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Pharmaceutical and Medical Packaging News Magazine
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Originally Published December 2000

Pharmaceutical Focus:

Buying New Packaging Machinery with Safety in Mind

As equipment for pharmaceutical production becomes increasingly advanced, buyers and suppliers need to pay particular attention to operator safety.

by Erik Swain, Senior Editor

Packaging machines in this day and age are often expected to move with greater speed and efficiency than their predecessors and to provide more features. These expectations are made clear by the manufacturers during the marketing of their equipment and by packaging engineers when they go through the purchasing process.

But as the machines become more complex, so does the task of ensuring the safety of their operators. Suppliers and buyers know that safety is just as important as productivity, so much so that it is taken for granted that any machine sold in an advanced industrial nation will meet minimum safety standards. But, with packaging machinery, buyers need increasingly customized equipment. Highly specific safety concerns can come into play, and expectations there do need to be made clear.

"Safety truly is on everyone's mind," says Gene Fuchs, vice president, Genesis Machinery Products Inc. (Exton, PA). "Veteran machine buyers have come to expect that safety features will be built into the machine. The concern is there, but it's not always voiced as such, and each customer likes to have things work to their own specifications."

Indeed, says Bob Hartwig, vice president of Pester USA (Allendale, NJ), "90% of the equipment in pharmaceuticals is way ahead when it comes to guarding. Pharmaceutical companies have lots of packaging equipment and tend to implement companywide standards. They are very particular about the placement of E-stops, the guarding, and the access points below the guards."

With those factors in mind, safety standards are evolving so that all potential issues are sure to be covered, and some buyers and suppliers are making sure to address those issues more overtly.

There are a variety of approaches that can be taken to ensure operator safety, and different vendors follow different standards to achieve it. Buyers need to know what those methods are and to communicate whether they require anything different or extra.

"Right from the [start], with the receipt of the initial specification, we talk safety," says Mel Bahr, chief executive officer of MGS Machine Corp. (Maple Grove, MN). "We highlight the standards we follow, and we itemize safety concerns in the equipment description."

THE PMMI STANDARD

A significant development in packaging machinery safety standards occurred recently with the passage of ANSI/PMMI B155.1-2000: "American National Standard for Packaging Machinery and Packaging-Related Converting Machinery—Safety Requirements for Construction, Care, and Use." The document, approved by the American National Standards Institute (ANSI; Washington, DC) and published by the Packaging Machinery Manufacturers Institute (PMMI; Arlington, VA), endorses techniques already embraced in European standards, providing harmonization. It is the only U.S. safety standard specific to packaging machinery, and can be downloaded for free at www.pmmi.org.

Significantly, the document calls for risk assessment and hazard identification to be the primary tools in safety analysis. It calls on manufacturers to eliminate as many "dangerous parts and conditions" as possible during the design process. If any such things cannot be eliminated practically, the appropriate safeguards and warning labels need to be put in place. To determine what is appropriate, the designer should study operator and maintenance personnel activities required for normal operation, changeover, setup, and routine maintenance. Safeguarding should be done in accordance with 29 CFR 1910.147, 29 CFR subpart O, and ASNI/ASME B151.1, and preferably also with OSHA (Office of Safety and Health Administration) publication 3067. Warning labels should comply with ANSI Z535.4. In addition, buyers must be notified of any significant residual risks that have not been eliminated by design and should be informed of any safe working procedures, training requirements, or personal protective equipment that should be used.

The standard is written so that it can be used by anyone involved in the broad spectrum of packaging equipment, but the document can also serve to identify the most specific of problems and hazards, says consultant Fred Hayes of Hayes & Associates Inc. (Marshall, MI), secretary to the PMMI Standards Committee, which was responsible for revising the document.

"As new technologies come in, new hazards come with it, and standards are always behind the curve," he says. "With risk assessment, you can reach your correct goals and acceptable levels of safety regardless of what you face."

The technique also gets end-users involved and improves communication between vendor and customer, Hayes says.

"As part of risk assessment, the users must give the builders information on how they intend to use and staff the machine," he says. "All of these interactions between people and machines present potentially hazardous situations. The more of them that are known by the builders, the more it will help them address any hazards. The process side of the drug business employs risk assessment, so it makes sense for it to filter down to the machinery side."

