Choosing the right equipment for pharmaceutical manufacturing is a lot more complicated than picking out a washer and dryer in the household appliance department. Not only do mechanical processing needs vary, but so do sanitary requirements.
Each year, Americans consume about 425 billion pharmaceutical products. Sanitary problems during manufacturing potentially affect millions of people. So it’s extremely important that companies meet or exceed the guidelines established by the government and professional organizations.
Unfortunately, the guidelines are, of necessity, rather general. It’s up to manufacturers to make sure the quality and effectiveness of their products live up to the highest standards. Individual pharmaceutical producers can fill the “gap” between guidelines and standards by setting their own hygiene requirements, including those for the instrumentation they purchase and use.
When it comes to instrumentation, three categories help define how critical sanitation is in producing pharmaceuticals: high-, medium- and low-sensitivity environments. It sounds simple, but it’s only the basis on which to build a much more comprehensive approach to hygiene. And a lot of the construction work has to be done by individual companies.
Going beyond the limits of regulations and guidelines
Of the factors affecting how pharmaceutical companies meet sanitation standards, perhaps the most important are the U.S. Food & Drug Administration requirements; the industry’s Current Good Manufacturing Practices and the bioprocessing equipment standard established by the American Society of Mechanical Engineers.
But even with all this regulation and guidance, pharmaceutical companies are, in the end, on their own. Given the kind of processes being used and the nature of the product and its ingredients, what specific hygiene requirements must be met, and how can the choice of equipment used in each environment help in meeting them?
For example, the presence of “niches” where pathogens and other contaminants can hide and multiply, and how easily and well a piece of equipment can be cleaned, will grow in importance from one environment to the next. The factors affecting these variables can change depending on the product and its processing needs. This formula is not one size fits all. The bottom line is that just following Good Manufacturing Practices and FDA requirements might not be enough to make the right equipment choice.
Getting an assist from the engineers
The American Society of Mechanical Engineers’ bioprocessing equipment standard doesn’t answer all the questions, either, but it offers some solid suggestions for addressing the nitty-gritty details. Thanks to a section added to the ASME’s bioprocessing equipment standard in 2012, have a more comprehensive view of the variables the have to look at.
The following is a partial list of the factors affecting sanitation that come into play when it’s time to choose manufacturing equipment:
- Technology used in the instrumentation
- Surface characteristics, such as design and finish
- Resistance to corrosion (which metal alloy to select, such as stainless steel)
- Nature of surface finishes
- Non-metallic components used
- Where and how equipment will be placed
- Temperature exposures
- Kinds of welds, gaskets and seals
These and the other considerations outlined in the ASME’s bioprocessing equipment standard should lead to better equipment selection if they are:
- Looked at in light of the manufacturing environment and specific products and manufacturing processes
- Viewed holistically as part of the larger manufacturing process
- Implemented with an eye toward meeting both the letter and the spirit of CGMP guidelines and FDA requirements for sanitary production
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