Pharmaceutical Technology Editors

ROSS FDA-1500 Duel-Shaft Mixer | Image Credit: Charles Ross & Son

Designed for processing high viscosity dispersions and suspensions, the ROSS line of Dual-Shaft Mixers are versatile systems utilized in the chemical, pharmaceutical, food, cosmetic, adhesive, coating, composite, and other industries. The purpose-built ROSS FDA-1500 (pictured) has a maximum working capacity of 1500 gallons and features a dish-bottom stainless-steel mix vessel with a 50-psig dimpled heating/cooling jacket. The dome-style cover includes multiple charging ports as well as a hinged manway providing access for major ingredient additions and cleaning. The FDA-1500 is capable of operating under vacuum up to 29.5”Hg.

The mixer’s independently-driven agitators—a 40 HP Two-Wing Anchor and a 150 HP High Speed Disperser—are supported from a heavy-duty agitator bridge. Agitator shafts are sealed via flexible Teflon lip seals with Viton elastomers. The disperser shaft runs up to 695 rpm and is equipped with two 20” diameter sawtooth blades. The lower blade is stationary, while the upper blade is attached by means of an adjustable hub, enabling it to be raised or lowered to accommodate various batch volumes and ensure rapid wet-out of solid ingredients. The two-wing anchor is fabricated with a triangular cross-section, and is driven by a 40 HP motor up to 20 rpm that promotes bulk flow, continuous movement of the product towards the disperser blades, and efficient heat transfer across the jacketed surfaces. Both motors are explosion-proof, suitable for use in a Class I, Div 1, Groups F & G hazardous environment.

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Designed for processing high viscosity dispersions and suspensions, the ROSS line of Dual-Shaft Mixers are versatile systems utilized in the chemical, pharmaceutical, food, cosmetic, adhesive, coating, composite, and other industries.

ROSS Dual-Shaft Mixers

Opt-Diss–In-Situ Fiber Optic UV System for Dissolution Testing, Version 3.20 | Image Credit: © Distek

The release of Distek’s software update for the Opt-Diss–In-Situ Fiber Optic UV System for Dissolution Testing, Version 3.20, introduces enhancements designed to streamline the dissolution testing process and expand the system’s capabilities. Among the key updates in Version 3.20 are an integrated media addition, a dosage weight correction feature, and run automation for complete systems.

The process of analyzing tests that employ changing or adding additional media during testing has been simplified and automated, and automatically pauses measurements for media changes, which generates a consolidated report with visual demarcation of media change instances.

Recording individual dosage weights are now allowed, enabling the correction of % dissolved/concentration values for each dosage form. Non-uniform dosage forms particularly benefit from this feature.

Complete run automation is now possible for Distek systems equipped with a dosage auto-dropper option. This culminates in the automatic generation, storage, and optional printing of final reports.

Distek’s software update for the Opt-Diss–In-Situ Fiber Optic UV System for Dissolution Testing, Version 3.20, introduces enhancements designed to streamline the dissolution testing process and expand the system’s capabilities.

Dissolution Testing Software

Galbraith Laboratories' Analytical Services

Galbraith Laboratories, a Bureau Veritas Company, offers a full range of analytical services for pharma, from R&D to final release testing. Galbraith aims to provide accuracy and speed with its services, which encompass high-quality routine analyses, technically complex projects, custom developed methods, and method validation. Some other services include:

As an ISO 17025 accredited and a current good manufacturing practice-compliant laboratory, Galbraith has been providing testing solutions for more than 70 years. Galbraith maintains a long-standing reputation for offering adaptable and solution-driven analytical services, aiming to meet the needs of any client.

Galbraith Laboratories, a Bureau Veritas Company, offers a full range of analytical services for pharma, from R&D to final release testing.

Pharmaceutical Testing Services

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.

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. 