By Kevin Richards, Industry Vice President, Reed ExhibitionsThe common bacterium, Serratia marcescens, causes the pinkish “mildew” that appears in bathrooms. Once considered to be harmless, it is now recognized as a broad host pathogen that can cause opportunistic infections. Serratia marcescens is a leading cause of contamination in petri dishes, and laboratory and medical equipment. And it recently caused headlines when it was accidentally introduced-most likely by human error during the filling process-into millions of doses of flu vaccine intended for the US market.
Potential for increased regulatory scrutinyIn addition to highlighting the fragility of the world’s vaccine supply, this contamination also demonstrates the critical importance of good manufacturing practices at every step of the sterile manufacturing process. Ironically, this high profile incident occurred at roughly the same time as the FDA released a new guidance document for sterile drug products produced by aseptic processing. The guidance gives insight into the FDA’s view of aseptic processing, which, as one of the most complex and challenging drug manufacturing processes, may be considered to require a higher level of regulatory oversight. The 63-page FDA guidance document includes recommendations for buildings and facilities, qualification and monitoring, components and containers, laboratory controls, process simulation, sterility testing, batch record review and more.
State-of-the art solutions for the industry’s most difficult challengesFortunately, suppliers have evolved sophisticated solutions for airflow control, isolation, restricted access barrier systems, aseptic filling systems, improved cleanroom garments, and automation for such risk-intensive operations as component replenishment or checking and adjustment of container fill weight. You can see, test and compare many of these advanced products at INTERPHEX 2005, April 26-28 at the Javits Convention Center in New York City. The INTERPHEX exhibits provide convenient, one-stop shopping for solutions and suppliers that can help ensure that every aspect of your sterile manufacturing operations will stand up to increased FDA scrutiny, including:
• A full line of aqueous critical cleaning detergents from Alconox.
• Environmental control and security systems that support maintenance of a system’s validated state from Andover Controls Corporation.
• Medical Blow-fill-seal machines from American Plastics Technologies, Inc. combine blow molding of hollow containers with a process for filling and sealing, all in one machine cycle.
• Advanced aseptic process equipment including mixing systems, valves, actuators and diaphragms from ASEPCO.
• Autoclaves and washers for laboratory, life sciences and cGMP markets from Belimed Inc.
• A complete line of isolator and Restricted Access Barrier Systems from Bosch Packaging Technology integrate aseptic filling with barrier technology to increase sterility assurance.
• Gaseous chlorine dioxide sterilization for product sterilization and room & isolator decontamination from Clordisys Solutions Inc.
• Epoxy, MMA and urethane seamless flooring systems from Dur-A-Flex, Inc. that meet FDA requirements.
• Pharmaceutical processing isolation systems from Flanders Absolute Isolation.
• Turbulence free, high-level containment workstations from Flow Sciences, Inc.
• Washing/disinfectant systems, sterilization equipment, water systems & steam generators, closure processing systems, validation & commissioning from Getinge USA, Inc.
• Stability rooms, environmental rooms, and clean rooms and complete validation protocols from Harris Environmental Systems.
• Filters for any application requiring an ultra-clean environment, from HEPA Corporation.
• Anemometers, dust meters and particle counters for testing of laminar flows, continuous monitoring of air velocity, temperature, and RH in contained environments from Kanomax USA, Inc.
• Applications for microfiltration, ultrafiltration, nanofiltration and reverse osmosis processes from Koch Membrane Systems, Inc.
• Fully GMP compliant washing equipment from Lancer USA, Inc.
• Solutions for the most critical pharmaceutical filtration applications from Meissner Filtration Products, Inc.
• Solutions and services for aseptic processing, sterile filling, QA/QC, and water purification from Millipore Corporation.
• Filtration, pathogen and analytical laboratory services, cleaning and hygiene services from Nalco Company.
• Ozone generators and systems for Pharma water treatment from Novazone, Inc.
• Environmental monitoring and alarms systems for temperature, humidity and other critical applications from Rees Scientific Corporation.
• Portable and stationary C.I.P. and automated COP parts washers from Sani-Matic.
• Ultra clean air delivery units, air handling units, modular barrier wall systems, and fan powered plenum systems from SBB.
• Isolators, barrier system, RABS, air locks and compounding for aseptic and toxic applications from Skan AG.
• Foam probes, applicators and swabs for cleaning and applying surface treatments from Super Brush.
• Lyophilizers, biohazard safety cabinets, and clean rooms from Telstar Industrial S.L.
• Validation of computerized applications utilized in Laboratory, Manufacturing, Clinical and Preclinical areas by ValiMation Inc. For an up to date list of INTERPHEX exhibitors and a convenient online registration form, please visit www.interphex.com.
Education to enhance technical skills and reduce errorsUpdating skills and technical knowledge is key to reducing the likelihood of contamination in critical operations. The INTERPHEX2005 conference offers many sessions with a high degree of relevance for those involved in aseptic manufacturing, including:
• Decontamination of Fully Loaded Transfer Isolators Using Gaseous Chlorine Dioxide
• Simulating the Future: Ensuring More from the Process Facility
• Effective Validation Project Management
• Increasing Plant Efficiency Through CIP Engineering
• Biocontainment: Beyond the Lab
• 21 CFR Part 11 – Why it Hasn’t Gone Away and How Part 11 is Affecting Process Validation
…plus an accredited workshop by the Center for Professional Advancement entitled “Lyophilization: Operational Difficulties – Problems with Equipment – Problematic Freeze-Drying Behavior – Troubleshooting the Product. ” To learn more, see complete list of conference sessions at www.interphex.com.