Purchasing Nutraceutical Equipment
August 13, 2008
There are many important issues to address when purchasing equipment for a nutraceutical manufacturing operation. First is to figure out what specific equipment is needed. While this may seem obvious, it must be the initial step in the process. In order to choose the right equipment, a company must determine the characteristics of the finished products to be produced. Among the considerations are productivity, size, functionality, electric requirements and available services.
These requirements can be set on a URS (User Requirement Specification) document, which establishes the requested characteristics of the machine. A URS is commonly used by pharmaceutical companies to comply with FDA requirements. The URS establishes the specs to be fulfilled and helps a bidding supplier understand the most important items to deliver. It adds value without incurring cost.
Next is to determine whether there is a preference for new or used equipment. Often, a company makes the choice of buying new or used equipment based on price. However, there are several important considerations. The cost of running a used machine is higher because the equipment is older and less efficient. Additionally, old machines generally require more time to run product. It is also good to know how the machine was used before; if it was used to produce certain pharmaceuticals, hormones or cytotoxins, for example, that could theoretically contaminate production in a new facility. Additional questions to consider include whether the used machine has available manuals, and if they are specific to the actual equipment? Further, were changes were made to the machine, and were those changes validated?
In our experience, used machines require more maintenance and sometimes the spare parts are no longer in stock or are discontinued by the suppliers. Used machinery is no longer covered by supplier warranty, and the technical service to maintain and repair could, in most cases, be more expensive, causing production delays.
In contrast, purchasing new equipment means retaining control and having the opportunity to validate the design of the equipment based on the URS. Most pharmaceutical companies do this, and it can be done for nutraceutical companies; it ensures confidence that the machine is made under specific conditions to perform as required without increase in costs.
Another important step is selecting the right supplier. There are thousands of companies offering the same equipment at a variety of price points; the question then becomes how to choose the right one? Here some suggestions:
Ask for references at companies that purchased equipment similar to yours. Speaking to a final user can clarify the machine’s capabilities.
Ask to witness the actual performance of the machine to verify the machine functions accordingly to URS requirements with actual product.
Several companies offer to perform the FAT (factory acceptance test) in order to verify that the machine performs as expected. This is crucial in order to have official evidence that your machine meets the quality required.
Request verification that the equipment complies with cGMPs (current good manufacturing practices).
Does the company offer all necessary documentary requirements?
Is training included with the purchase?
In case of breakdown, how long does it take to have spare part(s) delivered and to repair? Are spare parts kept in stock and available at a reasonable cost?
Take the time to select a company that also offers adequate service post-sale. This is an important matter, because some changes or questions could be required after the machine is installed. For example, if the equipment needs to be customized for another product, to address capacity increases, and/or changing certain operation conditions.
Purchasing equipment is a costly endeavor for a nutraceutical manufacturing operation. Vetting suppliers adequately in advance, and working in partnership to ensure both parties understand the requirements of the transaction can ensure long-term success.
Greta Vega Orozco is a validations manager in pharmaceutical machinery sales with CIMA Industries (CIMAindustries.com), a leading supplier of analytical lab, manufacturing and processing equipment to the pharmaceutical, nutraceutical, food supplement and related industries. Asset Crossings and Keith Machinery are the U.S. sales and marketing agents for CIMA Industries.
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