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The Risks You Run Without Proper Cleanroom Cleaning Processes in Place

Sep 7, 2018 3:31:10 PM / by The Pegasus Team

Having a cleanroom cleaning process in place is incredibly important. After all, it’s not much of a cleanroom if it isn’t clean! Beyond that, the state of your working environment impacts all facets of business operations. From your employees to your consumers, from your reputation to your bottom line, proper cleanroom cleaning is of paramount importance for any company that produces products in a controlled environment.

You should not rely on your employees, your janitorial staff, or even a cleaning service to know the nuances and requirements for cleanroom cleaning. You need to have a process in place. Without a proper cleanroom cleaning process, you run the risk of violating the industry’s contamination control, maintenance, and safety regulations.

Furthermore, to increase your employees’ morale and productivity, you need to ensure they are safe and healthy. To limit operational costs, reduce accidents, and minimize product defects. The bottom line is regardless of your business’s revenue; you can’t afford to have anything short of meticulous cleanroom cleaning processes in place.

Pain Points Caused by Improper Cleanroom Cleaning Processes

Here are some specific issues you will likely face if your cleanroom cleaning process is anything short of professional and authoritative:

  • Improper Cleaning
    You may think having your janitorial staff tackle cleanroom cleaning is a good idea. After all, cleaning is what janitorial staff does, right? However, cleanroom cleaning is very different from typical janitorial duties. Similarly, a standard housekeeping or cleaning service will not have the skills or knowledge necessary to keep your cleanroom compliant with industry regulations. Again, you need professionals trained and certified in comprehensive decontamination and aware of all regulations, or the job won’t be done properly.

  • Failed Audits and Quality Checks
    A major tenant of a proper cleanroom cleaning procedure is quality management, which includes definitions and measurements of quality. Once the quality is defined, inspectors measure the state of the cleanroom against that definition and help manage the cleaning services to continue hitting the mark for quality standards. Without these quality checks and management, you won’t know where you stand until an audit is conducted. If you fail that audit, you’re in trouble. You need to stay on the ball by knowing whether you’re meeting regulations at any given point in time with proper quality management from certified professionals.

  • Critical Failures
    Other non-pharmaceutical manufacturers, like those that produce robotics or electronics, may have more lenient standards, but they still have strict regulations. For example, a high-tech company producing microchips cannot have so much as a speck of dust on the chip or the chip may malfunction. These companies don’t have to produce the full paper trail like pharmaceutical companies and perform their own internal checks and, if the product works, it ships. But, the tiniest blemish can tarnish the product, so standards must still be held high internally. No matter what type of cleanroom you have, you need professional help keeping it compliant with regulations.

  • Lost Money
    Any product that is contaminated needs to be scrapped and restarted. This means the cost of the raw materials and labor used to create the product was wasted. Having to start over also means delayed production time, which gives competitors an advantage. Contamination issues can also threaten a company’s International Organization Standardization (ISO) certification, and without that certification, many consumers won’t purchase the product. At the end of the day, any contamination issues are costly, and the best way to avoid those issues and save money is to ensure you have professionals keeping up with your cleanroom cleaning.

  • Improperly Utilized Employees
    If you hold your cleanroom employees responsible for keeping the cleanroom clean, you’re asking them to perform tasks that are outside of their typical job responsibilities and for which they aren’t trained. While some employees may be natural team players who are willing to jump in anywhere, you’ll likely run into a few who will carry a chip on their shoulder because of the extra work — and you can’t fault them for that. You’re asking them to do something they truly aren’t qualified to do. Additionally, using your own employees means managing them as well. In a time when human resources are scarce, you don’t want to pull yourself or your employees away from their core responsibilities. You need to hire credentialed professionals to keep your cleanroom clean, not rely on existing staff to take on the extra work.

This list of issues you may face without proper processes in place is by no means extensive. You could be sabotaging the reputation of your brand. You could be putting the health and safety of employees in jeopardy. You are putting the health and safety of consumers in jeopardy. The dangers are vast, so what are you waiting for? Update your processes and get in compliance today!

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Now that you know why you need a proper cleanroom cleaning process in place, the next step is to actually start the process. As this article has mentioned time and time again, your best bet is to hire third-party professionals. Seek out an organization that exists solely to deliver high-quality, innovative cleaning services that meet your specific needs. Find a company that understands how critically important it is to prevent and eliminate contaminants in your controlled environment. Ensure the company you hire follows ISO guidelines. Your due diligence will ensure that you partner with a company that does theirs.

You Need a Cleanroom Cleaning Company That:

  • Has knowledge of general cleanroom protocol, regulations, safety (MSDS, HAZMAT, and OSHA), terminology, and theory

  • Understands the types and classifications of controlled environments, including FDA and GMP requirements

  • Has a grasp on what effect people and movement have within controlled environments

  • Is familiar with appropriate cleanroom apparel for each environment

  • Can demonstrate proper gowning and gloving

  • Knows about entries, exits, tacky mats, air showers, and pass-throughs

  • Understands the types, uses, and care of cleanroom cleaning equipment, supplies, and chemicals

  • Knows when, where, and how to use different chemicals

  • Knows the different requirements for cleaning particle and aseptic environments

  • Is familiar with the standards for communicating, reporting, and logging activity

  • Is familiar with dwell time protocol, recording, safety, directional cleaning (based on the setup of the room and its airflow), and the nuances of cleaning horizontal versus vertical surfaces and ceilings

  • Is committed to frequent and ongoing monitoring of work performance, reviews, and updates

Each member of the team should be able to explain the points mentioned above as well as demonstrate any processes. Cleaning and disinfecting are not the same, and you need dedicated resources to ensure your cleanroom is truly clean enough to comply with regulations, meet guidelines, and follow standards.

If you don’t have those dedicated resources, you’re taking a major risk. From untrained employees who become disgruntled by trying to perform tasks they don’t understand, to janitorial staff who do their best but are also not trained in proper cleanroom cleaning procedures. Morale and productivity will suffer without third-party, qualified resources in place.

Additionally, cleanroom cleaning resources are necessary to help you avoid FDA fines, failed audits and quality checks, and other critical failures. To limit operational costs, stay in compliance with industry regulations, prevent accidents, and increase safety, you must have a proper cleanroom cleaning process in place.

We have a free guide to help you get your cleanroom cleaning process started. You can download it here >>

In summary, your bottom line is directly related to your cleanroom cleaning. Incorrect procedures that cause wasted products are money straight out of your pocket. Don’t throw your profit away. Don’t waste resources. Don’t risk your company’s profitability and reputation. Hire a third-party resource dedicated to and qualified for the maintenance of your cleanroom cleaning today.

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Posted in: Cleanroom

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