Now, more than ever, pharmaceutical manufacturers are enhancing production capabilities by implementing vacuum technology to deliver drugs to consumers faster, safer and more economically. Vacuum technology provides safer transfer of bulk dry materials as well as delivering solutions for maintaining tight industry standards for sanitation and environmental safety.

The increased use of vacuum technology is due, in part, to ongoing support, guidance and clarifications from the FDA which eases the way for pharmaceutical processors to implement newer production technologies by documenting them in annual reports rather than time-consuming supplements through post approval manufacturing changes.

Across the board, according to FDA regulations and guidances implementing material handling equipment, such as pneumatic conveyors, is a level one change that requires submitting documentation with annual reports rather than pre-approval documentation.

The language discussing these changes vary somewhat from document to document, yet still communicate that automated material transfer is the preferred method to deliver bulk powders and solids in a pharmaceutical environment, as vacuum conveying equipment, is unlikely to have an adverse effect on product quality.

For instance, Appendix A in “CMC Post-Approval Manufacturing Changes to be Documented in Annual Reports” states that a “decrease in the number of open handling steps or manual operation procedures,” has “minimal potential to have an adverse effect on product quality.” This correlates with the assertion in Scale Up and Post Approval Changes (SUPAC), “change from non-automated or non-mechanical equipment to automated or mechanical equipment to move ingredients,” are “are unlikely to have any detectable impact on formulation quality and performance.”

Even though this opened the door for pharmaceutical companies to make changes that increased production or protected product and employees, because vacuum conveyors operate in semi-continuous and continuous cycles, there was still confusion about how vacuum conveying operating in these modes coincided with batch processing and where that fit into reporting changes.

Just the term continuous brings about serious debate on what that means exactly. In some industries, it means operating 24 hours a day, seven days per week, shutting down only once or twice per year. In other industries, it means something different. Often the idea of continuous processing is associated with a mode of manufacturing.

To get away from the definition of batch being tied to a mode of manufacturing, the FDA changed the definition of batch in CFR Title 21 210.3(b)(2) to read:

CFR – Code of Federal Regulations (2) Batch means a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

This single-cycle batch process can be a continuous or semi-continuous process depending on the level of automation employed. Vacuum transfer is the heart of continuous processes moving dry bulk materials from one processing machine to the next—including mixers and reactors, hammermills, tablet presses, gel caps and packaging machinery.

While it’s true that is it possible to completely automate drug manufacturing with sophisticated equipment and very little human intervention; in lieu of complete infrastructure overhauls, drug manufacturers are investing in pneumatic conveyors that are more accurate, cleaner, safer, and money saving than the manual materials handling methods.

Versatile vacuum conveying systems easily integrate into existing processes by routing conveying lines between floors, through partitions, around machinery, and are easily re-routed to accommodate process modifications.

Whether it is employing vacuum technology for dust containment, labor savings, cleanliness, or safety and environmental reasons, the success in adding vacuum technology lies in the ability of vacuum experts to understand powder characteristics and how those characteristics interact with equipment design.

When pharmaceutical processors work with expert conveyor manufacturers to design equipment that will perform well with existing equipment and specific processes, they are utilizing not only industry specific know-how, but expertise in powder characteristics that transfer from industry to industry assuring processors, through written guarantees, that the equipment will perform as promised.

Mass flow and material separation
There is much attention given to the prospect of segregation in pharmaceutical applications, especially during manual transfer of materials in containers, from machine to machine throughout the production process. The vibration, caused by moving containers, promotes segregation, threatening the quality of the batch.

It is this reason that pharmaceutical manufacturers primarily use mass flow methods that move all particles at the same velocity, minimizing segregation.

Vacuum transfer systems, with virtually no moving parts, gently transfer pharmaceutical ingredients using, for the most part, mass flow.

While each pharmaceutical application requires a unique resolution based on distinctive environments and equipment, systems are generally built using standard components and customized according to need by conveyor manufacturers that have fabricating abilities.

Dust containment
Aside from automating material transfer for efficiency, productivity, and product integrity, dust containment, is one of the principal reasons for manufacturers adding pneumatic conveyors to production lines.

