I receive calls every day that start with sentences like, "I need a clean pouch." As I ask a series of questions that will help me understand the needs of this potential customer, I can feel a growing impatience at the other end of the phone. You can almost sense the caller thinking, "I just want a clean bag for gods sake, quit asking questions." But the questions need to be asked, because, "clean packaging" is a relative term.

There are many issues related to choosing a packaging format that matches the requirements of your products. You can ignore them if you wish, but you do so at your peril. (See Figures 1, 2 and 3 as examples of different packaging solutions.) Countless times over the years, I have received desperate calls from people who have produced the highest quality product that exists in the market, only to encounter contamination difficulties by failing to properly incorporate the protection of that product into their process. The result; embarrassment, delays, confusion, costs, and lost customers. “I don’t understand,” they say, “all our information indicates there is no problem with our process, or our packaging.” Yet when their product arrives at the customer’s door, it is contaminated, or even ruined.

The best advice I can give is to involve packaging professionals, and packaging suppliers, in the process development of the product as early as possible. Partner with packaging industry contacts and manufacturers with strong experience, and keep them involved. Here are some actual examples that will hopefully convince you.

One company manufactured a beautiful injected molded plastic container to carry clean parts. They then searched the Web for clean film to wrap their clean part, and ordered the film. They tested the parts, process, and film thoroughly. Everything tested beautifully—no leachables, contaminants, or particles. They started shipping the new parts but when they reached their destination they were literally covered with particles. Investigation showed that although the film was extremely pure and clean, the coefficient of friction (COF) of the film was quite high. The result was that friction generated particles during transit.

Another manufacturer made parts that were packaged and then stacked on staging tables at the end of the production line. Purchasing switched to a different and cheaper film that had processing additives that made the film slippery. On the first day of use, the parts were falling off the stacking tables onto the floor. Many parts were ruined, and production was disrupted for days.

A company purchased a barrier film specifying a concern only for moisture and oxygen barrier. On use, they discovered that the adhesive used to bond the layers of plastic on their pouches off-gassed a chemical that ruined their product.

To save costs, a company switched their packaging, to a lower cost film, not realizing that many films have processing additives in them. They lost two weeks of finished product, which had to be scrapped due to the additives leaching onto the product.

Another company bought barrier film for a product that had to be shipped air freight. The buyer specified resistance to moisture, however, did not realize that the seal strength had to be stronger than their current pouches. When the air expanded inside the bag due to lower pressure at high altitudes, the seals burst open, and their product was contaminated.

A product and process development team worked for two years to develop a product. They congratulated themselves on a successful effort, and communicated a time line for market introduction to their sales team. The sales team dutifully began pre-selling the item, generating interest and excitement throughout their customer base. To the development team’s dismay, after belatedly involving packaging specialists, they discovered that the protection and shipping of the product to market would be more expensive than their traditional products, and that the development of the packaging would take a minimum of eight more months. The dampening of excitement, and the loss of trust from the customer base, made the actual introduction of the product extremely difficult. In addition, because of this delay, their competitors were forewarned well in advance, and were able to take marketing countermeasures.

A company in Japan packaged their products at an altitude of 6000 feet. They normally used permeable packaging that allowed pressure to equalize within their packages. A new item was produced that was moisture sensitive, and they purchased clean impermeable barrier film to protect the product. To their dismay, when their product packaged in the barrier film was brought to sea level, the air in the package became denser, drawing the film tight enough to crush the product. Their entire inventory had to be repackaged at great expense.

A company justified their process, clean film, and product perfectly. They put their product in boxes and shipped them to Southeast Asia, a new market area for the company. Their customer called complaining that all the products delivered had turned yellow. The boxes, when subjected to high heat and humidity of that region, leached box coloring onto the outer packaging, and it migrated to the product. A small change in film on the outer packaging eliminated the problem, but the first shipment was lost.

As you can infer from these stories, clean packaging is not just about how many particles there are per square foot. The physical properties and additives of the packaging play a major role in choosing the right type of package. Never make a commitment to a new clean packaging format unless the type of packaging being considered has been specified for physical properties, leachables, cleanliness, and off- gassing characteristics. Your clean packaging suppliers should have this information readily available. Your packaging suppliers should also be audited and have the resources to provide you with consistent product, which should include a clean room, a supporting laboratory, and a strong quality assurance program. In addition, all packaging formats should be tested for use from loading to delivery to the customer, before being incorporated fully into a process.

Next time someone in packaging starts asking you some seemingly unrelated questions in a product development meeting, an alarm should go off. You might want to get on the phone and find out who your packaging engineer is and talk to them—it might save your job. Finally, remember that your packaging is your product’s last line of defense, and your customer’s first impression of your company. Treat it with respect.