Sourcing Packaging Machinery
by Michael Semiraro
Selecting a machine to help produce a product is a simple task when one knows what questions need answers.
Obviously, the machine must meet the needs of a product application in terms of size range and output requirements. Once this is determined, there are a number of questions that need to be identified and then answered. They include:
- What is the quality level of the products the company produces (low, medium or high)?
- What is the skill level of the company's operator and maintenance personnel?
- What would give the company a competitive edge?
- What is the market trend in similar industries?
- Does the product need to comply with any regulatory organizations?
- How can one determine if the equipment supplier can meet all company and product needs?
[There may be more questions, but let us concentrate on the six points listed. They will allow us to focus our attention on a company's present needs, market trends, and future demands.]
Determining Quality Levels in Machinery
When selecting a manufacturing machine, you may find that product quality is low, medium or high, based on consumer needs. Case in point: how sterile must a filling machine be to fill plastic bottles with engine oil? The answer--not sterile at all--indicates that lower quality equipment can satisfy this packaging requirement.
Now, let us change this fill product to cooking oil. Suddenly the equipment selection landscape changes considerably--therefore, the quality of the machine must be stepped up a notch. Consider finding a more focused machine supplier whose core business is geared toward meeting the demands of food and drug products.
Next, you must determine the degree of sophistication. Machinery for producing a given product can range from a high to low degree of sophistication. In many cases, today's highly sophisticated machines can be operated and maintained by personnel with lower skill levels. This creates a trade-off situation. Consider this: Should a company purchase a more sophisticated (and usually more expensive) machine that requires less cost dedicated to machine operation, or should it purchase a less expensive but more labor-intensive piece of equipment? No matter which route is chosen, the machine supplier should have a good service organization, complemented by a readily available inventory of spare parts.
Finding A Competitive Edge
What gives a company the competitive edge? Could it be what its customers observe when visiting the manufacturing facility? What would impress them the most: adherence to the company's SOPs? The machines used to produce the products? Statistical data maintained on a per-batch basis to insure repeatable and consistent products?
Complying with standards that can be validated is the key to answering these questions. It is always good to have a strong working knowledge of manufacturing standards [normal operating procedures] utilized in similar industries. Compare and contrast them with the manufacturing standards in your industry. This tactic is common in the nutraceutical and pharmaceutical business arenas and may help you determine which standards you need to meet or exceed.
Pharmaceutical companies have already felt the pinch as more consumers purchase dietary supplements and natural products to "self-medicate." The argument presented to their shareholders is that this trend is an addition to chemical formulation. However, it is actually due to a reduction in chemical formulation (thus, a reduction in market share).
Often, pharmaceutical companies' shareholders are told that the recipe for continued growth is through acquisition or start-up of a nutritional products group within the parent company. This will bring regulatory compliance to the method in which natural products are produced.
An example of this is evident in label identification of ingestible products. The number two reason for product recall is misidentified product. Therefore, validating a label application must be in the foreground when selecting a labeling machine. In the event of a missing expiration date or lot code on a label, it is not good enough to merely have the machine send a signal for an automatic rejection of that product. The labeling system must also verify whether the faulty product was, in fact, rejected, or if the machine must stop and signal for operator intervention.
Ensuring Validation Compliance
There are many other critical check devices that must be considered in order to validate a control system. Those devices could include bar code scanning, optical character verification (OCV) [also known as a vision system] and unlabeled container detection. Documentation that proves each critical check device has been tested and is functioning correctly must accompany each labeling machine. It is imperative that each labeling system has a machine-specific validation documentation package that includes, as a minimum, application notes, machine validation master plan, software quality procedures, pre-delivery inspection protocols, installation qualification protocols and operational qualification protocols. Having these in place ensures a high degree of control, which in turn helps ensure reliability of the production operation and consistent performance. Material used to package the product is also documented to support repeatable performance. Product details such as container size and material, label size and material, web size and material, and pressure-sensitive adhesive specifications should be well documented for additional product control.
Validation compliance of a machine must then be considered through all phases--from the machine design phase to manufacturing to the Factory Acceptance Test. With this kind of attention to detail, production control of packaging elevates natural products and dietary supplements to a higher class of quality. However, this requires high quality/low maintenance equipment to yield consistently good product. With this kind of equipment, companies will see increased customer confidence in their ability to produce reliable products. A company that adheres to these standards should reap the rewards of continued growth.
Michael Semiraro is the vice president of operations at Newman Labeling Machines Inc., www.newman-machinery.com.