In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production. Every day of production seems to create a day of compliance verification. The most effective way for companies to cope is by standardizing their processes for meeting standards.

There are a lot of processes that need to be standardized. Beyond the common standard operating procedures (SOP), there are protocols to ensure proper setup, operation, and performance of equipment and software. There’s required and verified training for personnel. And there’s setting up restrictions so that only authorized individuals can access a system. All of these processes must be documented, and those documents verified.

For pharmaceutical and medical device manufacturing, these and other compliance chores fall under the Code of Federal Regulations (CFR), a set of guidelines that codify general and permanent rules published in the Federal Register by executive departments and agencies of the U.S. government. The CFR is divided into 50 titles that represent broad areas subject to federal regulation. Of specific importance to pharmaceutical and medical device manufacturers is Title 21, Part 11, which is the U.S. Food and Drug Administration’s (FDA) rules concerning electronic records and signatures. It’s referred to as 21 CFR Part 11.

None of this is news for these manufacturers, since 21 CFR Part 11 has been in effect since 1997. However, advancements in technology have spurred advancements in manufacturing, which in turn have increased compliance requirements to 21 CFR Part 11. And therein lies the news: Olympus’ CIX100 industrial microscope, long considered the go-to instrument for technical cleanliness inspection, has been revamped to help users acquire, process, and document technical cleanliness inspection data to comply with company and international standards.

A reliable workhorse with new features

“We had a lot of customers telling us they really needed the microscope to comply with 21 CFR Part 11,” says Megan Farell, technical sales support specialist at Olympus. “It started coming up quite a bit from the medical device and pharmaceutical industries, and we knew we needed to take action to develop something that would help our customers.”

What they came up with is an inspection system for manufacturers that must maintain high quality standards for the cleanliness of their manufactured components. This routinely involves verifying the cleanliness—down to counting the number of contaminating particles—of components, parts, and fluids that are part of the manufacturing process.

Automation and intelligence

The CIX100 cleanliness inspection system is a package solution that includes the microscope, software, and compliance documents. Among these are 21 CFR Part 11-compliant work instructions for setting up and operating the microscope. A separate validation protocol ensures the validity of the installation and operational qualifications. There’s also an SOP for the CIX100 system that’s in compliance with the regulation.

The documentation, along with the software and microscope itself, enable users to validate the inspection system, provide training, ensure proper operation, restrict access to authorized users, and—in conjunction with Adobe Sign—provide electronic signatures and track inspection reports. Those are a lot of compliance headaches that Olympus has crossed off a manager’s list.

“One of the benefits of the CIX100 is it takes away a lot of the burden our customers would face when getting a new piece of equipment, a new microscope, and figuring out all the documentation and how they can make that equipment comply to 21 CFR Part 11,” says Farell. “This can be challenging because first you really have to know the system and its capabilities. You often have to develop installation and operational qualifications. You have to make sure you have proper training on that equipment, maybe you even need to write a standard operating procedure with specific steps that guide you. The CIX100 system can help you streamline cleanliness inspections and meet compliance with these important FDA standards for electronic records and signatures.”

The microscope’s software offers prompts and guidance when in use, but it also ensures reproducibility for technical cleanliness inspections. The preconfigured and precalibrated system ensures that settings are correct. An automatic workflow minimizes the risk of contaminating a sample or misaligning the system. It automatically counts, measures, and classifies particles in accordance with the selected cleanliness standard.

Finally, for those all-important documents, the CIX100 system’s report function generates professional reports with predefined, compliant templates. There’s also long-term data storage.

“Documentation has become more important as companies have transitioned from paper to electronic records,” says Farell. “What Olympus has done is create a package, basically a road map, for our CIX100 microscope to comply with CFR 21 Part 11.”