Blow-Fill-Seal (BFS) Improving Uptime in Aseptic Liquid Processing

Aseptic BFS filling technology has been widely used in the global pharmaceutical industry. However, with the increasing use of BFS equipment, a series of problems such as poor management of some equipment, low operating efficiency, and failure to reach planned capacity have arisen. How to improve the operation efficiency of BFS equipment is very important.

In recent years, the pharmaceutical industry has encountered new opportunities and challenges as more new drugs and new pharmaceutical technologies have emerged. As well as pharmaceutical machinery manufacturers are dedicating to provide new and more flexible solutions. But pharmaceutical manufacturing processes have historically lagged behind in efficiency compared with those of other consumer products industries. With the stricter requirements from regulatory agencies, the cost of bringing new drugs to market is increasing, pharmaceutical companies have  to take a closer look at their manufacturing processes to make them more efficient, and to stay competitive.

Aseptic BFS filling technology has been widely used in the global pharmaceutical industry. However, with the increasing use of BFS equipment, a series of problems such as poor management of some equipment, low operating efficiency, and failure to reach planned capacity have arisen. How to improve the operation efficiency of BFS equipment is very important. It should ensure the normal operation time of the equipment to the greatest extent, the equipment is working in a high-performance state and  the product qualification rate to the greatest extent.

1.BFS Processing of Aseptic Pharmaceutical Liquids

BFS technology focus on uptime and changeover time improvement, aseptic BFS machines present highly efficient systems for production of sterile liquid products.

BFS is a self-contained process. It streamlines efficiency for the entire liquid filling and packaging production process with the consolidation of process steps.

BFS technology integrates a three-step process of blow molding, sterile filling, and hermetic sealing in a continuous, highly-automated operation. The capability for rapid container closure and minimized aseptic interventions is the unique advantage for aseptic BFS systems compared with conventional aseptic processing. Furthermore, the use of recyclable plastic resins. low-density polyethylene, high-density polyethylene and polypropylene the BFS process to produce aseptic containers for injectables, ophthalmics, biologicals, and vaccines are generally considered inert by FDA.

2. Simplified BFS Machine Design Improves Uptime

There are multiple steps involving conventional aseptic procedures for packaging pharmaceutical liquids to handle and manipulate of the material, containers, and sterilize filling processes with human intervention, therefore have a greate potential for system downtime and product contamination during processing. Manual processing steps for conventional aseptic processing include receiving, inspection, and warehousing of incoming containers; washing and sterilizing of containers; separate processing steps and equipment for filling and sealing; and end processing handling such as labeling.

In pharmaceutical processing, the filling process determines line speed.Such as the manually dependent processes can cuase the system delays and downtime in aseptic packaging,which can bring significant throughput and cost consequences.

Conversely, automation plays important role in the aseptic process on improving uptime. The most advanced aseptic BFS systems are quite automated, compared with conventional aseptic processing. These BFS machines are designed to require minimum human access while operating under a controlled environment. Various in-process control parameters utilizing the latest generation of fully system integrated PLCs control and monitor container weight, fill weight, wall thickness, isolation of visual defects, and other factors, facilitating optimized system function.

The forming, filling, and sealing steps in BFS machines are achieved in one-unit operation—the cycle being completed within seconds. Such automation eliminates unneeded manpower and reduces the risk to product integrity. These BFS machines shorten machine cycle time and minimize the time required to perform complex tasks and increase efficiency in process operations. The automated process technologies improve product quality and consistency as well as increase production throughput.

3. Guarantee the Uptime of Equipment

Maintaining uptime is a key factor to reaching high levels of efficiency in pharmaceutical manufacturin, which has always been of critical importance to manufacturers in every industry. When throughput is interrupted, or not running because of downtime or changeovers, the entire process line is affected, which can present a significant production loss to the pharmaceutical manufacturer.

Advanced BFS machines can approach 99% uptime efficiency, significantly higher than conventional aseptic processing, which is plagued with slow-downs, in part because of manual interventions. BFS also performs noticeably higher than the peak 70% operating efficiency of the world’s most streamlined pharmaceutical manufacturing facilities.

One of the most costly and time-consuming activities within pharmaceutical manufacturing is changeovers of packaging equipment Indeed, the most critical packaging machine feature is the changeover adaptability .To change the packaging equipment impact production time greatly.The versatility of packaging equipment to facilitate rapid changeovers plays very important role in pharmaceutical manufacturing, and aseptic BFS systems exemplify this initiative.

Many BFS machines are configured to produce more than one bottle shape or format, which is easy to change over from one container size to another. A BFS machine can be designed to produce a series of 2ml, 3ml and 5ml containers, then switch to a series of 5ml, 10ml and 15ml containers, or to one of 10ml, 15ml, and 20ml containers, moving from one to the other with relative ease of machine set-up. This is ideal for manufacturers with the need of changeover flexibility , such as those performing contract packaging of aseptic liquid pharmaceutical solutions, BFS systems from Tofflon are capable of producing containers ranging in size from 0.1 ml to 1000 ml，the production rates from 1200 to 17,000 units per hour, depending on container configuration.

Improved uptime, minimized changeover time and efficient performance are key factors that have influenced the acceptance of aseptic BFS. These are critical functions for achieving improved product quality and profitability in the packaging of aseptic pharmaceutical liquids.