Tag ffs

Pharmaceutical Manufacturers Turn To Form, Fill & Seal Technology For Single Dose Medication Packaging.

Growing demand for single dose pharmaceutical packaging, particularly for aseptically filled liquid medications, is creating an opportunity for form-fill-seal (FFS) technology suppliers like ORICS Industries.

Used for the aseptic packaging of ophthalmic products, respiratory (inhaled) medications, biologics and vaccines and other injectable drugs, FFS technology enables continuous, automated forming, filling and sealing of unit-dose liquid packs.

Package formats include ampoules, vials and bottles, and product sterility can be assured throughout the process. Benefits of FFS, versus glass packaging, include reduced waste and breakage and the elimination of product preservatives, which patients may be allergic to.

The FFS-30 is an inline, intermittent motion sealing system that forms real steroids trays, cups and pouches in real time from roll stock film.

By forming trays online, this system has the ability to save the user tens of thousands of dollars by eliminating the costs associated with purchasing and shipping pre-formed trays.

What’s more, with a simple tooling change, this flexible system is capable of creating multiple tray/pouch sizes and configurations.

Film may be flexible, semi-rigid, or rigid.

Final package may be ambient, vacuumed, gas flushed to create a gas/air filled package or vacuum gas flushed to create a true Modified Atmosphere (M.A.P.) package.

FS offers cost savings over conventional aseptic processing in glass. Traditional  filling and packaging requires many steps and individual machines for filling, stoppering and capping. In contrast, FFS requires one piece of automated machinery, and takes place in six seconds or less.

When used to manufacture products intended for subsequent sterilization, these machines may be installed within an environment that would normally be considered appropriate for the manufacture and filling of terminally sterilized products. If the machines are to be used for the aseptic filling of sterile products they are usually provided with a localized environment at the point of fill with Grade A air.

For many brands, horizontal form-fill-seal (FFS) equipment represents a significant investment. FFS machines can be the most expensive machine on the packaging line. To maximize return on the investment, companies re-purpose machines for packaging a range of products. This makes quick tooling changes an attractive feature.

Over the last few years, ORICS Industries has worked to ease changeover in our FFS-30 for changing package sizes. We understand that our customers have been looking for ways to make it more efficient.

The ease of changeover can depend upon how easy it is to get tools in and out. Tools are often heavy and require a lot of muscle to remove and replace. This can result in injury risks, such as strained backs, broken fingers, etc. The risk of damage to tools is also heightened.

Changeover varies in complexity. The change may simply be to the packaging material, maintaining the same packaging footprint. Or, an entirely new package size or style may be needed. The amount of tooling changes depends on the degree of packaging change.

Tooling that can be changed includes forming dies, sealing platens, and cutting knives. There are control issues that may need to be changed to accommodate different packages, such as changing temperature, pressure, and index length. And there are peripheral issues associated with things like lot coders and in-line printers to changeover.

Should You Change?

Many companies that employ FFS machinery do so because they want better productivity and lower costs. Higher volumes may justify a dedicated packaging line, thus obviating the need for routine changeover. A daily production on FFS could be more than 100,000 packages, depending on the product being manufactured. Thus, the goal is often not to change out tooling.”

There may be other reasons for foregoing changeover. Validation of FFS is directly tied into forming tooling, loading, printing, sealing, and cutting. This process, when properly done, can take up to a week or more per tooling set. Once this activity is successfully completed, manufacturers would not want to upset the apple cart by making changes. This is also reinforced by the fact that FFS runs are generally three shifts for many weeks, sometimes months.

A partial if not complete validation would be required every time tooling is changed out. Depending upon the actual situation, the cost of the re-validation could exceed the potential cost savings of ‘quick-change’ tooling.