Manually dumping feeders creates small dust clouds with each scoop, creating fugitive dust. Fugitive dust, or particulate matter (PM), is basically any solid or liquid suspended in the air through wind or human interaction. While half of all fugitive dusts are greater than 10 microns (a human hair is 70 microns) and settle on surfaces rather quickly, the other half are smaller than 10 microns (not visible to the naked eye) and can remain suspended in the air for days or weeks.

Because materials do not escape from vacuum systems, particulates that can endanger workers health or settle on equipment and surfaces, posing cross-contamination dangers from dislodged fugitive dust or explosion hazards, are prevented from entering the environment.

For transferring ingredients that require higher levels of containment to protect worker health, minimizing exposure requires additional scrutiny in conveyor equipment design. Whenever air moves through a vacuum conveyor system, it cycles through filters before being exhausted. One method that offers some additional guarantee of safety for exhaust air is additional HEPA filtration.

In addition to providing a safer environment through dust containment, automatic feeding of hammermills, mixers, reactors and other equipment eradicate ergonomic issues that occur with repetitive motion, lifting, and climbing to manually dump materials into feeders.

Reducing ergonomic hazards
Automatically feeding materials into and out of hammermills has multiple advantages beyond dust containment such as reducing the amount of manpower needed to feed the mill and eliminating safety hazards.

Hammermills and screeners are common types of equipment that require unique resolutions based on distinctive environments. Again, expert manufactures with a keen understanding of powder characteristics and behaviors, and a wealth of experience in pneumatically transferring powders to and from many different types of equipment, can customize standard components according to each application to ensure no product alterations occur, such as size reduction.

Generally, most processing equipment, including hammermills, stand taller than workers do, requiring the addition of ladders or stairs to access feeders. In many processing facilities, these set-ups warrant a second worker for safety.

Employing automated, or semi-automated, pneumatic conveying systems to deliver product to and from hammermills eliminates the need for workers to climb stairs or haul heavy containers of material away from the hammermill, alleviating fall hazards and repetitive motion injuries. In addition to reducing costly safety hazards, these systems facilitate the ability to redistribute manpower more economically because only one person needs to monitor equipment function.

If a manufacturer is paying $250,000 a year in disability suits from manual transfer injuries, investing in vacuum conveying equipment can produce instant, or near instant, ROI depending upon the level of automation added to the process.

Increased uptime during blender loading
Blenders, mixers and reactors are common types of equipment used in pharmaceutical processing facilities; and, just like many other types of equipment, require a mezzanine level for manual loading or specialized equipment like drum loaders or vacuum conveying equipment.

Although drum loaders are better than manual loading, limitations, such as the ability to load only one drum at a time, make the delivery of materials to the blender or reactor time-consuming. In some circumstances, it may also be necessary to load multiple ingredients into drums prior to loading blenders and reactors, further slowing the process by increasing processing steps.

One of the most efficient advances in loading blenders, mixers, reactors, or any vessel capable of withstanding vacuum, is packaged conveying systems designed specifically for the direct charge loading of blenders. With a drug processer’s blender or mixer as the primary receiver, the conveyor manufacturer provides the rest of the system: power source, filters, controls, and adapters.

Configured specific to each application with standard equipment, direct charge blender loading systems come with the option of either floor standing or suspended blender loaders designed to significantly reduce the amount of carry over, eliminating product loss and ensuring batch integrity.

Carry over is the amount of product collected in the filter separator during the loading process that separates the air from solids (dust) inside the vessel to prevent solids from reaching the vacuum pump.

Standing units are readily accessible for cleaning and can be equipped with casters, allowing them to service more than one blender. In addition, once the blender is loaded and equalized, carry over releases into an airtight vessel that preserves product integrity allowing for reuse or safe disposal.

With suspended units, once the blender is loaded and equalized, material automatically discharges back into the blender eliminating the need to handle product manually.
Because the units are easy to take apart without tools, clean up between batches and products takes only 30-45 minutes to wash down equipment and change out bags, filters and hoses (when using different hoses for every product).

