Dublin, Aug. 31, 2022 (GLOBE NEWSWIRE) -- The "2 Day Course on Aseptic Processing in the Manufacture of Pharmaceutical and Biotech Products" training has been added to ResearchAndMarkets.com's offering.
Aseptic Processing in the manufacture of Pharmaceutical and Biotech products course objective is to explore the role of aseptic filling to assure that manufactured product will retain the sterility assurance level prescribed by GMPs
Sterile products may be broadly classified into two main categories based on their production mode -- those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled, and then sealed.
Aseptic Processing play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated through the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period.
Aseptic Processing involves risk assessment on an on-going basis because of the inherent risks due to consequences of management and process failure and challenges within the detection, isolation, control, and management of product contamination. Within aseptic processing, the severity of the consequences of a failure can be severe to the end user while detection through sterility testing remains rather limited because of the small number of final products tested.
The FDA and EMA require that any product that may be terminally sterilized be managed in that fashion. However, almost all large molecules and some small molecules can only be sterilized by aseptic processes, i.e., membrane filtration.
With membrane filtration, it is essential to establish acceptable levels of microbiological contamination to ensure both product safety and compliance. Meeting sterility claims for Phase 1, 2, 3 and commercial products in a timely and effective manner is important in avoiding costly delays. In addition, since aseptic processes are associated with endotoxin control, it too, must be managed to acceptable levels.
A variety of variables can impact sterility assurance and the accompanying endotoxin level. These include the personnel, process, equipment, components, sterilization, depyrogenation as well as facilitates and utilities that impact the management and processing of the ultimate products. Issues that need to be considered include the monitoring of environmental areas and personnel, water sources, media, and media fills, gowning and sanitization.
Products that have historically been aseptically filled have relied upon the use of USP <71> Sterility Tests to demonstrate sterility. However, since no more than 20 containers are tested per media (TSB and FTM) regardless of the production lot size, the use of sterility tests does not provide a high degree of sterility assurance (SAL).
Thus, media fills are now utilized to simulate the actual fills and to demonstrate at least a 10-3 sterility assurance level of no contamination. If the facility uses RABS or isolators to meet their filling requirements, a SAL of 10-5 to 10-6 is possible since the interactions with personnel and the environment decrease markedly.
Media fills are required during the commissioning of an aseptic operation within a new facility, when a new container configuration (volume or neck size) or other unique activities associated with aseptic filling occur. Following the on-going performance of a new aseptic filling line, a requalification is required at six-month intervals.
It will review the issues regarding preparing media and setting up the "filtration train", environmental monitoring, interruptions that may occur during the operation of the Clean Room (planned and unplanned) and the cleaning of the room and its equipment. Equipment used to monitor the equipment and personnel will also be reviewed along with gowning issues that periodically arise. The seminar will also discuss media failures and how to "work through" them.
Because of the sensitivity and importance of media fills, this live, interactive training seminar is a MUST for anyone in your organization that is involved in aseptic filling in general and media fills in particular.
Seminar participants will learn the following:
Gain an understanding of the fundamental principles and skills necessary to conduct Aseptic Processing of Sterile Drug Products with minimum risk
Analyze issues impacting Aseptic Processing to include the environment, personnel, gowning and sanitization
Acquire the skills necessary to control the process environment
Minimize media fill failures to permit production throughput
Determine how to develop media fill simulations to include the "worst case" scenarios
Learn best practice techniques for determining media fill sizes
Understand the "critical factors" required to maintain compliance
Avoid Warning Letters and Consent Decrees
R&D/technical writing/quality management/original and post-approval submissions in pharmaceutical companies,
Join the conversation 7:45 -8:00 AM
Maintenance and control of critical environments
Development of procedures for operation, calibration, Preventive Maintenance, CAPA, etc.
Training of operators to include gowning
Documentation and evaluation of changes
Contamination Sources in Aseptic Manufacturing
Particle Content Controls, Cross Contamination Risks
Cleaning Process and Agents for Sterile Production
Join the conversation 7:45 - 8:00 AM
Developing Media Fill Requirements in An Aseptic Environment
Smoke studies and their emphasis in Aseptic Production (ISO Class 5 facilities)
For more information about this training visit https://www.researchandmarkets.com/r/hw2bfi
(Bloomberg) -- Amazon.com Inc., determined to reduce the size of its sprawling delivery operation amid slowing sales growth, has abandoned dozens of existing and planned facilities around the US, according to a closely watched consulting firm. Most Read from BloombergAmazon Closes, Abandons Plans for Dozens of US WarehousesGazprom Won’t Reopen Gas Pipeline in Energy Shock to EuropeStocks Suffer Third Weekly Loss on Rate-Hike Woes: Markets WrapLukoil Chairman Ravil Maganov Dies After Falling From
Five years after Amazon announced that it would buy supermarket chain Whole Foods for $13.7 billion, a big new change has just taken place -- on September 1, incoming chief executive Jason Buechel is taking over for John Mackey. "As a co-founder of Whole Foods, I've often explained my relationship to the company with a parent-child metaphor," Buechel wrote in a letter announcing his retirement to Whole Foods Staff in September 2021. The transition took nearly a year and, now, former Chief Operating Officer Jason Buechel is stepping in to lead the high-end supermarket chain.
