An Overview Of Blow/Fill/Seal Technology And Its Acceptance By The FDA

For those that are not familiar with Blow/Fill/Seal, can you tell us the Blow/Fill/Seal process?

The BFS process is simply the consolidation of an automated form, fill and seal packaging sequence into one machine. Plastic containers are blow-molded, filled with liquid product and sealed in one continuous operation under aseptic processing conditions.

Can you describe what products are developed from Blow/Fill/Seal machinery?

Weiler Engineering has machines operating in many applications with a primary focus on the liquid pharmaceutical market, typically including solutions for ophthalmic, respiratory therapy and injectable drug products.

A wide range of other products are also compatible with BFS technology, from cosmetic creams and topical ointments to oral medicines and nutraceuticals. Isotonic beverages, herbal drinks and medicines and personal healthcare products are also produced with BFS technology.

How has the FDA's acceptance of Blow/Fill/Seal equipment into the aseptic processing world assisted in the marketing and sales of your product lines?

The inherent safety of the process, packaging sterile products under aseptic conditions without human intervention, has led the FDA to characterize Blow/Fill/Seal technology as an "advanced aseptic process", indicating its use as a preferred technology going forward. The technology is ideal for packaging liquid products that cannot be terminally sterilized.

Where do you see the largest growth potential for Blow/Fill/Seal technology in the next 5 years?

BFS technology has gained rapid world wide acceptance in the injectable drug marketplace, replacing glass vial processing in many applications. New advances in drug delivery, increasing emphasis on combination products and the increased focus on proteins and other biologics represent growth opportunities for BFS technology.

Do you see a philosophical difference of the use of Blow/Fill/Seal manufacturing equipment in North America vs. Internationally? If so, why?

The success of BFS products in the ophthalmic and respiratory therapy markets in North America is well established, but I see reluctance on the part of drug manufacturers to adopt BFS technology in some sectors. The US in particular has been slow to recognize the benefits of BFS technology for injectable products from an overall cost and patient safety aspect. I believe this is due in part to the perceived regulatory hurdles to be overcome in changing from an established technology (glass), particularly with injectable products. The large installed base of existing conventional (glass) filling equipment creates an investment cost barrier as well. This environment will change, as more imported drug product employing the BFS process enters the market.

How much of your revenues are generated from the pharmaceutical market? What are the other industries that Weiler sells into?

Weiler concentrates on the pharmaceutical market. We do provide equipment for beverage and cosmetic clients, but the majority of our business comes from the pharmaceutical segment.

How has the increased number of International manufacturing plants affected sales and marketing?

Obviously growth is good. Successful companies entering new markets are creating the need for more International manufacturing sites. Weiler is very well positioned to serve the International market and a significant part of our growth is in emerging market areas such as India, China, the Middle East and Africa.

How would you characterize Weiler's current position in the market?

Weiler is aggressive, well-positioned and gaining market-share internationally. Our technology is based on good science and is supported with hundreds of successful installations. Our focus is to drive the technology through science and innovation.

In one sentence how would describe the future for Weiler in the pharmaceutical market?

Weiler is challenged to maintain its leadership position in developing the science of the technology and we are committed to serve our customers needs as their products evolve and as regulatory changes dictate.

Chuck Reed is the Sales Manager of the Americas for Weiler Engineering, Inc., responsible for sales and marketing activities for North, Central and South America. He has extensive experience in specialized equipment design and manufacture, process technology and pilot plant design and construction. He is a member of both PDA and ISPE and is an author for the Packaging, Labeling and Warehousing (PACLAW) Baseline Guide. Mr. Reed holds a Bachelor of Science in Chemical Engineering from Clarkson University and a Master of Science in Management from National Louis University.

Source: Weiler Engineering, Inc.