Case Study: Allergy Labs puts peristaltic pump to the test
While primarily used for developmental purposes, peristaltic pump technology today offers a safe, clean and flexible alternative to conventional filling systems. Allergy Laboratories, Inc. has been successfully working with this technology for just over two years and reports some very positive user experiences.
Allergy Laboratories, Inc. was established in 1929 in Oklahoma City for the manufacture of allergenic extracts needed to support the growing immunotherapy practice of founder Dr. Raymond Balyeat. Allergy Labs, as the company is more widely known, has since evolved into an FDA-licenced pharmaceutical manufacturer of over 500 different biological extracts for the diagnostic testing and therapeutic treatment of allergies. Additional manufacturing and supply capabilities have been added over the years, including a parenteral production facility for contract manufacturing.
In 2010, Allergy Labs acquired a new filling and closing machine for vials and infusion bottles from Bosch. Two main requirements had to be fulfilled: the line needed to operate with peristaltic pump technology, and it had to fit exactly into the space that had become available by discarding an old machine.“We work with piston pump technology on another line, which can lead to cleaning and maintenance difficulties, so we started looking for a filling and closing machine that operates with peristaltic pump technology,” explained Lee Beaver, director of manufacturing at Allergy Laboratories, Inc. “We checked the market, and Bosch has a good reputation for this kind of technology. The open communication and expertise of our contacts at Bosch facilitated our decision. They were always quick in responding to our queries and requests, which enabled a quick turnaround time for the project.”
Traditional concept revisited
Six years ago, Bosch started to develop its own peristaltic pumps to supply the growing needs of its pharmaceutical customers. They combine the advantages of the traditional peristaltic concept with optimised dosing accuracy and a very flexible operating concept. The new tubing makes the technology suitable for all kinds of filling operations, from development purposes to production-scale filling operations. The offset alignment of the rollers reduces mechanical strain on the tubing and permits longer periods of use. Product and batch changeovers are easier, faster and safer.
The pump can be opened and closed in two simple steps without removing any parts, saving time and increasing safety, especially for isolator applications. With the exception of the tubing, the system completely eliminates product contact. This ensures high product quality by reducing the risk of cross-contamination and minimises the potential downtime associated with product changeovers.
The low pulsation volumetric flow ensures very precise filling tolerances. Allergy Labs mainly uses the Bosch filling and closing line for water-based, easily soluble products such as injectable, sterile generic drugs. The peristaltic pump is suited for filling volumes of 0.1 to 30 ml. The pump can also be modified to handle even smaller sizes, flexibly adjusting to each manufacturer’s requirements. “Allergy Labs operates with 2 ml fills, so filling accuracy was a big concern for us, but Bosch met all of our specifications,” added Beaver. “Filling operations are drip-free, and the single-use components significantly contribute to clean handling.”
Pretty much maintenance-free
Along with the peristaltic pump, Allergy Labs opted for a new filling and closing line from the FLC series. The FLC 3080 filling and closing machine is designed to fill, sample check-weigh and stopper vials in a continuous motion process. The FLC 3080 uses a vacuum star wheel to accurately position each vial for capping. Additional features include a V-cleat conveyor system that enables users to conveniently run different size vials without changing parts. The containers are carried freely in the laminar-flow stream in an upright position. “The FLC line not only provides the cleanliness we require for our filling operations, it also handles the vials very gently,” summarised Beaver.
The peristaltic pumps and a disposable tubing system are fully integrated with the machine’s control system, drive and controllers. An integrated touchscreen ensures easy and automated operations.
Beaver concluded: “At first, we were skeptical about the degree of automation of the FLC, but its set-up was easy; our operators quickly adapted to it and it’s pretty much maintenance-free. The line has been in operation for over two years now, but it didn’t take us that long to recognise the key benefits for us — safe and reliable vial handling, filling accuracy of the peristaltic pump technology and the cleanliness of the entire process.”
Robert Bosch Packaging Technology, Inc., www.boschpackaging.com.