Medical Device Facility Cleaning

We make sure your facility and your reputation are spotless.

Source One specialized cleaning for medical device facilities.

Maintaining GxP compliance in medical device facilities requires a high level of attention to detail and adherence to strict safety and cleaning standards. Professional cleaning and sanitation services are the key to staying compliant and achieving great results. That means cleaning done by a company that is ISO- and GMP-certified. 

“So generally medical device facilities have gone through an ISO certification, so they’ll look to their janitorial service to provide them with an ISO certification.”

– John Nigro, SourceOne

That’s Why You Need SourceOne on Your FM team.

A closeup of a medical monitor in a hospital setting

Cleanroom Cleaning is a Big Deal.

If your facility makes medical devices, you are subject to comprehensive regulations from the FDA designed to ensure cleanliness throughout the manufacturing process. (eCFR :: 21 CFR 211.56 — Sanitation.)

You’re going to need fully documented procedures (SOP), and documented proof that the procedures have been followed meticulously. The cost of non-compliance can be severe…from lost productivity due to remediation work to a complete shutdown of a facility.

Our Cleaning Specialists Receive Classroom and Rigorous Hands-on Training.

Your SOP sets the standard. But documents don’t clean facilities, people do. It’s up to you to make sure that the people who do the work can meet your standards and be compliant with FDA regulations.
At SourceOne, we place special emphasis on having a certified team that undergoes comprehensive training in clean rooms and controlled environments.
Before they step foot in any medical device facility, our employees have classroom experience and hands-on instruction. They’re also going to be trained to your specific SOP.
That’s how you know the cleaning and sanitation work will be done to your standards and FDA standards with accurate legible work logs.
For us, it’s the only way to ensure that your facility will always meet standards and stay productive.

We Know The Questions to Ask. We Know Where The Problem Areas Are.

We’ve been at this a while now and when needed, we solve problems. We’re resourceful and innovative. When Covid-19 hit, we developed intensive protocols so that facilities could remain open and do their essential work.

More about our Covid-19 solution

At the beginning of the COVID-19 outbreak in March 2020, SourceOne quickly designed a plan for our client to keep their employees safe and their facility open.

We proposed our Healthy Covid-Cleaning ProtocolsTM   program which includes a dedicated SourceOne technician to disinfect high-traffic areas and critical laboratories.

Together, we worked with our client to identify a list of high-touch surfaces and potential high-risk areas. SourceOne performed the day/night disinfection 6 days a week, in 6 different buildings. This included electrostatic spraying in high-risk areas such as conference rooms and bathrooms at night.

The result was a substantial decrease in Covid-19 cases.

Put Our Depth of Cleaning Knowledge, Experience and Expertise to Work at Your Facilities.

Whether you have a small research operation or a large production facility, you can count on SourceOne to deliver ISO-and CGMP-certified cleaning. Our attention-to-detail and thorough documentation truly set us apart in medical device facility cleaning.

We can tailor a cleaning schedule to your SOP. We can be your daily go-to or supplement your own team as much as you require.

Discover the SourceOne difference.

    Medical Device Facility Cleaning Consulting

    We offer newer facilities and start-ups resources and comprehensive consulting on required cleaning processes and procedures to ensure their compliance and for maintaining proper containment, sanitation, and waste disposal.

    Ongoing Maintenance Programs

    We develop customized maintenance programs tailored to your specific needs, ensuring consistent cleanliness and compliance throughout your facility.

    Let’s Take a Deeper Dive on Cleanrooms.

    SourceONE is your go-to choice for medical device cleaning and sanitizing services in San Jose. Our staff is made up of experienced professionals who specialize in deep cleaning and sterilization, ensuring that your medical devices are safe and properly sanitized to prevent any potential contamination. Contact us today for a customized quote for all of your medical device cleaning needs!

    Cleanroom Maintenance

    SourceOne provides secure contamination control from ISO 3-ISO 9, using ISO-compliant and GMP quality programs and environmentally friendly and sustainable solutions. 

