Single-use systems offer essential advantages – especially when standardized single-use sets are employed. They can be implemented quickly and affordably while reducing complexity.
Mixing equipment employed in the production of pharmaceuticals and medical devices deal with a higher level of complexity because their use is more specialized. Not one design fits all.
For the 50 or so years that cleanrooms have been in use, a steady debate has centered on the best ways to keep them clean, and regulatory and advisory agencies have weighed in on maintenance.
Cell and gene therapies are currently produced in fixed facilities that require a significant upfront investment. Modular concepts offer an opportunity to shift from these large, fixed assets.
A comparison of the EPA Trace Metal Analysis test was performed using duplicate sets of glassware. One set was acid washed by hand. The other was cleaned in the Miele Model PG8593 Flex Series Labwasher.
As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs.
The team at Polypeptide Labs' overall project aim was to achieve homogenization (blending/tumbling) of potent lyophilized polypeptide product offloaded from a separate isolator.
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.