Maria Ferrante, PMMI's director of technical services, agrees. "Because today's machines tend more towards customization, there has to be some evaluation of each machine as [it is] designed for each customer," she says.

John Herman, operational excellence manager for R. A. Jones & Company, Inc. (Cincinnati), says he collaborates closely with customers because, "while the safety standards we use set a foundation, some customers want to exceed standards in terms of safeguarding, and others may question the extent of selected safeguarding applications. So we often deal with customer safety needs on a case-by-case basis."

The risk-assessment technique also makes sense for vendors who want to market their equipment globally, Ferrante says. "By doing hazard analysis and risk assessment, you are meeting a lot of the requirements of the European standards," she says.

Bahr, who served as chair of the PMMI Standards Committee, notes that many customers "lean toward specifications that are reminiscent of or mirror [European] standards in terms of safety. For a large multinational company with a European presence that wants equipment standards to be universal across the globe, the [European] standard becomes a key element in its safety specification development."

Those European standards include EN 98-37-EC, the Machinery Directive; EN 292, "Safety of Machinery": and three specific to packaging machinery, EN 415-2, "Pre-formed Rigid Container Machines," EN 415-3, "Form-Fill-Seal Machines," and EN 415-4, "Palletizers and Depalletizers." Closely tied is ISO 12100-2, "Safety of Machinery."

Some manufacturers take their safety cues from other sources, which range from the National Electric Code to OSHA. But whatever the procedure, all say they make sure to follow it rigorously. "It is a very big priority," says Wilhelm Bronander III, president of Scandia Packaging Machinery Co. (Clifton, NJ). "Customers are most concerned with the safety of their workers."

Response from the end-user community to the new ANSI/PMMI standard has been overwhelmingly positive, Ferrante says, because it allows manufacturers a close look at their process.

"Not only does it mean there will be safer machines over time, but when you go through the risk-assessment process, you can also see ways to become more cost-effective and increase productivity, because you are evaluating each part of the machine," she says.

PMMI will be publishing a guide for machinery manufacturers and end-users on how to go about doing risk assessment. It held a seminar on the subject in July; a Web cast is on-line at www.seminarsource.com.

INTERNET RESOURCES

The Internet is becoming a more prominent tool for doing research before the purchase of a packaging machine, and safety information can be part of that research, says Edward Bauer, vice president of industry relations for Packexpo.com (Fairfax, VA). Some vendors may list the safety standards they follow on their Web sites, "though often [the information is] implied. PMMI manufacturers work very hard to meet all standards that might be out there."

Jim Moretti, chief financial officer of NJM/CLI Packaging Systems International (Lebanon, NH), says the Internet can be used to "put more emphasis on safety, in the written material, for the end-user. We feel that this is just one of the expected requirements of being a first-class, quality supplier and employer."

"Safety standards are a major component of our machine design and are discussed in all of our literature and on our Web site," says Joel Fener, vice president of TechnaSeal (Livermore, CA). "It is of the utmost importance. You must look at yourself in the mirror every morning and know that what you're putting out [there] on the market is safe."

INTEGRATION AND TRAINING

There are a few other principles that vendors and users should keep in mind. One is that when machines are being integrated into a line, it is most crucial that safety issues be addressed overtly.

"A lot of users don't realize that when they buy three machines and then put them together, they become a builder," Hayes says. "We need to make them aware of that."

"As you do more integrated lines, that is when safety-logic kicks in," Hartwig explains. "For example, when you put an E-stop on a machine, should it stop the machine or the whole line? That's a question each company has to answer."

It is also paramount that the vendor play some sort of a role in operator training. "Training is a key aspect of any overall safety program," says Dave Schuh, vice president of sales and marketing for MGS. "If you're not in the position to offer training support, you're not [acting as you're supposed to] as it relates to safety. Part of our value-added process on every order we execute includes helping customers understand the safety process and practices they should follow in the operation of their machinery."

CONCLUSION

As technology evolves, so will safety requirements, and suppliers and end-users will need to continue working together to make sure everything moves at the same pace.

"I think this industry does a very good job with safety. You don't see many accidents," Hartwig says. "Interlocking guards, E-stops, and the like are all expected in our industry. It's like Ford or GM saying 'our cars come with a spare tire.' "