    Microbial Control and Diversity

    Cleanrooms are traditionally designed to minimize microbial contamination. However, recent studies have revealed a diverse range of microbes in cleanrooms, challenging the assumption of a completely sterile environment.

    While cleaning efforts reduce the abundance of microbes, they do not significantly impact the diversity. Archaea, including survival specialists like bacterial spore formers and halophiles, have been found alive in cleanrooms.

    Temperature, Humidity, and Atmospheric Pressure

    Cleanrooms must meticulously control temperature, humidity, and atmospheric pressure levels. These factors are critical for maintaining consistency, reliability in test results, and minimize particulate contamination.

    Antibiotic Resistance and Cleaning Practices

    Stringent cleaning practices correlate with the emergence of antibiotic-resistant microbes. This poses challenges for containment and potential economic losses.

    The Benefits of Hiring SourceONE

    When it comes to commercial cleaning in the Bay Area, you want a janitorial company that you can trust will provide you with the highest quality services. Here are a few reasons to choose SourceONE

    industrial cleaning experience

    Experience

    Having been in the industry for over two decades, you can rest assured that we know what we are doing and will leave your facility spotless.

    comprehensive cleaning service

    Comprehensive Services

    Whether you have very demanding needs or just require standard cleaning, we will get it done. From building maintenance to cleanroom services and beyond, we can help.

    Dedication to Quality

    Dedication to Quality

    We have incredibly high standards when it comes to the quality of the work that we provide. We make sure to only hire the best and make sure that we assess the work of our employees so that your expectations are not only met but are exceeded.

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    Green Cleaning

    We are committed to helping the planet in any way that we can, which is why we are a leader in the environmentally-preferred green cleaning industry.

    Why Green Cleaning Matters.

    For decades, cleaning products have relied on a potent cocktail of chemicals to combat dirt and grime. However, these very chemicals, designed to sanitize our surroundings, often end up poisoning them instead. Volatile organic compounds (VOCs) commonly found in cleaners pollute indoor air, contributing to respiratory problems, allergies, and even cancer. They also leach into waterways, disrupting aquatic ecosystems and jeopardizing sensitive species.

    These traditional cleaning products, made with harsh chemicals and pollutants, pose multifaceted challenges. Despite their surface-level efficacy, these chemicals infiltrate indoor air, jeopardizing employee health and compromise indoor air quality. Moreover, the production and disposal of these products contribute significantly to environmental degradation.

    The pervasive use of these chemical-laden products in office spaces exacerbates health concerns like respiratory issues and allergies among employees. Too often, a result of their disposal is harmful residues seeping into ecosystems, furthering environmental concerns.

    And the environmental toll doesn’t stop at the product itself.

    Manufacturing and transporting traditional cleaning products require significant resources and fossil fuels, further adding to the carbon footprint. And then there’s the problem of plastic packaging that ends up in landfills or our oceans after a single use.

    A person's hands using a spray bottle to clean a surface, with a fine mist in the air and a microfiber cloth, demonstrating thorough disinfecting procedures.

    We Take Documentation Very Seriously…a Case Study.

    Good Documentation Practices (GDP) are the measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original, and accurate. 

    Compliant documentation builds confidence in the quality assurance system and practice. GDP ensures there is traceability in what is being documented. This process is useful for reviews and investigations. A reduction in assumptions/second guessing around procedures that are carried out by the SourceONE team is also a result of this process. Effective documentation practices provide consistent quality, performance of staff, and specifies clear instructions on what has been accomplished with the controlled environment.

    Poor Documentation Practices Include: 

    • Missing signatures and dates at the time an activity was performed
    • Non-uniform date and signature
    • Activities performed on one day and signed for on another day.
    • Illegible handwriting
    • Too many corrections & missing reasoning within corrections
    • Spaces being left blank and using white out or other masking devices

    One of SourceOne’s Life Sciences clients come to us because of continual issues and lapses in GDP (Good Documentation Practice) including missing entries, improper entries, and corrections. 

