By Olivier Loeillot, General Manager of Enterprise Solutions, GE Healthcare Life Sciences
Meeting the rising demand for vaccines, while simultaneously ensuring a safe and reliable supply of affordable product, presents a number of challenges for manufacturers.
By Max Blomberg, Director of Operations, Meissner Filtration Products; and Trisha Gladd, Editor, Bioresearch Online and Pharmaceutical Online
Meissner Filtration Products recently introduced two new products related to single-use systems — a next-generation, single-use mixing system, and a plug-and-play filter solution. Max Blomberg, director of operations, discussed Meissner Filtration Products recently with us.
By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.
The single-use application market in biopharmaceutical manufacturing is rapidly expanding and highly innovation-driven. Adoption of single-use equipment in early manufacturing has reached a level of maturity that will spill into commercial-scale manufacturing in the near term. Indeed, results from our 10th Annual Report and Survey of Biopharmaceutical Manufacturers indicate that nearly half of biopharmaceutical manufacturers and CMOs either strongly agree (18 percent) or agree (28 percent) that they expect to see 100 percent single-use facilities in operation within five years.
A Q&A With Doan Pendleton, VAC-U-MAX
Lean manufacturing and financial pressures loom over pharmaceutical manufacturers. Plant managers are under increased pressure to streamline practices while keeping product reliability and quality high.
By Maik W. Jornitz, COO, G-CON Manufacturing LLC
The current need of a paradigm shift in the facility design of pharmaceutical and biopharmaceutical production sites has been stated in multiple papers and conferences.
By Darrick Niccum, Senior Global Product Manager - Biotechnology, TSI Incorporated
While real-time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators. This article will address the unique challenges associated with evaluating, testing, and validating this new family of RMM instruments.
By Paul R. Miller, Nilfisk Industrial Vacuums
By now, most manufacturers are familiar with the story of combustible dust. They've read about it in the newspaper, Googled it online, watched it on a CBS 60 Minutes special, or received a letter from the Occupational Safety and Health Administration (OSHA) informing them their facility is considered high-risk for a combustible dust explosion.
By Fred Monsuur and Julia Poncher, W. R. Grace & Co
An excipient's role has traditionally been viewed as merely a filler or binder contributing to the stability of the end product. The full value that a formulation can bring to a final dosage form, or the real importance of ensuring an excipient's quality and performance, is often underestimated, overlooked, misunderstood, or disregarded. In reality, the functionality of the excipient can help determine whether or not a drug succeeds or fails.
By Adrian Possumato, Vice President, Healthcare Packaging
Maintaining drug stability, quality, shelf life, safety, and efficacy is often achieved by using a sorbent to manage moisture, remove oxygen, or eliminate volatiles in the drug or device packaging headspace. With so much at stake, sorbent insertion is a critical step in the pharmaceutical packaging process. Unfortunately for manufacturers, automated insertion can create challenges on the packaging line when not properly implemented by a reputable supplier that can offer technical expertise and customized solutions.
By Robert Rosen, Filamatic
There are a few questions to ask yourself when determining which liquid filling machine is right for your project. As each machine is unique in its filling techniques and performance abilities, certain questions that are asked will help to narrow down the choices and select a machine that will best suit your application.
By Dr. Rüdiger, Lomb Global Director, Quality and Technical Compliance, World Courier
This article covers improving compliance and efficiency in the pharmaceutical supply chain with reduced cost and risk. How does the sponsor ensure that product transfer conforms to the same established written procedures demanded at the investigator level throughout the full length of the supply chain, or more specifically, while in the hands of nonpharmaceutical, noninvestigator personnel?
By Giuseppe Bonfiglioli, Bonfiglioli Engineering SPA
Production of tablets and capsules is carried out in cleanrooms and under stringent procedures as per GMP requirements. However, the process also relies on machines and machine operators, whereby misappropriate handling can result in a faulty blister pack containing micro leaks in the packaging, thus allowing air and moisture to enter the blister and damage the product.