Pharmaceutical and Medical Packaging News Magazine

Originally Published December 1998

PHARMACEUTICAL

How to Buy Packaging Machinery

Buying decisions require continuous communication—even with staff not directly involved.

by Erik Swain, Senior Editor

Buying pharmaceutical packaging machinery is not a decision that should be taken lightly. Because of the costs involved, the complexity of today's machines, and their role in getting a product to market, users cannot afford any purchasing mistakes.

The hardest and most important thing in the purchasing process, say people involved on all sides, is not the engineering or the fabrication, but rather communication among all parties. No detail is small enough to ignore, and early omissions of information can lead to the purchase of a machine that doesn't meet user requirements.

Some vendors, consultants, and end-users have developed guidelines for what to do at each stage of the decision-making process, whether for purchasing a single machine or an entire line. Following are some of their recommendations.

GETTING STARTED

At the beginning, machine end-users must assess their needs by determining the most basic elements, such as drug formulation and packaging format. Production capabilities, such as line speed and package sizes, and the space and environment needed for machinery, must also be considered.

"With any new machine, you have to ask what is upstream and what is downstream," says Paul Ellis, senior engineering manager of packaging at Bristol-Myers Squibb Co. (New York City). "There's no sense in putting the fastest machine in the middle, as a line can only go as fast as its slowest feed."

A packaging engineer conducts machine acceptance tests on Doyen's MT 2500 form-fill-seal machine. Photo courtesy Doyen Medipharm Inc. (Morris Plains, NJ); Photo by Art Beaulieu.

Therefore, every detail that could affect the company's ability to meet production requirements needs to be considered. Are utilities capable enough or do they need to be upgraded? Is a room configured for L-shaped, U-shaped, or straight-line machinery? Is there any existing equipment that will be used as part of the line, and how will it affect new machines? Is product changeover an issue? What safety, sterility, and cleanliness concerns are involved? What are the regulatory requirements for the production of the product? There are dozens, maybe hundreds of considerations. "You must be aware of the latest standards the product must conform to and define the performance criteria in hard numbers," says consultant Fred Hayes of Hayes & Associates Inc. (Marshall, MI). "Pertinent codes and standards are changing all the time."

Every relevant department, from production to engineering to maintenance to financial, should be asked for input at the earliest stage. If someone who was left out of planning chimes in with a demand when fabrication is under way, serious and expensive delays could occur. Even staff not directly involved with packaging must be consulted. "A big problem for some companies is that they do not seriously look at the packaging end of things," says Bradford Smith, vice president of Modular Packaging Systems Inc. (Pine Brook, NJ). "If they buy the wrong equipment, it can cause bottlenecks in production. And even if the equipment is proper but the space is not, it still won't work. Certain things are physically impossible in a 10 X 35-ft space."

Finances must be considered during this stage, as return on investment is an essential statistic for many end-users. "Most companies today require some sort of budgetary process before they can decide if they can afford what is required," says Jeff Frost, vice president of DT Industries Packaging Group (Springfield, MO). "At that time, a decision will be made on how the project will be funded, i.e., lease, cash, bank loans, etc."

A timetable should be set, and if delivery time is going to be critical, it should be made very clear to everyone involved. Many people have unrealistic expectations because they don't realize that it usually takes a few months from the beginning of the process until the completion of the purchase order, and at least six months from the purchase order to a finished product. If integration or other complexities are involved, the time frame is even longer.

SEEKING VENDORS

Once a company understands its needs, it is ready to contact vendors. The company should start with vendors it has worked with, but it should also consult as many companies as possible that produce equipment that meets assessed needs. Word-of-mouth is one way to find out about vendors, as are trade shows, trade magazines, the Internet, and the Thomas Register.

The first formal contact with a vendor is often with a request for information (RFI), in which one seeks general information about the vendor, such as size, business practices, production capability, and financial condition. Topics might include validation assistance, changeover requirements, utility and space requirements, and manuals. This is the first indication of whether a vendor can meet the required needs or not.

A company in Latina, Italy, installed packaging machinery to handle Maxipime, a cardiovascular drug. Photo courtesy Bristol-Myers Squibb Co. (New York City).

Another thing to ask about is ease of maintenance. If a machine is complicated to run and even harder to maintain, it could affect long-term costs and productivity.

When the vendors respond, the company must convene a panel to evaluate all submissions at this stage as well as future ones. The panel should include a representative from every relevant department.

Vendors who respond encouragingly should then be sent a request for proposal (RFP). This is where earlier research is put to use. The RFP should describe specifically what the machine needs to do and what kind of documentation is required. Enclosing a product sample helps convey needs.

However, it is too early in the decision-making process to supply certain specifics. Engineers should focus on what to build, not on how to build it. Demanding certain kinds of tools or materials could discourage a vendor from sharing ideas on how to do it better or at less cost. "A big mistake is to try to tell the manufacturers how to build the machine," says Ray Johnson, president of Doyen Medipharm Inc. (Morris Plains, NJ). "Tell us what you want in terms of package requirements and machine accessories. Let us apply our best standard, proven technology to meet your requirements. An example would be wiring and electrical components. Any custom request increases the chances of the manufacturer making errors and having difficulty troubleshooting in the future."

SELECTING A VENDOR

When vendors respond, their answers must be evaluated very carefully, not only for what the vendors say, but also for what they don't say. "Read between the lines as to whether the vendor has read the whole specification or just given a standard quote," says Howard Leary, vice president of applied engineering for Luciano Packaging Technologies Inc. (Somerville, NJ). "You can't assume that because they didn't take exception to anything that they actually read the spec. You can go back and ask them item-by-item, or you can ask them to send a letter saying they will be in compliance with everything. Then they will read it."