(Bloomberg) -- The US government’s new restrictions on the ability of Nvidia Corp. to sell artificial intelligence chips to Chinese customers threatens to deal a heavy blow to the country’s development of a sweeping range of cutting-edge technologies.Most Read from BloombergAmazon Closes, Abandons Plans for Dozens of US WarehousesGazprom Won’t Reopen Gas Pipeline in Energy Shock to EuropeStocks Suffer Third Weekly Loss on Rate-Hike Woes: Markets WrapLukoil Chairman Ravil Maganov Dies After Falli
While more than three in 10 U.S. retirees say they would be motivated to rejoin the workforce if inflation continued to eat into their savings, 43% of retirees see their age as a barrier to getting a new job. According to an American Staffing Association survey, the fear of ageism poses a barrier to retirees contemplating un-retirement. Overall, 14% of current retirees said they are open to or actively looking for work.
Yahoo Finance's Pras Subramanian reports live from Rivian's first, newly opened service center on the East Coast on how the company plans to expand across the U.S. by 2023.
FRANKFURT/GDANSK (Reuters) -Russia has scrapped a Saturday deadline to resume flows via a major gas supply route to Germany, deepening Europe's difficulties in securing winter fuel, after saying it had found faults in the Nord Stream 1 pipeline during maintenance. Nord Stream 1, which runs under the Baltic Sea, had been due to resume operating at 0100 GMT on Saturday after a three-day halt for maintenance. But Gazprom, the state-controlled firm with a monopoly on Russian gas exports via pipeline, said on Friday it could not safely restart deliveries until it had fixed an oil leak found in a vital turbine.
Yahoo Finance Live anchors discuss Ford after the company reported a slowdown in new vehicle sales for August.
SEOUL/DETROIT (Reuters) -After grabbing the No. 2 spot in the U.S. electric vehicle market with stylish, long-range models, Hyundai Motor and Kia are the automakers with the most to lose from new rules that halt subsidies for EVs made outside North America. These two companies, which make the popular Ioniq 5 and EV6 models, sold more than 39,000 EVs in the United States between January and July – doubling last year's sales and blowing past Ford Motor Co, Volkswagen AG and General Motors Co. But the Inflation Reduction Act signed into law by U.S. President Joe Biden last month excludes Hyundai Motor Co and its affiliate Kia Corp from federal tax credits because they don't yet make EVs in North America, knocking their EV ambitions in the short term at least, a Hyundai official, parts suppliers, analysts and car dealers said.
Artist and independent Kyle McDonald said on CoinDesk TV’s “First Mover,” the possibility Ethereum’s Merge will reduce energy costs by 99.95% is “highly realistic.”
(Bloomberg) -- 3M Co. should be blocked from spinning off its health care business and paying shareholder dividends in order to preserve money that soldiers suing the industrial conglomerate expect to win, according to a new federal lawsuit.Most Read from BloombergAmazon Closes, Abandons Plans for Dozens of US WarehousesGazprom Won’t Reopen Gas Pipeline in Energy Shock to EuropeStocks Suffer Third Weekly Loss on Rate-Hike Woes: Markets WrapLukoil Chairman Ravil Maganov Dies After Falling From Ho
The Nord Stream 1 pipeline that transports Russian gas to Germany will undergo further maintenance, Gazprom said on Friday after scrapping a Saturday deadline to resume flows, deepening Europe's difficulties in securing fuel. Gazprom was already undergoing maintenance from Aug. 31-Sept. 2, prompting concerns about supply to Europe ahead of the onset of winter if the outage was extended. Russia slashed flows through the pipeline to 40% of capacity in June and to 20% in July.
Recent monthly jobs reports are stretching credulity. Evidence suggests recession may be close at hand.
(Bloomberg) -- As summer winds down and the holiday season nears, California’s $1 billion walnut industry is gearing up for its busiest shipping season. The problem is getting nuts out the door. Most Read from BloombergAmazon Closes, Abandons Plans for Dozens of US WarehousesGazprom Won’t Reopen Gas Pipeline in Energy Shock to EuropeStocks Suffer Third Weekly Loss on Rate-Hike Woes: Markets WrapLukoil Chairman Ravil Maganov Dies After Falling From Hospital WindowGlobal Bonds Tumble Into Their Fi
The U.S. Labor Department alleges the bank fired a senior manager after the person reported concerns about falsified customer information, price-fixing and interest-rate collusion.
President of the Association of Flight Attendants CWA Sara Nelson joins Yahoo Finance Live to discuss the August jobs report and how it affects the airline industry, grappling with labor shortages, travel demand, flight delays and cancellations.
The auto maker reported a fourfold surge in electric-vehicle sales amid strong interest in its all-electric F-150 Lightning truck.
Billionaire money managers have used the sizable market downturn to buy these seven stocks at a perceived discount.
J.P. Morgan analyst Jeffrey Zekauskas downgraded chemical producers Dow and LyondellBasell to Neutral from Overweight.
Amid high inflation and worries over a more severe recession, bank stocks have not fared well this year. As the largest bank by assets in the U.S., JPMorgan Chase (NYSE: JPM) has not been spared. With the Federal Reserve still aggressively raising interest rates and a lot of economic uncertainty still in the environment, is JPMorgan Chase stock a buy?
Nord Stream 1, which runs under the Baltic Sea to supply Germany and others, had been due to resume operating after a three-day halt for maintenance on Saturday at 0100 GMT. But Gazprom, the state-controlled firm with a monopoly on Russian gas exports via pipeline, said on Friday it could no longer provide a timefrme for restarting deliveries after finding an oil leak that meant a pipeline turbine could not run safely. Moscow has blamed sanctions, imposed by the West after Russia invaded Ukraine, for hampering routine operations and maintenance of Nord Stream 1.