Supply meets demand with continuous powder processing system 

Over the past century the industry has realized unprecedented advances in human health, yet the pharmaceutical industry is struggling to keep up with demands. Increased demand results in the need for increased production which poses a complete set of new challenges for companies in the supply chain.

Such production challenges were realized by A&C, a service driven organization finding unique solutions to its customer’s Good Manufacturing Practices (GMP) challenges. It is a custom manufacturer and supplier of excipients, process solutions, buffers, and APIs. They are audited by both FDA and Health Canada affirming their constant and stringent efforts to meet regulatory requirements for pharmaceutical and biopharmaceutical raw material suppliers.

With two GMP facilities located in Montreal, A&C manufacture, pack and distribute bioprocessing liquid and bulk materials under Good Manufacturing Practices with full compliance to all international regulatory requirements.

With product demand increasing A&C realized the need for significant investment in bulk material handling capabilities to support expanding business and increased production, while focusing on minimal downtime. As part of this initiative, A&C continually focused not only on process, but also on end-product quality, safety, and compliance. “A major challenge our customers face is the way bulk materials are supplied to the market,” according to Damien O’Rourke, VP and COO at A&C.

“We needed a material handling system that would keep up with our demand, ensure worker safety and limit manual manipulation of material.”

A&C’s team: An Activator version bulk bag unloader features four pneumatically operated actuator petals to massage the lower portion of the bag in an alternating-side pattern to promote optimal material flow toward the centre of the bag.

A&C promotes a leadership position in providing full transparency in the supply chain, as demonstrated through EXCiPACT, GMP & GDP certifications. EXCiPACT (International Pharmaceutical Excipients Certification) is a non-profit organization that owns and manages oversight of an independent, high-quality, third-party certification available to pharmaceutical excipient manufacturers and distributors worldwide. “The Vac-U-Max team designed and manufactured a material handling system capable of conveying over four and half million pounds of powders per year that now allows us to continually meet our growing business,” continues O’Rourke.

“A&C’s quality management system is based on providing the highest quality product to companies worldwide while safeguarding public health. We place strong focus on plant and personnel safety, product lead times, minimizing product contact and manual manipulation of product in support of GMP initiatives.”

Among A&C’s service offerings, the powders processed are supplied in custom packaging meeting customer specific requirements. Product must be conveyed from different containers to the discharge point at a rate of 2,200 lb/h. Manual handling of product poses its own set of challenges including slip and fall hazards, fugitive combustible dusts and other sanitary issues that may result in decreased production and lengthy downtime. Employing vacuum conveying technology for dust containment, labor savings, cleanliness, or safety and environmental reasons lies in the ability of vacuum conveying experts to understand powder characteristics and how those characteristics interact with equipment design. A&C also wanted the best ergonomics for their employees, so they also selected a Vac-U-Max LoadLifter for the repetitive action of lifting bags from a pallet and depositing it on the bag-opening grate of the bag dump station.

Material Properties & Conveying Behaviour

As most pharmaceutical and nutraceutical processes start with a powder or granular material, material characteristics must first be defined with focus on the materials attrition and segregation, vacuum conveying behaviour, flow properties, and particle properties like shape, size, cohesiveness, and bulk density. The bulk density of a material is one of the first indicators of design in terms of sizing various system components such as vacuum receivers and air sources. Bulk density helps determine how many cubic feet per minute (CFM) of air is needed to move the material through the convey line. In A&C’s case, the bulk densities were on the heavy side at 95 and 133 lb/ft³.

Attention is given to the prospect of segregation especially during manual transfer of materials in drums or other containers, to the next process vessel in the production process. Vibration caused by moving containers promotes segregation. While each application requires a unique resolution based on distinctive environments and equipment, systems are generally built using standard components and customized according to the application requirements. A&C’s process requires the convey and discharge of multiple materials, from diverse types of packaging (bags, bulk bags, and drums), in a clean room environment which is subject to washdown sanitation.

Introduction to the Process

Equally important is the introduction of material to the process (i.e., the pickup point). Product can be introduced via simple suction wand (from a drum), or a sanitary bag dump station with integral dust hood or via bulk bag (a.k.a. super sac) unloading systems. A&C introduces product to the process via the Vac-U-Max sanitary bag dump station and the Activator bulk bag unloading system with “Chisel Bottom” screw dischargers. The bulk bag unload system features a dust-tight cover and cantilevered open flight 150 mm auger to provide a consistent, controlled flow of powder into the convey line.

