Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.
AseptiSafe aseptic transfer Split Butterfly Valves (SBV) provide improved sterility assurance during powder handling operations in aseptic processing. This animation shows how the AseptiSafe system can be used in conjunction with generic sterilization machines and dedicated cleaning stations to ensure the SBV Passive connection and container is suitable sterilized prior to powder dispensing.
Requiring no integrated plant air to function, the Mac Process MCF PowerSaver generates energy cost-savings of up to 50% over conventional high pressure pulse jet or reverse air cleaning systems.
This sterilizer is offered in a Prevacuum configuration and is designed for fast, efficient sterilization of heat- and moisture-stable materials in scientific applications. Prevacuum configuration sterilizers are equipped with prevacuum, gravity, liquid, leak test, and daily air removal (Bowie-Dick) test cycles.
The Bioquell L-3 utilizes patented 'dual circuit' hydrogen peroxide vapor (HPV) technology to provide fast and reliable 6-log deactivation of viruses, bacteria, fungi, and mold.
The sterilizer, type SWS, is designed to sterilize liquids in 100% sealed containers using a hot water shower process. The advantage of this process is a fast cycle time with reduced cooling periods especially for temperature sensitive liquid loads. To avoid deformation or break of the product after sterilization, the sterilizer is working with a support pressure. This pressure can be set individually for each product or calculated in relation to the pressure inside the load container.
The cGMP series washer/dryers are available in multiple chamber sizes to fulfill virtually every application. Chamber sizes range from smaller 23.6"W x 23.6"H x 23.6"D chambers to large floor-loading chambers 51"W x 70"H x 78"D. Units are ASME BPE designed to minimize deadlegs and maximize slopes.
The MPH is built to handle fine particulates and heavy dust loads. MPH filters come in sizes and configurations to fit most industrial air quality control applications— from grain, flour and wood dust to coal, rock mineral and chemical fines.
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.
Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.
Use of environmental isolates in the pharmaceutical microbiology laboratory has been increasing in popularity. This article discusses the current regulations andguidance documents, regulatory expectations, and expert opinions on the use of environmental isolates.
Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.
Natural hazard events may seem like distant topics to some in the biopharmaceutical industry, but they hold relevance for all companies. Opportunities exist for risk management, including an important lesson in avoiding the gradual acceptance of such events as normal, until an even greater catastrophic event occurs.
This is Part 2 of a two-part article on objectionable microorganisms in the nonsterile microbiology industry It discusses a risk-based approach to determine if a microorganism is objectionable for an application.
