At main plant, flexibility is the best medicine: the plant at Abbott's headquarters has adaptability that helped when it was called on to package the Humira Pen

Food & Drug Packaging, Dec, 2006 by Pan Demetrakakes

Versatility is one of the biggest imperatives at the main production facility at Abbott's headquarters.

In Building AP 16 on Abbott's sprawling headquarters campus in far north suburban Chicago, 250,000 square feet is devoted to producing and packaging medicine, with 11 packaging lines that are able to handle many different packages of tablets and capsules, plus one of Abbott's big new stars: an easy-inject pen for Humira, its biologic medicine for a variety of autoimmune diseases like rheumatoid arthritis, psoriatic arthritis and arthritis of the spine.

The facility handles various types of drugs and packages them in about 230 different configurations, ranging from physician samples in blisters to bulk bottles and containers for pharmacists and drug distributors. It operates 24 hours a day, five days a week (sometimes six, to run medicine for flu and other illnesses that peak in winter).

It's a lot of responsibility. To help take it on, Abbott is focused on continuous improvement and has driven out approximately 20% of controllable cost in AP 16 over the past two years. The facility is using Kaizen workshops and other continuous improvement tools aimed at improving the quality, customer service and cost of its products.

Rapid changeover has been a key focus as part of continuous improvement. This is critical in light of the variety and complexity in the packaging operations. The team has applied SMED (single minute exchange of die) techniques in attacking changeover. An example is color-coding of change parts to facilitate changes from one bottle size to the next.

In 2006, the AP 16 operations launched the Class A certification process, which is the planning and control business model used across the Abbott Global Pharmaceutical Operations group. Class A certification at AP 16 is targeted for mid-2007.

The Humira Challenge

The latest challenge at AP 16 was the packaging of the Humira Pen, which was approved by the U.S. FDA this June. Assembling the pen was unlike any task the plant's personnel had ever undertaken. To make sure everything went smoothly, Abbott had the equipment, for both assembly and packaging, in place months before the scheduled start of production. The work team for Humira practiced on syringes filled with water.

One of the innovative aspects of Humira's packaging is its versatility. The syringe inside the pen can be used, as is, on its own. This is important because, while almost 90% of patients in a study preferred the pen to the stand-alone syringe, there's still a minority that prefers the syringe to the new device. The Humira packaging line can handle both pens and pre-filled syringes.

The assembled pens arrive in the clean area in palletized totes. Polypropylene film feeds into a thermoformer platen, which forms pockets five across. Operators hand-load pens into the pockets, and the thermoformer applies a web of paper/foil laminated lidding film.

Before being applied, the lidding is labeled by a flexographic printer, using UV-cured black ink. Once applied, the thermoformed pockets pass under a sealing plate that activates heat-sensitive sealant on the underside of the lidding.

The sheets of filled, sealed blisters are cut apart. (The lidding scrap is shredded to reduce its volume before landfilling. Due to its composite nature, it can't be recycled.) A vision system looks for empty blisters.

A pick-and-place robot picks up blisters, two at a time, and drops them into a pocket on a parallel conveyor, on a magazine above this conveyor, an operator maintains supplies of booklets, printed inserts, and packets of alcohol swabs. Rotating suction cups pick up a booklet, an insert and swab packets, and deposit them atop the injector pens in each conveyor pocket.

A cartoner sets up carton blanks and drops them onto a track parallel to the product components. Rams push the pens, booklet, insert and swabs sideways into the cartons. The side-entry cartoning ram has to be relatively genfie. With multiple elements going into the package, they can't be pushed too forcefully.

An ink jet coder marks the carton bottom with a lot code and expiration date. The cartons pass over a checkweigher, which is well-tuned enough to detect if even the lightest element in the carton is missing. A labeler then seals both ends of the carton with security tape, bearing Abbott's stylized lowercase "a" logo in color-shifting ink.

Coordination

The Humira operation represents only a fraction of the activity at AP 16. The other 10 lines, divided equally between blisters and bottles, package capsules and tablets that are mostly made on-site.

Having production and packaging in the same facility requires careful coordination. This extends to the very first step: Ingredients get weighed out into exactly the amounts needed for a given batch, and they're all grouped together in the ingredient storage area.

In one of the bottling lines, capsules are loaded into a hopper and deposited into individual holes inside rows of slats in a filler. This set-up allows a precise number of capsules to drop into the bottles, which sit under the filler.