Pharmaceutical Technology Editors

Emerson’s Fisher FIELDVUE DVC7K Digital Valve Controller

Emerson’s Fisher FIELDVUE DVC7K Digital Valve Controller is a new digital valve controller featuring Emerson’s Advice at the Device technology. Digital valve controllers are accessories for control and on-off valves are used to provide local analysis of valve data and digital communications with host systems, as well as other features. These features improve uptime by alerting personnel to developing problems, reducing maintenance costs by providing information required for proactive rather than reactive maintenance, and cutting troubleshooting time in the event of an issue by providing recommended corrective actions.

The DVC7K ‘s Advice at the Device technology contains embedded computing and real-time analytics that convert raw data into information with Bluetooth capability. This allows maintenance personnel to receive data via their phone, tablet, or computer wirelessly without having to be in a control room at the plant location. Information can be accessed wirelessly from one or more digital valve controllers from up to 30 ft, and the local user interface displays detailed information via LEDs.

Articles

Fisher FIELDVUE DVC7K combines patented technology with real-time analytics to provide real-time awareness of valve health. 

Digital Valve Controller

Charles Ross & Son Company's PD-40-gallon PowerMix Mixer

ROSS Mixers are high-performance mixers that are designed for durability and efficiency. The company’s original equipment manufacturer (OEM) team has reconditioned ROSS Mixers to restore them to “like new” working condition. These reconditioned mixers are intended to enhance existing equipment or expand production and are designed to perform at the same standard as brand-new equipment while offering cost savings and expedited shipping. Purchasers of the reconditioned machines receive the same standard warranty as a new ROSS Mixer: one year from the date of shipment.

Reconditioned equipment may utilize existing components to minimize waste, without compromising quality and value. A recent example is the pictured ROSS PD-40-gallon PowerMix, recovered through the ROSS Buy Back Program wherein owners sell mixers no longer in use back to ROSS. The PowerMix is a patented hybrid planetary mixer featuring a planetary stirrer blade and a High Speed Disperser, designed for heavy-duty mixing of high viscosity formulations up to 2 million cP. Reconditioning entails a thorough inspection of each part of the mixer, all of which are tested, cleaned, repaired, replaced, repolished, or modified as needed.

ROSS’ reconditioned mixers are restored to “like new” working condition by the ROSS OEM team and are designed to perform at the same standard as brand-new equipment while offering cost savings. 

ROSS Reconditioned Mixers

Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the important components of nitrosamine impurities from a manufacturing point of view as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."

Yeah, so with what I've been highlighting within with my session is studies that we've done at Big Pharma, but also taking studies from across the globe into impurity formation, impurities that can lead to nitrosamine creation. As an excipient supplier, we think we're really well positioned to help the industry understand risk factors that may come from excipients. What we see when we look at these different impurity levels is that we focus specifically on nitrates. And when we look at nitrites, then we see that within different excipients, you have different levels of nitrates and within the same Excipient, but from different suppliers, you again have different levels of nitrates, and also these different suppliers may have different batches which contain a very varying amount of nitrates. These nitrites are then potential, again, potential risk factors for nitrosamine formation in the end drugs, and that they need to be controlled and understanding how to control them. That is something that we've that we've been working on. And yeah, the industry needs to partner with reputable, reliable suppliers to really connect and understand what kind of risk nitrosamine brick risk and drug may have. 

 Yeah, so it's a continuous journey. So the whole nitrosamine topic has been around for a couple of years now. And we've been focusing very much about on the raw material and different impurity levels within the supply chain. But one of the things that we've also been seeing is that the the manufacturing route itself can also have an influence. At the pharma one of the root causes of nitrites within our excipients which can potentially lead to the formation of nitrosamines is actually in the drying process itself. In the manufacturing drugs, the drying process is an inherent part of wet granulation techniques that a lot large part of the industry uses, and we think that next steps can be taken by going, transferring to dry granulation or directing. And again, you're working together with suppliers can really support in improving the drug safety.

