Pharmaceutical Technology Editors

Charles Ross & Son Company's ROSS Model PDM-1/2 PowerMix Planetary Disperser

ROSS Mixers, a provider of US-designed and manufactured mixing equipment, offers a Trial Rental Program, giving process managers an opportunity to optimize R&D projects before committing to a substantial investment. ROSS maintains an extensive inventory of pre-owned and new mixing equipment for the Trial Rental Program. These laboratory- and production-scale ROSS mixers are intended to meet the diverse needs and timelines of manufacturers in nearly all the process industries.

One such mixer is the pictured ROSS Model PDM-1/2 PowerMix Planetary Disperser, which features two independently driven agitators: a High Viscosity “HV” Planetary Stirrer (25–254 rpm) and a 2” diameter High Speed Disperser (600–6000 rpm). In addition to rotating on individual axes, the Planetary Stirrer orbits the vessel (18–175 rpm), ensuring constant turnover regardless of the product’s flow characteristics. The PowerMix can handle a wide range of applications including dry powder blends, slurries, gels, and highly viscous pastes.

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ROSS Mixers, a provider of US-designed and manufactured mixing equipment, offers a Trial Rental Program, giving process managers an opportunity to optimize R&D projects before committing to a substantial investment.

Trial Rental Program for R&D Scale Equipment

Charles Ross & Son Company's 42N-18SS Ribbon Blender

ROSS’ Ribbon Blenders are designed to handle a wide range of dry materials, from seasonings and beverage mixes to pharmaceuticals, chemicals, plastics, and agricultural powders or granules. These blenders also incorporate minor liquid components to effectively coat individual solid particles. They are manufactured with long-term performance and quality in mind.

The pictured ROSS Model 42N-18SS is crafted from type 316 stainless steel with interior surfaces polished to a 150-grit finish. With a maximum working capacity of 18 ft³, the blender is direct-driven by a 10-horsepower gearmotor for processing materials with a bulk density of up to 60 lbs/ft³.

The agitator is a solid double ribbon design, designed for center discharge, with internal flanges welded to shaft stub ends and a heavy-duty anti-friction bearing on the non-driven end. The blender includes a two-piece safety grating with half-inch diameter perforations for safe operation while the split folding covers are open. A spray bar with fan-type spray nozzles is installed on the trough via sanitary tri-clamp connections for liquid additions. The blender is operated from a four-inch color touchscreen that includes a cycle timer, start/stop, forward/reverse, and speed controls. The finished product is discharged through a pneumatically operated four-inch dust-tight knife gate valve.

ROSS’ Ribbon Blenders are designed to handle a wide range of dry materials and effectively coat individual solid particles, keeping long-term performance and quality in mind.

Ribbon Blenders

Suncombe’s IsolatorCIP Automatic Cleaning System

Suncombe’s IsolatorCIP automatic cleaning systems provide aqueous, detergent, and/or solvent cleaning of glovebox isolators. IsolatorCIP uses a clean-in-place (CIP) system to reduce the possibility of cross-contamination after each use and remove any product or debris. This design allows for repeatable cleaning of isolators and gloveboxes without a breach of the isolator in the process. The cleaning sequence can be configured to include different water qualities, chemicals, detergents, and sterile hot, cold, and dry air streams. These can be provided at accurately controlled temperatures, flowrates, and pressures.

Using variable recipe-derived configurations, the IsolatorCIP can also be used to clean additional processing equipment enclosed inside the isolator or be fitted onto the in-feed or discharge sides. Incorporating replaceable modules, the base unit is a fully hygienic version, with optional modules for sterile use, including sanitizing and sterilizing configurations.

Suncombe’s IsolatorCIP systems can be integrated with isolators of any manufacturer. With pre-configured mechanical and control interfaces, they minimize the potential for cross contamination and downtime while also ensuring the protection of personnel. The machines are manufactured from type 316 certified stainless steel, and use an easily configured recipe structure, providing confirmation at the successful completion of cycle. Remote control facilities can be incorporated for interfacing with the isolator’s control systems.

Suncombe’s IsolatorCIP automatic cleaning systems provide aqueous, detergent, and/or solvent cleaning of glovebox isolators. 

Automatic Cleaning System

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.

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.