Such production challenges were realized by A&C, which is a service-driven organization finding unique solutions to its customer’s Good Manufacturing Practice (GMP) challenges. It overcomes the challenges through many methods, including the use of advanced technology.
Focusing on Process, Quality, Safety & Compliance
A&C (www.acggp.com) is a custom manufacturer and supplier of excipients, process solutions, buffers and Active Pharmaceutical Ingredients (APIs). The company is audited by both the Federal Drug Administration in the United States 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, Canada, A&C manufactures, packs and distributes bioprocessing liquid and bulk materials under GMPs with full compliance to all international regulatory requirements. GMP ensures products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.¹
As product demand increased, 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. We needed a material handling system that would keep up with our demand, ensure worker safety and limit manual manipulation of material. 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,” said Damien O’Rourke, Vice President & Chief Operating Officer at A&C.
Driving Transparency in the Supply Chain
A&C promotes a leadership position in providing full transparency in the supply chain, as demonstrated through EXCiPACT, GMP and Good Distribution Practices (GDP) certifications. EXCiPACT 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.²
“A&C’s quality management system is based on providing the highest quality product to companies worldwide while safeguarding public health,” said O’Rourke. “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 it processes 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 pounds per hour.
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 its solutions to incorporate the best ergonomics for employees.
Material Properties and Conveying Behavior
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 behavior, 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 pounds per cubic foot.
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 conveyance and discharge of multiple materials from diverse types of packaging, such as bags, bulk bags and drums. The process is also in a cleanroom environment, which is subject to wash-down sanitation.
Introducing Materials 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 VAC-U-MAX’s sanitary 316 stainless steel bag dump station. The process uses a VAC-U-MAX LoadLifter to assist with the repetitive action of lifting heavy bags and placing them in the bag dump station.
A bag dump station with integrated dust collection and load-lifter allows the operator to remove heavy bags from a pallet and easily place them on the bag station grate.
The bag dump station is also 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 collected on the static-conductive filters is pulsed automatically into the bottom of the dump station so no material is lost. The materials have high bulk densities, so the station has a screw discharger on the bottom to provide a metered feed of material into the convey line. It is also designed to prevent any dribbling of powder into the convey line which might affect the accuracy of the conveying process.
The process also uses an ActivatorTM Bulk Bag Unloading System with “chisel bottom” screw dischargers. The system features a dust-tight cover and cantilevered open flight 6-inch (150 millimeter) auger to provide a consistent, controlled flow of powder into the convey line. Four pneumatically operated actuator petals massage the lower portion of the bag in an alternating-side pattern to promote optimal material flow toward the center of the bag.
The bulk bag unloading system assembly includes a NEMA 4X control panel and level control so the bag is only massaged when powder is needed. The bag access door is capped for dust collection during bulk bag discharge. It also uses lubrication-free pneumatic lifters that consume 50% 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 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 using 316 stainless steel. The entire bulk bag unloader is constructed in stainless steel to meet A&C’s Current GMP (cGMP) program.
The Activator system features lubrication-free pneumatic lifters that consume 50% less compressed air than air-cylinders.
Observing Materials Travel Distances
Another key factor in sizing and determining the type of system needed is the distance the material is traveling. In pneumatic conveying, the need for more tubing incorporated into the bulk material handling system, or the further the conveying distance, results in the need for larger vacuum pumps since it takes more airflow to pull (or push) the air through the tube.
Vacuum conveying systems move product vertically and are 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 feet (34 meters) and vertically 110 feet (34 meters) with four 90-degree sweeps results in an overall conveying distance of 300 feet (91 meters).
A&C selected vacuum conveying technology because any leaks in the system will be inward, which mitigates the risk of an appositive-pressure system that can develop a leak, resulting in a cloud, or pile, or powder in the work environment. This not only reduces exposure for the operators, but it also aids in reducing combustible dust, sanitation and product yield issues.
The bulk material handling system also factors in the number of equipment connections, headroom requirements for vacuum receiver mounts, and any containment or clean room requirements, as required by A&C. By reducing the number of overall process steps, processors reduce the potential for product segregation resulting in better quality control, smaller equipment, simplified 1:1 scale-up, and shorter production time – while reducing labor and maintenance costs.
Vacuum Conveyor: The Heart of the System
The heart of the process is the sanitary pharma-grade VAC-U-MAX Vacuum Conveyor, which is mounted on a rolling lift frame to allow A&C to remove the equipment from the production room for cleaning. It also allows the conveyor to be raised into operating position above the drum on a scale, and lowered to a travel position..
The vacuum conveyor is integrated into a screw discharger to eliminate conical hoppers and discharge valves. All product contact parts are designed in 316L stainless steel per 3A Sanitary and USDA design standards. A pneumatic poppet valve on the end of the screw discharger prevents any chance of dribble feed from the receiver into the conveying line. A gas pulse is sent to the receiver’s filter to release any entrained material that may have accumulated on the filter during conveying.
A good vacuum conveyor needs a good vacuum producer. The vacuum producer selected for A&C’s system is a VAC-U-MAX continuous-duty 5 horsepower (hp) regenerative blower unit due to its good vacuum production and airflow, compact size, direct-driven impeller and low noise level.
The vacuum conveyor also features a C-UL-labeled main control panel in compliance with Canadian electrical standards. The control panel at A&C incorporates all electrical and pneumatic functions from the bulk bag unloader, bag dump station, vacuum conveyor, screw dischargers and a platform scale. The remote devices are plugged into the main control panel with quick disconnect plugs that can be disconnected and capped before wash-down.
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 the receiver holding a charge of material until the process below requests a refill. Level sensors are used to determine the level of material in the vacuum receiver. When the process requires a refill, the discharge valve opens, discharging material to the process below – keeping material moving from source to process. The vacuum receivers are designed to be crevice-free and easily cleaned.
The process at A&C involves the use of a vacuum receiver mounted on mobile cart with attached pick-up adapter to convey powders.
Now more than ever pharmaceutical and nutraceutical manufacturers are enhancing production capabilities by implementing vacuum technology to deliver drugs to consumers faster, safer and more economically. Vacuum technology can also provide safer transfer of bulk dry materials, delivering solutions to tight industry standards for sanitation and environmental safety.
About the Author
Doan Pendleton is Vice President, VAC-U-MAX.
VAC-U-MAX is a worldwide leader in the design and manufacture of pneumatic conveying components and systems for conveying, weighing, and batching over 10,000 various powders and bulk materials in the food, pharmaceutical, chemical, and plastics industries. Since 1954, VAC-U-MAX has offered solid application and process automation expertise for bulk material handling with a product range including pneumatic, aeromechanical and flexible screw conveying. It developed the world’s first industrial vacuum cleaner operating only on compressed air for use in the highly combustible textile mills industry of New Jersey. Its product range also includes industrial vacuum cleaners for high volume recovery of a wide range of materials including combustible dusts, fine powders, granular materials, and flammable liquid recovery. For more information visit www.vac-u-max.com, or email firstname.lastname@example.org.
All photos courtesy of VAC-U-MAX.
¹ ISPE. https://ispe.org/initiatives/regulatory-resources/gmp GMP Resources. International Society of Pharmaceutical Engineering.
² EXCiPACT. https://www.excipact.org/ What is EXCiPACT? International Pharmaceutical Excipients Certification.
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