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PTI could be considered the largest contract manufacturer, packager and outsourcing services provider of powder products in terms of capacity.

A family- and key-employee owned company in busines for more than 35 years, PTI also develops products, technology transfer and turnkey manufacturing systems for pharmaceuticals and personal care products.

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Most products are contained in foil pouches from 2.5 to 40 g or in HDPE bottles in sizes from 1 to 30 oz. The company molds the HDPE bottles and labels and fills them with products such as baby powder, cosmetic talc or bath powder.

The company molds its bottles separately from packaging operations and the bottles are put into a work-in-progress (WIP) holding area before being loaded onto the packaging lines. The bottles are either decorated or labeled on the lines or during the molding process.

PTI uses Fette America tablet presses to produce effervescent tablets. Its two production facilities are equipped with full-service microbial and analytical laboratories for on-site product testing. PTI also has what it calls technology-transfer capabilties with global pharmaceutical clients and others.

Recently, it was able to successfully transfer production equipment for an effervescent denture cleanser being produced in Puerto Rico and installed new, improved processes that allowed the customer to benefit from reduce costs, tighter quality controls and faster speed to market.

New level of performance

To meet customer and industry specifications for new business and to package products sensitive to temperature, humidity or products with special formulations that have tight manufacturing/packaging controls, in January and August of 2009, the company completed the installation of its first ISO 8 Level (Class 100,000) clean rooms—two were added to its Royston facility for filling pouches and one to its production plant in Union, MO, for primarily filling bottles with powder-based products. No floorspace was added to the facilities, but internal modifications were made.

“We are packing some products now that are new to us, and they prompted the addition of the clean rooms,” says Edward (Tee) Noland, Jr., PTI's director of business development. “These include new ingestible powder drug products. One is an OTC laxative and the other is a prescription product for reducing cholesterol. We wanted to pack these in a separate and controlled packaging and manufacturing environment.

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Clean rooms expand capabilities

“Adding the clean rooms allowed us to expand our capabilities for pharmaceutical customers,” explains Noland.

Specially engineered with positive pressure, HEPA filtration and humidity-monitoring systems, the clean rooms have highly-sensitive controls that closely regulate and monitor both temperature and humidity. No paperboard or carton board is allowed in the rooms. Products enter and exit the rooms in different ways—either manually by pallet tote or by forklift.

“In Royston, some of the equipment was refurbished and some is new, and in Union, all of it existed before we added the clean rooms,” he says. “We didn't use a systems integrator for this project. Our engineering staff chose the equipment.”

Outside of the clean room environments, PTI operates several packaging lines at the two plants to keep up with demand. Each line runs multiple products, package sizes and configurations but certain products require dedicated equipment or dedicated contact parts that meet certain customer requirements, Noland points out. “And obviously, flexible changeovers are always important for us. Each changeover is different depending what's involved. But if we're changing from one product to another, a detailed cleaning validation must be performed, which can take eight to 16 hours.”

There are three bottling lines in the Royston operation, three tablet-pouching lines and three form/fill/seal pouching lines. One of the bottling lines, for example, starts off with a Ronchi Mario Rotomatic centrifugal bottle unscrambler that orients bottles on a high-speed powder filling line.

The plant also has unit-dose pouch filling lines, and compounding and blending areas for powder-based products. The compounding/blending room has an area dedicated to preweighing and product sampling. “That's used to follow batch formulas of a product,” says Noland. “The equipment in this station is mostly weigh scales. There's one preweigh room that supports the clean room but it's not physically connected to the clean room.”

Royston's three integrated pouch-filling lines for ingestible prescription powders and OTC products run pouch sizes from 1.5 to 17 g. These include a line in one of the clean rooms that's outfitted with KHS “Bartelt” horizontal form/fill/seal pouch machines that pack prescription drugs including unit-dose ingestibles in flexible pouches from film rollstock. These lines include checkweighers from Mettler-Toledo Hi-Speed. Two Model XS1 checkweighers from Hi-Speed are used for gross weight verification and two Micromate checkweighers are on a non-cleanroom pouching line. Two Hi-Speed Checkmates and a Hi-Speed Checkmate 2 are equipped on the bottle filling lines. There are also three Siebler Romaco pouching lines (one of which is new) for effervescent tablets and a new, in-line Smartchek 300 x-ray system from Mettler Toledo Safeline on a cleanroom line running foil-based pouches of powders.

There are also cartoners from KHS, seven Nordson hot melt gluers, case packers from BVM Brunner and new metal detectors from Thermo Fisher on a line running nonmetal and nonfoil pouches of OTC topical powder. “We use the x-ray system to actually detect foreign matter with larger particle sizes than the particles that go into the pouch,” Noland points out. “The metal detectors are on a pouching line (not in the cleanroom) that runs an OTC topical powder. This product doesn't have foil in it, so we can use the metal detectors, which find metal only.”

Currently, secondary packaging is handled outside of the cleanrooms and adjacent to them. Shipping cases and product loads are moved around the plants manually. “Eventually, we will be installing conveyors from the cleanrooms into the secondary packaging areas directly through the wall,” says Noland.

In the Union, MO, production plant, there is one KHS Bartelt pouching line and four high-speed bottling lines. The bottling lines feature equipment such as All-Fill auger powder fillers integrated with Kaps-All cappers.

Packaging line speeds at the two plants range from 30 to 180 packs/min, depending on the products they run, which is consistent with the company's standards, Noland tells PD. The tablets are packed at 4,000/min. The PTI staff has significant background and experience with packaging equipment of this kind, Noland says, because the company has used such equipment to fill OTC topical powder sample pouches in the past. “We have owned similar equipment for more than 10 years.”

A pleasing outcome

The company is pleased with the outcome of its clean-room additions and packaging line upgrades. As PTI president Carl Oberg states, the powders, which include laxatives, cholesterol-lowering ingestible powders, diabetic control ingestible powders, topical medicated powders and much more, aren't always easy to work with.

“Powder shares some of the material characteristics of solids with flow characteristics more like liquid, and it has a long-standing reputation for causing distinctive processing challenges,” continues Oberg. “Powder filling requires material uniformity, consistency and an even flow during the filling process and when particle size variations occur, it can in some instances, cause a significant amount of particulate to become airborne.”

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“We're driven by what our next piece of business will be and what the timing is,” Noland explains. “We hope to get more involved in the tableting of OTC and prescription products and see our focus in powders continue to bring other opportunities that may use similar equipment. We're pleased with our upgrades. They allow us to get into other classes of products (new drug applications [NDAs] and prescription ingestibles), which opens up new opportunities for us. We're excited to have more capacity to offer technologies such as tableting and effervescents production, which we didn't have before. Competitors focus on more narrow areas, so this gives us more capability to cross-sell. Our tech-transfer and engineering know-how let us look into areas beyond our current focus.”