Drought conditions are making it increasingly difficult for pharmaceutical manufacturers to secure the proper wastewater permits in The Golden State.
Manufacturing facilities in the pharma industry may set the bar high for complexity and capital density when compared to the wider industrial community. At the very beginning of the design process, however, where the initial concepts are developed and decided upon, all too often a sense of urgency overtakes, leading to shortcuts in the process. However, two factors seem poised to change this pattern.
Delivering safe and efficacious products to patients and care-givers is the healthcare industry's greatest responsibility. The critical path to achieving this and fulfilling our responsibility is embedding quality in everything we do, and more importantly, into the thinking and actions of everyone in the system.
Unconfined yield strength (bulk strength) is the major principle stress that will cause material in an unconfined state to fail in shear. It is the primary flow property that governs the development of hang-ups in process equipment. It is used to compute critical arching and rathole dimensions for a given material in a hopper or bin.
Water activity aw, or the relative humidity inside a package, is commonly measured by manufacturers in industries such as food and pharmaceuticals.
Instead of comparing barrier systems solely in terms of investment costs, energy consumption offers another insightful approach – especially as it is in line with the recent trend towards green pharmaceutical manufacturing. Depending on ambient conditions, regulatory- and production-related parameters and the respective air supply systems, the energy consumption of Restricted Access Barrier Systems (RABS) and isolators varies significantly. For instance, isolator systems can save up to 65 percent of energy compared with RABS, while active RABS are up to 30 percent more energy-efficient than passive RABS.
Stepping out of my hotel room on the last day of the 2015 International Society of Pharmaceutical Engineering (ISPE) annual meeting in Philadelphia (November 8 – 11), I reach down and pick up the USA Today that is blocking my egress. Flipping through the newspaper the headline “Allen Always Aimed High” catches my eye. As writer Nicole Auerbach relates how Duke University basketball standout Grayson Allen strived to achieve his childhood dream, I am struck by the similarity between the story and this year’s ISPE annual meeting. “I had so much joy,” recalls Allen of the sensation experienced the first time he successfully slam dunked a basketball on a 10 foot hoop — a goal that took years of persistent practice to finally achieve. It is important to remember that biopharma executives and engineers are not immune to deeply experiencing human emotions (e.g., joy, sorrow). And while attendees of ISPE were certainly treated to high-caliber networking and educational opportunities at this year’s show, they were also provided a strong dose of emotional reality to fuel their passionate pursuit of excellence. Like Duke’s Allen, to achieve beyond your expectations, sometimes it is important to be reminded of why it is you do what you do.
As the FDA continues to compose guidances on the labeling and interchangeability of biosimilar medicines, there remains one big, overarching concern in the industry, and that is making sure biosimilar medicines are not treated as small molecule generics. But should we really be considering the two types of drugs as drastically different as we have been over the past few months?
Last week, Matthew Herper of Forbes published an eye-opening article providing a closer look at FDA approvals in recent years, coming to the conclusion that the industry is facing what could be a dangerously high approval rate for new drugs. But how could high approval rates be a bad thing?
In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.
At this point, it is well known that single-use technology (SUT) can offer many benefits to a manufacturer and their facility. However, there are concerns that single-use technology produces too much harmful waste to achieve sustainability. But is this true?
Ropack Pharma Solutions provides a seamless drug development process for solid oral dosage.
In general, when they talk about risk management, one of the main driving points behind that is that regulators, even our customers, recognize that with the supply chain as it is, it is pretty complex, and there's no way one organization can have total control over the whole chain.
Smart technology as you all know the smart phones are getting more sophisticated and same for the technology to monitor products while they're in transit.
The biggest trends that we see is that in terms of packaging solutions, 120-hours validation time for shipping systems is becoming the industry standard. Anything less is no longer really cutting it. And we also see that the old active container systems are no longer being able to handle this new requirement.
You should consider Custom Powder Systems for your material handling needs. We're much different than other companies that work in the same business. You come to us, we guide you through the process. We customize our equipment to what you need. We just don't sell you model A or model B and hope it works for you; we make sure that it works for you. We go through the details to find what your installation requirements are, what your utilities are and especially the unique things that you don't find off the shelf in places.
PolyPid, a clinical stage pharmaceutical company and developer of PLEX, a protected drug reservoir platform for effective localized, controlled and prolonged drug delivery, recently announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 9,173,976, covering compositions for sustained and/or controlled release of doxycycline.
Breakage Protection|Insulation|Temperature Maintenance
Packaging Technologies & Inspection (PTI) is a leading manufacturer of inspection technologies for the pharmaceutical industry that are non-destructive, non-invasive, and require no sample preparation. Recognized as a thought leader in new delivery systems for leak detection, seal, package, and container integrity testing, PTI has set the standard for inspection systems that provide repeatable, reliable results. | Non-destructive package leak testing | Package integrity testing | Micro leak testing | Pouch seal inspection | Seal quality analysis |Blister package leak detection | Blister package seal integrity testing | Seal integrity testing | Package testing & inspection services | Leak testing empty bottles | Leak testing empty containers | Micro leak testing of vials | Micro leak testing of ampoules
World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.
Membrane & Depth Filter Cartridges & Capsules|Fermention & Bioreactor Systems|Crossflow Micro & Ultrafiltration Systems|Validation & Extractable Testing Services|Water Purification, Air Monitoring & Filter Integrity Test Devices
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