    SourceONE addressed this by providing retraining on how to properly review logbooks. The client’s Quality Assurance team created a GDP tracker where all errors found on client-controlled logbooks and corrections made in logbooks are recorded to increase visibility into site documentation. Together, we created a QR code that supervisors can use to track a procedure to review client logbooks and perform any corrections. The QR code acts as a supplement to training.

    Following the implementation, the clients noted a significant reduction in GDP errors.

    At SourceOne, our focus is always on ensuring that your established processes are failsafe to keep your site production capable.

    Pharmaceutical FAQs

    WHAT TYPES OF LIFE SCIENCES FACILITIES DO YOU WORK WITH?

    SourceOne focuses on the Life Sciences industry with specific focus on biotechnology, pharmaceutical, and medical device laboratories (R&D) and manufacturing facilities.

    WHAT MAKES YOUR LIFE SCIENCES SERVICES DIFFERENT FROM OTHERS IN THE INDUSTRY?

    The nature of Life Sciences work creates serious challenges for facility managers due to the need for high standards of cleaning required to combat contamination from bacteria, mold and virus. 

    HOW DO YOU TAILOR YOUR FACILITY MANAGEMENT SOLUTIONS TO MEET OUR NEEDS?

    We begin with an assessment to determine the standards and protocols required to achieve the appropriate level of cleanliness for your specific facility. This includes ISO cleanroom standards and BSL (Biological Safety Levels).

    WHAT IS GMP CLEANING?

    GMP stands for Good Manufacturing Practices which is a system that consists of processes, procedures and documentation that ensures products are consistently produced and controlled according to set quality standards. Implementing GMP cleaning protocols can help cut down on losses and waste. Overall, it protects both company and consumer from negative safety events.

    WHAT TYPE OF TRAINING DO SourceOne GXP TECHNICIANS RECEIVE?

    Your SourceOne team undergoes comprehensive training and thorough classroom and hands-on instruction in cleanroom and controlled environment practices, tailored to the unique needs of life science facilities including biotechnology, pharmaceuticals, and medical devices.

    WHAT ARE THE CHALLENGES IN GMP/GXP CLEANING?

    Biopharma products demand a strict stand against contaminants of all types. Additionally, in the ever-evolving realm of biopharma, where new innovations emerge frequently, GMP cleaning remains the consistent foundation ensuring product and worker safety and efficacy.

    WHAT IF I DON’T YET HAVE AN SOP?

    If you are launching a new Life Sciences venture and need to develop a cleaning and sanitation SOP, we can provide consulting services that include an audit of your facility and operations. Together we will build a detailed cleaning plan that conforms with all necessary ISO/GMP procedures and protocols, along with Good Documentation Practice log books.

    SourceONE Building Maintenance

    Life Science Facility Cleaning

    When it comes to pharmaceutical and biotech cleaning, we take quality control very seriously. Each of our cleaning technicians undergoes extensive training in order to join our team and is always briefed on facility protocols and procedures before each job.

    Commercial Janitorial Cleaning

    We provide the most reliable janitorial services in the Northern California area to help you ensure that your work area is immaculate. Learn a little bit more about the commercial cleaning services that we offer and make sure that you contact us today to get started!

    Industries Served

    SourceONE focuses on clients where the quality of cleaning, safety, maintenance, and appearance is critical to the basic function of the establishment. We serve a wide variety of market sectors, including the following, with our vast expertise and superior quality.

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    Contact SourceOne

    SourceONE Building Maintenance, Inc. Corporate Headquarters

    2974 Scott Blvd.
    Santa Clara, CA 95054

    Phone: 408-437-3046

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    Whether you run a biotech research lab, a pharmaceutical manufacturing plant, or a medical device testing lab, you face specific challenges, standards, regulations and protocols for maintaining a safe, sterile environment for your scientists and technicians.

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    The pursuit of excellence in healthcare begins with maintaining clean and hygienic spaces where drugs are manufactured, tested, and packaged.

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    This is one area of business operation that demands quality control, which is exactly what SourceONE’s laboratory cleaning services provide.

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    With our meticulous approach and advanced cleaning techniques, we offer peace of mind, knowing that every medical device is thoroughly sterilized and free from contaminants.

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