By Mike Bacidore, managing editor
In most industries, automation is a solution to labor cost and safety issues. But in the pharmaceuticals industry, automation is a matter of regulatory compliance.
What the FDA is striving to achieve is patient safety, says Sales Manager, Americas, Chuck Reed of Weiler Engineering. Anything that can eliminate the human from the environment is what they want. Automation really lends itself to removing the human from the equation.
Weilers Asep-Tech blow/fill/seal (BFS) machine combines the three-step process of blow molding, aseptic filling, and hermetic sealing of liquid products in one sequential operation. All equipment is designed and manufactured by approximately 100 people at its 140,000-square-ft. plant in Elgin, Ill. We do not outsource any engineering work, says Reed, who is a chemical engineer. Weiler also employs more than 20 mechanical engineers, as well as some electrical engineers and a dedicated technician in the R&D prototype area.
MEETING REGULATORY REQUIREMENTS
In general, the FDA and European and external agencies are working on harmonization so the requirements are very similar, explains Reed. China and Africa have less-stringent regulations, but we still sell the same machine to all of these locations. Everyone in the industry is focusing on a big push to eliminate glass as a supplied base and BFS technology lends itself to this. The injectable market is growing for BFS and that trend is replacement of glass. Theres still a lot of glass vial production out there, particularly in the U.S.
Weilers largely international customer base is trained and serviced through a centralized process that begins at its plant. We have an extensive group of service technicians that works through the building and customer qualification process and supports our customers internationally, says Reed. We work with agents and reps throughout the world, but the main service comes directly from our plant. We include a week of operator training and machine information checkout at the factory acceptance test. And then once the machine is installed, we provide two weeks of assistance and training at the customer site. Each machine is shipped with a spare-parts package, which typically includes large lead-time items and six months to a year of disposables.
Almost 50 years old, Weiler started in the business as an agent for European BFS machine builder Rommelag.
After a number of years, the licensing arrangement expired, and our CEO Gary Weiler elected to stay in the market, says Reed. Weve become Rommelags competitor. Weve made a lot of innovations and had our own patents on certain improvements to the machine, and thats when we split.
When the arrangement with Rommelag dissolved, the company branded its machines as ALP (Automatic Liquid Packaging) as it ventured into contract packaging. When Weiler sold the packaging arm of the business to Cardinal Health, which is now part of the Blackstone Group, it kept the machine building company. We had to rebrand the machines then, explains Reed. But the machines under those other brands always were made by Weiler. The innovations weve madefor example, controlling the environment around the machinehave been through the science of BFS.
Weilers patented electronically controlled fill system, automatic sterilization system with integral data collection, and filter integrity test system are provided as standard equipment for each machine configuration. Each machine is also equipped with a HEPA air shower to ensure a Class 100 environment under dynamic conditions in the nozzle shroud area. Optional parison shrouding is available to ensure a Class 10,000 environment under dynamic conditions in the extrusion zone and the critical transport area.
Moving forward, Reed sees technology trends on the horizon that could impact the industry significantly. The move away from hydraulics and toward electronics is in the fore, and the replacement of multilayer film with nanotechnology is making headway, but Weiler has met the challenge of data-acquisition needs seamlessly.
Weve always treated our machines as islands of automation, says Reed. But were seeing more integration of our machines with existing or upgraded SCADA systems in plants, and our machines are well-suited to those environments.
Click here to read Obsolescence Happens. A case history on Weiler Engineering's automation component changes.