For those who do list exceptions or offer alternatives, "Have an open mind," Leary says. "Their recommendations are often as good as or better than what you had in mind."

Representatives from Harro Hofliger (Doylestown, PA), which offers highly customized packaging machines, like to ask their customers a lot of questions, says Jeff Shane, vice president of sales and marketing. "We'll ask about what experience they have in handling the product," he says. "They're the experts on that, and they may have learned things we can build from."

Once the choice is narrowed to a few finalists, engineers should check references carefully and possibly even visit sites of companies that are using these vendors' machines. "We keep the communication lines open and encourage them to talk with someone using the machine," says Debbie Johnson, account manager, North America division, Sepha Products (Irvine, CA, and Newtonards, Northern Ireland), which makes blister machines for producing small batches. "But we don't talk someone into something they don't need."

Engineers should then make the decision, taking into account ability to meet needs, resources, references, and cost. Basing a decision on price alone can lead to problems down the road because if the bids are not evaluated thoroughly, the job may go to a vendor who is incapable of meeting requirements, or who is unclear about what they are. Correcting mistakes, especially once a machine is built, can erase whatever savings were achieved earlier.

THE PURCHASING SPEC

The first thing to work on once a vendor has been chosen is the purchasing specification. This will detail what the machine will look like and confirm such things as number and sizes of change parts, electrical classification and voltage requirements, and the materials of parts that will contact products. At this stage, negotiations on all other outstanding issues should take place. This could entail, among other things, price and payment plan, delivery requirements, acceptance-test criteria, and validation responsibilities. Labeling and bar coding details should also be addressed, as they are commonly overlooked. At least one site visit before beginning is essential. "Without the correct specs, the sizing of the equipment could be substantially more than what you need," says Brad Budde, project manager of induction cap sealers for Pillar Technologies (Hartland, WI). That would add unnecessary costs.

"A lot of specs are written in vacuums," says Gene Fuchs, vice president of Genesis Machinery Products Inc. (Exton, PA). "Emergencies and oversights do occur, but look at what [happens] down the line. Changes a customer feels are trivial might cause a headache somewhere else. And that affects time and money."

If the vendor is doing the design work, the purchasing specification should be the basis for the first drawings. If the end-user is doing the design work, the spec should include the first drawings. "You have to look at the shop drawings to see if this is what you really want," says Mark Wilson, pharmaceutical business development manager for O'Neal Inc. (Greenville, SC). "You can approve them, approve them with modifications, or say they are wrong. But they are critical. After you approve them, get a schedule of how long it will take for the engineering time, fabrication, assembly, run-off, and testing time. Have a member of your team expedite the process to make sure they are reaching the milestone dates."

INTEGRATION ISSUES

If the machine will be integrated with those from other vendors, representatives from all should convene to discuss everyone's role. Any consultants or integrators on the project should also be there. At the very least, each vendor should know where the input to its machine is coming from and where the output from it is going. Any details that help implement a smooth transfer along the line, even down to types of conveyors, should be discussed.

An operator inspects packages at a Moscow facility. Photo courtesy of Bristol-Myers Squibb Co.

When many people are involved, it is important to delineate who has responsibility for what, and who should be contacted when. "When a consultant is involved, it must be established early on who the primary contact or contacts will be for the project," says Claudio Radossi, director of sales for MG America Inc. (Fairfield, NJ). "With regard to correspondence, who needs to be copied?"

FABRICATION

Once the engineering plans are approved and fabrication begins, it is still important to stay in touch with the vendor. Experts recommend three to five personal visits to the vendor during the process. With constant communication, minor problems can be dealt with quickly before they become major ones.

Not only should engineers from both sides be in touch, but so should documentation staff, as that is an area that can produce last-minute surprises if ignored.

TESTING AND VALIDATION

When fabrication is done, a factory acceptance test should be conducted at the vendor's facility. This way, bugs that come up can be handled before installation so the vendor won't have to travel to address them. The test should mimic production conditions as much as possible, including using safety measures, though it may be difficult to bring large amounts of product and packaging materials to the site.

It is essential that acceptance criteria be agreed to well in advance. The criteria should be specific and quantifiable, including the number of outputs per minute and the percentage of allowable downtime, if any. "I ask for 15-minute runs at production speed, and it's not unreasonable to expect 100% efficiency for that time, unless there are problems with the material," Luciano Packaging's Leary says. "Don't try to help feed product, because then you don't see what's going on. Just watch and get a good evaluation." It is a good idea to run the machine at all possible speeds and use all possible package sizes.

Also, it helps to inform the vendor about who exactly is coming to the testing session. If validation staff members are attending, the vendor will want to be ready to discuss documentation. If operators and maintenance people are coming, it might be a good time to do some training.

The vendor should also be involved in the installation, and if possible should take charge of the project up until the final connections. Another, longer test should be performed at the site and its parameters should be well defined before the machine is accepted. If a third-party integrator is involved, the machine could be delivered to that site for integration, even though that incurs more freight charges.

While on-site, the vendor should conduct more training and assist with validation if those things are called for in the contract. Before the vendor is released, engineers should ensure that the machine performs to standards, both internal (production and quality control) and regulatory (FDA, OSHA, and EPA).

CONCLUSION

There is no substitute for frequent and clear communication, both internally and with vendors, when buying packaging machinery. Packaging machines and lines are expensive enough as it is. They become even more costly if they don't function according to precise requirements. For a successful project, it is best to think of the interaction among vendors, end-users, and consultants not only as a business relationship, but also as a partnership.