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NEWS

The Automated Filling Machine from Advanced Scientifics is suitable for aseptic and nonaseptic filling of 25-ml to 5-L bags.

As a contact manufacturer of disposable IV bags, fluid-transfer systems, and injection-molded medical devices for bag systems, Advanced Scientifics (Millersburg, PA) would like to see more companies adopt bag packaging for drugs and pharmaceutical media.

But the lack of an efficient method for filling premade bags has been an obstacle for companies considering bag packaging, says Carl Martin, Advanced Scientifics’ CEO.

“We want to support pharmaceutical companies that are looking at bag alternatives for new drugs or to switch from bottle packaging. The chink in the armor for many companies is that there is nothing on the market that answers the need for filling a premade bag. We have seen companies spend thousands of dollars developing bag systems, but then decide to use bottles because they couldn’t find an efficient way to fill the bags,” Martin says.

Some drugs just don’t have the volume for contract packaging with a major bag packaging company such as Baxter or Abbott that converts film from stock in form-fill-seal (FFS) applications.

“The marketplace is changing with the advent of new drug-delivery systems where [for instance] the drug is packaged in a bag that is integrated with a drug-delivery device for home use. Drug companies are trying to launch drugs with 5000-unit volumes in the first year. That is not high enough to justify FFS packaging costs. The large contract fillers require 2 million units to start a line,” says Martin.

In addition, biologics can’t stand up to the autoclaving often used in high-volume bag-filling processes. “The market is seeing more biologics that can’t withstand the heat of autoclave. Companies have used laminar-flow hoods for aseptic applications, but these are labor intensive, time-consuming, and prone to human error,” he says.

Addressing the need for a premade bag-filling solution, Advanced Scientifics has developed the Automated Filling Machine. The stand-alone unit is suitable for aseptic and nonaseptic filling of 25-ml to 5-L bags.

For applications requiring a sterile fill, bags are supplied preirradiated and closed. After connectors on the bags are pulled into a chamber, the cap pulls off, and a nozzle extends to fill from a sterile disposable filling system. Misting with hydrogen peroxide during the filling procedure kills off bioburden, maintaining a sterile transition of solution into the bag.

After filling, the retention cap is pushed beyond the original detent to a locking detent. The customer can utilize the port by breaking off the tab and applying a cap with an internal spike or a typical spike from an administration set.

The unit employs an irradiated, disposable mass-flow filling system from PDC (Hartland, WI) that supports “much faster filling than in bottle filling,” he says.

But finding someone to validate the Automated Filling Machine has been a hurdle. Since the debut of the system this year at WestPack, Advanced Scientifics has developed an alternate automated bag-filling solution in its quest to promote the use of its custom-made bags in the market.

“The validation requirements for aseptic filling are huge. We can’t spend millions to validate a $100,000 machine for a customer doing 5000 bags,” says Martin.

The company is developing a $5000 fixture for filling bags under laminar-flow hoods. The device is a pneumatic tool that, when integrated with the connector system on the bag, supports instantaneous bag filling. “Most customers understand the laminar-flow process technique. This one profile can work in many bag-filling applications and make aseptic bag filling easier for the 5000-unit customer,” says Martin.