Videos

Crucial Points from a Manufacturing Perspective (PDA/FDA Joint Regulatory Conference 2023)

Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the recent findings of nitrosamine impurities in human drugs as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."

 So, since 18, there's been a lot of investigation into nitrosamines as a potential carcinogenic, yeah can impact drug safety. So naturally across the supply chain of drug manufacturer, the partners within the industry have all been looking at it, including players like DFE pharma, supplying decisions to the industry. And we're continuously investigating and, you know, one of the challenges that we as an industry have also needed to overcome is, you know, also looking at the analytical techniques that are necessary to not only detect the nitrosamines in the end product, but also the potential root causes of those nitrosamine formations in the entire supply chain.

 There are a lot of potential root causes of nitrosamine impurities. And we've been studying this since 2018. A lot of the suppliers of raw materials, such as excipients, have been looking at nitrosamine levels with in their products that can lead to those nitrosamine impurities in in drug, end product drugs. I think you know, for most reliable reputable suppliers, this is now pretty much under control. To take the pharma as an example, we've studied the nitrosamine levels in our excipients, and they're all below two ppb parts per billion. To put parts per billion into perspective to control a football field... It's like controlling a football field to 10 particles of sand to get to that two ppb level. However, the industry has moved on a little bit from nitrosamines to actually looking at what are potential causes of nitrosamines being created in the end product itself. And over here, the research is into the pathways leading to nitrosamine creation in the end product after it's been manufactured. If we look at what what's happening there we have, for example, nitride impurities, which are within different raw materials that can react with a means in certain API's to create nitrosamines over time and product.

The Recent Discoveries of Nitrosamine Impurities (PDA/FDA Joint Regulatory Conference 2023)

Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the requirements needed to be successful in global cell therapy as a part of his session, "Successfully Navigating Global Cell Therapy Requirements."

 Well, that is an interesting question. As I mentioned before, in terms of the challenges from the regulatory space, each country have its specific requirements. Some of them are common across the different countries. However, some are very specific to the country. For example, in China, there are multiple offices that manage requests around cell therapies in the US or fewer offices within FDA; in Europe, same thing. So each group each particular sub office, in a regulatory body, we have different roles and having or presenting a product to different countries will have a requirement to want to extend their specific country requirements to ensure you satisfy them. And you answer their questions and expectations in a satisfactory manner to avoid going back and forth or delays in the approval of your problem. 

 There's so much... internal landscape in the regulatory space. Each company as each product is now being launched into different countries, it is critical to understand the expectation for that country, critical to understand what others have done, that helped shape the expectation from the regulatory point of view. If that exercise is not properly conducted, the chances for failure will increase because it's not an issue of building or creating your own elements, it's making sure as an industry everyone target the same requirements and help shape the regulations around the world and avoid different directions across countries.

Global Cell Therapy Requirements Need Thorough Understanding

Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the journey from clinical to commercial cell therapies as a part of his session, "Successfully Navigating Global Cell Therapy Requirements."

 The case of cell therapies is one word data is now being generated. And the different companies are learning about processes and products, as they are in development. It is not a new journey, it began back in the 70s and even earlier, but the learning about sales and the immune system really grew during the last 20 years with the advantage of technologies and that is one challenge that is being overcome. Now, the regulatory space and the compliance space is something that is now being developed, is growing, and each country has various specific requirements, looking not only on having a product that is safe, but also protecting the patient from the use of the cells and how those products are now develop use, and in the future, they will become the mainstream. So, the challenge is making sure that all the regulatory aspects are properly addressed during clinical stage and development all the way into the routine commercial promotion.


 One key element is understanding what is expected from the regulatory space, having a close communication with the agency, having clear, a change of information with those regulatory bodies to ensure their expectations, their regulatory space, is very clear to the company and the group developing and transitioning into a commercial space in particular products. So, there are no surprises at the time, the product is fine, and all the information required by the regulatory group is provided and explain and justify, and then once approved, how to maintain the quality and the regulatory posture as a production is now in a commercial stage.