates and catalysts filtered from the APIs. To help remedy the problem, Pall Corp is introducing its GBK containment system, to provide the pharmaceutical industry with its first all-in-one contained glove bag /housing system for filter change-out.
fastest growing segment of smallmolecule custom synthesis. The increased need for new and enhanced containment solutions is also driven by the growing investment of both major pharmaceutical companies and small biotech firms in the anticancer area.
The new system reduces the risk of cross contamination and shields operators from exposure to harmful compounds when handling APIs during filter change-out procedures, reports Pall.
The GBK system provides an alternative to glove boxes and other bulky isolation systems that can require more costly capital expense and more manufacturing floor space.
Operators can access replacement filters from zippered feed-in sleeves, and then remove spent filter cartridges through a feed-out sleeve using nitrile gloves. The userfriendly system enables trained operators to perform a complete filter cartridge change-out in less than two minutes on average. Currently about 5 to 10 percent of commercially available drugs are high potency. With more potent and targeted drug molecules under development, this figure increases to about 25 percent and is the
“This global trend is a serious concern for drug manufacturers, which need to set new occupational exposure limits (OELs) into their operations,” reports Gareth Leach, global API market manager for Pall Life Sciences. “The introduction of our GBK containment system provides an innovative, compact and cost-efficient solution to help meet this critical industry need.”
The GBK system can be used for multiple steps in a production process. After a batch or campaign is completed, plastic bags and gloves can be easily discarded. For multi-purpose manufacturing sites, the GBK system also protects from crosscontamination between different systems that might otherwise be susceptible to airborne contamination. Independent tests with a worst-case containment challenge show that the GBK system could be used to provide a containment level to 1 mg/m3. The Pall PATK series housings incorporated in the GBK
containment system offer a robust design for secure locking of code seven cartridges, ideal for API applications. For each installation, Pall specialists will provide technical support and user training. The GBK system is the latest addition to Pall’s line of filtration and processing innovations. As a total solutions provider to the pharmaceutical marketplace aligned to customer needs, Pall’s technologies help improve drugprocessing safety, efficiency and speed time-to-market of new therapies. www.pall.com
GBK glove bags are made of antistatic polyurethane with a built-in HEPA filter to prevent condensation. They are available with double-zippered feed-in sleeves for maximum operational flexibility, and feature an elastic ring that ensures an effective seal to the housing to prevent airborne particles from escaping. GBK gloves bags are also available with sealed sleeves for more critical applications where additional protection is needed.
BZc win contract for world’s largest ammonia removal plant BZc International has been selected as the main contractor for the construction of a project designed to prevent ammonia entering the natural water course after concluding sewerage treatment.
by Waterco Lacron – with innovative under drain and distribution systems to ensure maximum flow and ammonia take up as water passes over the Zeoclere bed.
BZc’s high-grade zeolite, Zeoclere, which removes ammonia from swimming pool water, was selected as the best choice for the far tougher task of attrition and ammonia collection in the final sewerage process.
Using the cycling system, the effluent first passes through No 1 filter where it is stripped of its ammonia content. As the first filter bed becomes saturated with ammonia, the monitors indicate that the ammonia levels have risen to the maximum level permitted by the Rivers Authorities.
down No 1 filter and directs the flow along to No 2 filter, where the process is repeated. Simultaneously, No 1 filter automatically drains down into specially-constructed holding tanks. This is immediately followed by an influx of fresh water to backwash and rinse the filter. Because of the depth of the media bed and the need to maintain and ensure a clean and efficient process, high-pressure compressors introduce air into the system to work in conjunction with the backwash water.
When the ammonia level is reached, the control system closes
At the end of the procedure, an influx of air is again introduced
The plant consists of a control cycling system implementing 38 tonnes of Zeoclere into four vast filters – specifically manufactured
along with a monitored saline solution (together with hypochlorite), which fills the filter to its full capacity. The solution then remains static within the filter for a predetermined period whilst the Zeoclere regenerates itself in readiness to come back on line. Should the control system recognise that ammonia levels have risen outside of the normal predicted parameters and No 2 filter becomes saturated before the set period, then the third filter automatically comes on line. Filter No 4 is used as a standby and during maintenance periods. www.bzc.co.uk