This article is based upon the authors' travels over the last 10 years, looking at aseptic filling operations and seeing what was described to be “a RABS” by the various owners. Some of these are actually amusing, and they illustrate what happens when “hands-on” engineering meets the needs of operations while the compliance department is asleep at the wheel.
Airflow visualization testing, conducted as part of a routine review program, can help assure that aseptic filling areas remain under a state of proper control.
Better containment in powder transfer helps to protect staff from exposure to APIs and HPAPIs, as well as improving efficiency, maintaining product quality and supporting compliance.
Maximized uptime, minimized changeover time, and efficient OEE are key factors that have influenced the acceptance of aseptic blow-fill-seal in the packaging of pharmaceutical liquids.
BFS technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.
Sustainability means a balancing act and the ability to maintain a certain regulatory standard and the approach of in-built sustainability is essential when designing biopharmaceutical facilities.
The Bosch series RRN 20x3 (without ultrasonic bath) is a solution for the low and medium performance range. The RRU 20x3 continues in the tradition of innovative design and reliability while providing improved operational flexibility and ease of operation. Each cleaning station is supplied via its own pipe connection to the cleaning media, making the washing area completely free of hoses.
The RRN 3xx5 series (without ultrasonic bath) is the perfect solution for the high output range Each cleaning station is completely free of hoses. This not only increases pharmaceutical safety, but also simplifies maintenance and cleaning efforts. By using a servo driven internal spraying needle motion, different container sizes can be processed without changing the internal spraying needles. The external cleaning stations are mounted above the transport system and can be easily adjusted for a specific height, angle, and lateral position.
For the safety of personnel and customers as well as an undisturbed processing, thorough cleaning of the outside surfaces of filled and sealed receptacles such as injection bottles, ampoules, or cylinder ampoules is essential. This applies especially for highly potent and/or freeze-dried products. With the new external cleaning machine RAN 30x0 you will reach a level of cleaning quality that has never been achieved before, thus ensuring that your receptacles remain free of product residues or other contaminants.
The sterilizer type ADV, is designed for use in the pharmaceutical and biotechnological industry for production, laboratory and R & D applications. The vacuum steam process, ensures complete elimination of air from the chamber and sterilizing load.
The sterilizer type SDR, is designed to sterilize liquids in open, semi sealed or 100% closed containers according to the steam-air mixture process. The big advantage of this process is a complete dry product at the end of the cycle.
The safe and reliable sterilization and depyrogenation of pre-cleaned containers is the most important pre-treatment step in the pharmaceutical process. The modular HQL 6000,7000 and 8000 tunnel series offer maximum process safety and reproducible treatment quality combined with high flexibility, cost effectiveness and efficiency.
Thermolab Scientific Chambers are perfectly designed for the high requirements of stability studies and climatic tests. With Stability Chambers specifically developed to meet FDA/ICH stability requirements generating exceptional control and uniformity of both temperature and humidity. Thermolab Stability Chambers feature various safety feature, audio visual alarms, 21 CFR part 11 software and a vast range of options and is the most preferred choice for stability studies. Every Thermolab Scientific Chamber repeatedly produces required conditions, structural integrity that keeps the chamber working properly through years of demanding test cycles and measuring equipment’s that precisely records all test data.
Thermolab Cooling Cabinets are of superior quality and precise control best suited for storage of reference standards, raw materials and vaccine storage. Thermolab Cooling Cabinets feature various safety feature, audio visual alarms, 21 CFR part 11 compliant software and are the preferred choice in cooling solutions.
This video shows an integrated project for the sterilization of parenteral bags. Robotized handling systems interact in a fully automatic high-throughput manufacturing line.
Senior Product Manager Jon Aldous announces the launch of the newest version of the Vaisala viewLinc environmental monitoring system for monitoring temperature, humidity, CO2, and other variables. The new viewLinc system features long-range wireless communications capabilities that allow data logging devices to communicate reliably in obstructed environments. The signal can travel over 100 meters indoors and does not interfere with existing Wi-Fi networks and devices.
Interested in a More Intuitive User Experience When Monitoring Controlled Environments? Take a peek at a video where our User Interface Designer Heta describes what it takes to create a better experience for environmental monitoring system users.
Using proprietary optical technology, the IMD-A microbial detection system is capable of simultaneously detecting both size and intrinsic fluorescence of airborne particulates – screening for biologic particles as small as 0.5 microns.
As global demand for the commercial and practical insights provided by intelligent processing and analysis of large data sets continues to gather pace, CAMO Software has launched a new version of its all-in-one Multivariate Data Analysis (MVA) and Design of Experiments (DoE) software, The Unscrambler® X.
WEST LAFAYETTE, Indiana - December 27, 2012 -- BASi (Bioanalytical Systems, Inc.) (NASDAQ: BASI) today announced the launch of Culex® NxT, the latest generation of the Company’s proprietary in vivo automated sampling system.
