The traditional method of big batch manufacturing must change as companies move away from the one-size-fits-all blockbuster model toward more innovative, targeted biologics that deliver better outcomes.
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.
The Ventilated Enclosure System combines the benefits of Flexible Containment with a unique, light weight ventilation unit. This system provides all the advantages of a negative or positive pressure isolator providing reduced costs for cleaning and validation with the disposable enclosure that is utilized.
The SureClean conveyor is designed specificially for the needs of the pharmaceutical and nutraceutical industries, and reduces the lengthy cleaning tiems assoicated with most conveyors. Service Industries is partners with Sepha and is their exculsive distributor of blister packaging, deblistering, and non-destructive leak testing machines for the U.S., Canada, and Puerto Rico.
The Miele G 7825 Glassware Washing System is designed to provide high-throughput glassware cleaning in areas where space is at a premium. This unit is designed for cleaning both large volumes of small items, and difficult to clean large items.
ILC has adapted the DoverPac® Flexible Containment Technologies to include enclosures for almost any process. Use of the ArmorFlex® film and integral gloves and sleeves will support operations from filter dryer discharge and heel removal to tray dryer loading and unloading. The benefits of this technology are:
Thermolab’s Oven provides heated conditions for curing, drying and exposures for high temperature testing with high accuracy and superior quality.
The Bosch integration advantage assures that the isolator and filling equipment and control systems work efficientlyto ensure proper system operation.
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.
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.
Bioburden is that dirty little topic nobody wants to talk about in mixed company (operations and QA) — a contamination that can get into our products at several entry points. Our fundamental responsibility is to eradicate it, but since it is invisible, we often make believe it doesn’t exist.
This article explains what an objectionable microorganism is and explores the regulatory expectations for objectionable microorganisms in nonsterile products.