The Activator version bulk bag unloader features four pneumatically operated actuator petals to massage the lower portion of the bag in an alternating-side pattern to promote optimal material flow toward the centre of the bag. “We have tested two-sided actuators, but the four-petal design is far more effective in promoting material flow to the bag outlet,” states Doan Pendleton, VP of Vac-U-Max. The Activator assembly includes a NEMA 4X control panel and level control so that the bag is only massaged when powder is needed. The bag access door is capped for dust collection during bulk bag discharge. The Activator uses lubrication-free pneumatic lifters that consume 50 percent less compressed air than air-cylinders, providing A&C with lower operating costs.

A&C can minimize material handling devices such as forklifts in the work area by leaving the bulk bag on a pallet, lifting, and placing it into the bulk bag unloader with its integral I-Beam and 2 hp hoist. The operator controls the hoist from a remote pendant, taking them safely away from the lifting zone. The “I” beam and bag lift frame are constructed in 304L stainless steel and handle bags up to 122 cm high with weights up to 1020 kg, with typical I-beam and hoist rated for up to 1800 kg.

The unloader is equipped with a manual iris valve in the bag access housing which allows the operator to untie a full bulk bag discharge spout without any release of product. All product contact surfaces are designed in 316 stainless steel including the sealing collar, operator housing with access door, conical pickup adapter and screw discharge devices. The entire bulk bag unloader is constructed in stainless steel to meet A&C’s current GMP program.

The sanitary 316 stainless steel Vac-U-Max Bag Dump Station is equipped with an integral dust collector that automatically turns on when the dump station door is opened, to keep dust from the bag opening away from the operator.

The sanitary 316 stainless steel Vac-U-Max bag dump station is equipped with an integral dust collector that automatically turns on when the dump station door is opened, to keep dust from the bag opening away from the operator. Dust that is collected on the static-conductive filters is pulsed automatically into the bottom of the dump station so that no material is lost. The materials have high bulk densities, so the bag dump station has the same screw discharger on the bottom to provide a metered feed of material into the convey line. Like the Activator bulk bag unloader, the screw discharger has a pneumatic poppet valve on its outlet to prevent any dribbling of powder into the convey line which might affect the accuracy of the conveying process.

Observing Distances

Bulk density, while one of the most important factors in sizing a system, is not the sole criterion used to determine components. Another key factor in sizing and determining the type of system needed is the distance that the material is traveling. In pneumatic conveying, the more tubing incorporated into the bulk material handling system, or the further the conveying distance, results in larger vacuum pumps since it takes more airflow to pull (or push) the air through the tube.

Vacuum conveying systems move product vertically and calculated the same as moving product horizontally — in linear feet. However, each 90-degree sweep in the system equals 20 linear feet; thus, moving material horizontally 110 ft and vertically 110 ft with four 90-degree sweeps results in an overall conveying distance of 300 ft. Vacuum conveying technology was selected by A&C. Any potential leaks in a vacuum system will be inward, where a positive-pressure system leak results in a cloud, or pile, exposed to the work environment. This not only reduces exposure for the operators, but also aids in reducing combustible dust, sanitation, and product yield issues.

The Heart of the System

Self-sufficient and the heart of the process, the sanitary pharma-grade Vac-U-Max vacuum conveyor is mounted on a rolling lift frame to allow A&C to remove the equipment from the production room for cleaning. The lifting frame allows the conveyor to be raised into operating position above the drum on a scale, and to lower it to a travel position which is also a convenient height that encourages good maintenance and sanitation of the equipment.

A good vacuum conveyor needs a good vacuum producer. The vacuum producer selected for A&C’s system is a continuous-duty 5HP regen blower unit due to its good vacuum production and airflow, compact size, direct-driven impeller, and low noise level—perfect for a pharmaceutical environment.

If the vacuum conveyor is the heart of the system, the controls must be the brains of the operation. Vac-U-Max has been selling equipment in Canada for decades and was able to provide A&C with a C-UL-labelled main control panel in compliance with Canadian electrical standards. “This is a great benefit for my customers in Quebec,” states John Hamilton of Hamilton Process Systems Inc; the Vac-U-Max representative for the province for over 16 years.

The vacuum transfer principle is used as a continuous refill device for continuous operation. Pneumatic receivers use negative pressure to draw material required for refill into the vacuum receiver, which is filled to a pre-determined level, with receiver holding a charge of material until the process below requests a refill. The level of material in the vacuum receiver is determined by level sensors. When the process requires a refill, the discharge valve opens, discharging material to the process below – keeping material moving from source to process.

Team cGMP Effort

According to Andy Pizans, Canadian sales manager for Vac-U-Max, “this was a coordinated effort between A&C and Vac-U-Max. Without this level of cooperation, the project would never have achieved the objectives of supplying a system that was easy to operate, safe, GMP compliant and efficient. All this was accomplished within a tight delivery schedule. A tremendous effort by both companies.”

Vac-U-Max contributed this article.