Cleanrooms, Contamination and the Realities of Pharmaceutical Automation – BioSpace

Massive strides in automation have rippled through the pharmaceutical manufacturing industry in recent years, affecting multiple tiers of the drug development process. Quality is easier to control, processes are easier to regulate and product outcomes are more consistent than ever before.

Relative to proportionate industries, however, "the biopharma industry is comparatively behind the times. Although most biopharma companies and some academic labs use liquid-handling robotics to automate parts of their processes, such as high-throughput screenings, robotics have not been utilized to its full potential through the entire process to improve productivity and product quality," according to an earlier Biospace article.

In the cleanroom environment specifically, the benefits of automation are more than meets the microscope.

"Automation as applied to clean manufacturing has two-fold purposes," said Dave Nobile, Technical Services Manager at Contec, Inc. "In general manufacturing, automation is almost entirely to produce products of a quality greater than can be done by hand. Removing the human variation of a manual process in pharmaceutical manufacturing increases value."

In clean spaces, automation has an additional benefit.

"When you take out the human element, you are removing a huge source of contamination from the cleanroom environment. Machinery has been designed for the cleanroom, so it generates far less contamination," Nobile said in an interview with Biospace.

Dave Nobile is no stranger to contamination control. He fell into a part time job in the field back in 1983, then found himself 37 years later in a fully-fledged career. As a mechanical engineer, much of his background involves product development and process design, with an impressive number of patents for cleanroom products.

Today, as Technical Services Manager at Contec, he primarily focuses on customer interface. Nobile and other experts visit facilities in a myriad of industries, taking stock of company goals, then provide solutions that improve contamination control and reduce product quality risks. According to the company website, Contec is the leading manufacturer of contamination control products for critical cleaning and manufacturing environments worldwide. Our innovative wipes, mops, and solutions are used in various industries across the globe.

Naturally, the COVID-19 pandemic has made physically visiting facilities a seemingly distant dream of the past, but Nobile and his team have adapted to restrictions with a few surprising benefits.

"With available technology and growing virtual finesse, both our team and customers have found comfortable ways around a physical visit. With specific planning for any given facility's situation, we can organize virtual tours using both mobile and stationary onsite cameras," he said.

In addition to the convenience of scheduling a virtual tour, users can now have their footage viewed by more than one subject matter expert. "Before, just one expert would visit a facility. Now, our subject matter experts from all over the world can be virtually brought into a tour, integrating knowledge from multiple continents into a customer's provided solutions."

Over the years, Nobile and his fellow experts have certainly witnessed their fair share of common mistakes and challenges in the pharmaceutical manufacturing space.

"The biggest single issue is employees not following their SOPs, or Standard Operating Procedures. In an automated process, tiredness and other factors of human variation don't exist, he said. With people, it's challenging to do the same exact tasks every day, every month, every year. It's a lot to ask of a person. When you compound this with employee turnover, the issue escalates.

Perhaps the most common challenge of pharmaceutical and other manufacturing comes down to employee training.

"Fundamentally, the biggest mistake in any clean room environment is training an operator to complete a task without explaining why it's meant to be done in that way," Nobile said. "If you tell the operator why each step along the way is important, they understand that contamination can be reduced or that quality can be improved with specificity, and it's much more likely that consistent work will be completed. The why is massively important, not just the what."

Regardless of whether a cleanroom is operated mostly by humans or machines, some level of contamination is to be expected.

"When a cleanroom is originally constructed with no activity, numbers will show that it's perfectly pristine. As soon as you start bringing in equipment, however, the potential for contaminants is introduced. Every piece of equipment will generate contaminants. Introduction of anything in the clean room interrupts air flow," Nobile said.

"As soon as people are introduced, there is an entirely new level of contamination. People are, by far, the most contaminating presence in the cleanroom, Nobile said. In pursuing cleaner and cleaner environments, in-depth studies have shown that whether sitting still or walking vigorously, talking or coughing, the contaminants a person sheds in just the natural act of existing is a far greater contaminant than anything else."

With this being said, removing human operators from the cleanroom certainly reduces the risk of contamination, but will not eliminate it entirely.

"When you automate a process from the equipment perspective, you employ disposable, single-use components for maintenance, Nobile said. There are requirements for specific use and handling when taking machines apart and putting them back together in order to keep the rest of the process clean and functioning. Thus, people are not completely removed from the operations, and new considerations with robotics arise.

In addition to this, full automation in pharmaceutical manufacturing is much less realistic than it has proved to be for other industries.

"Back in the 90s, for example, semiconductor manufacturing really strove to remove the human element," Nobile said. "25 years ago, a manufacturer had nearly 600 people in a cleanroom. Today, you may have as few as 50. Investments were made into automated equipment, utilizing robots in completely sealed and separated manufacturing cells. The cleaner environment leads to greater product quality."

"It's been more difficult to automate pharmaceutical processes due to the constant evolution of manufacturing procedures. Any operation requires stability for automation. For example, tablet manufacturing has remained stable for the past couple of decades, making automation realistic. In pharmaceuticals, there's a lot of hand manipulation due to the novelty of the processes, he said.

Above all, Nobile wants end users to be informed of the immense and valuable resources that are available to them.

"If end users could see the available resources, equipment, and products from companies and manufacturers who are not just ready, willing, and able, but have a vested interest in helping them, their product outcomes would improve greatly, Nobile said. Generally, at no cost to the end user, there are very conscientious, dedicated providers in every field who can help improve processes, remove contaminants, and provide assistance. Patient health and safety depends on it."

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Cleanrooms, Contamination and the Realities of Pharmaceutical Automation - BioSpace