Direct charge blender loading is not the only complete, ready-to-operate systems available to pharmaceutical managers who want to automate their batch process.

Eliminating product mishandling and spills
Manual scooping of blended formulations into tablet presses has the potential for messy spills or mishandling. Fully enclosed tablet press loading systems protect product from air, dirt and waste. Vacuum tablet press loading systems are turnkey systems for mounting on customers’ presses and are available for single or dual hopper tablet presses—and the construction of the equipment is USDA accepted.

These systems automatically convey tablet granulations from drums, or other containers or equipment, to surge bins over tablet presses. A tube hopper material receiver, with vertical sides to minimize material hang-up, is located over each surge bin and the control panel and vacuum pump located in an adjacent room. Vacuum is applied to all material receivers over the presses using one vacuum pump.

Combining modern electronic technology with innovative mechanical and pneumatic design, the programmable control panel, with its microprocessor, is the nerve center for the system and has reserve capacity to handle a total of sixteen presses. The microprocessor constantly scans level controls on the surge bins and initiates conveying of tablet formulation to the receiver over any press requiring material, insuring that no press will run dry, which could cause costly tooling damage.

Increased throughput with automation
Nearly any time a process is automated increased throughput is a given, especially when eliminating manual transfer methods. The gel cap conveyor, designed to deliver gel caps, soft gels, or tablets from inspection machines to packaging lines or gel caps to filling machines is another type of turnkey conveyor package for pharmaceutical processors. These turnkey packages transfer 500-1000 lbs per hour—approximately 2500 units per minute, increasing the amount of product throughput.

Pneumatically transferring delicate gel caps requires expertise to protect product integrity, especially since the manufacture of gel caps can be an expensive process. In addition to product integrity however, expert conveyor manufacturers also anticipate solutions in a broader framework than just the end goal, which often means incorporating environmental improvements as well.

For instance, when pneumatically transferring gel caps, the capsules can sound like little bullets when they hit the side of the hopper creating additional noise in a facility. To combat this, new tangential inlets were utilized to eliminate noise, and protect delicate product from damage.

Environmental improvements
Environmental improvements aren’t limited to cleaner, safer and quieter vacuum conveying equipment. Vacuum technology is also integral in assisting pharmaceutical processors comply with FDA and EPA guidelines—especially in the collection of wastewater.

Wet central pharmaceutical vacuum systems are specifically to assist pharmaceutical facilities comply with regulations that prohibit disposal of liquids containing active pharmaceutical ingredients (APIs) and non-regulated PPCPs into municipal wastewater sewer systems and municipal wastewater treatment plants (WWTP).

This pharmaceutical liquid recovery system provides multiple hose connections located throughout a facility where washdown processes occur. The liquid generated from the washdown process (containing the API and PPCPs) is vacuumed into a sanitary tubing network and then collected in a wet separator. When the central tubing network needs to go vertical, special tubing valves are available to eliminate water falling back down the tubing network when the system shuts down.

A unique washable, corrosion-resistant filter media then separates the liquid from the airstream and an integral pump transfers the solution to an in-house treatment system designed to address the APIs and PPCPs prior to discharge to the local municipal WWTP.

Depending on the treatment process, the liquid may also be suitable for re-use within the pharmaceutical facility via a closed looped treatment system. Other features of this type of industrial vacuum system include a full controls package, liquid level sensors, sanitary construction, and protective secondary containment in the event of a release during maintenance or normal operations.

Vacuum technology is also ideal for limiting solids delivered to WWTPs which can cost processors upwards of $10,000 a month in back-charges. To keep solids from entering drains, vacuum technology experts borrowed techniques used in other industries and applied them to pharmaceutical and food applications to separate materials in the vacuum stream. These types of systems are constructed of stainless steel and built from the ground up to be explosion proof.

Whether employing a central vacuum system to eliminate harmful waste from the wastewater stream, employing vacuum conveying systems to eliminate hazards, increasing the speed at which a processing line operates or streamlining production through automation, working with a manufacturer who has extensive experience in the delivery of powders ensures that pharmaceutical processors get the right equipment for the job.